Introduction Coexisting multiple health conditions is common among older people, a population that is increasing globally. The potential for polypharmacy, adverse events, drug interactions and development of additional health conditions complicates prescribing decisions for these patients. Artificial intelligence (AI)-generated decision-making tools may help guide clinical decisions in the context of multiple health conditions, by determining which of the multiple medication options is best. This study aims to explore the perceptions of healthcare professionals (HCPs) and patients on the use of AI in the management of multiple health conditions. Methods and analysis A qualitative study will be conducted using semistructured interviews. Adults (≥18 years) with multiple health conditions living in the West Midlands of England and HCPs with experience in caring for patients with multiple health conditions will be eligible and purposively sampled. Patients will be identified from Clinical Practice Research Datalink (CPRD) Aurum; CPRD will contact general practitioners who will in turn, send a letter to patients inviting them to take part. Eligible HCPs will be recruited through British HCP bodies and known contacts. Up to 30 patients and 30 HCPs will be recruited, until data saturation is achieved. Interviews will be in-person or virtual, audio recorded and transcribed verbatim. The topic guide is designed to explore participants’ attitudes towards AI-informed clinical decision-making to augment clinician-directed decision-making, the perceived advantages and disadvantages of both methods and attitudes towards risk management. Case vignettes comprising a common decision pathway for patients with multiple health conditions will be presented during each interview to invite participants’ opinions on how their experiences compare. Data will be analysed thematically using the Framework Method. Ethics and dissemination This study has been approved by the National Health Service Research Ethics Committee (Reference: 22/SC/0210). Written informed consent or verbal consent will be obtained prior to each interview. The findings from this study will be disseminated through peer-reviewed publications, conferences and lay summaries.

Background: Digital health literacy is considered a health determinant that can influence improved health and well-being, health equity, and the reduction of social health inequalities. Therefore, it serves as an asset for individuals to promote their health. However, low digital health literacy is a major problem among forced migrant populations. They do not always have the capacity and skills to access digital health resources and use them appropriately. To our knowledge, no studies are currently available to examine effective interventions for improving digital health literacy among forced migrant populations. Objective: This paper presents the protocol for a systematic review that aims to assess the effectiveness of digital health literacy interventions among forced migrant populations. With this review, our objectives are as follows: (1) identify interventions designed to improve digital health literacy among forced migrant populations, including interventions aimed at creating enabling conditions or environments that cater to the needs and expectations of forced migrants limited by low levels of digital health literacy, with the goal of facilitating their access to and use of eHealth resources; (2) define the categories and describe the characteristics of these interventions, which are designed to enhance the abilities of forced migrants or adapt digital health services to meet the needs and expectations of forced migrant populations. Methods: A mixed methods systematic review will be conducted according to the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) checklist. The research will be conducted in an iterative process among the different authors. With the help of a medical information specialist, a specific search strategy will be formulated for the 6 most relevant databases (ie, MEDLINE, Embase, CINAHL, Web of Science, Academic Search Premier, PsycINFO, and the Google Scholar search engine). A literature search covering studies published between 2000 and 2022 has already been conducted. Two reviewers then proceeded, individually and independently, to conduct a double selection of titles, abstracts, and then full texts. Data extraction will be conducted by a reviewer and validated by a senior researcher. We will use the narrative synthesis method (ie, structured narrative summaries of key themes) to present a comprehensive picture of effective digital health literacy interventions among forced migrant populations and the success factors of these interventions. Results: The search strategy and literature search were completed in December 2022. A total of 1232 articles were identified. The first selection was completed in July 2023. The second selection is still in progress. The publication of the systematic review is scheduled for December 2023. Conclusions: This mixed methods systematic review will provide comprehensive knowledge on effective interventions for digital literacy among forced migrant populations. The evidence generated will further inform stakeholders and aid decision makers in promoting equitable access to and use of digital health resources for forced migrant populations and the general population in host countries.

Background: The present study protocol is designed to cover the Norwegian part of the European Union Collaborative Project—REgioNs of Europe WorkINg together for HEALTH (RENEWING HEALTH). Self-management support is an important element of care for persons with type 2 diabetes (T2D) for achieving metabolic control and positive lifestyle changes. Telemedicine (TM) with or without health counseling may become an important technological aid for self-management and may provide a user-centered model of care. In spite of many earlier studies on TM, there remains a lack of consensus in research findings about the effect of TM interventions. Objective: The aim of RENEWING HEALTH is to validate and evaluate innovative TM tools on a large scale through a common evaluation, making it easier for decision makers to choose the most efficient and cost-effective technological interventions. The Norwegian pilot study evaluates whether the introduction of a mobile phone with a diabetes diary application together with health counseling intervention produces benefits in terms of the desired outcomes, as reflected in the hemoglobin A1c level, health-related quality of life, behavior change, and cost-effectiveness. Methods: The present study has a mixed-method design comprising a three-armed prospective randomized controlled trial and qualitative interviews with study data collected at three time points: baseline, after 4 months, and after 1 year. The patients’ registrations on the application are recorded continuously and are sent securely to a server. Results: The inclusion of patients started in March 2011, and 100% of the planned sample size is included (N=151). Of all the participants, 26/151 patients (17.2%) are lost to follow-up by now, and 11/151 patients (7.3%) are still in the trial. Results of the study protocol will be presented in 2014. Conclusions: The key goals of this trial are to investigate the effect of an electronic diabetes diary app with and without health counseling, and to determine whether health counseling is important to the continued use of the application and the patients’ health competence and acceptability. Research within this area is needed because few studies have investigated the effectiveness of apps used in long-term interventions with this degree of self-management. Trial Registration: Clinicaltrials.gov NCT01315756; http://clinicaltrials.gov/ct2/show/NCT01315756 (Archived by WebCite at http://www.webcitation/6BTyuRMpH).

Background: Hip fractures among older adults remain a public concern. Consequences of a hip fracture include the subsequent decline in function and mobility for the older adult, and an increased burden placed upon their caregivers and the health care system. The consequences may be more challenging if an older adult also has a compromised cognitive reserve. Although rehabilitation programs have proven effective, the best practices and resources required to maintain the gains in function and mobility, to negate diminution of effect, and to enable this patient population to continue living at home are currently unknown. Objective: The objective of this study is to develop a systematic review protocol focused on identifying the evidence and evaluating the effectiveness of post discharge rehabilitation programs for older adults with a cognitive impairment following a hip fracture. Methods: The search strategy will include a combination of text words and subject headings relating to the concepts of cognitive impairment, dementia, delirium, cognitive reserve, and hip fractures. Searching various databases will identify peer-reviewed journal articles. There will be two independent reviewers who will screen the titles and abstracts to determine which articles comprise a rehabilitation intervention within a community setting prior to being included for a full article review. A data extraction form and an evidence and quality checklist will be used during the full article data analysis and synthesis. It is expected that there will be a paucity of studies that focus on post discharge rehabilitation interventions for older adults with cognitive impairment following a hip fracture, and few studies that use the same or similar outcome measures. However, if possible, a meta-analysis will be conducted on studies that used similar outcome methods. Results: This review will synthesize knowledge focusing on activities to maintain and restore function in older adult patients with cognitive impairment once they have completed their active rehabilitation program and return home. A synthesis of the findings will be conducted to determine which components of the interventions identified were the most advantageous to the patient population. The results will be used to develop a multi-faceted post discharge rehabilitation intervention aimed at enabling older adults to return and remain living at home after a hip fracture. Conclusions: The aim of this systematic review is to generate results that can be used to create interventions that focus on the care necessary to enable older adults to remain living at home post discharge from acute or inpatient rehabilitation care for a hip fracture. With the support and contributions by our associated knowledge users, this systematic review will be used to help inform procedures and policies to facilitate the necessary care and resources required by our patient population.

