• A Personalized and Smartphone-Based Serious Gaming App Targeting Cognitive Impairments in Alcohol Use Disorder: Double-Blinded, Randomized Controlled Efficacy Trial Among Outpatients

    Background: Alcohol use disorder (AUD) is associated with cognitive impairments that are known to affect the outcomes of conventional treatment. Digital cognitive training programs have been examined as a possible way of addressing these overlooked challenges. Existing findings regarding the efficacy of such training programs are divergent, and further studies are warranted to examine more engaging cognitive training programs using the latest technology. Smartphone-based training built upon the principles of serious gaming would not only increase the accessibility of the program, but it could also increase the motivation of the patients, potentially maximizing adherence to the training program. Objective: The aim of the present feasibility and efficacy study was to examine the feasibility and acceptability of the Brain+ Alco-Recover app (Brain+ A/S) with gamified elements among patients with AUD when delivered as an add-on to treatment-as-usual (TAU) and with minimal guidance from health care practitioners. In addition, the effects on cognitive and alcohol-related outcomes were examined. Methods: A total of 72 outpatients were randomized into either group A, experimental + TAU (n=36), or group B, sham + TAU (n=36), and they had to complete a 1-month training program in addition to primary treatment. Self-reported experience at the 6-month follow-up as well as actual game usage was used to determine the feasibility of the training program. Cognitive performance and alcohol consumption were assessed as well. Results: The patients in both groups reported a high level of acceptability, and up to 83% of the patients in the experimental group met the minimum requirements for the usage of the app. The experimental group also demonstrated significant improvements in working memory (P<.001). Although no significant differences were found between the 2 groups regarding clinical outcomes, a greater reduction in alcohol consumption was evident at the 6-month follow-up in the experimental group. Conclusions: The acceptability and adherence to the minimum training requirements deems the gamified Brain+ app as a feasible tool for cognitive training when delivered as an add-on to TAU. Furthermore, the potential improvements in cognitive functions should be further replicated in a larger-scale trial to assess whether these could be used to improve the treatment of AUD in the future.

    Nicolaj Mistarz, Laust Vind Knudsen, Anna Mejldal, Kjeld Andersen, Anneke Goudriaan, Lotte Skøt, Tanja Maria Michel, Angelina Isabella Mellentin·2025·JMIR Mental Health
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  • A Multifaceted Digital Intervention for the Prevention of Type 2 Diabetes Mellitus in Primary Care (PREDIABETEXT): Cluster Randomized Trial

    Background: The diabetes epidemic continues to surge worldwide, demanding urgent and innovative solutions. Digital health interventions, particularly those targeting behavior change, hold promise due to their affordability and scalability. However, research in this field remains in its early stages. Objective: This study aimed to evaluate the effectiveness of PREDIABETEXT (Prediabetes Text Message Digital Intervention for the Prevention of Type 2 Diabetes Mellitus), a digital health intervention, in reducing glycated hemoglobin (HbA1c) and in improving secondary clinical, physiological, and behavioral outcomes. Methods: We conducted a 6-month, 3-arm, pragmatic cluster randomized clinical trial. We recruited patients with prediabetes (HbA1c levels between 6% and 6.4% in the previous 3 months or 2 consecutive fasting plasma glucose measurements of 110-125 mg/dL) registered at primary care centers in the Balearic Islands, Spain. The PREDIABETEXT intervention consisted of 3 personalized SMS text messages per week aimed at supporting lifestyle behavior changes and online training for their primary health care professionals. A total of 58 professionals (clusters) from 16 centers participated in the study and were randomized (1:1:1) to intervention group A (patient SMS text messaging), intervention group B (patient SMS text messaging+health care professional web-based training), or the control group (usual care). Following the 6-month intervention period, we conducted individual qualitative interviews with 8 patients and 7 health care professionals to evaluate their experiences with the intervention in terms of utility, satisfaction, and implementation barriers. Results: In total, 58 health care professionals (clusters) were included, allocated to the control group (n=20, 34%; 119/365, 32.6% patients), intervention group A (SMS text messaging only; n=18, 31%; 106/365, 29% patients), and intervention group B (SMS text messaging+training; n=20, 34%; 140/365, 38.4% patients). The mean age of the patients was 59.79 (SD 9.75) years, and 54.5% (199/365) were female. The results of the intention-to-treat analysis at the 6-month time point showed that intervention A led to a small, nonsignificant reduction in HbA1c levels compared to the control group (β=−0.05, 95% CI −0.21 to 0.10; P=.50), whereas intervention B showed a similar nonsignificant reduction (β=−0.04, 95% CI −0.12 to 0.10; P=.56). No substantial differences were observed in the remaining secondary outcomes. Interviews revealed positive feedback from patients, who appreciated the intervention’s dietary messages and their frequency and practicality. Participants suggested enhancements such as increased personalization, links to recipes, and nursing follow-ups. Health care professionals valued the online training but highlighted time constraints, suggesting shorter or blended formats to improve accessibility. Conclusions: While PREDIABETEXT did not significantly improve HbA1c levels, it demonstrated potential benefits for patient engagement. Further studies involving more intensive interventions are warranted to confirm the clinical impact on diabetes prevention. Trial Registration: ClinicalTrials.gov NCT05110625; https://www.clinicaltrials.gov/study/NCT05110625

