Background: US children’s diets are high in calories and are of poor nutritional quality, and a likely contributing factor is the consumption of food from restaurants. While children readily accept the sweet and salty foods that characterize restaurant children’s menus, research shows that their taste preferences are malleable, and regular exposure to healthier foods can promote their acceptance. Objective: We describe a cluster-randomized controlled trial testing the effects of behavioral intervention strategies (choice architecture and repeated exposure) on ordering and dietary intake among children in restaurants and present baseline demographic data for the study cohort. Methods: Six locations of a regional quick-service restaurant chain were randomized to the intervention or control group in pairs based on income in surrounding census tracts. Families with children aged 4 to 8 years were recruited and asked to complete 8 visits to the study restaurant, including a baseline assessment completed at the time of enrollment, followed by 6 visits during a designated 2-month exposure period and a final posttest assessment. Intervention content provided to intervention group families after baseline assessments includes placemats promoting 2 healthier kids’ meals and the opportunity to redeem their kids’ meal “cone token” for a toy instead of a dessert (choice architecture strategies). In addition, participating families receive frequent diner cards, which can be used to earn a free kids’ meal after purchasing a promoted kids’ meal 6 times (repeated exposure strategy). Families in control restaurants receive generic versions of these materials (eg, frequent diner cards that can be redeemed for a free kids’ meal after purchasing any 6 kids’ meals). The primary outcome is the meal ordered for the child at a posttest restaurant visit following the exposure period (ie, whether or not a promoted meal was ordered). Additional order data will include calories, saturated fat, sodium, and sugar content of children’s orders at posttest. Other outcomes include children’s in-restaurant and daily consumption of calories, saturated fat, sodium, and sugar. Results: This study was funded in 2019, with preregistration completed in 2020, data collection occurring from June 2021 to November 2024, and data processing, analysis, and primary outcome manuscript preparation in 2025-2026. A total of 236 families provided baseline data on children’s orders and comprise the study cohort; 234 of these families provided demographic data (n=184, 78.3% female parents; n=133, 56.8% female children; child mean age 6.5, SD 1.3 years). Conclusions: Given that restaurants are normative eating contexts for many children, this intervention has the potential to impact children’s dietary intake and health. If found to be successful, future directions could include scaling the current intervention approach and conducting further effectiveness, implementation, and dissemination research to understand its applicability and impact across different types of restaurants and sociodemographic contexts. Trial Registration: ClinicalTrials.gov NCT04334525; https://clinicaltrials.gov/study/NCT04334525

Background: Mobile health (mHealth) technology is widely used in health care systems globally to improve patients’ quality of life and reduce the burden on caregivers. Mobile apps allow users to manage different health-related situations from their homes, such as self-monitoring their symptoms, keeping track of progress, and maintaining a profile for a particular condition. However, the benefits of mHealth apps are compromised due to a lack of sustainability evaluation. Currently, there is a lack of all-inclusive research that presents sustainability evaluation from economic, social, and environmental perspectives of mHealth and wearables. Thus, it is important to evaluate the sustainability of newly proposed or already in-use mHealth solutions. Objective: The objective of this systematic literature review is to deeply understand and analyze different dimensions of sustainability in the health care domain and identify existing evaluation criteria and frameworks for mHealth solutions. Methods: This protocol was developed following the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) guidelines. A planned and systematic approach will be used to identify, evaluate, and synthesize relevant studies reported in English. We have conducted a systematic search focusing on search terms related to sustainable health care, mHealth solutions, and evaluation or assessment criteria in digital databases of Scopus, Web of Science, ACM, PubMed, PubMed Central, and CINAHL. Results: As of September 19, 2024, preliminary searches have been conducted, identifying 1368 relevant papers that meet the inclusion and exclusion criteria and are eligible for further screening. Conclusions: This protocol will guide the review of existing literature on essential aspects of the sustainability of mHealth solutions and evaluation frameworks. To the best of our knowledge, the proposed systematic review will be the first review to extensively study essential concepts related to defining sustainable mHealth solutions, identifying key dimensions founding the basis for evaluation frameworks, and discussing the existing sustainability evaluation frameworks for mHealth solutions. Trial Registration: PROSPERO CRD42024599333; https://www.crd.york.ac.uk/PROSPERO/view/CRD42024599333

Background: A large number of socio-demographic, economic, environmental, and psychosocial changes have contributed to the epidemiological transition of African countries and fundamentally shifted the primary drivers of health. Cohort studies are essential for understanding and improving population health, but remain scarce in sub-Saharan Africa. Objective: The main objective of the Taabo multi-generational cohort project (Taabo MGC) is to establish a large, regionally representative multi-generational cohort. The cohort will be established within the Taabo Health and Demographic Surveillance Site (HDSS) and used for studying the life-course and intergenerational dynamics of disease in south-central Côte d’Ivoire. Methods: The Taabo MGC focuses on children born between January 1, 2024, and December 31, 2025 in the Taabo HDSS, as well as their parents, grandparents and great-grandparents. Eligible women and their children are enrolled during pregnancy and those not reported during pregnancy are enrolled after the birth. After enrollment of pregnant women biological ancestors of the index child who are still alive and living in the study area are recruited into the cohort. The cohort is expected to enroll at least 3’000 pregnant women and their children, as well as the infants’ fathers, grandparents, and great-grandparents with an expected sample size of approximately 15’000 individuals. To ensure the entire local population is covered in this study, we will also include 100 adults without children in the study. The baseline assessments covers data on demographics, household wealth, tobacco and alcohol consumption, diet, physical activity, health history, quality of life, environmental exposures, depression, anxiety, stress, resilience, obstetric history, birth outcomes, cognitive function and physical performance for elders. We also collect anthropometric measurements, blood pressure, hemoglobin levels and conduct a malaria infection test with all participants. Results: We expect this to become one of the largest current cohort studies in Sub-Saharan Africa. Through the HDSS, we will be able to follow all cohort members over time to verify and monitor survival and general health status. Conclusions: The Taabo MGC is designed to become one of the largest cohort studies in the region. We hope to use this study as a platform for future observational and interventional studies at the local level and contribute to the much-needed evidence base on lifetime disease risk in south-central Côte d'Ivoire and sub-Saharan Africa.

Background: Childhood obesity is a lifestyle-oriented disorder, which may lead to many comorbidities such as hypertension, coronary diseases, increased incidence of diabetes, and metabolic syndromes. Lack of diet control and increased screen time specifically after the COVID-19 pandemic among children and adolescents are the major reasons for this rising global concern. Despite various campaigns being carried out to lessen the rising rates of childhood obesity, the objectives have not yet been achieved. Ayurveda offers a multidimensional modality in managing children with overweight. The purpose of this study is to evaluate the combined efficacy of Ayurvedic medicine administration, diet restriction, and Sun Salutation. Navak Guggulu is a herbo-mineral compound already proven for its antiobesity action. Vachaharidradi Gana mentioned in Ayurvedic classics is a group of herbs, which are Kaphamedohara and Karshana. Ayurveda also emphasizes the importance of diet and physical activities for the treatment of obesity. The interventions together may help in promoting a healthy weight, improving metabolism, and reducing fat accumulation. So, in this study, the efficacy of Vachaharidradi Gana Vati will be compared with Navak Guggulu to treat children with overweight in addition to diet restrictions and Sun Salutation. Objective: The aim of the study is to evaluate the efficacy of Navak Guggulu versus Vachaharidradi Gana Vati along with diet restriction and Sun Salutation in overweight (Sthaulya) children. Methods: A double-blind randomized interventional study will be conducted on selected children with overweight in the age group of 10 to 16 years. They will be equally distributed into 2 groups. The control group will be given Navak Guggulu, and the trial group will be given Vachaharidradi Gana Vati for 90 days. Both groups will be advised of diet restrictions and the daily performance of the Sun Salutation. The study duration is 180 days, with assessment at baseline, followed by every 15 days up to 90 days, and at the end point, that is, after 180 days. Appropriate statistical techniques, such as analysis of covariance paired 2-tailed t test, Wilcoxon signed rank test, Mann-Whitney U test, and multivariate regression analysis, will be used to evaluate the efficacy of the interventions. Results: The study got underway in April 2024. Since participants may begin at any time, our goal is for everyone to be finished by May 2025. Conclusions: This research will be useful to provide new insight into the effectiveness of the Ayurveda pharmacological approach in treating obesity in children. The results will guide evidence-based multimodality in treatments aimed at changing lifestyle behaviors in children with obesity, thus reducing social stigmatization in them. Trial Registration: Clinical Trial Registry of India CTRI/2023/03/051135; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NzgzNzE=&Enc=&userName=

Background: A majority of nursing home residents do not fulfill physical activity guidelines. Many existing interventions to promote physical activity and prevent falls in nursing home residents have low adherence rates, lack theoretical foundation, or require a large amount of time from staff for preparation and/ or delivery. Objective: To describe the rationale, development steps, and implementation approach of the BeStAge app through a cluster randomized controlled trial (cRCT), as well as to provide baseline characteristics of the study sample and discuss possible implications for further app developments. Methods: We iteratively developed a novel, tablet-based mobile application named BeSt Age app that enables nursing home staff to deliver individualized physical exercise training to residents with or without motor or/ and cognitive impairments. The app was designed and developed based on an intervention-mapping approach. A needs assessment was performed, followed by defining objectives, theory-based methods, program development, implementation, and evaluation. We took several steps to ensure that the app was based on a sound theoretical background, as well as results derived from and limitations identified in prior empirical research. For implementation and evaluation purposes, we conducted a cRCT, and results from the cRCT will be used to examine the effectiveness of the app with regard to different outcomes of interest. Primary outcomes among participating nursing home residents are quality of life, fall risk evaluated through two performance-oriented balance tests, and fall incidence. Secondary outcomes include motor performance, cognition, activities of daily living, life space/ physical activity behavior, and fall efficacy, amongst others. Results: 229 older adults from 19 different nursing homes (171 females, 58 males; mean age 85 years) participated in the cRCT. The intervention group (IG; N = 137 from 11 nursing homes) received a 12-week intervention with the BeSt Age app in small, homogenous groups of 5-7 nursing home residents, with two exercise sessions per week, each lasting 25-30 minutes. The control group (CG; N = 92 from 8 nursing homes) received usual care. At baseline, the IG had a statistically significantly larger number of females, participants had a higher body mass index, and more participants rated attending physical activity programs as important; there were no further statistically significant differences between IG and CG. Results with regard to the effectiveness of the BeSt Age app are expected to be published in summer/ fall of 2025. Conclusions: If proven effective, the BeSt Age app may be a viable solution for physical activity promotion and fall prevention among older adults residing in nursing homes, thereby ultimately contributing to maintaining quality of life and overall well-being in this vulnerable population. The app can support nursing home staff in delivering exercise training to residents with minimal additional workload and without requiring specific resources. Clinical Trial: German National Register of Clinical Trials (DRKS00032349)

Background: Families play a pivotal role in shaping children’s emotional development through emotion socialization. However, most research has focused on individual or dyadic relationships, such as those between parents and children, overlooking the more complex dynamics that emerge when multiple family members interact simultaneously. This limited perspective fails to capture the full scope of the interconnected emotional processes within family units. A contributing factor to this gap is the limited availability of models suited for capturing and analyzing complex, family-level data. Objective: The Family and Child Emotion Study aims to address this gap by examining family-wide emotion dynamics across all family members—including parents and children—as they naturally unfold in daily life. Methods: This protocol uses a pre-post design and a 7-day ecological momentary assessment period combined with ambulatory monitoring of heart rate and electrodermal activity within whole family units to examine interactions among mothers, fathers, and siblings, providing a comprehensive understanding of family-wide emotion processes. Data will be analyzed using a network analytical approach, specifically multilevel vector autoregressive modeling, to investigate dynamic emotional processes within and between family members. Results: Funding was received in April 2020. Data collection began in September 2022 and will continue until March 2026. As of May 2025, the Family and Child Emotion Study has collected data from 48 eligible families. Data analyses will begin after March 2026, with results expected to be published in Fall 2027. Conclusions: This study introduces an innovative approach for examining emotion dynamics within whole-family systems in naturalistic settings, offering practical guidance for collecting and analyzing complex, multilevel, and nested data. The primary aim is to investigate how family emotion networks contribute to children’s emotional functioning and development. A secondary aim is to explore key factors, such as parental psychological functioning and child emotion regulation abilities, that may shape these networks. This protocol serves as a valuable framework for future researchers exploring family-wide emotion dynamics.