Background: Filipino Americans are the second largest Asian subgroup in the United States, and were found to have the highest prevalence of obesity and type 2 diabetes (T2D) compared to all Asian subgroups and non-Hispanic whites. In addition to genetic factors, risk factors for Filipinos that contribute to this health disparity include high sedentary rates and high fat diets. However, Filipinos are seriously underrepresented in preventive health research. Research is needed to identify effective interventions to reduce Filipino diabetes risks, subsequent comorbidities, and premature death. Objective: The overall goal of this project is to assess the feasibility and potential efficacy of the Filipino Americans Go4Health Weight Loss Program (PilAm Go4Health). This program is a culturally adapted weight loss lifestyle intervention, using digital technology for Filipinos with T2D, to reduce their risk for metabolic syndrome. Methods: This study was a 3-month mobile phone-based pilot randomized controlled trial (RCT) weight loss intervention with a wait list active control, followed by a 3-month maintenance phase design for 45 overweight Filipinos with T2D. Participants were randomized to an intervention group (n=22) or active control group (n=23), and analyses of the results are underway. The primary outcome will be percent weight change of the participants, and secondary outcomes will include changes in waist circumference, fasting plasma glucose, glycated hemoglobin A1c, physical activity, fat intake, and sugar-sweetened beverage intake. Data analyses will include descriptive statistics to describe sample characteristics and a feasibility assessment based on recruitment, adherence, and retention. Chi-square, Fisher's exact tests, t-tests, and nonparametric rank tests will be used to assess characteristics of randomized groups. Primary analyses will use analysis of covariance and linear mixed models to compare primary and secondary outcomes at 3 months, compared by arm and controlled for baseline levels. Results: Recruitment was completed in January, 2016, and participant follow-up continued through June, 2016. At baseline, mean age was 57 years, 100% (45/45) of participants self-identified as Filipinos, and the cohort was comprised of 17 males and 28 females. Overall, participants were obese with a baseline mean body mass index of 30.2 kg/m2 (standard deviation 4.9). The majority of participants were immigrants (84%, 38/45), with 47% (21/45) living in the United States for more than 10 years. One third of all participants (33%, 15/45) had previously used a pedometer. Conclusions: This study will provide preliminary evidence to determine if the PilAm Go4Health weight loss lifestyle intervention is feasible, and if the program demonstrates potential efficacy to reduce risks for metabolic syndrome in Filipinos with T2D. Positive results will lend support for a larger RCT to evaluate the effectiveness of the PilAm Go4Health intervention for Filipinos. ClinicalTrial: ClinicalTrials.gov: NCT02290184; https://clinicaltrials.gov/ct2/show/NCT02290184 (Archived at http://www.webcitation.org/6k1kUqKSP)

Background: Individuals with disabilities are typically more sedentary and less fit compared to their peers without disabilities. Furthermore, engaging in physical activity can be extremely challenging due to physical impairments associated with disability and fewer opportunities to participate. One option for increasing physical activity is playing active video games (AVG), a category of video games that requires much more body movement for successful play than conventional push-button or joystick actions. However, many current AVGs are inaccessible or offer limited play options for individuals who are unable to stand, have balance issues, poor motor control, or cannot use their lower body to perform game activities. Making AVGs accessible to people with disabilities offers an innovative approach to overcoming various barriers to participation in physical activity. Objective: Our aim was to compare the effect of off-the-shelf and adapted game controllers on quality of game play, enjoyment, and energy expenditure during active video gaming in persons with physical disabilities, specifically those with mobility impairments (ie, unable to stand, balance issues, poor motor control, unable to use lower extremity for gameplay). The gaming controllers to be evaluated include off-the-shelf and adapted versions of the Wii Fit balance board and gaming mat. Methods: Participants (10-60 years old) came to the laboratory a total of three times. During the first visit, participants completed a functional assessment and became familiar with the equipment and games to be played. For the functional assessment, participants performed 18 functional movement tasks from the International Classification of Functioning, Disability, and Health. They also answered a series of questions from the Patient Reported Outcomes Measurement Information System and Quality of Life in Neurological Conditions measurement tools, to provide a personal perspective regarding their own functional ability. For Visit 2, metabolic data were collected during an initial 20-minute baseline, followed by 40 minutes of game play. The controller (balance board or gaming mat) played was randomly selected. A set of games was played for 10 minutes, followed by 5 minutes of rest, and then another set of games was played for 10 minutes, followed by rest. Quality of game play was observed and documented for each set. During rest, the participant completed questions regarding enjoyment. Following the same procedures, the participant then played the two sets of games using the other version (off-the-shelf or adapted) of the controller. The entire procedure was repeated during Visit 3 with the controller that was not played. Results: Enrollment began in February 2016 and ended in September 2016. Study results will be reported in late 2017. Conclusions: We hypothesized that the adapted versions of the Wii Fit balance board and gaming mat would produce greater quality of game play, enjoyment, and energy expenditure in persons with mobility impairments compared to off-the-shelf versions. Trial Registration: ClinicalTrials.gov NCT02994199; https://clinicaltrials.gov/ct2/show/NCT02994199 (Archived by WebCite at http://www.webcitation.org/6qpPszPJ7)

Background: As the population ages, the need for appropriate geriatric rehabilitation services will also increase. Pressures faced by hospitals to reduce length of stay and reduce costs have driven the need for more complex care being delivered in the home or community setting. As a result, a multifaceted approach that can provide geriatric rehabilitation patients with safe and effective person- and family-centered care during transitions from hospital to home is required. We hypothesize that a technology-supported person- and family-centered care transition could empower geriatric rehabilitation patients, engage them in shared decision making, and ultimately help them to safely manage their personalized needs during care transitions from hospital to home. Objective: The purpose of this study is to design and test the feasibility of a novel Path to Home mobile app to manage the personalized needs of geriatric rehabilitation patients during their transitions from hospital to home. Methods: This study will consist of (1) codesigning a patient- and provider-tailored mobile app, and (2) feasibility pilot testing of the mobile app to manage the needs of geriatric rehabilitation patients when leaving the hospital. In phase 1, we will follow a user-centered design process integrated with a modern agile software development methodology to iteratively codesign the personalized care transition Path to Home mobile app. In phase 2, we will conduct a single-arm feasibility pilot test with geriatric rehabilitation patients using the personalized care transition Path to Home mobile app to manage their needs during the transition from hospital to home. Results: The project was funded in May 2018, and enrollment and data analysis are underway. First results are expected to be submitted for publication in 2019. Conclusions: Our findings will help validate the use of this technology for geriatric rehabilitation patients discharged from the hospital to home. Future research will more rigorously evaluate the health and economic benefits to inform wide-scale adoption of the technology. Registered Report Identifier: RR1-10.2196/11031

Introduction Although many effective treatment options exist, depression is still undertreated indicating gaps in the healthcare system. The complementary provision of mental healthcare through technologies (eg, computer, smartphone) has the potential to fill treatment gaps and to overcome access barriers to mental healthcare. Until now, no systematic review integrates the evidence on different technology-based psychological interventions (TBIs) concerning their effectiveness and acceptance in different clinical phases of depression management (bridging waiting periods, acute treatment and aftercare). The aim of this project is to structure evidence on TBIs regarding different phases of depression management, and to determine effectiveness and acceptance for each clinical phase considering both active (eg, face-to-face treatment) and inactive (eg, waitlist) controls as comparators. Methods and analysis We will include studies on adults with a formal diagnosis of unipolar depression. Treatments delivered by technologies based on scientific psychological theories will be considered as experimental interventions. The primary effectiveness outcome will be depressive symptoms at study endpoint measured by symptom severity rating scales, and the primary acceptance outcome will be dropping out of the study due to any reason. We will consider only randomised controlled trials, which will be identified by key database searches (including Cochrane Central Register of Controlled Trials, Medline, PsycINFO, PSYNDEX, CINAHL) complemented through searches in clinical trial registries (eg, clinicaltrials.gov) and grey literature searches (eg, Open Grey). Two review authors will independently conduct study selection, data extraction and quality assessment of included studies (using the Cochrane Collaboration’s tool for assessing risk of bias). Meta-analyses applying random-effect models as well as subgroup, meta-regression and sensitivity analyses will be performed. Ethics and dissemination Ethics approval is not required for this study, as we conduct research on secondary data. We will disseminate results via peer-reviewed journal publications, presentations on conferences and via plain language summaries. PROSPERO registration number CRD42016050413; Pre-results.