    Sofía Mira-Martínez, Narges Malih, Escarlata Angullo-Martínez, Rocío Zamanillo-Campos, Aina M. Yañez, Miquel Bennasar-Veny, Rocío Gómez-Juanes, Jadwiga Konieczna, Rafael Jiménez, Maria J. Serrano-Ripoll, Maria Antonia Fiol-deRoque, Alfonso Leiva, Aina M. Galmes-Panades, Jerónima Miralles-Xamena, Maria Clara Vidal-Thomàs, Cristina Gómez-Cobo, Elena Gervilla, José Iván Oña-Gil, Ignacio Ricci-Cabello·2025·Journal of Medical Internet Research
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  • Assessing Self-Help Orientation Among German Rehabilitation Clinics: Website Content Analysis

    Background: Patient-centeredness has become a guiding principle of delivering quality health care. Integrating self-help services in healthcare facilities through collaboration is a vital part of this, also in rehabilitation. Despite increasing efforts to promote patient-centered care in Germany, implementation remains inconsistent, and research on this is particularly limited for rehabilitation. Objective: This study sought to examine the patient-centeredness of rehabilitation clinics, considering the significance of self-help in their internet presence as a central source of patient information. The research objectives are thus to measure and compare the self-help orientation among rehabilitation clinics’ websites to assess which clinic criteria correlate with certain levels of self-help presentation on the clinic websites. Methods: A quantitative content analysis of 400 rehabilitation clinic websites was conducted as a part of the KoReS project (Self-help friendliness and cooperation with self-help among rehabilitation clinics in Germany) that is co-designed, conducted and disseminated in collaboration with public health and patient representatives. Websites were systematically screened using a newly developed 16-criteria coding instrument assessing self-help orientation. A score was formed from these criteria ranging from 0-16 points. Univariate analyses were applied to describe the score distributions. Binomial logistic regression analyses were performed to determine the self-help orientation levels of the websites based on clinic characteristics. Results: Approximately 61% of the clinics scored low on self-help orientation, with the majority (42%) not being self-help oriented at all. Conversely, nearly 40% of the clinic websites demonstrated high self-help orientation, with 7% of them achieving exceptional scores. On average, 4.4 (±4.1) of 16 points were reached and basic self-help orientation criteria were fulfilled by the clinics. Regression analysis revealed clinics covering the indication areas oncology (OR=2.64, P<.05), neurology (OR=2.73, P<.01) or addiction (OR=3.04, P<.001) to significantly predict higher self-help orientation scores. Facility size, sponsorship type and the number of specialist indication areas did not impact the self-help orientation of the websites overall. Conclusions: This is the first analysis measuring the self-help orientation of rehabilitation clinic websites and indicates that it falls short of its potential. The findings suggest that greater emphasis on self-help display and collaboration with self-help in rehabilitation is needed. It can be achieved by using the concept of self-help friendliness, integrating self-help closely into clinic missions and treatment plans and considering the criteria developed in designing clinic websites to increase patient orientation.