Background: Hemolytic transfusion reactions are a major complication in patients with β-thalassemia major receiving regular transfusions. These reactions can be influenced by blood group incompatibilities, particularly in settings with limited genotyping practices. In Indonesia, the role of blood group genotyping in predicting hemolysis has not been thoroughly studied. Objective: This study aims to analyze the association between blood group genotyping and the incidence of hemolysis in people with thalassemia undergoing repeated transfusions. Methods: This is a cross-sectional study involving people with β-thalassemia major younger than 18 years old who received regular transfusion with intervals of 2-4 weeks and have received more than 20 units of transfusion. Participants with leukemia, lymphoproliferative diseases, diabetes, solid tumors, and immunosuppression disorders were excluded from the study. Genotyping examination was conducted using Allele-Specific polymerase chain reaction (PCR ASP) while phenotyping was examined using immunoserology. Follow-up gene sequencing was conducted to observe the blood group variants. Hemolysis was assessed using several markers such as haptoglobin, free hemoglobin, lactate dehydrogenase, bilirubin, and hemoglobinuria, measured by Cobas C113, the enzyme-linked immunosorbent assay, and urinalysis. Results: Clinical and laboratory data collection is completed. A total of 90 samples were collected, data analyses were undertaken, and the initial results were reported in September 2024. Conclusions: The results of this study will provide information on the blood groups’ systems that can predict hemolysis occurrence in patients with β-thalassemia undergoing repeated transfusion. These data will contribute to the best possible patient care management and blood transfusion therapy, thereby reducing the risk of hemolysis and improving the quality of life for patients with thalassemia in Indonesia.

Background: The health and economic burdens of Alzheimer’s disease and related dementias (ADRD) are exacerbated for people living in rural social contexts who experience geographic barriers to care. There are currently few resources specifically designed to support socio-culturally diverse rural ADRD care dyads, including early detection of potential precursors to ADRD such as Mild Cognitive Impairment (MCI) and Subjective Cognitive Decline (SCD). Objective: The primary objective of the Northern Arizona Memory Study (NAZMS) is to develop culturally-informed and scalable resources to identify and support rural families at risk for ADRD. The purpose of this study is to introduce the NAZMS protocol and discuss its role in addressing dementia risk and promoting cognitive health in rural communities. Methods: This dyadic study uses a mixed-methods, digital health approach. A sample of rural care dyads with MCI or SCD is screened and recruited through partnerships with community centers across Northern Arizona. Consenting dyads complete semi-structured interviews where they answer questions about technology preferences for monitoring symptoms and engaging in remotely-delivered interventions. Next, care dyads complete separate baseline questionnaires assessing dyadic (e.g., experiences with caregiving/care-receiving) and health factors. Participants with cognitive impairment then complete a 14-day mobile protocol of brief end-of-day surveys and cognitive assessments delivered via study-provided smartphones. Results: Data from the qualitative interviews provide dyad preferences for intervention development. Data from the quantitative protocol specify for whom (i.e., between-person) and on which days (i.e., within-person) modifiable factors are related to better cognitive health in everyday life. Conclusions: This study takes a mixed-methods, digital health approach to supporting rural families at risk for ADRD by understanding intervention preferences and identifying the modifiable protective and risk factors that influence cognitive health in everyday life. The findings will directly support rural Arizonans and respond to national priorities in ADRD research for the development of community-based disease education programs and use of digital assessments of cognitive health and well-being. Clinical Trial: Not Applicable.

Background: Sexual assault (SA) is a serious problem at universities. It is estimated that 1 in 5 women students will experience SA before they graduate. Objective: The primary aim of this randomized controlled trial is to test whether a synchronous web-based facilitated adaptation of an efficacious intervention (the Enhanced Assess, Acknowledge, Act [EAAA] program) can reduce the 1-year incidence of rape among first- and second-year undergraduate women. Secondary aims will assess the impact of the Internet-Delivered EAAA (IDEA3) on other forms of SA (attempted rape, attempted and completed coercion, and nonconsensual sexual contact). Tertiary aims will evaluate effects of the program on (1) survivor self-blame in the event of an assault, (2) 6 known mediators of the intervention effect to guide revision of IDEA3 if necessary, and (3) 2 exploratory outcomes measuring acceptance of sexualized aggression and sexual empowerment. Methods: In this multisite open-label randomized controlled trial, 1920 diverse women students at 2 Canadian and 4 US universities will be randomly assigned to receive either the 12-hour IDEA3 (intervention arm) or standard of care (control arm: 60-minute, web-based, live-facilitated consent workshop). Outcomes are measured at baseline, 1 week, 6 months, and 12 months post intervention. SA will be assessed using the Sexual Experiences Survey-Short Form Version. Survivor self-blame and outcomes known to be mediators of EAAA’s reductions in SA will also be measured. Results: Funding was received in October 2022. Recruitment began on October 2, 2023, and the first participant was randomized on October 23, 2023. As of August 2025, a total of 683 participants have been enrolled and randomized. Data collection will end in May 2027. Conclusions: If efficacious, IDEA3 will be made available to universities in Canada and the United States. To date, 6 provinces in Canada and the Campus SaVE Act in the United States require institutions to provide SA prevention programming. An evidence-based, cost-effective option that can be delivered remotely via the internet has the potential to become the gold standard. The research, therefore, has the potential to impact women’s health and safety internationally. Trial Registration: ClinicalTrials.gov NCT06058455, https://clinicaltrials.gov/study/NCT06058455

Background: Preeclampsia is 1 of the 3 leading causes of maternal mortality worldwide. Unfortunately, its exact pathogenesis is still unclear. Published metabolomic and gene expression analyses point to coenzyme A (CoA) restriction in the placenta as a factor underpinning the observed complications of preeclampsia, but this hypothesis has never been tested. Objective: This pilot study aims to discover evidence supporting the CoA-restriction hypothesis through 2 avenues. The first of these involves developing a procedure for the quantitative determination of metabolites to discover if harmful metabolites are elevated in patients with preeclampsia, while the second seeks to emulate the onset of CoA restriction in cultured cells. Methods: This manuscript provides a rationale and a protocol for a clinical study and laboratory experiments to test the hypothesis. The methods have 3 key aspects. Phase 1 comprises optimization of assays of 5 key metabolites arising from CoA restriction, namely L-leucine, ketoisovalerate, ketodeoxycholate, oleic acid, and sphingosine-1-phosphate. Phase 2 comprises recruitment of patients to obtain serum samples to measure the metabolites, and phase 3 comprises culturing and treating trophoblast cells to induce CoA restriction and test the effects of the metabolites on the cells. Patients with preeclampsia and healthy controls will be recruited based on World Health Organization criteria for preeclampsia. Exclusion criteria include multiple pregnancies, premature rupture of membranes, and various medical complications. Blood samples will be collected and analyzed using high-performance liquid chromatography/mass spectrometry (HPLC/MS) to quantify key metabolites associated with CoA restriction. For trophoblast cell studies, BeWo cells will be cultured under conditions likely to induce CoA restriction, including hypoxia and human chorionic gonadotropin supplementation, and will also be treated with the key metabolites to determine what effect they might have. Cell viability, apoptosis, energy metabolism, and gene expression (focusing on genes involved in CoA synthesis and metabolism) will be assessed. Statistical analysis will involve 2-tailed t tests or Mann-Whitney U tests to compare metabolite concentrations between patients with preeclampsia and controls. A correlation matrix will be used to explore associations between metabolite levels and patient characteristics. Results: Institutional review board ethics approval has been obtained for this study. Patient recruitment started April 1, 2025. The 5 metabolites have been purchased in synthetic form and used to optimize the HPLC/MS assays in preparation for receiving blood samples. The trophoblast cell-line culture is being optimized. Conclusions: The findings of this study will demonstrate that key metabolite concentrations can be quantified using HPLC/MS and indicate if CoA restriction is associated with preeclampsia. If so, this provides a significant, novel avenue for research into the treatment and prevention of the disease.

Background: Older adults with complex care needs and polypharmacy are at risk of experiencing medication-related problems such as administration errors and adverse drug events. These problems lead to increased utilisation of emergency care and hospital admissions. Technology-based interventions have been introduced to address some of these problems. This review aims to establish key concepts and address the gaps in the evidence base to improve the use of technology-based interventions and reduce medication management-associated problems in home care settings. Objective: This scoping review aims to understand the extent and type of evidence regarding the management of medications for older people in home care settings using technology-based interventions. Methods: The review will follow the Joanna Briggs Institute (JBI) methodology. The published studies will be searched through MEDLINE, CINAHL, Scopus, Web of Science, Embase, IEEE Xplore and ACM digital library and the unpublished studies through the EBSCO Open Dissertations database. Studies published in all languages will be considered. A broad scope of evidence, including quantitative, qualitative, text and opinion studies, will be considered. This review will include studies of older adults (aged 60 years or older) living in home care settings and receiving formal or informal social care support for medication management. Studies that focus on the application of the technology for medication management will be included. The titles and abstracts will be reviewed initially for relevance, and then the full text will be reviewed for in-depth analysis. The results of the search and inclusion process will be presented in a Preferred Reporting Items for Systematic Review and Meta-Analysis extension for Scoping Reviews (PRISMA-ScR)) flow diagram. Data will be extracted from the included studies using a data extraction tool developed for this study. Results: A draft charting table will be developed as a data extraction tool. Results will be presented in a graph, diagram, or table, accompanied by a narrative summary. Conclusions: This review will identify and synthesise evidence associated with applying technology-based medication management interventions to older people in home care settings and the strategies to overcome those identified challenges. This review will identify knowledge gaps, clarify concepts, and make recommendations for future research on technology-based medication management interventions.

Background: Childhood obesity is a serious global health concern that affects around 20% of children worldwide. Digital health behaviour change interventions have the potential to improve behaviours that can contribute to childhood obesity, such as diet and physical activity, but often lack sufficient user engagement to achieve significant impact. Objective: The aim of this project is to develop evidence to better understand how users engage with digital interventions and how Behaviour Change Techniques can be leveraged to support engagement. Specifically, the study will examine the impact of a family-focused app for childhood obesity prevention on health behaviours, health outcomes, and communication between families and healthcare professionals. Methods: A pre-post, mixed-methods evaluation will examine the impact of the NoObesity app on families’ physical activity and dietary behaviours and on healthcare professionals’ self-efficacy at communicating with families about childhood obesity. Secondary outcomes will include well-being, usability, and users’ engagement with and perceptions of the intervention. An initial sample of 1000 families (children and young people of any age and weight and their parents) and 180 healthcare professionals will be recruited to participate in the study, a subset of whom will be invited to qualitative semi-structured interviews. The study implementation and follow-up period will last for 6 months, with the outcomes measured at baseline and 3- and 6-months post-baseline. Quantitative outcomes will be compared over time using repeated-measures ANOVA and qualitative data will be analysed thematically and triangulated with app use data. Results: Ethical approval was received from Newcastle University Faculty of Medical Science Ethics Committee (2688/41816) on 22 March 2024. Recruitment has not yet begun. Conclusions: The project’s key contributions will be to generate evidence of potential for a family-based digital intervention to support families’ health behaviour change and healthcare professionals’ confidence in their ability to support them and to improve our understanding of how particular Behaviour Change Techniques can be used to support engagement with the intervention and its target behaviours. Findings will be disseminated via peer-reviewed journal and to the general public with support from patient and public involvement representatives.

Background: Alcohol consumption remains a major societal problem, contributing to myriad health conditions. Australian midlife women (aged 45-64 years) consume more alcohol than previous generations of midlife women and more than younger women now. Alcohol poses health risks that are unique to midlife women, including increased risk of breast cancer; 10% of breast cancers result from alcohol consumption and there is no “safe” limit. There is a global gap in knowledge about socially and culturally appropriate interventions for reducing alcohol consumption in these heavy-drinking groups of midlife women.

Background: The growing population of cancer survivors faces persistent physical and emotional challenges that significantly impact health-related quality of life (HRQL). To address these multifaceted needs, robust and culturally adapted patient-reported outcome measures, such as the Measure Yourself Concerns and Wellbeing (MYCaW®) questionnaire, are essential for understanding and improving survivors’ subjective experiences. Objective: This protocol outlines the systematic translation and cultural adaptation of the MYCaW® questionnaire into German. The MYCaW® questionnaire, a patient-reported outcome measure, is designed to capture individualized concerns and assess overall well-being, particularly in cancer care settings. By adhering to common guidelines, this research will provide a tool for assessing individualized concerns and patient needs among German-speaking cancer patients. Methods: Following International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines, this study will employ a structured methodology involving forward and backward translation, expert review, patient review process, and preliminary validation to ensure linguistic and cultural equivalence. The present study is approved by the ethics committee of the Medical Association Berlin with the reference number Eth-27/10. Construct validity will be assessed through comparison with the EORTC QLQ-C30 and the MIDOS questionnaire, to evaluate both quality of life and symptom burden. Results: Funding of the study was obatained in January 2023. Patient recruitment started in Q1 2023, and the cognitive debriefing phase is ongoing. Validation with the larger patient sample (n=120) is scheduled to conclude in Q4 2025, with publication of the study results anticipated in Q1 2026. The adaptation process will include translation, expert review, and cognitive debriefing with patients and healthcare professionals to ensure linguistic clarity and cultural relevance. Conclusions: The translation and adaptation of MYCaW® into German will contribute to expanding the availability of validated patient-reported outcome measures for German-speaking populations. By following rigorous international guidelines, this study aims to produce a reliable, culturally appropriate, and linguistically adapted German version of the MYCaW® questionnaire for assessing patient concerns and well-being in oncology and supportive care settings. Future validation studies will be necessary to assess the psychometric properties of the adapted questionnaire and its applicability in clinical and research contexts. Potential challenges, such as maintaining conceptual equivalence in translation and ensuring broad representativeness in the validation process, will be addressed through iterative refinement. Once validated, the German MYCaW® will provide a valuable resource for patient-centered research and care, helping to capture individualized concerns that might be overlooked by standardized instruments. Clinical Trial: German Clinical Trials Register; DRKS00013335; https://drks.de/search/de/trial/DRKS00013335.