Background: Substance use disorders are highly prevalent globally. Relapse rates following conventional psychological interventions for substance use disorders remain high. Recent reviews have highlighted attentional and approach or avoidance biases to be responsible for multiple relapses. Other studies have reported the efficacy of interventions to modify biases. With advances in technologies, there are now mobile versions of conventional bias modification interventions. However, to date, no study has evaluated bias modification in a substance-using, non-Western sample. Existing evaluations of mobile technologies for the delivery of bias interventions are also limited to alcohol or tobacco use disorders. Objective: This study aims to examine the feasibility of mobile-based attention bias modification intervention among treatment-seeking individuals with substance use and alcohol use disorders. Methods: This is a feasibility study, in which inpatients who are in their rehabilitation phase of clinical management will be recruited. On each day that they are in the study, they will be required to complete a craving visual analogue scale and undertake both a visual probe-based assessment and and modification task in a smartphone app . Reaction time data will be collated for the computation of baseline attentional biases and to determine whether there is a reduction of attentional bias across the interventions. Feasibility will be determined by the number of participants recruited and participants’ adherence to the planned interventions up until the completion of their rehabilitation program and by the ability of the app in detecting baseline biases and changes in biases. Acceptability of the intervention will be assessed by a short questionnaire of users’ perceptions of the intervention. Statistical analyses will be performed using SPSS version 22.0, while qualitative analysis of the perspectives will be performed using NVivo version 10.0. Results: This study was approved by the National Healthcare Group Domain Specific Research Board, with approval number (2018/00316). Results will be disseminated by means of conferences and publications.Currently, we are in the process of recruitment for this study. Conclusions: To the best of our knowledge, this is the first study to evaluate the feasibility and acceptability of a mobile attention bias modification intervention for individuals with substance use disorders. The data pertaining to the feasibility and acceptability are undoubtedly crucial because they imply the potential use of mobile technologies in retraining attentional biases among inpatients admitted for medical-assisted detoxification and rehabilitation. Participants’ feedback pertaining to the ease of use, interactivity, and motivation to continue using the app is crucial because it will determine whether a codesign approach might be warranted to design an app that is acceptable for participants and that participants themselves would be motivated to use. International Registered Report Identifier (IRRID): PRR1-10.2196/11822

Pre-exposure prophylaxis (PrEP) is a promising and effective tool to prevent human immunodeficiency virus (HIV) transmission; however, context-specific data to guide optimal implementation are currently lacking in China. This study aims to systematically collect comprehensive, empirical data to determine effective ways to implement PrEP among at-risk men who have sex with men (MSM) in China.

Introduction Approximately 5–8% of children report severe chronic pain and disability. Although evidence supports pain-self management as effective for reducing pain and disability, most youth do not have access to psychological intervention. Our prior studies demonstrate that an existing internet-delivered pain self-management program (WebMAP) can reduce barriers to care, is feasible, acceptable, and is effective in reducing pain-related disability in youth with chronic pain. The current trial seeks to: 1) determine the effectiveness of a mobile app version of WebMAP for improving patient pain-related outcomes, and 2) evaluate a novel implementation strategy to maximize the public health impact of the intervention including the determination of adoption, reach, and sustainability of WebMAP in specialty clinics serving children with chronic pain in the United States. Methods This hybrid effectiveness-implementation cluster randomized controlled trial employs a stepped wedge design in which the WebMAP mobile intervention is sequentially implemented in 8 specialty pain clinics following a usual care period. This trial aims to enroll a minimum of 120 youth (ages 10–17) who have chronic pain. Outcome analyses will determine effectiveness of treatment on adolescent pain-related outcomes as well as public health impact via reach, adoption, implementation, and maintenance. Conclusions This trial examines an innovative approach to evaluate a technology-delivered pain self-management program for youth with chronic pain. Findings are expected to yield a strategic approach for delivering a digital pain management program for youth with chronic pain that can be sustained in clinical settings. Clinical Trial Registration #: NCT03332563

Background App-based strategies are a promising solution to deliver nutrition and exercise interventions during social distancing. With limited RCT data in individuals with chronic disease, further information is required both to determine impact, and to guide delivery. The Heal-Me app is an evidence-based, theoretically informed nutrition and exercise solution that can be tailored for use across a range of individuals with chronic disease. As compared to controls receiving educational material, the aim of this study is to assess the acceptability, effectiveness, and cost of Heal-Me app programming delivered alongside two levels of dietitian and exercise-specialist support. Methods Heal-Me PiONEer is a 12-week, 3-arm RCT with randomization to one of three study groups (n=72 per group, 216 total). Group 1 (control: educational material), Group 2 (Heal-Me app + virtual group dietitian/exercise-specialist sessions), Group 3 (Heal-Me app + virtual group and 1-to-1 dietitian/exercise-specialist sessions). Inclusion criteria: adults with cancer, chronic lung disease or status post-transplantation from liver or lung transplant; previous completion of an exercise rehabilitation program; access to an internet-connected device. Study outcomes measured at study weeks 0 and 12 include: Primary - Lower Extremity Functional Scale; Secondary – virtual physical function tests, loneliness, resilience, anxiety, well-being and health-related quality of life; Exploratory outcomes – protein intake, behavioral beliefs around exercise and nutrition, adherence, adverse events, acceptability, and cost-utility. Conclusions The Heal-Me PiONEer RCT holds promise to provide a comprehensive understanding of the delivery and impact of app-based nutrition and exercise programming in a diverse group of participants with chronic disease.

Introduction The past decade has seen a rapid increase in the volume and proportion of testing for sexually transmitted infections that are accessed via online postal self-sampling services in the UK. ASSIST (Assessing the impact of online postal self-sampling for sexually transmitted infections on health inequalities, access to care and clinical outcomes in the UK) aims to assess the impact of these services on health inequalities, access to care, and clinical and economic outcomes, and to identify the factors that influence the implementation and sustainability of these services. Methods and analysis ASSIST is a mixed-methods, realist evaluated, national study with an in-depth focus of three case study areas (Birmingham, London and Sheffield). An impact evaluation, economic evaluation and implementation evaluation will be conducted. Findings from these evaluations will be analysed together to develop programme theories that explain the outcomes. Data collection includes quantitative data (using national, clinic based and online datasets); qualitative interviews with service users, healthcare professionals and key stakeholders; contextual observations and documentary analysis. STATA 17 and NVivo will be used to conduct the quantitative and qualitative analysis, respectively. Ethics and dissemination This study has been approved by South Central – Berkshire Research Ethics Committee (ref: 21/SC/0223). All quantitative data accessed and collected will be anonymous. Participants involved with qualitative interviews will be asked for informed consent, and data collected will be anonymised.Our dissemination strategy has been developed to access and engage key audiences in a timely manner and findings will be disseminated via the study website, social media, in peer-reviewed scientific journals, at research conferences, local meetings and seminars and at a concluding dissemination and networking event for stakeholders.