    Elâ Ziegler, Thea Bartzsch, Sabine Bütow, Alf Trojan, Ines Krahn, Daniel Lüdecke, Nicole Usko, Christopher Kofahl·2025·Journal of Medical Internet Research
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  • The Experience of Cancer-Related Cognitive Impairment Across Common Cancers: Protocol for a Qualitative Systematic Review

    stage 1
    Maryam Ibrar, Kaur Harleen Rai, Ashleigh Main, Haruno McCartney, Roma Macguire, Mario Alfredo Parra Rodriguez·2024·JMIR Research Protocols
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  • Effects, Feasibility, and Safety of an Early Mobilization Protocol With Immersive Virtual Reality for Dyspnea in Patients With Acutely Decompensated Heart Failure: The MOVE Randomized Clinical Trial

    Iasmin Borges Fraga, Larissa Gussatschenko Caballero, Carlos Eduardo Maciel Tremea, Janaína dos Santos Prates, Gabrielle Perin, Alves Guedes Vitor, Pedro Dal Lago, Eneida Rejane Rabelo-Silva·2025·JMIR Formative Research
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  • Daily Time-Use Patterns and Quality of Life in Parents: Protocol for a Pilot Quasi-Experimental, Nonrandomized Controlled Trial Using Ecological Momentary Assessment

    Background: The gender gap in time use and its impact on health and well-being are still prevalent. Women work longer hours than men when considering both paid and unpaid (eg, childcare and chores) work, and this gender disparity is particularly visible among parents. Less is known about factors that could potentially mediate or moderate this relationship (eg, work-family conflict and gender role beliefs). Ecological momentary assessment (EMA) allows for the documentation of changes in momentary internal states, such as time use, stress, or mood. It has shown particular validity to measure shorter-term activities (eg, unpaid work) and is thus useful to address gender differences. Objective: The feasibility of the daily EMA surveys in a parent sample will be examined. The associations between time use, well-being, and stress will be examined, along with potential moderating and mediating factors such as gender, gender role beliefs, and work-family conflict. Finally, the act of monitoring one’s own time use, well-being, and stress will be examined in relation to, for example, the quality of life. Methods: We conducted a quasi-experimental, nonrandomized controlled trial with 3 data collection methods, namely, online questionnaires, EMA surveys, and qualitative interviews. The intervention group (n=64) will participate in the online questionnaires and EMA surveys, and a subsample of the intervention group (n=6-17) will also be invited to participate in qualitative interviews. Over a period of 1 week, participants in the intervention group will answer daily EMA surveys (4 times per day). In contrast, the control group (n=17) will only participate in the online questionnaires at baseline and after 1 week. The following constructs were surveyed: sociodemographic background (eg, age, gender, and household composition; baseline questionnaire); mediators and moderators (eg, gender role beliefs and work-family conflict; baseline and follow-up questionnaires); well-being, quality of life, and trait mindfulness (baseline and follow-up questionnaires); momentary activity and well-being, as well as state mindfulness (EMA); and feasibility (baseline and follow-up questionnaires as well as interviews). We anticipate that participants will regard the daily EMA as feasible. Particular daily time-use patterns (eg, high paid and unpaid workload) are expected to be related to lower well-being, higher stress, and health-related quality of life. These associations are expected to be moderated and mediated by factors such as gender, gender role beliefs, work-family conflict, and social support. Participants in the intervention group are expected to show higher values of mindfulness, well-being, health-related quality of life, and lower stress. Results: Patient recruitment started in November 2023 and ended in mid April 2024. Data analysis commenced in mid April 2024. Conclusions: This study aims to provide valuable insights into the feasibility of using EMAs and the potential benefits of activity tracking in various aspects of daily life. Trial Registration: Open Science Framework 8qj3d; https://osf.io/8qj3d