Background: Children with acute lymphoblastic leukemia (ALL) undergoing chemotherapy have limited access to rehabilitation support. While rehabilitation on the basis of physiotherapy has been found to enhance psychosocial well-being and motor performance, a viable substitute for this can be aquatherapy. However, no trials have currently evaluated the effectiveness of aquatherapy in this population. Objective: We aim to evaluate the comparative efficacy of aquatherapy versus conventional physiotherapy on the motor function and psychosocial well-being of children with ALL. Methods: We will conduct a parallel, single-blinded (participant-blinded), randomized controlled trial with embedded quantitative analysis. In total, 54 survivors of ALL undergoing chemotherapy will be recruited from the Acharya Vinoba Bhave Rural Hospital in Sawangi (Meghe), Wardha, Maharashtra, India. The experimental group will attend a 4-week, thrice-weekly, 45-minute aquatherapy session focusing on exercise-based rehabilitation. The comparison group will receive conventional physiotherapy including standardized exercises. Assessments will be completed at weeks 0 (baseline), 4 (postintervention), and 12 (follow-up). The primary outcome related to motor function will be measured using the timed up and go test and the Pediatric Balance Scale at week 4. Secondary outcomes will include psychosocial well-being measured with the Hospital Anxiety and Depression Scale and functional abilities measured with the Functional Independence Measure for Children (WeeFIM). Health service data, including length of stay in the hospital, hospital readmissions, and emergency department presentations, will be recorded. Semistructured interviews will be completed within an interpretive description framework to explore participant descriptions. The primary outcome will be analyzed using linear mixed effects models. Results: The trial is scheduled to commence in October 2025. Conclusions: The trial will inform future implementation of rehabilitation for children with ALL by providing important data regarding the efficacy of aquatherapy compared with conventional physiotherapy as well as patient experience. Trial Registration: Clinical Trials Registry - India CTRI/2025/03/083036; https://tinyurl.com/v446cd6z

Background: Integrative nursing (IN) involves the application of external naturopathic nursing interventions, such as compresses, embrocations, and therapeutic baths and washes. As part of a university hospital project, patients receiving oncology care in participating wards receive IN interventions as supportive care during their hospital stay as part of a consultation service. Objective: This study aims to investigate the acceptance, feasibility, and contextual conditions of implementing IN in inpatient care and to evaluate perceptions, experiences, and perceived impact of IN interventions from multiple stakeholder perspectives. Methods: We used a convergent parallel mixed methods approach guided by the Consolidated Framework for Implementation Research. The evaluation consists of 5 substudies reflecting multiple perspectives on the project. Patients, relatives, and hospital staff will participate. Substudies include a single-arm pre-post questionnaire (substudy 1) and semistructured interviews (substudy 2) with patients, a cross-sectional survey of relatives (substudy 3), semistructured interviews with health care professionals (substudy 4), and analysis of project-related documentation (substudy 5). Qualitative data will be analyzed using qualitative content analysis, and quantitative data will be analyzed using descriptive and inferential statistical methods. Results: Following separate analyses of each substudy, the findings will be integrated and triangulated to generate overarching meta-inferences. The recruitment phase lasted from October 2023 to January 2025. Data collection was completed in March 2025. As of October 2025, after data verification and plausibility checks, data analysis is ongoing. The first results are expected to be published in 2026. Conclusions: This study presents a mixed methods research protocol aimed at exploring the implementation of IN within a university hospital setting. It is expected to provide a theory-based contribution to IN implementation in inpatient care while also offering insights into its potential effects at the patient level. The study is anticipated to advance understanding of how IN can be sustainably embedded in hospital practice and to provide actionable insights for improving patient-centered supportive care. Trial Registration: German Clinical Trials Register DRKS00032318; https://drks.de/search/de/trial/DRKS00032318

Background: Hypertension is a significant risk factor for cardiovascular diseases and is associated with an increased risk of mild cognitive impairment (MCI). The lack of effective treatment for these conditions underscores the urgent need for novel therapeutic approaches. Previous studies have indicated that microcirculation serves as the pathological basis for the comorbidity of hypertension and cognitive dysfunction. Our initial clinical studies have indicated that acupuncture could be a safe and effective treatment for managing hypertension and MCI. Whether acupuncture can enhance hypertension and cognitive impairment by modulating microcirculation, and the precise mechanisms involved, warrants further exploration. Objective: The objective of the trial is to evaluate the clinical efficacy of electroacupuncture on MCI of patients with hypertension and to explore whether it can improve hypertension and cognitive impairment by regulating microcirculation. Methods: In this multicenter, large-scale, single-blind, randomized controlled trial, we will recruit 252 patients with hypertension and cognitive impairment from 3 hospitals and randomly assign them to 3 groups in a 1:1:1 ratio: the electroacupuncture group, the sham electroacupuncture (SEA) group, and the waiting list group. The electroacupuncture group and SEA group will receive either electroacupuncture or SEA for 12 weeks, while the waiting list group will not receive acupuncture treatment for the first 12 weeks. The primary outcome will be the changes in overall cognitive function, as measured by the Montreal Cognitive Assessment. The secondary outcomes include blood pressure status, subdomain cognitive function, mental status, sleep quality, hemodynamics, and microcirculation indicators. Results: The study protocol has been approved by the institutional review board of the First Affiliated Hospital of Tianjin University of traditional Chinese medicine. This study was registered on April 26, 2024, with the Chinese Clinical Trial Registry. Data collection began in May 2024 and ended in April 2025. Currently, data from this trial are in the collection phase, and no data analysis has been performed. As of January 1, 2025, we have collected data from 65 patients. The results of this trial are expected to be submitted for publication in July 2026. Conclusions: This clinical trial aims to compare the efficacy of electroacupuncture versus SEA or waiting list control in the treatment of hypertension with cognitive impairment and to explore its impact on microcirculation through hemodynamic and microcirculatory indices. The results of this trial will contribute to clarifying the microcirculatory mechanisms of electroacupuncture in the treatment of hypertension with cognitive impairment, providing a solid foundation for further research on electroacupuncture therapy. Clinical Trial: Chinese Clinical Trial Registry ChiCTR2400083501; https://www.chictr.org.cn/showproj.html?proj=220722

Background: Women and girls around the world face significant barriers in participating in health care decisions, particularly in low- and middle-income countries. Despite growing interest in shared decision-making (SDM), little is known about its implementation in these countries, and no rigorous assessment of the decision-making needs of women and girls in these contexts has been conducted. There is little SDM training and there are few decision-support tools (DSTs) specifically designed for health care decision-making by women and girls in these countries. DSTs (paper or digital) present options and probabilities and help users articulate their values and preferences. Objective: We aim to codevelop an SDM resource platform, including locally relevant DSTs and instructional materials, to support SDM with women and girls in Brazil, Cameroon, and Senegal. Methods: We will conduct a 4-phase participatory research project. We will use the Gender-Based Analysis Plus tool to support inclusive participatory research throughout the study. First, we will follow the Integrated Knowledge Translation framework to form a local steering committee in each country, including patients and community representatives, health and social service professionals, and decision-makers. Second, we will follow the Ottawa Decision Support Framework to conduct individual interviews and focus groups to identify the decision-making needs of women and girls. We will include 20 women and girls, along with their family members, 15 health and social service professionals, and 15 representatives of community-based organizations in each country (n=150). The Double Diamond human-centered design framework will be used to codevelop a digital SDM resource platform where DSTs and instructional materials for SDM training can be made accessible. Finally, we will assess the scalability of the platform by using the Innovation Scalability Self-Administered Questionnaire. We will report our study by using the Standards for Reporting Qualitative Research guideline and the Guidance for Reporting Involvement of Patients and the Public. Results: Financial support for this project was received on February 1, 2023. This protocol was submitted during data collection but before analysis. Data collection began in January 2025. By July 2025, 92 of the 150 participants had been recruited. We expect to publish our results in December 2026. Conclusions: Ultimately, more women and girls from low- and middle-income countries will be involved in health care decisions, and more clinical teams will be able to integrate SDM into their care practices. The local steering committees will ensure equitable partnerships and the SDM resource platform will promote more inclusive approaches to SDM worldwide. The scalability assessment will help us plan to expand the impact of the platform to other regions. Trial Registration:

Background: Over 30% of people in the United Kingdom are living with a long-term physical health condition. Early preventative peer support interventions could improve the lives and psychosocial well-being of people with long-term physical health conditions and reduce progression of any symptoms of low mood to more significant depression. In partnership with people with long-term conditions and industry stakeholders, we have co-designed an online peer support platform, CommonGround, to help people with long-term health conditions connect, support others, share experiences, and receive evidence-based information and advice on self-management. Objective: This feasibility randomized controlled trial will investigate whether the CommonGround platform is usable and acceptable for people with long-term physical health conditions experiencing mild depressive symptoms and whether conducting a future, larger confirmatory randomized controlled trial is feasible. Methods: A mixed methods, 2-arm, parallel-group, unblinded randomized controlled feasibility trial will be conducted nationally across the United Kingdom. Participants will include 150 adults (aged ≥18 years) who have access to the internet and are living with at least one long-term physical health condition and subthreshold depression (scoring 5-9 on the Patient Health Questionnaire–8). Following baseline assessments, eligible participants will be randomized to a coproduced online peer support and psychoeducation platform or a control condition where participants will receive fortnightly emails containing links to the National Health Service mental health web pages. Assessment measures will be collected at baseline and the midintervention (6 weeks) and postintervention (12 weeks) time points. A purposive sample of approximately 40 participants will be interviewed after the intervention to evaluate participant experiences and views on acceptability. The primary feasibility outcome is the number of participants recruited to the trial per week and in total via each recruitment route (as self-reported by participants). Results: Recruitment for the feasibility trial began on February 12, 2024. Quantitative data collection was completed by October 23, 2024, and qualitative data collection was completed by December 3, 2024. Conclusions: This trial will explore the acceptability and feasibility of our coproduced online peer support platform with embedded psychoeducational resources targeted for people living with long-term physical health conditions and subthreshold depression who are at risk of developing major depressive disorder. The findings will inform the future design of a larger randomized controlled trial exploring the platform’s clinical efficacy and cost-effectiveness.

Background: Continuous monitoring of patients’ vital signs is critical for early detection of postoperative complications. Traditional manual monitoring by nursing staff is time-consuming and provides only intermittent data. Wearable devices offer continuous monitoring capabilities, potentially enhancing early warning systems, reducing nurse workload, and facilitating earlier patient discharge. However, research on their implementation and effectiveness in clinical settings remains limited. Objective: This study aims to evaluate the implementation and feasibility of continuous monitoring using photoplethysmography sensor technology (a viQtor device) in a surgical ward. We will also assess the impact on nursing workload and the usability of this workflow. Methods: The REQUEST (Remote Monitoring by viQtor Upon Implementation on a Surgical Department) study is a prospective observational implementation study conducted over 8 months in a surgical ward. The vital signs of 500 postoperative patients will be continuously monitored using the viQtor device, which measures heart rate, respiratory rate, and oxygen saturation. The study consists of 2 phases: an initial period with manual spot checks, followed by a phase using the wearable device as the primary monitoring tool. Outcomes include the Integrated Workload Scale for nursing workload and a framework evaluating acceptability, feasibility, adoption, and sustainability. Data collection involves device performance metrics, questionnaires (the Evidence-Based Practice Attitude Scale and the System Usability Scale), and thematic analysis of focus groups. Results: Staff training was completed in October 2024, and full implementation is ongoing. Preliminary findings, including data on usability and workload, are expected by July 2025. Conclusions: This study will provide insight into the practical implementation of continuous vital sign monitoring in surgical care. The findings may support future adoption of wearable technology in clinical workflows. Trial Registration: ClinicalTrials.gov NCT06574867; https://clinicaltrials.gov/study/NCT06574867