Background: In young children, bronchiolitis is the most common illness resulting in hospitalization. For children less than age 2, bronchiolitis incurs an annual total inpatient cost of $1.73 billion. Each year in the United States, 287,000 emergency department (ED) visits occur because of bronchiolitis, with a hospital admission rate of 32%-40%. Due to a lack of evidence and objective criteria for managing bronchiolitis, ED disposition decisions (hospital admission or discharge to home) are often made subjectively, resulting in significant practice variation. Studies reviewing admission need suggest that up to 29% of admissions from the ED are unnecessary. About 6% of ED discharges for bronchiolitis result in ED returns with admission. These inappropriate dispositions waste limited health care resources, increase patient and parental distress, expose patients to iatrogenic risks, and worsen outcomes. Existing clinical guidelines for bronchiolitis offer limited improvement in patient outcomes. Methodological shortcomings include that the guidelines provide no specific thresholds for ED decisions to admit or to discharge, have an insufficient level of detail, and do not account for differences in patient and illness characteristics including co-morbidities. Predictive models are frequently used to complement clinical guidelines, reduce practice variation, and improve clinicians’ decision making. Used in real time, predictive models can present objective criteria supported by historical data for an individualized disease management plan and guide admission decisions. However, existing predictive models for ED patients with bronchiolitis have limitations, including low accuracy and the assumption that the actual ED disposition decision was appropriate. To date, no operational definition of appropriate admission exists. No model has been built based on appropriate admissions, which include both actual admissions that were necessary and actual ED discharges that were unsafe. Objective: The goal of this study is to develop a predictive model to guide appropriate hospital admission for ED patients with bronchiolitis. Methods: This study will: (1) develop an operational definition of appropriate hospital admission for ED patients with bronchiolitis, (2) develop and test the accuracy of a new model to predict appropriate hospital admission for an ED patient with bronchiolitis, and (3) conduct simulations to estimate the impact of using the model on bronchiolitis outcomes. Results: We are currently extracting administrative and clinical data from the enterprise data warehouse of an integrated health care system. Our goal is to finish this study by the end of 2019. Conclusions: This study will produce a new predictive model that can be operationalized to guide and improve disposition decisions for ED patients with bronchiolitis. Broad use of the model would reduce iatrogenic risk, patient and parental distress, health care use, and costs and improve outcomes for bronchiolitis patients.

Background: Worldwide incidence of type 2 diabetes (T2D) is rapidly increasing. Given the numerous negative health consequences associated with T2D, prevention of this disease has become a priority. Lifestyle changes, including regular exercise, can reduce the onset of T2D in those at elevated risk. However, long-term adherence to exercise is often poor in this population. Existing lifestyle interventions targeting exercise are labor intensive and costly for staff and participants. Evidence-informed counseling delivered in a manner that reduces dependence on staff and facilitates self-regulatory skills could alleviate time and financial barriers while promoting independent exercise. Objective: This protocol outlines the design, recruitment, and proposed analysis of a brief, 2-week evidence-informed exercise counseling intervention combined with either high-intensity interval training (HIIT) or traditional moderate-intensity continuous training (MICT). Methods: Small Steps for Big Changes is a 2-arm randomized controlled trial that will examine the effectiveness of combining brief exercise counseling with HIIT or MICT on adherence to moderate and vigorous exercise over 1 year. Cardiorespiratory fitness will be assessed at baseline, post intervention (2 weeks), and at 6- and 12-month follow-up. Physical activity behavior will be examined at baseline, post intervention, and 3-, 6-, 9-, and 12-month follow-up. The impact of the intervention on psychosocial outcomes pertinent to exercise adherence will be examined. Results: Data collection was complete in March 2017. Data analysis is currently underway, and the first results are expected to be submitted for publication in 2019. Conclusions: The results of this brief intervention have the potential to inform future public health efforts designed to increase exercise in individuals at risk of T2D. Trial Registration: ClinicalTrials.gov NCT02164474; https://clinicaltrials.gov/ct2/show/NCT02164474 (Archived by WebCite at http://www.webcitation.org/74Hx1ipj6) International Registered Report Identifier (IRRID): DERR1-10.2196/11226

Introduction The use of adequate self-management strategies for people with chronic obstructive pulmonary disease (COPD) reduces healthcare use, improves health-related quality of life (HRQoL) and recovery after acute exacerbations. However, not many people with COPD receive support that promotes the use of such strategies and therefore new methods to facilitate and promote the use of self-management strategies are highly warranted. This pilot trial aims to evaluate the feasibility of the study design and study procedures considering effectiveness of the novel intervention, the COPD-web. Methods and analysis The overall design is a pragmatic controlled pilot trial with preassessments and postassessments and a parallel process evaluation. Patients with the diagnosis of COPD will be eligible for the study. The intervention group will be recruited when visiting one of the six participating primary care units in Sweden. The control group will be identified from the unit's computerised registers. The intervention, the COPD-web, is an interactive web page with two sections; one directed at people with COPD and one at healthcare professionals. The sections aim to support patients’ self-management skills—and to facilitate the provision of support for self-management strategies, respectively. Effectiveness with regard to patients’ symptoms, HRQoL, knowledge of and readiness for COPD-related self-management, health literacy, self-efficacy for physical activity and time spent in physical activity and time being sedentary, and further, healthcare professionals’ knowledge of and readiness to support COPD-related self-management strategies will be assessed using questionnaires at 3 and 12 months. The process evaluation will include observations and interviews. Ethics and dissemination Ethical approval has been obtained. Findings will be presented at conferences, submitted for publication in peer-reviewed publications and presented to the involved healthcare professionals, patients and to patient organisations. Trial registration number ClinicalTrials.gov: NCT02696187

Major depression and depressive symptoms are common in patients with a recent myocardial infarction (MI), and depression is associated with adverse cardiovascular outcomes. Anxiety post-MI is less studied, but occurs commonly in patients with heart disease, and is also considered a risk factor for recurrence of cardiac events. Cognitive behavior therapy (CBT) is an established therapy for depression and anxiety disorders. To the best of our knowledge, there have not been any studies to determine if internet-based CBT (iCBT) can reduce the symptoms of depression and anxiety in patients with a recent MI. The main aim of the U-CARE Heart trial is to evaluate an iCBT intervention for patients with a recent MI.

Introduction SCALE-UP II aims to investigate the effectiveness of population health management interventions using text messaging (TM), chatbots and patient navigation (PN) in increasing the uptake of at-home COVID-19 testing among patients in historically marginalised communities, specifically, those receiving care at community health centres (CHCs). Methods and analysis The trial is a multisite, randomised pragmatic clinical trial. Eligible patients are >18 years old with a primary care visit in the last 3 years at one of the participating CHCs. Demographic data will be obtained from CHC electronic health records. Patients will be randomised to one of two factorial designs based on smartphone ownership. Patients who self-report replying to a text message that they have a smartphone will be randomised in a 2×2×2 factorial fashion to receive (1) chatbot or TM; (2) PN (yes or no); and (3) repeated offers to interact with the interventions every 10 or 30 days. Participants who do not self-report as having a smartphone will be randomised in a 2×2 factorial fashion to receive (1) TM with or without PN; and (2) repeated offers every 10 or 30 days. The interventions will be sent in English or Spanish, with an option to request at-home COVID-19 test kits. The primary outcome is the proportion of participants using at-home COVID-19 tests during a 90-day follow-up. The study will evaluate the main effects and interactions among interventions, implementation outcomes and predictors and moderators of study outcomes. Statistical analyses will include logistic regression, stratified subgroup analyses and adjustment for stratification factors. Ethics and dissemination The protocol was approved by the University of Utah Institutional Review Board. On completion, study data will be made available in compliance with National Institutes of Health data sharing policies. Results will be disseminated through study partners and peer-reviewed publications. Trial registration number ClinicalTrials.gov: NCT05533918 and NCT05533359.