    Laura Altweck, Silke Schmidt, Samuel Tomczyk·2024·JMIR Research Protocols
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  • Cluster randomised controlled trial on the effects of long-term home-based exercise for patients with chronic obstructive pulmonary disease with recent exacerbation: research protocol of the <i>COPDtoParis</i> Project

    stage 1

    Background Chronic obstructive pulmonary disease (COPD) is a highly prevalent respiratory disease associated with significant health decline and economic burdens. Pulmonary rehabilitation is an effective intervention, but securing adherence to exercise is difficult, particularly for frail and disabled patients, challenged by leaving their home. Home-based exercise is an emerging alternative for persons with COPD, but long-term adherence is unclear. This study aims to investigate the effects, experiences and acceptability of long-term home-based cycling for patients with COPD post exacerbation.

    Anna Lei Stoustrup, Lars Pilegaard Thomsen, Jane Andreasen, Thorvaldur S Palsson, Ulla Møller Weinreich·2025·BMJ Open Respiratory Research
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  • Testing a Dashboard Intervention for Tracking Digital Social Media Activity in Clinical Care of Individuals With Mood and Anxiety Disorders: Protocol and Design Considerations for a Pragmatic Randomized Trial

    stage 1

    Background: Mood and anxiety disorders are prevalent mental health diagnoses. Numerous studies have shown that measurement-based care, which is used to monitor patient symptoms, functioning, and treatment progress and help guide clinical decisions and collaboration on treatment goals, can improve outcomes in patients with these disorders. Including digital information regarding patients’ electronic communications and social media activity is an innovative approach to augmenting measurement-based care. Recent data indicate interest and willingness from both mental health clinicians and patients to share this type of digital information in treatment sessions. However, the clinical benefit of systematically doing this has been minimally evaluated. Objective: This study aims to develop an electronic dashboard for tracking patients’ digital social activity and a protocol for a pragmatic randomized trial to test the feasibility and efficacy of using the dashboard in real-world clinical care of patients with depression or anxiety disorders. Methods: We developed a personalized electronic dashboard that tracks patients’ electronic communications and social media activity, visualizes data on these interactions through key graphics and figures, and provides a tool that can be readily integrated into routine clinical care for use by clinicians and patients during treatment sessions. We then designed a randomized trial to evaluate the feasibility and effectiveness of using the electronic dashboard in real-world care compared to treatment as usual. The trial included patients aged ≥12 years with a mood or anxiety disorder who were receiving treatment in outpatient psychiatry clinics in the Johns Hopkins Health System and the Kennedy Krieger Institute. The primary outcome includes changes in patient-rated depression symptoms. Secondary outcomes include changes in patient-rated anxiety symptoms and overall functioning. Exploratory analyses examine the impact of the intervention on measures of therapeutic alliance and the detection of clinically actionable targets. Results: We successfully developed an electronic dashboard for tracking patients’ electronic communications and social media activity, and we implemented a protocol for evaluating the feasibility and efficacy of using the dashboard in routine care for mood or anxiety disorders. The protocol was approved by the Johns Hopkins University School of Medicine Institutional Review Board. In this study, we report the technological, ethical, and pragmatic considerations in developing the dashboard and testing it in a real-world setting. Conclusions: The integration of an electronic dashboard to monitor digital social activity in mental health care treatment is novel. This study examines the feasibility and effectiveness of the dashboard and the challenges in implementing this protocol. The lessons learned from developing and implementing the study will inform ongoing discussions about the value of gathering collateral information on patients’ digital social activity and how to do so in a way that is acceptable and clinically effective. Clinical Trial: ClinicalTrials.gov NCT03925038; https://clinicaltrials.gov/study/NCT03925038