Background: In the United States, transgender men and transmasculine people who have sex with men (TMSM) face an increased risk of HIV and encounter unique barriers to HIV prevention services, including preexposure prophylaxis (PrEP). Peer-based, digitally delivered support interventions that address these barriers in 1-on-1 or small-group settings may be effective in increasing PrEP engagement. Objective: This study aims to compare the efficacy of digitally delivered individual and small-group peer-based strategies for improving PrEP uptake and adherence among at-risk adult TMSM without HIV. Methods: The Transmasculine One-on-One and Group Empowerment for Targeted HIV Reduction (TOGETHR) study was a digital, open-label, randomized 2×2 factorial trial (1:1:1:1 randomization) of peer-delivered HIV prevention strategies designed to increase PrEP engagement in 300 PrEP-indicated TMSM without HIV. Participants were randomized to 1 of 4 conditions: (A) standard of care (SOC) package (information and PrEP locator tools), (B) SOC + PrEP for TMSM (PrEP4T; individual peer-based HIV prevention intervention), (C) SOC + LifeSkills for TMSM (LS4TM; group peer-based HIV prevention intervention), or (D) SOC + PrEP4T and LS4TM (both individual and group interventions). Interventions were delivered over a 6-week period. The study enrolled adults 18 years or older who were “transgender men or transmasculine,” sexually active with 1 or more partners who had a penis and were assigned male sex at birth, living without HIV, behaviorally at risk for HIV acquisition, and residing in geographic hot spots identified in the US Ending the HIV Epidemic initiative. Results: Study protocols and procedures were codeveloped with our community advisory board, including eligibility criteria, operationalization of geographic stratification, study branding, and detailed recruitment plans. Recruitment and enrollment began on April 1, 2024, and as of March 20, 2025, 103 TMSM had been enrolled. The median age was 26 (IQR 24-31) years. Among the 103 participants, 39 (37.9%) identified as Black, Indigenous, and People of Color, and 18 (17.5%) as Latine; 36 (35.0%) identified as “transgender man or trans man”; 31 (30.1%) as transmasculine; and 15 (14.6%) as nonbinary, genderqueer, or gender nonconforming. Additionally, 69 (67.0%) had at least a four-year college degree, and only 7 (6.8%) had no health insurance. Granger causality tests indicated that recruitment activities via social media (P=.006) and transgender-inclusive dating platforms (P=.02) were most effective and predicted higher baseline enrollment survey completion 2 weeks later. On March 21, 2025, the National Institutes of Health terminated the grant award, citing gender ideology and stating, “it is the policy of NIH not to prioritize such research programs.” Conclusions: This study was part of a critical research pathway to identify effective strategies for preventing HIV acquisition in TMSM, a group traditionally underserved in HIV prevention, and to inform prevention packages that incorporate peer-delivered interventions. Strong engagement with the TMSM community was central to the study’s success and provided valuable insights for future HIV prevention research and practice. Trial Registration: ClinicalTrials.gov NCT06182280; https://clinicaltrials.gov/ct2/show/NCT06182280

Background: Atopic dermatitis (AD) is a recurrent, inflammatory, and chronic skin disease that influences over 200 million individuals around the world and is viewed as an important health problem due to its elevated prevalence, long course of disease, and heavy disease burden. WuSheZhiYang (WSZY) pills are composed of 11 Chinese herbs and have the effects of nourishing the blood, drying dampness, and relieving itching. In clinical practice, WSZY pills are recommended for itching skin diseases, but high-quality clinical trial evidence is still limited. Objective: In this study, we will implement a double-blind, randomized, placebo-controlled trial to evaluate the efficacy of WSZY pills for mild-to-moderate AD. We hypothesized that WSZY pills can effectively alleviate the disease condition of patients with mild-to-moderate AD. Methods: In this study, we will recruit 60 patients with mild-to-moderate in Shanghai Skin Diseases Hospital from December 2024 through December 2025. In this study, 60 male and female patients with AD aged 18 years to 65 years will be randomly assigned (2:1) to the treatment group (urea ointment and WSZY pills; n=40) or control group (urea ointment and placebo WSZY pills; n=20), and both groups will receive 4 weeks of treatment and 4 weeks of follow-up. The treatment group will receive 3 sessions of urea ointment and 7.5 g of WSZY pills each day for 4 weeks, and the control group will also receive 3 sessions of urea ointment and 7.5 g of placebo WSZY pills each day for 4 weeks. The primary indicator is the change in the objective Scoring Atopic Dermatitis (SCORAD) score between baseline and week 4. The secondary indicators include SCORAD at week 2 and week 8; Peak Pruritus Numerical Rating Scale (PP-NRS), Investigator's Global Assessment (IGA), Patient-Oriented Eczema Measure (POEM), and Dermatology Life Quality Index (DLQI) at week 2, week 4, and week 8; and the proportion of participants receiving remedial treatment, amount of levocetirizine tablets used, and recurrence rate at week 8. In this study, we will analyze the full analysis set and per-protocol set using SAS software version 9.4, and a 2-tailed alpha level of .05 will be viewed as statistically significant. Results: The study received ethics permission in September 2024, and trial registration was completed in October 2024. Recruitment started in December 2024 and is expected to be completed by December 2025. As of June 2025, 30 participants with mild-to-moderate AD were enrolled. Data analysis will begin in January 2026. The main results of the trial are expected to be submitted for publication in peer-reviewed scientific journals in the summer of 2026. Conclusions: This study will evaluate the efficacy of WSZY pills for AD and provide additional evidence, suggest new therapeutic options for patients, and reduce their disease burden. Clinical Trial: International Traditional Medicine Clinical Trial Registry ITMCTR2024000724; http://itmctr.ccebtcm.org.cn/zh-CN/Home/ProjectView?pid=bda070f8-a733-4f52-87b0-39e4be57ac00

Background: Children and youth with medical complexities have chronic conditions, functional limitations, and extensive care needs requiring significant family involvement and frequent health service use. Pediatric medicine has improved their life expectancy, shifting care from acute to home settings. In Ontario, home care is publicly funded and includes nursing, therapy, personal support, and allied health services. However, families continue providing the bulk of care, often at great personal costs. As care complexity increases, so does the reliance on home care providers. Yet, many providers report feeling unprepared due to insufficient pediatric training, lack of supervision, and system-level gaps. Here we applied Weiner’s theory of organizational readiness for change, framing readiness as a shared psychological state involving commitment to and confidence in delivering change, thus helping conceptualize provider readiness as encompassing individual competence, contextual supports, and motivational factors. Despite its importance, provider readiness in pediatric home care remains poorly understood. Objective: We examine how home care providers perceive their readiness to care for children and youth with medical complexities, factors influencing readiness, and strategies proposed to enhance their capacity to deliver safe, coordinated, developmentally appropriate home care. Methods: This scoping review follows the updated Joanna Briggs Institute scoping review methodology and PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. Articles focusing on (1) children and youth with medical complexities aged 0-18 years receiving home care and (2) with at least one chronic medical condition, and (3) paid home care providers will be searched on MEDLINE, CINAHL, Scopus, ProQuest Nursing & Allied Health, PsycINFO, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews. Gray literature will be searched on Google Scholar and ProQuest (Dissertations & Theses). A 2-stage screening process will be conducted in Covidence, involving title and abstract screening and full-text review by 2 independent reviewers. Data will be extracted using predefined charting categories and analyzed using both qualitative and quantitative approaches. Results: As of May 2025, screening is underway. The review will map key themes across provider types, care settings, and training contexts and identify factors influencing provider readiness including access to training, system navigation supports, and workplace role clarity and chart recommendations or strategies to enhance readiness. Gaps in pediatric-specific competencies and workforce preparation may also emerge. Conclusions: This review will synthesize current evidence on provider readiness in pediatric home care, identifying strengths, challenges, and development areas. Findings will inform provider training, workforce development, and policy strategies to ensure children and youth with medical complexities receive safe, coordinated, effective home care. A deeper understanding of provider readiness will support more sustainable home care systems and improve outcomes for children and youth with medical complexities and their families. Clinical Trial: OSF Registries 10.17605/OSF.IO/N4FAJ; https://osf.io/n4faj

Background: African American men are at a higher risk for serious health conditions such as cardiovascular disease, diabetes, and stroke compared to non-Hispanic White men. Physical activity (PA) is a modifiable health behavior that has been shown to decrease chronic disease risk; yet, PA engagement is alarmingly low in African American men. Interventions to improve PA engagement are effective in a number of populations; however, very few have been tailored to the unique needs of African American men. Even fewer have leveraged mobile health apps, despite African American men’s interest in and willingness to use such technologies for health improvement. Objective: This comparative effectiveness trial aims to evaluate MobileMen, a PA promotion app tailored to the needs and preferences of African American men. This trial will compare the MobileMen app to a commercially available PA promotion app with similar features but lacks culturally tailored components. Methods: We will recruit a sample of “low active” (accumulating <7500 steps per day) African American men (n=100) aged >30 years from Baton Rouge, Louisiana, and the surrounding communities. All participants are given a Fitbit Charge 6 wearable activity tracker to assess daily PA and steps and are randomized to either the MobileMen intervention app or the comparator app, which is a commercially available PA tracking app called Stridekick. The Stridekick app has features similar to those in the MobileMen app but was not intentionally designed for African American men. The intervention period is 6 months during which participants will interact with their assigned mobile app. MobileMen includes features such as digital badges earned for PA; tangible prizes like exercise equipment; challenges among participants; goal setting; nutrition; PA; and behavior change educational information in text, audio, and video formats. Participants will complete assessments at baseline and at 6 months post randomization. Assessments include objective measurements of daily steps and minutes of moderate to vigorous PA, quality of life, dietary measures, self-efficacy for fruit and vegetable consumption and PA, and autonomous motivation for PA. Results: This trial is in the start-up phase. The MobileMen app development and usability testing was completed in August 2024. Participant recruitment efforts began in October 2024. The trial and associated data analyses and interpretation are planned to be completed by fall 2025. Conclusions: Mobile apps are a widely accessible means to disseminate culturally tailored PA promotion interventions to various populations, including African American men. MobileMen has the potential to impact PA engagement in African American men, which would dramatically improve the overall health and chronic disease risk in this underrepresented group. Trial Registration: ClinicalTrials.gov NCT05621044; https://clinicaltrials.gov/study/NCT05621044

Background: Emotional resilience is a dynamic process by which individuals may prevent, overcome, and thrive following challenging events. Emotional resilience can be defined as absence of negative outcomes (ie, symptoms of psychopathology) and/or the presence of adaptive outcomes (ie, well-being). Despite the wealth of research tracking the nature of and contributions to emotional resilience in adolescence and adulthood, there is a dearth of evidence on the nature of resilience and its development during preadolescent childhood despite this being an important preventative period for later mental health difficulties and a period when emotional experiences change. Objective: Our primary study objectives are 3-fold: to explore how preadolescent children growing up in deprived areas of London may operationalize resilience, evaluate whether there are differences in the development or trajectories of resilience among our target population, and understand what contributes to resilience pathways over time. Additionally, our research aims to better understand the psychometric properties of resilience measures used in a preadolescent sample and assess the feasibility of developing a longitudinal cohort study of preadolescent children in East London. Methods: We will conduct an accelerated longitudinal cohort study in primary schools across the broad geographical area of East London. The multimethod approach will span across 3 data collection arms: (1) child cognitive tasks and psychometric questionnaires in classroom settings, (2) teacher ratings, including teacher assessments of school mental health provisions, and (3) parent questionnaires. We aim to recruit approximately 1200 children aged 7-11 years at baseline across UK school years 3, 4, and 5. Our measures will span themes of resilience and mental health, as well as personal, social, and community resources available to the children. We will collect quantitative data via questionnaires from children, their parents, and school staff. We will collect qualitative data from the children through paper-based tasks. Results: Study recruitment commenced in October 2022 and continued till December 2023. Baseline testing commenced in October 2022 and continued till December 2023; 873 students were enrolled at baseline. Follow-up is anticipated to continue at least annually until June 2027. Conclusions: This study will assess the feasibility of conducting a longitudinal cohort study on preadolescent children in East London. Alongside evaluating the psychometric properties of resilience measures used in this age group, this study will explore how resilience develops in children across time and relate this to other outcome measures. By identifying how personal, social, and community resources may affect resilience in preadolescent children, we will enhance the understanding of how emotional resilience develops in preadolescent children, and future studies will be able to develop interventions to boost resilience by targeting young and diverse populations. Trial Registration: ISRCTN ISRCTN12430839; https://www.isrctn.com/ISRCTN12430839

Background: Nasopharyngeal carcinoma (NPC) is the fourth-most-prevalent cancer in both Indonesia and Asia. Globally, an estimated 133,354 cases and 80,008 deaths were attributed to NPC in 2020. Early diagnosis plays a key role in managing NPC. Molecules found in bodily fluids, such as saliva, contain compounds (including microRNAs [miRNAs]) that can aid in detecting diseases like NPC. More studies on the expression, role, use, and accuracy of salivary miRNAs as potential diagnostic biomarkers of NPC are needed. Objective: This protocol provides a framework for conducting a scoping review aimed at mapping the expression, role, use, and diagnostic accuracy of specific salivary miRNAs as potential diagnostic biomarkers of NPC. Methods: The guidelines established by the JBI will be followed, which include defining the research questions, identifying relevant studies, and selecting studies based on titles and abstracts. The process will involve charting the data; collating, summarizing, and reporting the findings; and consultation. The synthesis will specifically examine the expression, role, use and accuracy of salivary miRNAs as potential diagnostic biomarkers of NPC. Both quantitative and qualitative analyses will be performed. Results: The selection of studies based on keywords was completed in August 2024, and the study screening and review processes were finished by November 2024. The drafting of the scoping review manuscript is currently underway. The development of this scoping review protocol was supported by funding from the Centre for Higher Education Funding and the Indonesia Endowment Fund for Education. Conclusions: The findings of this study will offer a comprehensive overview of the expression, role, use, and diagnostic accuracy of salivary miRNAs as potential diagnostic biomarkers of NPC. The findings of this review are expected to serve as a basis for further research. Clinical Trial: Open Science Framework k3prh_v1; https://osf.io/preprints/osf/k3prh_v1