Introduction Electronic health (eHealth) applications have become a very large repository of health information which informs critical decisions relating to the diagnosis, treatment and prognosis of patients. Poor information quality (IQ) within eHealth may compromise patient safety. Evaluation of IQ in eHealth is therefore necessary to promote patient safety. An IQ framework specifies what aspects of information to assess and how to conduct the assessment. This systematic review aims to identify dimensions within existing IQ frameworks in eHealth and develop a new IQ framework for the assessment of eHealth. Method and analysis We will search Embase, Medline, PubMed, Cumulative Index to Nursing and Allied Health Literature, Maternity and Infant Care, PsycINFO (American Psychological Association), Global Health, Scopus, ProQuest Dissertations and Theses Global, Health Management Information Consortium and reference lists of relevant publications for articles published in English until November 2018. Studies will be selected by two independent reviewers based on prespecified eligibility criteria. Two reviewers will independently extract data in each eligible study using a prepiloted Microsoft Excel data extraction form. Thematic synthesis will be employed to define IQ dimensions and develop a new IQ framework for eHealth. Ethics and dissemination Ethical approval is not required for this systematic review as primary data will not be collected. The result of the review will be disseminated through publication in an academic journal and scientific conferences. PROSPERO registration number CRD42018097142.

Nearly half of patients do not take their cardiovascular medications as prescribed, resulting in increased morbidity, mortality, and healthcare costs. Mobile and digital technologies for health promotion and disease self-management offer an opportunity to adapt behavioral “nudges” using ubiquitous mobile phone technology to facilitate medication adherence. The Nudge pragmatic clinical trial uses population-level pharmacy data to deliver nudges via mobile phone text messaging and an artificial intelligent interactive chat bot with the goal of improving medication adherence and patient outcomes in three integrated healthcare delivery systems.

BACKGROUND: Cervical cancer is a major health concern in Tanzania, caused by poor attendance for cervical cancer screening and follow-up of women at risk. Mobile telephone health interventions are proven effective tools to improve health behaviour in African countries. So far, no knowledge exists on how such interventions may perform in relation to cervical cancer screening in low-income settings. This study aims to assess the degree to which a Short Message Service (SMS) intervention can increase attendance at appointments among women who have tested positive for high-risk (HR) Human Papillomavirus (HPV) during cervical cancer screening. METHODS/DESIGN: Connected2Care is a non-blinded, multicentre, parallel-group, randomised controlled trial. Tanzanian women testing positive to HR HPV at inclusion are randomly assigned in an allocation ratio of 1:1 to the SMS intervention or the control group (standard care). In a period of 10 months, the intervention group will receive 15 one-directional health educative text messages and SMS reminders for their appointment. The total sample size will be 700 with 350 women in each study arm. Primary outcome is attendance rate for follow-up. Secondary objectives are cost-effectiveness, measured through incremental ratios, and knowledge of cervical cancer by a 16-item true/false scale questionnaire at baseline and follow-up. Barriers against implementing the intervention will be assessed in a mixed-methods sub-population study. DISCUSSION: This study may provide information on the potential effects, costs, and barriers in implementing an SMS intervention targeting a group of women who are followed up after testing positive for HR HPV and are, therefore, at increased risk of developing cervical cancer. This can guide decision-makers on the effective use of mobile technology in a low-income setting. Trial status: recruiting. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02509702 . Registered on 15 June 2015.

Background: Obesity is a major health problem in Brazil affecting 19% of Brazilian adults with a rising incidence over the last 10 years. Moreover, low fruit/vegetables consumption and high sweetened beverage intake are major issues. Facing the challenge of universal healthcare access, internet-based programs have the potential to reach a large number of inhabitants, be widely accessible and cost effective. Our aim is to to assess the efficacy of a webbased platform to promote weight loss and diet and physical activity habits change in a Brazilian adult population. Methods: We designed a three-arm parallel randomized controlled trial including 18–60 years university students or employees with 25 kg/m2 minimum body mass index (BMI). Pregnancy, conditions with specific dietary requirements and participation in other weight loss programs are exclusion criteria. Participants are allocated to one of three groups: (1) waitlist with minimal intervention, (2) web-based platform, (3) web-based platform plus online dietician assistance. Assessors are blinded. Weight and BMI loss are the primary outcomes. Diet and physical activity behaviours, health perception and online activity features are secondary outcomes. The intervention comprises recommendations of diet and physical activity habits tailored to the Brazilian population and principles of behaviour change. The web-based platform has online social network and gamification features. Analysis will be on an intention-to-treat basis at 12 and 24 weeks after baseline. Differences in weight loss between groups will be performed by analysis of covariate. Linear regression will be used to assess whether treatment group allocation is an independent predictor of weight loss. The study was approved by the Federal University of Minas Gerais (UFMG) Ethics Research Committee. All participants signed an informed consent form prior to recruitment. Discussion: We present the study protocol of a three arm parallel randomized controlled trial which aims to test the efficacy of an online platform to promote weight loss for adults with overweight and obesity. We anticipate that the adoption of healthy lifestyle habits and weight loss will be more important in participants randomized to the online platform group. Trial registration: NCT03435445 on February 16th, 2018.

Background: There is a need to address the implementation of technological innovation into emergency medical services to facilitate and improve information exchange between prehospital emergency care providers, command centers, and hospitals during major incidents to enable better allocation of resources and minimize loss of life. At present, there is a lack of technology supporting real-time information sharing in managing major incidents to optimize the use of resources available. Objective: The aim of this protocol is to develop, design, and evaluate information technology innovations for use in medical response to major incidents. Methods: This study has a qualitative action research design. This research approach is suitable for developing and changing practice in health care settings since it is cyclical in nature and involves development, evaluation, redevelopment, and replanning. The qualitative data collection will include workshops, structured meetings, semistructured interviews, questionnaires, observations, and focus group interviews. This study assesses the use of a digital solution for real-time information sharing by involving 3 groups of indented users: prehospital emergency care personnel, hospital personnel, and designated duty officers with experience and specific knowledge in managing major incidents. This study will explore end users’ experiences and needs, and a digital solution for prehospital and hospital settings will be developed in collaboration with technology producers. Results: The trial implementation and evaluation phase for this study is from April 2024 to May 2026. Interviews and questionnaires with end users were conducted during the planning phase. We have performed observations in connection with 2 major exercises in April 2024 and November 2024. The outcome of this analysis will form the basis for the design and development of a new information technology system. We aim to complete the observations in training sessions and exercises (phase 3) by September 2025, followed by modification of the technology solutions tested (phase 4) before dissemination in a scientific journal. Conclusions: This protocol includes several methods for data collection that will form the basis for the design and development process of a digital solution for real-time information sharing to support efficient management in major incidents based on the experiences and requirements of end users. The findings from this study will contribute to the limited research on users’ perspectives and the development of digital solutions for real-time information during major incidents.

Korea Nurses’ Health Study and the health of reproductive-aged women: a cohort profile

Due to the increasing use of online health information, symptom checkers have been developed to provide an individualized assessment of health complaints and provide potential diagnoses and an urgency estimation. It is assumed that they support patient empowerment and have a positive impact on patient-physician interaction and satisfaction with care. Particularly in the emergency department (ED), symptom checkers could be integrated to bridge waiting times in the ED, and patients as well as physicians could take advantage of potential positive effects. Our study therefore aims to assess the impact of symptom assessment application (SAA) usage compared to no SAA usage on the patient-physician interaction in self-referred walk-in patients in the ED population.

Introduction The coronavirus (COVID-19) pandemic has caused significant global mortality and impacted lives around the world. Virus Watch aims to provide evidence on which public health approaches are most likely to be effective in reducing transmission and impact of the virus, and will investigate community incidence, symptom profiles and transmission of COVID-19 in relation to population movement and behaviours. Methods and analysis Virus Watch is a household community cohort study of acute respiratory infections in England and Wales and will run from June 2020 to August 2021. The study aims to recruit 50 000 people, including 12 500 from minority ethnic backgrounds, for an online survey cohort and monthly antibody testing using home fingerprick test kits. Nested within this larger study will be a subcohort of 10 000 individuals, including 3000 people from minority ethnic backgrounds. This cohort of 10 000 people will have full blood serology taken between October 2020 and January 2021 and repeat serology between May 2021 and August 2021. Participants will also post self-administered nasal swabs for PCR assays of SARS-CoV-2 and will follow one of three different PCR testing schedules based on symptoms. Ethics and dissemination This study has been approved by the Hampstead National Health Service (NHS) Health Research Authority Ethics Committee (ethics approval number 20/HRA/2320). We are monitoring participant queries and using these to refine methodology where necessary, and are providing summaries and policy briefings of our preliminary findings to inform public health action by working through our partnerships with our study advisory group, Public Health England, NHS and government scientific advisory panels.