Background: Depression and generalized anxiety disorder (GAD) are widespread mental health diseases with significant individual and societal consequences. Psychotherapy, particularly cognitive behavioral therapy (CBT), is a common treatment approach, but its application is limited due to costs and staff shortages. Germany has been the first country to integrate and reimburse digital health applications (DiGAs) as an easily accessible treatment option since 2020. Despite regulatory processes, skepticism among physicians regarding clinical relevance and evidence persists. Objective: This protocol aims to describe the methodology of the planned systematic review. Using expert ratings, the app review will assess the guideline conformity, functions, and usability of German DiGAs for depression and GAD listed at the Federal Institute for Drugs and Medical Devices (BfArM). The additional systematic review will synthesize the effectiveness and quality of these DiGAs based on randomized controlled trials. Methods: The study protocol follows the 2015 PRISMA (Preferred Reporting Items for Systematic Reviews) guideline and was registered in the international Prospective Register of Systematic Reviews (PROSPERO). The review consists of 2 parts: (1) a systematic health app review of DiGAs addressing depression or GAD and (2) a systematic review of published evidence on these DiGAs. The systematic health app review comprises a summary of the DiGA features including the Institute for Healthcare Informatics (IMS) App Functionality Scoring System, a guideline conformity check, and the Mobile Application Rating Scale (MARS) assessment. The systematic review of published evidence is based on a systematic literature search in electronic databases (MEDLINE via PubMed, Cochrane Central Register of Controlled Trials [CENTRAL], Web of Science), as well as relevant websites. The approach includes an effectiveness evaluation, a risk of bias assessment using the Cochrane tool, Risk of Bias 2 (RoB2), and an overall quality evaluation using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) method. Results: The systematic literature search was conducted in July 2024 and August 2024, and an updated search is planned for November 2025. Data extraction, narrative synthesis, and evaluation of DiGA and corresponding studies are expected to be completed in spring 2026. The results will be presented using a PRISMA flow diagram and tables to display general information, risk of bias, and overall quality. Conclusions: The review will influence both the actual use and future developments of DiGAs. Good quality characteristics will enhance transparency and trust among physicians, while quality deficits provide options for improvement by manufacturers and governing institutions. Consequently, patients’ care with DiGAs may improve. Trial Registration: PROSPERO CRD42024557629; crd.york.ac.uk/PROSPERO/display_record.php?RecordID=557629

Background: This study explores the treatment of internal carotid artery stenosis in patients with a high risk for cardiovascular events. The use of regional anesthesia permits ongoing neurological monitoring and enhances patient safety during the procedure. However, the operation can be stressful and lengthy, highlighting the need for strategies to alleviate patient discomfort. This study evaluates audiovisual distractions such as video goggles to potentially improve patient experiences during carotid surgeries, a topic that has not yet been comprehensively researched. Objective: We aimed to (1) determine whether there is a benefit for patients regarding stress reduction when using video goggles during vascular surgery of the carotid artery and (2) determine whether any parameters can effectively measure such a potential benefit. Methods: This prospective, randomized study at the University Hospital Augsburg is evaluating the use of HappyMed video goggles by patients undergoing carotid endarterectomy under regional anesthesia. Participants are randomized into either the intervention group, which receives the video goggles, or the control group, which does not. The surgical and anesthetic procedures remain consistent across both groups. Patients are eligible if they meet the surgical criteria, are able to lie supine, and are cooperative. Patients are excluded if they are receiving corticosteroids, have dementia, or have a language barrier. The study uses questionnaires and vital/laboratory parameters, including cortisol levels and heart rate, to assess stress and anxiety. To monitor potential motion sickness, the occurrence of nausea or vomiting is documented. Both patients and surgical staff will evaluate the experience postoperatively to determine the goggles’ impact on patient experience and stress management during surgery. Results: The study has been approved by the local ethics committee and is registered at ClinicalTrials.gov. Patient inclusion started in September 2022 and should be completed within 3 to 4 years. This paper presents a study protocol that was finalized and approved by the local ethics committee in September 2022. At the time of this protocol’s final submission for publication, approximately 90% of the recruitment had been completed. Following completion of recruitment and data acquisition, the results are intended to be published within one year. Conclusions: This study aims to improve patient comfort and perioperative care during vascular surgery. Therefore, our study aims to investigate if the use of video goggles during surgery is feasible and if there are parameters that indicate a benefit for patients. This study is being conducted as a pilot trial to provide a foundation for future research aimed at improving patient comfort during carotid artery surgery under local anesthesia. Clinical Trial: ClinicalTrials.gov NCT06704230; https://clinicaltrials.gov/study/NCT06704230

Background: Sleep disturbance is one of the most common health concerns reported by individuals who have survived breast cancer (BC) and is associated with poor quality of life (QoL) and greater mortality after treatment. Cognitive behavioral therapy for insomnia (CBTi) has shown efficacy for improving sleep and QoL for this population. Considered the gold standard for insomnia treatment, CBTi can be delivered remotely, including via digital intervention. Despite the potential for wider dissemination of CBTi via digital means, these modalities have unique challenges, including technology barriers and poor adherence. We developed a conversational agent (CA) to deliver CBTi via a SMS text messaging intervention, supported by mobile-ready web content. Named “Cecebot,” this CA delivers sleep education, implements sleep compression, provides just-in-time interventions for sleep-disrupting behaviors, and includes enhanced support for physical activity (PA) beyond what is typically included in CBTi. This represents a novel modality for a CBTi and PA intervention among individuals who have survived BC. Objective: We aim to examine the safety and acceptability of the Cecebot intervention, developed by an academic partnership between Dr Reding’s research team and Moby Inc, for individuals who have survived BC and experience symptoms of insomnia, and to explore its efficacy. Methods: This trial will recruit 60 individuals who have survived BC and are experiencing moderate to severe sleep disturbance. Participants will be assigned to the Cecebot intervention or waitlist control group at a 1:1 ratio. The treatment group will receive the Cecebot intervention during weeks 1-6 of the study, while the waitlist control condition will receive the Cecebot intervention during weeks 6-12. The Cecebot intervention uses SMS text messaging technology paired with a Fitbit. Participants will be assessed at baseline, week 6, and week 12. Measurements will include feasibility and acceptability and will explore the effect of the Cecebot intervention. Feasibility will be assessed through recruitment, enrollment, and retention rates. Acceptability will be evaluated using a satisfaction survey and open-ended responses. Quantitative analysis, such as t test, Fisher exact tests, and generalized linear models, will be used to assess feasibility, baseline group differences, and the outcomes of the intervention. Results: Recruitment of participants began in Fall 2024. The completion of data collection is anticipated to be by Fall 2025. Conclusions: The study results will give insight into the potential for an SMS text messaging–based CA to improve sleep in individuals who have survived BC and experience sleep disturbances. Trial Registration: ClinicalTrials.gov NCT06392789; https://clinicaltrials.gov/study/NCT06392789

Background: Nursing in palliative medicine combines primary patient care with the special challenges of this medical field (eg, handling the processes of dying, grief, and death). These cause high stress levels and burden on the nursing staff, resulting in an early exit from working life because of physical or psychological disorders like burnout. Objective: DiPa (digitally identifying and minimizing stressors in palliative care) is a prospective study investigating the feasibility of measuring burden and its causes in palliative care using methods of subjective and objective stress detection. Based on these results, stress-reducing interventions are to be deduced and evaluated. In this paper, we present our study protocol. Methods: The nursing staff of an inpatient university palliative hospital ward gathered data over 6 weeks. Each was equipped with a smart wristband and a smartphone that continuously measure physiological and ambient parameters throughout their working day. These objective data were enriched by subjective measurements: a questionnaire at the beginning of the study that assessed multiple potential stressful situations and constellations in the private and working environment as well as ecological momentary assessments (EMAs) during the workday. The EMAs were prompted by scanning near-field communication (NFC) tags placed at different locations on the ward. The ongoing data analyses will be processed using computer algorithms partly programmed specifically for this study and partly drawn from existing libraries, such as toolboxes for neurophysiological signal processing for Python. Comparisons between subjective and objective measures and group comparisons between variables of interest will be made using inferential statistics, including regression analyses and analyses of variance. Data analysis using machine learning algorithms will be implemented once sufficient data are gathered. Results: The study was funded in October 2019. As of July 2025, 12 of 18 nurses in the palliative care unit consented to participate in our study. We expect to start detailed data analysis in in the third quarter of 2025 and to finish and publish our results in 2026. Conclusions: The DiPa study aims at testing the feasibility of measuring and merging subjective and objective stress parameters for palliative care nurses. Trial Registration: German Register for Clinical Studies DRKS00024425; https://drks.de/search/en/trial/DRKS00024425/details

Background: Kissing is a common social behavior that may influence physiological responses and impact oral health. Prior research has shown that affectionate behaviors like kissing can reduce stress and improve relationship satisfaction. However, the effects of kissing on salivary pH, particularly after consuming sugary or fermented beverages, have not been thoroughly investigated. Objective: This study aims to determine whether kissing accelerates salivary pH recovery following the consumption of sugary or fermented beverages. Methods: A randomized controlled trial will be conducted with 60 couples aged 18-30 years. Participants will be divided into 3 groups: a control group (no kissing), an experimental group where one partner consumes a beverage, and another experimental group where both partners consume a beverage. The study will measure salivary pH at baseline, after beverage consumption, and following a 40-second kiss or control period, with measurements taken every 5 minutes until the pH returns to neutral levels. The data will be analyzed using SPSS software (IBM Corporation). ANOVA will be used to compare salivary pH recovery between groups, and if assumptions of normality or sphericity are not met, alternative models such as generalized linear models or nonparametric tests will be considered. Results: The study is ongoing, with participant recruitment already initiated and preliminary data collection in progress. The study was funded by the Catholic University of Santiago de Guayaquil from June 2024 to June 2025. Ethics approval was obtained in June 2023. The results are expected to be published in the last quarter of 2025. Conclusions: This study will provide insights into the relationship between kissing, salivary pH, and oral health, potentially offering new strategies for the prevention of dental caries. The results may challenge existing assumptions about the role of kissing in oral health. Clinical Trial: ClinicalTrials.gov NCT06501729; https://clinicaltrials.gov/study/NCT06501729

Background: The US Veterans Affairs mental health residential rehabilitation treatment programs (MH RRTPs) provide residential care for veterans experiencing homelessness. However, those with co-occurring mental health and substance use disorders and criminal legal involvement require additional interventions to address risk factors for recidivism. Objective: We aimed to (1.1) evaluate whether the Maintaining Independence and Sobriety through Systems Integration, Outreach, and Networking Criminal Justice version (MISSION-CJ) intervention lowers criminal recidivism and improves health-related outcomes; (1.2) examine the mechanisms that impact outcomes; and (2) qualitatively assess the implementation of MISSION-CJ. Methods: Veterans participating in an MH RRTP (N=226) will be randomized to the enhanced usual care (EUC) or MISSION-CJ conditions in a hybrid type 1 randomized controlled trial to test the effectiveness and implementation of MISSION-CJ, a multicomponent intervention for co-occurring disorder. Both conditions will receive 6 months of services beginning within a week of MH RRTP enrollment (duration of stay: 3 months) and continue for 3 months after the MH RRTP in the community. The veterans in the EUC group (113/226, 50%) will receive a peer support curriculum and community outreach and linkage delivered by a peer support specialist. The veterans in the MISSION-CJ group (113/226, 50%) will receive team-based (case manager and peer support specialist) care, including treatment planning, case management using a critical time intervention model to promote referrals and linkages, enhanced dual recovery therapy sessions, and peer support sessions. Assessments, including questions regarding substance use and mental health history, criminal history and recidivism risk, housing, employment, medication adherence, mutual-help group attendance, antisocial attitudes, affiliations with peers, community involvement, and treatment services received, will be conducted at baseline and 6 months and 15 months after baseline. We will use generalized linear mixed effects regression models to evaluate MISSION-CJ based on outcomes (objective 1.1). We will conduct mediation analysis to examine mechanisms of action (objective 1.2). For the qualitative evaluation (objective 2), we will use thematic analysis to identify themes. Results: As of March 2025, 118 veterans (site 1: n=52, 44.1% and site 2: n=66, 55.9%) have been enrolled. Overall, 58 veterans (site 1: n=27, 47% and site 2: n=31, 53%) have been randomized to the MISSION-CJ group, and 60 veterans (site 1: n=25, 42% and site 2: n=35, 58%) have been randomized to the EUC group. Overall, 23 interviews for the qualitative evaluation have been completed with veterans. Veterans are continuing to receive treatment and completing follow-up assessments. The findings from this trial and qualitative evaluation will be available by 2026. The quantitative and qualitative components of this project are intended to work synergistically to reinforce knowledge of MISSION-CJ’s effectiveness, implementation, and scalability. Conclusions: If effective, the implementation of MISSION-CJ alongside the MH RRTPs may be advantageous to address risk factors related to recidivism. Trial Registration: ClinicalTrials.gov NCT04523337; https://clinicaltrials.gov/study/NCT04523337

Background: University students and staff members, especially those who frequently eat out and spend considerable time on campus, form a crucial demographic facing challenges related to high salt and sugar intake in out-of-home food. Recognizing the high prevalence of eating out among these populations, it is imperative to understand the salt and sugar consumption levels of campus communities. Objective: This protocol describes the rationale and design of a 3-part cross-sectional and longitudinal interventional study to reduce salt and sugar contents in canteen foods and intakes among students and staff at Sunway University and Sunway College in Malaysia. Methods: First, the knowledge, attitudes, and practices (KAPs) and perception, barriers, and enablers (PBEs) of salt and sugar intake and reduction were assessed among students and staff (part 1 of the study). Second, the KAPs and PBEs of salt, oil, and sugar reduction were assessed among canteen staff (part 2 of the study). Third, a longitudinal interventional study was conducted by implementing a campus-wide executive order to reduce salt and sugar in all foods sold on campus (part 3 of the study). The salt and sugar contents of selected foods were measured at baseline and at 3 months and 6 months postreduction. Participants who eat frequently on campus were selected as the intervention group, while those who do not comprised the control group. All participants had their urine electrolytes and body compositions measured and recorded 24-hour dietary intakes for 2 weekdays and 1 weekend at baseline, 3 months, and 6 months after salt and sugar reduction. Results: The study protocols were approved by the institutional review board of Sunway University (SUREC 2024/029 and SUREC 2024/040). Recruitment for the cross-sectional studies began in May 2024, while that for the longitudinal intervention study began in June 2024. The 6-month intervention began in September 2024 immediately after the official launch of the campus-wide executive order to reduce salt and sugar. We targeted recruitment of 1000, 50, and 300 participants for parts 1, 2, and 3, respectively. We anticipate reduced dietary salt and sugar intakes by 30% and 50%, respectively (World Health Organization targets), and beneficial health effects on the participants. Conclusions: The insights gained from this study will help to create a healthier food environment, benefitting individuals who regularly eat out, especially at the workplace. Trial Registration: ClinicalTrials.gov NCT06473038; https://clinicaltrials.gov/study/NCT06473038

Background: Pressure in combination with shear forces can deform soft tissues and lead to development of pressure ulcers. The prevalence rate of pressure ulcers in the United Kingdom remains unacceptably high and can occur across the human lifespan. The posterior heel represents a common anatomical site for pressure ulcers due to soft tissues lying adjacent to bony prominences and being exposed to pressure and shear during lying postures. Localized cooling and interface materials that reduce shear may offer potentially therapeutic benefits in the development of pressure ulcers. Yet the physiological mechanisms underpinning the potential benefits of localized cooling are not fully understood. Objective: This study protocol aims to investigate how localized cooling influences the skin’s microvascular, inflammatory, structural, and perceptual tolerance to repeated shear loading at the heel. Methods: The protocol will be tested on individuals of different age, sex, skin tone, and comorbidities, using a repeated measures design. Three cohorts will be recruited: (1) young and healthy (n=35), (2) older and healthy (n=35), and (3) with spinal cord injury (n=35). Participants will complete 3 testing sessions using a custom-built shearing rig with integrated thermal plate, during which the posterior aspect of the heel will be exposed to a standardized mechanical stimulus to elicit repeated pressure and shear loading. The experimental condition of each session will be determined by the temperature of the thermal plate, which will be set to either 36 °C (no cooling), 24 °C (mild cooling), or 16 °C (strong cooling). Continuous measurements will include kinetic coefficient of friction (CoF) and skin blood flow (via laser Doppler flowmetry; 40 Hz). Pro- and anti-inflammatory biomarkers in skin sebum (via Sebutape), structural skin properties (via optical coherence tomography), skin conductance (in microsiemens) and ratings of thermal sensation, comfort, and acceptance (via Likert scales) will also be assessed before and after the shear stress protocol. Results: Recruitment began in January 2024. As of February 2025, 43 participants had been enrolled in the study. Data collection and analysis are ongoing, and published findings are expected to be available in early 2026. Conclusions: This analysis will help identify mechanisms of skin damage following repeated shear stress at the heel, furthering our understanding of superficial pressure ulcers. It will also establish physiological and perceptual thresholds for the protective effects of cooling from shearing-induced damage at the heel.

Background: Anxiety disorders are among the most common mental health disorders, affecting a significant portion of the population. However, conventional treatments, such as pharmacotherapy and psychotherapy, often have limited effectiveness and may lead to undesirable side effects. Consequently, there is a growing demand for new alternative treatments for anxiety disorders. Recent studies suggest that electroacupuncture may demonstrate therapeutic effects in managing anxiety by mediating nerve stimulation. Objective: This study is designed to assess the efficacy and safety of electroacupuncture in treating anxiety disorders through nerve stimulation. Specifically, it will involve stimulating the median nerve at the PC6 acupoint (Neiguan) and the vagus nerve at the TF4 acupoint (Shenmen of ear acupuncture). Methods: This study is a randomized, assessor-blind, three-arm, parallel-group clinical trial comprising the PC6 electroacupuncture group, TF4 electroacupuncture group, and a control group. Participants will include patients diagnosed with social anxiety disorder, panic disorder, agoraphobia, and generalized anxiety disorder. Eligible participants will be randomly assigned to one of the 3 groups, with each group containing 20 individuals. The electroacupuncture groups will receive treatments at the designated acupoints twice weekly for 8 weeks, totaling 16 sessions. The control group will receive usual care without any treatment interventions through the end of the study period. The primary outcome is the comparison of Hamilton Anxiety Rating Scale scores between the treatment groups and the control group. Secondary outcomes include scores on the Hamilton Anxiety Rating Scale, Beck Anxiety Inventory, Beck Depression Inventory-II, Patient Health Questionnaire-15, World Health Organization Quality of Life Assessment Instrument abbreviated version, Penn State Worry Questionnaire, Panic Disorder Severity Scale, and Leibowitz Social Anxiety Scale. Safety evaluation variables include the frequency of adverse events, vital signs, and suicide risk assessment. Exploratory variables include performance on the Emotional Reactivity Test, empathy quotient, and heart rate variability. Results: The first participant was enrolled on December 15, 2022. As of October 2024, a total of 60 participants have been fully registered, and the intervention is currently in progress. We expect the completion of this trial to occur within the year 2025. Conclusions: In this study, we will evaluate the safety and efficacy of electroacupuncture for anxiety disorders. By elucidating the therapeutic mechanisms of electroacupuncture through nerve stimulation, this study will provide clinical evidence to support the development of potential interventions for patients with anxiety disorders. Trial Registration: Clinical Research Information Service of the Republic of Korea KCT0008378; https://cris.nih.go.kr/cris/search/detailSearch.do/24503

Background: Older Chinese Americans are at high risk of dementia, yet they often do not access culturally relevant services/programs to reduce their risks due to issues such as language barriers and transportation. BrainHQ is a mobile-based, effective cognitive training program that can potentially address these barriers and delay cognitive decline in older Chinese Americans. Objective: We aim to evaluate the feasibility and acceptability of a mobile-based cognitive training intervention co-designed by older Chinese Americans and their adult children. Methods: We applied an experience-based co-design approach that leverages existing cognitive training features and older Chinese Americans’ prior knowledge, lived experiences, and social norms around dementia to co-develop a cognitive training intervention. We conducted an experience-based co-design workshop with Older Chinese Americans (n=10), and their adult children (n=4) to optimize the cultural and linguistic relevance of the cognitive training intervention. Participants used a journey map to brainstorm challenges they may experience when participating in the intervention. Then, the participants created prototypes of intervention components to address these challenges. Finally, we incorporated these prototypes into the co-designed intervention protocol. A total of 30 participants will be recruited into the intervention study and will be randomly assigned to the intervention or waitlist control group (2:1 ratio). The intervention group will complete the mobile-based cognitive training for between 10 and 15 minutes daily for 12 weeks. The primary outcomes are feasibility and acceptability. Global cognition, mental health, physical functioning, and quality of life will be assessed at baseline, 8, and 12 weeks. Results: This pilot trial received institutional review board approval (Pro00109934l) in November 2024. We enrolled the first participant in December 2024 and aim to complete enrollment by May 2025. We expect to complete all data collection by September 2025. We will analyze the data and report study findings by February 2026. Conclusions: This study leverages partnerships with academic, industry, and community stakeholders and provides the groundwork for a large-scale randomized controlled trial to test the efficacy of a mobile-based cognitive training intervention for older Chinese Americans. The co-design workshop served as a feasible, innovative approach to engage with the participants and improve the study design. These findings will enhance the culturally tailored delivery of cognitive training to older Chinese Americans and provide insights for broader implementation, improving their engagement in dementia research. Trial Registration: ClinicalTrials.gov NCT05355870; https://clinicaltrials.gov/study/NCT05355870

Background: Falls are a critical source of injury and hospitalization and leave many older adults unable to return home, especially in rural communities with limited access to health care and support services. Studying falls prevention among rural older adults is essential because they may face an increased risk of falls due to unique environmental factors, geography, and outdoor activities. Moreover, rural older adults may have limited awareness regarding fall-related risks and preventive activities. Objective: The objective of this scoping review is to explore the literature about falls prevention from the perspectives of older adults living within a rural context. This review protocol aims to identify the search parameters and methodology that will be used in the scoping review. Methods: This scoping review will be guided by Arksey and O’Malley’s 5-step methodological framework. We will search for relevant peer-reviewed English language literature from 5 databases: CINAHL, PubMed, Academic Search Complete, PsycINFO, and Scopus. The reference lists of relevant studies will be hand-searched to identify papers. Inclusion criteria (English language, peer-reviewed journal papers, original research, focusing on rural perspectives to support falls prevention, and published from January 2013 to December 31, 2023) will be used to determine the eligibility of the journal papers. The data from the included papers will be extracted using a standardized table and analyzed using thematic analysis. Results: This protocol was registered with the Open Science Framework on June 26, 2024. The scoping review’s data collection and analysis were conducted from September to December 2024. Results from the review will be distributed through publication in a peer-reviewed journal paper, conference presentation, webinar, and a rural community workshop. Conclusions: Understanding rural older adults’ perspectives of falls prevention is critical to supporting independence and healthy aging in rural communities. This review’s findings about falls prevention may have important implications for rural community leaders, policy makers, and health practitioners working to support falls prevention in rural communities.

Background: Rheumatoid arthritis (RA) is a chronic autoimmune inflammatory disease that affects approximately 0.5% to 1% of the population in the United States and Northern Europe. Interstitial lung disease (ILD) is the most common and severe pulmonary manifestation of RA, collectively referred to as RA-associated ILD (RA-ILD). RA-ILD contributes significantly to morbidity and mortality and often presents with a variable clinical course. Although corticosteroids and disease-modifying antirheumatic drugs (DMARDs) remain the cornerstone of RA management, their role in RA-ILD is less clearly defined. In contrast, antifibrotic therapies such as pirfenidone and nintedanib, initially developed for idiopathic pulmonary fibrosis, are now being explored for their potential in treating fibrosing variants of RA-ILD. Despite increasing clinical use, no systematic review has comprehensively compared the safety and efficacy of antifibrotic versus anti-inflammatory therapies in chronic RA-ILD. Objective: This study aims to compare the impact of antifibrotic and anti-inflammatory therapies on lung function, radiologic progression, clinical outcomes, and safety in patients with chronic RA-ILD. Methods: This study will follow PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines and is registered with PROSPERO (CRD42024583847). A comprehensive search of PubMed, Embase, and the Cochrane Library will be conducted for studies published between January 1991 and August 2024. Eligible studies will include adult patients (aged ≥18 years) with a diagnosis of RA and confirmed ILD based on radiological or histopathological findings who have been treated with either antifibrotic or anti-inflammatory therapies. The PECOS (Population, Exposure, Comparator, Outcome, Study Design) framework will be used to define inclusion criteria. The primary outcomes assessed in this review will include the following pulmonary function parameters: forced vital capacity, forced expiratory volume in 1 second, and diffusing capacity of the lungs for carbon monoxide. Anti-inflammatory therapies will be stratified into corticosteroids, conventional synthetic DMARDs, and biologic DMARDs to account for heterogeneity. The Cochrane Risk of Bias 2 (RoB 2) and Risk of Bias in Non-randomized Studies - of Interventions (ROBINS-I) tools will be used for quality assessment, and GRADE (Grading of Recommendations Assessment, Development, and Evaluation) methodology will be used to evaluate the certainty of evidence. Results: The literature search and screening commenced in August 2024, and data extraction is underway. The final results are expected by December 2025. Conclusions: This systematic review and meta-analysis will provide a comprehensive comparison of antifibrotic and anti-inflammatory therapies in the treatment of chronic RA-ILD. The findings will help inform clinical decision-making, support evidence-based treatment selection, and identify gaps in current research. By addressing both efficacy and safety, this review aims to guide future studies and improve patient outcomes for this complex and debilitating condition. Trial Registration: PROSPERO CRD42024583847; https://www.crd.york.ac.uk/PROSPERO/view/CRD42024583847

Background: Speech and language biomarkers have the potential to provide regular, objective assessments of symptom severity in several neurological and mental health conditions, both in the clinic and remotely. However, speech and language characteristics within an individual are influenced by multiple variables that can make findings highly dependent on the chosen methodology and study cohort. These characteristics are often not reported adequately in studies investigating speech-based health assessment, which (1) hinders the progress of methodological speech research, (2) prevents replication, and (3) makes the definitive identification of robust biomarkers problematic. Objective: This study aims (1) to facilitate replicable speech research by presenting a transparent speech collection and feature extraction protocol and design checklist for other researchers to adapt and design for their own experiments and (2) to demonstrate in a pilot study the feasibility of implementing our example in-laboratory protocol that reduces multiple potential confounding factors in repeated recordings of healthy speech. Methods: We developed a collection and feature extraction protocol based on a thematic literature review to enable a controlled investigation of within-individual speech variability in healthy individuals. Our protocol comprises the elicitation of read speech, held vowels, and a picture description and extraction of 14 example features relevant to health. We collected speech using a freestanding condenser microphone, 3 smartphones, and a headset to enable a sensitivity analysis across different recording devices. Results: We collected healthy speech data from 28 individuals 3 times in 1 day (the “day” cohort), with the same schedule repeated 8 to 11 weeks later, and from 25 individuals on 3 days within 1 week at fixed times (the “week” cohort). Participant characteristics collected included sex, age, native language, and voice use habits. Before each recording, we collected information on recent voice use, food and drink intake, and emotional state. Recording times were also documented. Analysis relating to exploring within-individual variability within the day and week cohorts, as well as the device-type sensitivity analysis, is ongoing, with findings expected later in 2025. Conclusions: The wide variability in speech data collection, processing, analysis, and reporting in research on speech’s use in clinical trials and practice is the motivation for this paper and the development of the speech curation protocol design checklist. Increased, more consistent reporting and justification of study protocols is urgently required to facilitate speech research replication and translation into clinical practice.