Background: Repeated stigmatization due to group membership constitutes a recurrent stressor with negative impact on physical and mental health (minority stress model). Among European countries, Romania ranks low on LGBT+ (lesbian, gay, bisexual, and transgender people. The “+” represents individuals whose identities do not fit typical binary notions of male and female [nonbinary]) inclusion, with 45% of Romanian LGBT+ respondents reporting discrimination in at least 1 area of life in the year preceding the survey. Importantly, while all LGBT+ people might experience minority stress, younger sexual minority individuals are more prone to the detrimental impacts of stigma on their mental and physical health. As such, interventions are necessary to improve the inclusion climate within schools, where young people spend most of their time. Until now, most interventions addressing this topic have been conducted on undergraduate students in Western countries, with no studies conducted in countries that have widespread anti-LGBT+ attitudes. Objective: This paper describes the research protocol for a randomized controlled trial investigating whether LGBT+ stigma and bias among Romanian school teachers can be reduced using an internet-based intervention focusing on education and contact as primary training elements. Methods: A sample of 175 school teachers will be randomly assigned to either the control or experimental group. The experimental group participants will receive the intervention first and then complete the outcome measures, whereas the control group will complete the outcome measures first and then receive the intervention. The 1-hour multimedia intervention is developed for internet-based delivery under controlled conditions. It includes 2 interactive exercises, 2 recorded presentations, animations, and testimonies from LGBT+ individuals. Data for attitudinal, behavioral, cognitive, and affective measures will be collected during the same session (before or after the intervention, depending on the condition). We also plan to conduct a brief mixed methods follow-up study at 6 to 8 months post participation to investigate potential long-term effects of training. However, due to attrition and lack of experimental control (all participants will have completed the intervention, regardless of the condition), these data will be analyzed and reported separately using a mixed methods approach. Results: This paper details the protocol for the teacher intervention study. Data collection began in December 2022 and was completed by February 2023. Data analysis will be performed upon protocol acceptance. Follow-up measures will be completed in 2024. Results are expected to be submitted for publication following analysis in the spring of 2024. Conclusions: The findings of this study will establish the effectiveness of an internet-based intervention intended to lessen anti-LGBT stigma and sentiment in a nation where these views have long been prevalent. If successful, the intervention could end up serving as a resource for Romanian teachers and guidance counselors in high schools. Trial Registration: ISRCTN 84290049; https://doi.org/10.1186/ISRCTN84290049

Background: Gaps remain in achieving retention in care and durable HIV viral load suppression for people with HIV in Washington, DC (hereafter DC). Although people with HIV seeking care in DC have access to a range of supportive services, innovative strategies are needed to enhance patient engagement in this setting. Mobile health (mHealth) interventions have shown promise in reaching previously underengaged groups and improving HIV-related outcomes in various settings. Objective: This study will evaluate the implementation and effectiveness of a clinic-deployed, multifeature mHealth intervention called PositiveLinks (PL) among people with HIV enrolled in the DC Cohort, a longitudinal cohort of people with HIV receiving care in DC. A cluster randomized controlled trial will be conducted using a hybrid effectiveness-implementation design and will compare HIV-related outcomes between clinics randomized to PL versus usual care. Methods: The study aims are threefold: (1) We will perform a formative evaluation of PL in the context of DC Cohort clinics to test the feasibility, acceptability, and usability of PL and tailor the platform for use in this context. (2) We will conduct a cluster randomized controlled trial with 12 DC Cohort clinics randomized to PL or usual care (n=6 [50%] per arm) and measure the effectiveness of PL by the primary outcomes of patient visit constancy, retention in care, and HIV viral load suppression. We aim to enroll a total of 482 participants from DC Cohort clinic sites, specifically including people with HIV who show evidence of inconsistent retention in care or lack of viral suppression. (3) We will use the Consolidated Framework for Implementation Research (CFIR) and the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework to measure implementation success and identify site, patient, provider, and system factors associated with successful implementation. Evaluation activities will occur pre-, mid-, and postimplementation. Results: Formative data collection was completed between April 2021 and January 2022. Preliminary mHealth platform modifications have been performed, and the first round of user testing has been completed. A preimplementation evaluation was performed to identify relevant implementation outcomes and design a suite of instruments to guide data collection for evaluation of PL implementation throughout the trial period. Instruments include those already developed to support DC Cohort Study activities and PL implementation in other cohorts, which required modification for use in the study, as well as novel instruments designed to complete data collection, as guided by the CFIR and RE-AIM frameworks. Conclusions: Formative and preimplementation evaluations will be completed in spring 2022 when the trial is planned to launch. Specifically, comprehensive formative data analysis will be completed following data collection, coding, preliminary review, and synthesis. Corresponding platform modifications are ready for beta testing within the DC Cohort. Finalization of the platform for use in the trial will follow beta testing. Trial Registration: ClinicalTrials.gov NCT04998019; https://clinicaltrials.gov/ct2/show/NCT04998019

Background: For years, in Catalonia and in the rest of Spain, there has been a deficit and an unequal geographical distribution of health professionals specializing in pediatrics, especially in rural areas. Among the proposals to improve this situation is the promotion of the use of information and communication technologies (ICT) among users and professionals. Moreover, with the outbreak of COVID-19, the use of telehealth has become an essential tool, with an overall increase in non–face-to-face visits, including in primary care pediatrics. In this context, telemedicine, when used in primary care pediatrics, can be an effective means of improving families’ access to medical care. Currently, in Catalonia, telemedicine involving patients and health professionals is used in pediatric primary care through telephone consultation and asynchronous teleconsultation (eConsulta). Video consultation is in practice not used, although it could have different applications. Objective: The aim of this study is to evaluate the feasibility of a video consultation process with physical examination in acute pediatric pathology in rural areas among primary care professionals. In addition, the level of satisfaction with these remote consultations will be assessed from the perspective of both the users and the health care professionals. Methods: We will conduct a prospective experimental study to analyze the possibility of using video consultation in pediatric acute care in primary care in central Catalonia (Spain). A minimum of 170 children aged between 0 and 14 years attending the primary care center (PCC) for acute illness for a period of 1 year will be included in the study. Initially, the telemetric visit, including a physical examination, will include a nurse at the patient and family’s side and a pediatrician who will participate remotely. Subsequently, the pediatrician will visit the patient in person and the physical examination and diagnosis made during the remote visit will be compared with the physical examination and diagnosis of the face-to-face visit, which is considered the gold standard. Results: Recruitment was planned to begin in the second half of 2023 and continue for at least 1 year. It is anticipated to be a good resource for a variety of acute pediatric conditions in primary care. The evaluation will focus on the feasibility of performing live remote visits and comparing their diagnostic accuracy with that of face-to-face visits. Conclusions: We believe that this study could provide evidence on the feasibility and diagnostic accuracy of video consultation in pediatric acute primary care in a rural setting, as well as on satisfaction with video consultations among both users and professionals. If proven useful in addressing the acute needs of children in a variety of situations, it could become a digital health tool that improves the overall pediatric primary care service in rural areas, for both families and professionals.