Background: Gay and bisexual men who have sex with men (MSM) in the rural United States are less likely to test for HIV and sexually transmitted infections (STIs) and use pre-exposure prophylaxis (PrEP) compared to urban MSM. Given the challenges in building brick-and-mortar facilities serving the sexual health needs of MSM in rural communities, there is a need to evaluate digital engagement strategies. Combine is a smartphone app designed to provide HIV prevention information and resources to MSM that may be particularly well suited to support rural MSM. HealthMindr, an app from which Combine is adapted, has previously been shown to increase HIV testing and PrEP uptake among urban MSM. Because rural MSM face additional barriers to accessing HIV prevention services, a motivational interview (MI) focused on HIV prevention strategies might enhance the effectiveness of Combine to increase uptake of HIV testing, STI testing, and PrEP. Objective: This study aims to determine the effectiveness of the Combine app to increase HIV testing, STI testing, and PrEP initiation among rural cisgender MSM. We will also assess the effectiveness of 2 adjunctive interventions: the availability of free HIV and STI self-test kits and the offering of an MI. Methods: In this type 2 hybrid effectiveness-implementation randomized controlled trial, we will assess the effectiveness of Combine to increase HIV testing, STI testing, and PrEP initiation among rural MSM across the Southern United States. A total of 464 men will be recruited and randomized to 1 of the 4 arms. Participants in all 4 arms will have access to most app features (eg, health resources, quizzes, health care provider locators, and ordering free condoms and lubricants). Using a 2×2 factorial design, half (232/464, 50%) of the participants will be randomized to receive access to free at-home HIV and STI self-test kits and half (232/464, 50%) will be randomized to receive an MI. Participants will complete surveys every 6 months to allow for assessment of self-reported outcomes: app use, HIV testing, STI testing, and PrEP initiation over the 24-month follow-up period. Self-reported PrEP uptake will be verified by dried blood spot testing or uploading a photograph of a PrEP prescription. Results: Participant recruitment began in March 2024. As of July 2025, 395 participants have been enrolled and randomized. Recruitment is expected to be completed by December 2025. Conclusions: This trial will determine whether the Combine app increases HIV testing, STI testing, and PrEP uptake among rural MSM in the Southern United States. It will also provide critical information about the most effective strategies for implementing digital health interventions for rural MSM. Trial Registration: ClinicalTrials.gov NCT06205368; https://clinicaltrials.gov/study/NCT06205368

Background: Research indicates that many autistic adults are insufficiently active and overly sedentary. There is limited evidence on effective strategies to increase physical activity (PA) and reduce sedentary behavior (SB) in this population. Gamified mobile health (mHealth) interventions show promise for addressing these challenges by leveraging autistic individuals’ strengths in visuospatial learning and their affinity for digital gaming. Despite this potential, it remains unclear how well these interventions translate to real-world settings. This gap is compounded by the lack of community-based participatory approaches in the development of mHealth intervention for autistic adults. Objective: This study aims to (1) formulate gamification and behavior change strategies for the PuzzleWalk v2 app using a community-based participatory approach and (2) evaluate its feasibility and acceptability for increasing PA and reducing SB among autistic adults, including those with mild intellectual disability, in real-world settings. Methods: This study, consisting of 2 sequential phases, will be conducted entirely remotely: (1) online community-based design workshops to refine the PuzzleWalk gamified mHealth system with input from key autism stakeholders, including autistic adults and caregivers, and (2) an 8-week field deployment to assess real-world usability and engagement. In Phase I (completed), weekly workshops and usability testing focused on understanding autistic adults’ technology preferences, evaluating PuzzleWalk v1 and v2 prototypes, and incorporating stakeholder feedback into iterative app development (n=9). Phase II (in progress) will involve a single-arm clinical trial where approximately 70 participants will use the app alongside research-grade activity-tracking accelerometers to measure PA and SB. Outcome measures, including sedentary time, step counts, PA intensities, and app engagement (eg, time spent using the app), will be collected across 4 specific time points (ie, baseline and weeks 3, 5, and 8). Repeated measures ANCOVA will be performed to examine changes in participants’ objective levels of PA and sedentary time before, during, and after the intervention. Results: Phase I of the study, involving community-based participatory design workshops and usability testing, was completed in November 2024. Key autism stakeholders recognized the gamified PuzzleWalk app as a viable tool for enhancing motivation toward PA and SB changes among autistic adults. Data collection for Phase II, the field deployment, is currently underway and is expected to end in August 2025. As of July 2025, we had enrolled 69 participants in the study. The findings of these studies will be shared in a subsequent peer-reviewed publication. Conclusions: Results of the ongoing field deployment study (Phase II) will further clarify the app’s effectiveness and real-world applicability. Trial Registration: ClinicalTrials.gov NCT06566131; https://clinicaltrials.gov/study/NCT06566131

Background: Reducing blood pressure fluctuations during surgery is a key objective in improving patient outcomes. Although acupuncture has been suggested as a potential noninvasive intervention for blood pressure modulation, its effectiveness in reducing intraoperative fluctuations remains unclear. Objective: This study aims to investigate whether acupuncture can help stabilize blood pressure during surgery, particularly in women undergoing laparoscopic hysterectomy, a procedure known to cause marked hemodynamic changes during the early intraoperative phase. Methods: This is a prospective, single-center, randomized controlled clinical trial with a parallel-group design. Forty-eight adult patients scheduled to undergo a total laparoscopic hysterectomy are eligible for this study. Participants who provide consent will be randomly assigned in a 1:1 ratio to the acupuncture or placebo groups. They will be followed up for at least 14 days to assess the safety of the intervention, general anesthesia, and surgery. Researchers will compare the difference between the highest and lowest mean blood pressures from anesthesia induction to the postincision period as the primary endpoint. As secondary outcomes, systolic, diastolic, and mean blood pressures will be compared at each predetermined timepoint. The incidences of hypotension, hypertension, tachycardia, and bradycardia will be determined separately. The use of remifentanil at the early stage of surgery, rate of surgical discontinuation, and length of hospital stay will be assessed as surrogate indicators of stable general anesthesia and surgical procedures. For patient-reported outcomes, the Spielberger State-Trait Anxiety Inventory and EQ-5D-5L will be used to evaluate changes in anxiety and overall quality of life. This study may support the use of acupuncture as a complementary intervention to help maintain hemodynamic stability during laparoscopic hysterectomy. The study will be conducted in accordance with the Declaration of Helsinki and has been approved by the Institutional Review Board of CHA Ilsan Medical Center (ICHA 2022-11-010; date of approval: January 03, 2023). Results: Recruitment began in October 2023 and is expected to continue until December 2025. The intervention and data collection procedures are proceeding without major difficulties, with a dropout rate of 11.4%. As of June 2025, a total of 35 participants have been successfully recruited and randomized. Final data analysis is scheduled for completion by March 2026, and the study results are expected to be published in December 2026. Conclusions: This trial will provide valuable evidence on the efficacy of acupuncture for stabilizing intraoperative blood pressure and supporting hemodynamic control during laparoscopic hysterectomy. Trial Registration: ClinicalTrials.gov NCT05720884; https://clinicaltrials.gov/study/NCT05720884

Background: Compassion fatigue and burnout among health care professionals are growing concerns, impacting the well-being of both providers and patients. Objective: This scoping review aims to map existing evidence on the levels of compassion satisfaction, burnout, and secondary traumatic stress among health care professionals while identifying factors influencing their professional quality of life. Methods: We will conduct a scoping review using established methods proposed by Arksey and O’Malley and Levac et al, also incorporating the recommendations of the Joanna Briggs Institute for scoping reviews and reporting guidelines. EMBASE, ERIC, PubMed, Science Direct, Scopus, and Web of Science will be searched from March 2019 to March 2024, with an update closer to the time of manuscript submission. Gray literature sources will also be searched. Publications that contain primary studies, systematic reviews, meta-analyses, and clinical guidelines addressing compassion fatigue and burnout prevention in health care professionals will be selected for inclusion. Extracted data items will include study characteristics, interventions for the prevention of compassion fatigue and burnout, measures of compassion satisfaction, burnout, and secondary traumatic stress, as well as the quality of reporting and methodology. Results: A narrative synthesis with summary tables will be used to describe our findings. The review is expected to be completed by December 2025, and the search strategy has been developed and pilot-tested. Conclusions: Our findings will help identify gaps in the literature with respect to compassion fatigue and burnout prevention strategies for health care professionals. This review will provide a comprehensive overview of current research, informing future interventions and policies aimed at improving health care professionals’ well-being and job satisfaction. Trial Registration: Open Science Framework r83cu; https://osf.io/r83cu

Background: There is growing concern about the mental health of students in higher education institutions (HEIs) across the United Kingdom. Increasingly diverse student populations, the legacy of the COVID-19 pandemic, and variations in policies and service provision across the 4 UK nations have highlighted the need for a comprehensive understanding of student mental health. Current literature remains fragmented, with limited synthesis comparing national contexts. This protocol outlines a scoping review to systematically map the evidence base, identify key research gaps, and inform future research priorities and interventions. Objective: The primary aim is to identify and map existing research on student mental health in UK HEIs. Specific objectives include exploring how student mental health is defined and measured, identifying risk factors, assessing support systems and interventions, and highlighting gaps in research across England, Scotland, Wales, and Northern Ireland. Methods: This scoping review will follow Joanna Briggs Institute methodology and be reported in line with PRISMA-ScR (Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews) guidelines. Studies will be eligible for inclusion if they (1) were conducted in the United Kingdom; (2) involved students aged 16 years and older enrolled in HEIs; (3) addressed mental health–related outcomes, definitions, or interventions; and (4) were published in English from 2005 onwards. Excluded materials include gray literature not identified during database searching. A comprehensive 3-step search strategy will be used. Initially, APA PsycInfo and MEDLINE (Ovid) will be searched, followed by a broader search across Scopus, Web of Science (Core Collection), Child and Adolescent Development Studies, and the Cochrane Library. Reference lists of the included studies will be screened for additional sources. All citations will be managed using Covidence, and study selection will involve title/abstract screening and full-text review by independent reviewers. Data extraction will include information on study design, population characteristics, mental health outcomes, measures used, interventions, and key findings. Data will be presented in tabular and narrative forms and, where appropriate, descriptive content analysis will be used. Results: As of April 2025, preliminary searches and pilot screenings have been completed. The full database search and data charting phase will commence in June 2025. The final synthesis, analysis, and stakeholder consultation are scheduled between September and November 2025. The full review will be completed by December 2025, with dissemination activities planned through early 2026. Conclusions: This review will provide a comprehensive overview of student mental health research within UK HEIs. It will highlight the key national differences, emerging themes, and underresearched areas, supporting more targeted, evidence-informed policy and practice. Limitations include language and gray literature exclusions. Nonetheless, the findings are expected to make a timely and meaningful contribution to research and intervention strategies in UK higher education.