Background Poor management of mental illnesses is associated with lower treatment adherence, chronification, avoidable re-hospitalisations, and high costs. Remote measurement based care (RMBC) interventions have gained increasing relevance due to its potential in providing a comprehensive and patient-centric approach to mental health management. Objectives The systematic review and meta-analysis aims to provide a comprehensive overview and analysis of existing evidence on the use of RMBC for patients with mental illness and to examine the effectiveness of RMBC interventions in alleviating disorder-specific symptoms, reducing relapse and improving recovery-oriented outcomes, global functioning, and quality of life. Methods and analysis Our multidisciplinary research team will develop a comprehensive search strategy, adapted to each electronic database (PubMed, Medline, Embase, and PsychINFO) to be examined systematically. Studies with patients formally diagnosed by the International Classification of Diseases or the Diagnostic and Statistical Manual of Mental Disorders which include assessment of self-reported psychiatric symptoms will be included. Publications will be reviewed by teams of independent researchers. Quality of studies will be assessed using the Cochrane Collaboration’s tool for assessing risk of bias. Outcomes cover symptom-focused or disease-specific outcomes, relapse, recovery-focused outcomes, global functioning, quality of life and acceptability of the intervention. Further data that will be extracted includes study characteristics, target population, intervention, and tracking characteristics. Data will be synthesised qualitatively, summarising findings of the systematic review. Randomised controlled trials (RCTs) will be considered for meta-analysis if data is found comparable in terms of mental illness, study design and outcomes. Cumulative evidence will be evaluated according to the Grading of Recommendations Assessment, Development and Evaluation framework. Trial registration Trial registration number: PROSPERO CRD42022356176.

Background: Asthma is the most common chronic childhood illness and is a leading cause of emergency department visits in the United States. Obesity increases the risk of poor health outcomes, reduced quality of life, and increased health care expenditures among youth with asthma. Weight loss is crucial for improving asthma outcomes in children with obesity. Our study team developed the Childhood Health and Asthma Management Program (CHAMP), a 16-session behavioral family lifestyle intervention (BFI) for school-age children with asthma and obesity and evaluated CHAMP in a randomized controlled trial compared with attention control. There were medium effect sizes favoring CHAMP for changes in body mass index z-scores, asthma control, and lung function among completers (ie, those who attended ≥9 of 16 sessions). Despite high rates of satisfaction reported by families, attendance and trial attrition were suboptimal, which raised concerns regarding the feasibility of CHAMP. Qualitative feedback from participants indicated 3 areas for refinement: (1) a less burdensome intervention modality, (2) a more individually tailored intervention experience, and (3) that interventionists can better answer health-related questions. Objective: We propose to improve upon our pilot intervention by developing the Mobile Childhood Health and Asthma Management Program (mCHAMP), a nurse-delivered BFI, delivered to individual families, and supported by a mobile health (mHealth) app. This study aims to (1) identify structural components of mCHAMP and (2) develop and test the usability of our mCHAMP app. Methods: Participants will be recruited from an outpatient pediatric pulmonary clinic. We will identify the structural components of mCHAMP by conducting a needs assessment with parents of children with asthma and obesity. Subsequently, we will develop and test our mCHAMP app using an iterative process that includes usability testing with target users and pediatric nurses. Results: This study was funded in 2018; 13 parents of children with asthma and obesity participated in the needs assessment. Preliminary themes from focus groups and individual meetings included barriers to engaging in health-promoting behaviors, perceived relationships between asthma and obesity, facilitators to behavior change, and intervention preferences. Participatory design sessions and usability testing are expected to conclude in late 2019. Conclusions: Outcomes from this study are expected to include an mHealth app designed with direct participation from the target audience and usability data from stakeholders as well as potential end users. International Registered Report Identifier (IRRID): DERR1-10.2196/13549

The use of active comprehension strategies that encourage students to explain what they have read can improve students' comprehension of complex scientific texts. Most research has focused on either ...

Stage 1 IPA at PCI RR

Background: Our current understanding of how computerized brain training drives cognitive and functional benefits remains incomplete. This paper describes the protocol for Improving Neurological Health in Aging via Neuroplasticity-based Computerized Exercise (INHANCE), a randomized controlled trial in healthy older adults designed to evaluate whether brain training improves cholinergic signaling. Objective: INHANCE evaluates whether 2 computerized training programs alter acetylcholine binding using the vesicular acetylcholine transporter ligand [18F] fluoroethoxybenzovesamicol ([18F] FEOBV) and positron emission tomography (PET). Methods: In this phase IIb, prospective, double-blind, parallel-arm, active-controlled randomized trial, a minimum of 92 community-dwelling healthy adults aged 65 years and older are randomly assigned to a brain training program designed using the principles of neuroplasticity (BrainHQ by Posit Science) or to an active control program of computer games designed for entertainment (eg, Solitaire). Both programs consist of 30-minute sessions, 7 times per week for 10 weeks (35 total hours), completed remotely at home using either loaned or personal devices. The primary outcome is the change in FEOBV binding in the anterior cingulate cortex, assessed at baseline and posttest. Exploratory cognitive and behavioral outcomes sensitive to acetylcholine are evaluated before, immediately after, and 3 months following the intervention to assess the maintenance of observed effects. Results: The trial was funded in September 2019. The study received approval from the Western Institutional Review Board in October 2020 with Research Ethics Board of McGill University Health Centre and Health Canada approvals in June 2021. The trial is currently ongoing. The first participant was enrolled in July 2021, enrollment closed when 93 participants were randomized in December 2023, and the trial will conclude in June 2024. The study team will be unblinded to conduct analyses after the final participant exits the study. We expect to publish the results in the fourth quarter of 2024. Conclusions: There remains a critical need to identify effective and scalable nonpharmaceutical interventions to enhance cognition in older adults. This trial contributes to our understanding of brain training by providing a potential neurochemical explanation of cognitive benefit.

Proposal for cross-sectional dyadic study

Contrary to the claim that loneliness routinely impairs the decoding of social cues such as emotion displays, Knowles, Lucas, Baumeister, and Gardner (2015) proposed that lonely adults “choke under pressure,” experiencing impairments only when social monitoring is framed as diagnostic of general social skill. In four experiments, Knowles et al. showed that lonely individuals performed worse than nonlonely individuals at decoding social cues when the decoding task was framed as a test of social aptitude, but not when it was framed as a test of academic aptitude. The studies were small (N's ranging from 78 to 203), and all employed a convenience sample of mostly female undergraduate students, impairing both statistical power and external validity. In addition, the lack of a true control group precluded the studies from establishing whether loneliness inhibits social monitoring ability if no frame is offered. This study conceptually replicates the central hypothesis of Knowles et al. using a sample of adults that is substantially larger and more diverse demographically and geographically, and using a true control group in addition to the comparison group. Results revealed a significant main effect of loneliness on social monitoring ability but did not replicate the choking under pressure phenomenon.

Are experiences that bring meaning different from experiences that bring happiness? If so, do people seek out different experiences in pursuing meaning versus happiness? In an adversarial collaboration, we conducted three preregistered experiments (total N = 879) to address these questions. We asked participants to describe an experience from the past month (Study 1) or past day (Study 2) that had provided them with either happiness, meaning, happiness without meaning, or meaning without happiness. Experiences that were happy but not meaningful differed substantially from those that were meaningful but not happy. However, experiences that provided happiness showed only small differences from those that provided meaning. In Study 3, to examine whether people seek out different experiences in pursuing happiness versus meaning, we instructed participants to choose an activity over the weekend that would provide them with happiness, meaning, happiness without meaning, or meaning without happiness. Again, experiences differed substantially when people pursued happiness without meaning or meaning without happiness, but these differences disappeared when people were simply told to pursue happiness or meaning. Our findings suggest that happiness and meaning are linked to distinct sets of thoughts, feelings and behaviors, but the differences between them are small in everyday life.