Background: Multiple sclerosis (MS) is a chronic, progressive, and neurodegenerative disease affecting more than 2.8 million people globally. Mobility impairments are among the most significant challenges faced by people with MS, leading to physical inactivity, deconditioning, and disability progression (for some, even irreversible disability). This negatively impacts mental health, social participation, and quality of life while placing a considerable economic burden on society. Exercise can improve mobility and mitigate disability progression, but facility-based options are often inaccessible, especially for those in remote areas. Telerehabilitation offers a promising alternative, but current systems are limited by complexity and hardware requirements. Objective: The PLATINUMS (Implementation of an Advanced Telerehabilitation Solution for People With Multiple Sclerosis) project proposes an AI-driven telerehabilitation system to deliver accessible, cost-effective, and home-based exercise therapy for people with MS. Methods: The PLATINUMS project begins with working package (WP) 1, focusing on obtaining ethical approval and recruiting staff. Following this, WP2 involves a 4-week system feasibility and usability study (n=40) to assess and refine the digital platform. WP3 comprises a validity study (n=60) to evaluate remote mobility tests via the system, such as the Short Physical Performance Battery (SPPB), functional reach, and sit-to-stand tests, to ensure their reliability for use in WP4, the feasibility multicenter randomized controlled trial (RCT). The 10-week multicenter feasibility RCT will be conducted in MS centers across Denmark, Ireland, Israel, and Italy, with 96 participants varying in disability levels. The primary objective is to evaluate the efficacy of the AI-powered telerehabilitation system on mobility outcomes compared to usual care. Finally, WP5 will assess the cost-effectiveness of the telerehabilitation system by analyzing implementation costs, adherence, and use of health care. The PLATINUMS project aims to revolutionize exercise therapy for people with MS by demonstrating the feasibility, validity, and preliminary efficacy of the AI-driven telerehabilitation system. This approach addresses barriers such as accessibility, privacy, and standardization while promoting patient and therapist acceptance. Results: Funding for the PLATINUMS project was obtained in February 2024. WP2 data collection began in April 2025 across 4 European sites. WP3 is scheduled to launch in July 2025, with WP4 (the feasibility RCT) planned for January 2026. Initial WP2 results are expected by October 2025, with first publications anticipated in mid-2026. Conclusions: The PLATINUMS project is expected to generate critical insights into the feasibility, usability, and preliminary efficacy of an AI-based telerehabilitation system for people with MS. By leveraging widely available technology and real-time feedback, the system addresses key barriers to traditional rehabilitation. Findings from this protocol may inform future large-scale trials and support the broader implementation of digital health solutions in neurological rehabilitation. Trial Registration:

Background: The prevalence of type 2 diabetes mellitus (T2DM) is steadily increasing and has exceeded 20% in some rural Kentucky counties. In Kentucky, chronic diet-sensitive conditions and unhealthy behaviors are among the highest in the nation, with approximately 36.5% of adults with obesity and 13.3% diagnosed with T2DM, while only 15.3% meet physical activity recommendations, and 4.7% meet fruit and vegetable consumption recommendations. Family-based interventions can be used to promote health in rural communities that often comprise intergenerational households. Objective: The purpose of the study is to determine whether leveraging family units as sources of social support promotes nutritional and physical activity changes among those who are overweight or have obesity and are diagnosed with T2DM. Methods: This study consists of 3 phases (baseline, intervention, and postintervention). An overview of the study will be provided to interested participants, after which their consent will be sought. At baseline, demographic data, social support, physical activity, diabetes knowledge, diabetes self-management, dietary recall, obstructive sleep apnea, and sleep health, as well as social network data, will be collected using validated questionnaires. Anthropometric (weight, height, lean mass, and body fat) and T2DM-related (blood pressure, glycated hemoglobin A1c [HbA1c], total cholesterol, low-density lipoproteins, high-density lipoproteins, and triglycerides) clinical measures will also be obtained. During the intervention phase, participants will complete 6 months of medical nutrition therapy (MNT) alongside 1 member of their social network (eg, household member). In addition, participants will have the option to attend Dining with Diabetes program sessions that are offered at the county level through Cooperative Extension Service (Extension) agents. Follow-up data collection will include clinical measures, a dietary recall, and the assessment of participants’ stage of behavior change at 3, 6, 9, and 12 months postintervention. Results: This study was funded in November 2022 by the American Diabetes Association (ADA). Data collection started on September 1, 2023, and is projected to end in November 2025. We have enrolled a total of 48 participants in the study. Conclusions: T2DM is a growing problem, particularly among vulnerable populations in rural Kentucky. This study plans to leverage family units as sources of social support with MNT and nutrition education through the Dining with Diabetes program. If effective, this approach will inform future family-based interventions in rural communities. Trial Registration: ClinicalTrials.gov NCT06080425; https://clinicaltrials.gov/study/NCT06080425

Background: Antimicrobial resistance (AMR) is recognized as a global concern, with particularly severe consequences in low- and middle-income countries. Although it may occur naturally, it is also an anthropogenic problem linked to the irrational use of antibiotics in humans and animal husbandry and the use of pesticides in plant agriculture. Generally, data on AMR and evidence of effective and feasible multifaceted interventions are limited in many African countries. Objective: This study aims at (1) assessing baseline data on AMR pathogens in Burkina Faso and Ghana; (2) understanding perceptions and quantifying use of antibiotics among health care workers, communities, and livestock farmers; and (3) defining and refining an AMR intervention using a design thinking approach. Methods: This multidisciplinary study will be conducted in two rural districts and will consist of two phases. First, baseline data will be collected on AMR pathogens along dominant food production chains. extended-spectrum beta-lactamase (ESBL)–producing Escherichia coli and Klebsiella pneumoniae will be selected as indicator mechanisms for AMR because of their high occurrence among animals and humans. The perception and understanding of AMR and antibiotic use among different stakeholders and community members will be assessed using epidemiologic and socio-anthropological methods. Qualitative methods will include participant observations, in-depth and key informant interviews, and focus group discussions. The quantitative part will consist of the development of an inventory of circulating antibiotics and a household survey. Second, key informant and in-depth interviews will be conducted with One Health stakeholders in preparation for the intervention development. Subsequently, multidisciplinary “design teams” will develop ideas for an intervention on AMR using a design thinking approach. Results: Data collection started in April 2022. The analysis of microbiological, anthropological, and socio-epidemiological data is ongoing in both countries. The intervention development has been initiated in Ghana but has not started yet in Burkina Faso. All results are planned to be submitted to peer-reviewed journals by December 2025. First, manuscripts will be published for each discipline. Afterward, the results of the 3 disciplines will be combined in multidisciplinary papers, and a publication of the evaluation of the intervention will follow. Conclusions: Owing to the multifactorial nature of AMR, different perspectives need to be considered to develop a holistic context-based intervention that is tailored to local needs. This study stands out in its combination of different disciplinary and epistemological perspectives following the One Health paradigm and taking a design thinking approach to develop an intervention. Thereby, collaboration across disciplines and social levels and a participatory bottom-up approach will be promoted to achieve a common understanding of problems and needs and to develop an accepted and efficacious intervention. The national AMR networks and policymakers will be continuously involved in the project.

Background: Mobile health (mHealth) technology has the ability to integrate personalized health management into patients’ daily routines. In prior investigations of mHealth apps for asthma, patient satisfaction and acceptability have been high. However, rigorous randomized controlled trials (RCTs) examining their effectiveness are sparse; the majority of mHealth asthma apps lack personalization and real-time feedback and fail to include at-risk pediatric populations, and many previous studies are not randomized. Objective: This full-scale RCT will examine the effectiveness of the Pulmonary Education and Asthma Knowledge Mobile Asthma Action Plan (PEAKmAAP), an interactive mHealth asthma action plan (mAAP) smartphone app, among adolescents compared to enhanced usual care (eUC). The study has 3 aims: (1) examine the effectiveness of PEAKmAAP in reducing asthma morbidity, as measured by the Asthma Control Test (ACT) score, health care use, medication use, and lung function; (2) examine the effectiveness of PEAKmAAP in asthma self-efficacy and medication adherence; and (3) examine the impact of sharing PEAKmAAP-generated data with the primary care provider (PCP) for a subset of enrolled subjects. We hypothesize that the PEAKmAAP groups will experience reduced asthma morbidity compared to the eUC group. Furthermore, we hypothesize that PCP data sharing is expected to enhance PCP prescribing patterns and that more adolescents in the Pulmonary Education and Asthma Knowledge Mobile Asthma Action Plan with data sharing (PEAKmAAP-DS) group will have sustained controlled at follow-up visits compared to PEAKmAAP alone or eUC. Methods: Using a 3-arm RCT lasting 12 months, we will assess the effectiveness of PEAKmAAP in reducing morbidity among 432 adolescents (age 12-20 years). The study population includes adolescents with uncontrolled symptoms who receive primary care at the Arkansas Children’s Hospital (ACH) or asthma care at ACH specialty clinics. At baseline, participants are randomly assigned to 1 of 3 groups: (1) PEAKmAAP group, (2) PEAKmAAP-DS group, and (3) eUC group using a smartphone app with daily non–asthma-related notifications. Study procedures will include baseline, 3-month, and 12-month in-person visits and telephone visits at 6 and 9 months. In-person visits will measure the ACT score, lung function, and self-efficacy; telephone visits will measure the ACT score. Participants will complete monthly online surveys to assess health care use and medication use. Results: Recruitment and data collection began in March 2019, and data collection concluded in May 2024. Full data analysis began in December 2024. Conclusions: This RCT aims to examine the effectiveness of a mAAP with real-time feedback and PCP data sharing. The study addresses existing gaps in knowledge regarding implementation of a mAAP for high-risk adolescents and has the potential to serve as a model for other populations at high risk for asthma. Trial Registration: ClinicalTrials.gov NCT03842033; https://clinicaltrials.gov/study/NCT03842033

Background: Assisted vaginal birth is a lifesaving procedure where health workers use special devices to expedite birth vaginally when some complications emerge, such as due to prolonged labor. When the use of assisted vaginal birth is possible and appropriate, it provides benefits over cesarean section. These benefits include shorter recovery, reduced hospital stays, lower risks of complications, cost savings, and greater likelihood of vaginal birth in future pregnancies. Despite these benefits, the use of assisted vaginal births has declined in recent years. Challenges remain on how to implement assisted vaginal birth effectively, equitably, and at scale in different health systems. Formative research is useful to understand local health system preparedness, acceptability, feasibility, and resource availability for designing and implementing health interventions. Objective: We developed a generic formative research protocol that can be used to design and implement interventions to optimize use of assisted vaginal birth in any setting and context. Methods: This formative research protocol is to be conducted in the setting where interventions to optimize assisted vaginal birth will be implemented. The formative research has three components: (1) document review, (2) readiness assessment, and (3) primary qualitative research. Document review will examine existing policy and guidelines, while readiness assessment will assess the service delivery context. The 2 components aim to identify potential barriers and facilitators to use of assisted vaginal birth. Primary qualitative research will involve women, families, community members, health workers, facility administrators, and policy makers. Interview questions are structured around potential interventions to optimize use of assisted vaginal birth. This protocol includes all the essential study instruments. Results: This is a generic research protocol that can be used by any stakeholder aiming to optimize assisted vaginal birth in any setting. Serving as a preparatory guide, it provides a structured approach for planning and implementing evidence-based and context-specific strategies aligned with best practices in maternal health care. No data collection or analysis has been conducted to date. Conclusions: This generic protocol can serve as a guide in conducting formative research as intervention preparation to optimize use of assisted vaginal birth. The results can inform the design and implementation of appropriate interventions from the perspectives of important stakeholders. Therefore, we recommend that trialists, clinicians, researchers, administrators, and policy makers use this protocol before implementation to understand local context and incorporate perspectives of key stakeholders to promote equitable, high-quality, and women-centered care.

Background: Acute respiratory infections (ARIs) are frequent reasons for medical consultations in general practice and can lead to unnecessary recontacts. Introducing new point-of-care (POC) polymerase chain reaction (PCR) diagnostic equipment may offer an attractive and efficient way of providing a more precise and exact microbial diagnosis. Successful uptake of POC PCR equipment could potentially lead to a reduction in recontacts with benefits for both staff and patients. However, introducing new diagnostic technology is a complex intervention and several contextual factors may impact the implementation. Objective: This study aims to evaluate the effect of POC PCR test availability in general practice on the subsequent (1) number of recontacts to the general practitioner (GP) for patients with symptoms of ARIs (primary outcome) and (2) hospital admissions, deaths, antibiotic prescriptions, health-related quality of life, GP and patient satisfaction, costs, cost-effectiveness, and contextual facilitators and barriers conditioning the implementation process (secondary outcomes). Methods: This study is a cluster-randomized, crossover, nonblinded superiority trial with a 1:1 allocation ratio between usual care (control) and POC PCR test availability (intervention). Questionnaire data are collected at day 0, 7, 14, and 28 after the initial contact (health-related quality of life, absenteeism and presentism among patients, and patient satisfaction) and after finalization of the study period (GP satisfaction). Data on recontacts, hospital admissions, redeemed antibiotic prescriptions, costs, and deaths will be retrieved from the Danish national registries. The implementation process will be evaluated based on data from interviews with users of POC PCR tests (i.e., GPs, staff, and patients) and from observations in the clinics in line with Medical Research Council guidelines. Results: As per the randomized crossover design carried out during September 2023 to March 2024 investigating a sample of 100 GP clinics, we expect to obtain an in-depth and multifaceted understanding of the effects of the availability of the POC PCR test equipment in general practice. Conclusions: This study will provide valuable information about the diagnostic conditions and possibilities in general practice and provide insights into the organization of primary health care. Trial Registration: ClinicalTrials.gov NCT06120153; https://clinicaltrials.gov/study/NCT06120153