Multiple external representations (MERs) play an important role in the learning field of mathematics. Whereas the CTML and the ITPC model assume that the heterogeneous combination of symbolic and analogous representations fosters learning, the Design, Functions and Tasks framework implicates that learning benefits depend on the specific functions of MERs. The current paper will be a conceptual replication study of one of the few studies comparing single representations, heterogeneous and homogeneous MERs in the context of mathematics learning. In a balanced incomplete block design, the participants will be provided single representations (graphic, text, or formula) or a heterogeneous (e.g., text + graphic) or homogeneous (text + formula) combination of these to solve linear system of equations problems. Gaze behavior, task performance, and time on task will be recorded. On the basis of previous research, learning with MERs is expected to be superior to learning with single representations. Moreover, heterogeneous representations are expected to be superior to homogeneous ones. The relationship between MERs and performance is assumed to be (serially) mediated by cognitive load and number of transitions. Additionally, text is expected to be fixated more often and longer than formula or graphic.

Children's knowledge of arithmetic principles is a key aspect of early mathematics knowledge. Knowledge of arithmetic principles predicts how children approach solving arithmetic problems and the likelihood of their success. Prior work has begun to address how children might learn arithmetic principles in a classroom setting. Understanding of arithmetic principles involves understanding how numbers in arithmetic equations relate to another. For example, the relation to operands principle is that for subtracting natural numbers (A - B = C), the difference (C) must be smaller than the minuend (A). In the current study we evaluate if individual differences in arithmetic principle knowledge can be predicted by the learners' spontaneous focus on relations and if feedback can increase their focus on relations. We also evaluate the role of parent talk and the home environment in individual differences. Parent talk regarding number predicts variations in learner's performance on some early number tasks. We evaluate if the amount of parent's talk specifically about relations is associated with learner's spontaneous focus on relations and arithmetic principle knowledge.

Previous research has asserted that individuals hold cognitive associations between the constructs of hot temperatures and aggression. However, subsequent studies have cast doubt on whether these previously used methods reliably produce effects that support this assertion. Thus, the evidence for the existence of a cognitive heataggression association is mixed. To test for this hypothetical association using a different method, and to address shortcomings in the previously-used methods, the current studies used a modified Affect Misattribution Procedure to examine whether exposure to heatrelated words increased the accessibility of aggressive cognitions. Both a pilot study and a Registered Report showed that exposure to heat-related words increased the accessibility of aggressive cognitions. However, exposure to cold-related words also, and unexpectedly, increased the accessibility of aggressive cognitions. In addition, these results were only found for participants who reported that the primes influenced their Misattribution Task performance. Thus, although the current results found that exposure to heat-related stimuli caused theoretically predicted effects, the overall evidence is somewhat mixed as to whether this is due to a cognitive association between hot temperatures and aggression.

Background: Mental health problems among workers cause enormous losses to companies in Japan. However, workers have been considered to have limited access to psychological support because of time constraints, which makes it difficult for them to engage in face-to-face psychological support interventions. Objective: This study aimed to present an intervention protocol that describes a randomized controlled trial to examine whether brief guided mindfulness meditation (MM) or self-compassion meditation (SCM) provided by a smartphone app is effective for mental health and work-related outcomes among workers. Methods: This is an open-label, 3-arm randomized controlled trial. The participants will be recruited through an open call on relevant websites with the following inclusion criteria: (1) employees who are working more than 20 hours per week, (2) between the ages of 18 and 54 years, (3) not on a leave of absence, (4) not business owners or students, and (5) not currently diagnosed with a mental disorder and have a Kessler Psychological Distress Scale-6 score below 13 points. We will include 200 participants and randomly assign them to an SCM course (n=67), an MM course (n=67), and a waitlist group (n=66). The intervention groups (SCM and MM) will be instructed to engage in daily guided self-help, self-compassion, and MMs lasting 6-12 minutes per day over 4 weeks. Primary outcomes will include psychological distress and job performance, and secondary outcomes will include somatic symptoms, cognitive flexibility, self-esteem, self-compassion, perceived stress, well-being, emotion regulation, work engagement, anger, psychological safety, and creativity. All procedures were approved by the ethics committee of the University of Tokyo (22-326). All participants will be informed of the study via the websites, and written informed consent will be collected via web-based forms. Results: The recruitment of participants began in December 2022, and the intervention began in January 2023. As of September 2023, a total of 375 participants have been enrolled. The intervention and data collection were completed in late October 2023. Conclusions: This study will contribute to the development of effective self-care intervention content that will improve mental health, work performance, and related outcomes and promote mindful and self-compassionate attitudes when faced with distress. Trial Registration: University Hospital Medical Information Network Clinical Trials Registry UMIN000049466; https://tinyurl.com/23x8m8nf

Background: With the expected increase in the number of people needing care and the increasing shortage of skilled care workers, new care concepts are required. Therefore, digital assistive technologies (DATs), especially robotics, can improve the situation of people with different needs and create opportunities for participation. For a human-technology interaction to have a high level of usability, DAT’s meaningfulness and effectiveness must be accessible to end users. Significant barriers to the use of DATs in health care are the lack of controllability and adaptivity, as well as control functions that are too complex. Objective: The objective of this paper is to develop an interaction and control platform that is understandable to a layperson and has a programming interface for DAT interactions. The innovation consists of the expansion of usage and interaction options for carers of existing DAT in a more individual manner. This is to be achieved by combining modern interactive media, a modular software architecture, and already available DAT. Methods: The project is planned as a mixed methods study with a longitudinal design, with multiple user involvements and measurement times in collaboration with 3 care facilities in Germany. When assessing technologies, the satisfaction of the basic human needs of competence, connection, and autonomy plays an important role in the actual use of the technology. These needs can be measured in the form of usability (System Usability Scale), intention to use (Technology Usage Inventory), and satisfaction with the carers’ needs (Technology-Based Experience of Need Satisfaction). In the qualitative assessment, user experience is recorded using the think-aloud method and focus groups in order to obtain information about potential improvements of the platform. Results: The EduXBot (Educational Exploration Robot Application Platform) project was initiated in January 2023 and is scheduled to conclude in December 2025, at which point the project’s final results are expected to be available. The initial results were attained in the summer of 2024 when the final concept for the platform prototype was developed. In November 2024, an initial prototype of a functional platform for the simplified interaction and control of DAT was evaluated. Conclusions: It is expected that the open DAT system architecture enables caregivers without any previous technical knowledge to assemble their individual DAT functional portfolio. The results of the project will provide low-threshold access to interaction options for existing DAT as well as expand the usage of such technologies in an individual and patient-centered way. Trial Registration: Deutsches Register Klinischer Studien DRKS00034195; https://drks.de/search/de/trial/DRKS00034195

This project is an attempt to replicate the findings of Axelrod et al. (2015) who found an increase using anodal stimulation of the DLPFC. Axelrod, V., Rees, G., Lavidor, M., & Bar, M. (2015). Increasing propensity to mind-wander with transcranial direct current stimulation. Proceedings of the National Academy of Sciences, 112(11), 3314-3319.

In this registered report, we propose an evaluation of how sleep is related to school functioning. Vulnerable populations including children with disabilities, children of color, and children experiencing socioeconomic disadvantage are more likely to both experience learning difficulties (e.g., in achievement, classroom behavior, and executive function) and to experience suboptimal sleep health. Understanding which aspects of sleep have the strongest relations with school functioning is important to better direct resources to policies and programs that promote healthy sleep during childhood. Using data from the Fragile Families and Child Wellbeing Study, we propose a series of structural equation models evaluating whether sleep at age 5 has a direct or indirect nonlinear effect on academic achievement, executive function, and classroom behavior at age 9, and whether this relation is moderated by race or ethnicity, poverty, maternal education, or disability. Our project will provide insight into whether interventions for suboptimal sleep health are especially likely to benefit vulnerable populations including children with disabilities, those who are non-white, and those from economically disadvantaged homes.