    Brittany Nesbitt, Danielle Virgadamo, Carlos Aguirre, Matthew DeCamp, Mark Dredze, Keith Harrigian, Tenzin Lhaksampa, Jennifer M. Meuchel, Aja M. Meyer, Alex Walker, Ayah Zirikly, Margaret S. Chisolm, Peter P. Zandi, Leslie Miller·2025·JMIR Research Protocols
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  • Impact of Digital Interventions on the Treatment Burden of Patients With Chronic Conditions: Protocol for a Systematic Review

    stage 1

    Background: There is great potential for delivering cost-effective, quality health care for patients with chronic conditions through digital interventions. Managing chronic conditions often includes a substantial workload required for adhering to the treatment regimen and negative consequences on the patient’s function and well-being. This treatment burden affects adherence to treatment and disease outcomes. Digital interventions can potentially exacerbate the burden but also alleviate it. Objective: The objective of this review is to identify, summarize, and synthesize the evidence of how digital interventions impact the treatment burden of people with chronic conditions. Methods: The search, selection, and data synthesis processes were designed according to the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) 2015. A systematic search was conducted on October 16, 2023, from databases PubMed, Scopus, Web of Science, ACM, PubMed Central, and CINAHL. Results: Preliminary searches have been conducted, and screening has been started. The review is expected to be completed in October 2024. Conclusions: As the number of patients with chronic conditions is increasing, it is essential to design new digital interventions for managing chronic conditions in a way that supports patients with their treatment burden. To the best of our knowledge, the proposed systematic review will be the first review that investigates the impact of digital interventions on the treatment burden of patients. The results of this review will contribute to the field of health informatics regarding knowledge of the treatment burden associated with digital interventions and practical implications for developing better digital health care for patients with chronic conditions.

    Manria Polus, Pantea Keikhosrokiani, Olli Korhonen, Woubshet Behutiye, Minna Isomursu·2024·JMIR Research Protocols
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  • Digitally distributed Yoga Intervention in Breast Cancer Rehabilitation (DigiYoga CaRe): protocol for a randomised controlled trial

    stage 1

    Introduction Breast cancer is the most prevalent cancer among women. The treatment is extensive; in addition to surgery, various combinations of radiation therapy, chemotherapy and antibody and endocrine treatment can be applied. Cancer-related fatigue (CRF) is high in patients with breast cancer, peaking during chemotherapy, but may persist for several years. Physical activity has proven to be effective in reducing CRF in breast cancer rehabilitation, but many patients tend to be less active after the diagnosis. Yoga has a previously demonstrated effect on energy levels and digitally distributed yoga intervention can potentially increase accessibility in pandemic times and facilitate participation for patients susceptible to infection and those living far from organised rehabilitation opportunities. The purpose of this study, Digital Yoga Intervention in Cancer Rehabilitation (DigiYoga CaRe) is to investigate whether a 12-week digitally distributed yoga intervention can reduce CRF and stress, improve health-related quality of life (HRQL) and affect pro-inflammatory and metabolic markers in patients with breast cancer. Methods and analysis This multicentre study will adopt a randomised controlled design including 240 persons after their breast cancer surgery. They will be randomised to a 12-week digitally distributed yoga intervention or to a control group. The intervention group practice yoga two times a week, one yoga class live-streamed to the patient’s computer or mobile device and one prerecorded video class for self-training. The controls receive standardised care, gift cards for flowers and access to yoga video links after the data collection has ended. The primary analysis will be performed following the principle of intention to treat. Data will be collected by questionnaires, blood samples, accelerometers and interviews. Ethics and dissemination The DigiYoga CaRe study was approved by the Regional Ethical Review Board in Lund. The final results of this study will be disseminated to conference, patient and public involvements and peerreviewed publications. Trial registration number NCT04812652.

    Emma Ohlsson Nevo, MiaLinn Arvidsson-Lindvall, Susanne Hellerstedt Börjeson, Lars Hagberg, Elisabeth Hultgren Hörnqvist, Antonios Valachis, Åsa Wickberg, Anna Duberg·2022·BMJ Open
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  • Group Cognitive Behavioral Therapy With Virtual Reality Exposure Versus In-Vivo Exposure for Social Anxiety Disorder and Agoraphobia: Underpowered Results From the SoREAL Pragmatic Randomized Clinical Trial

    Background: Background: Social anxiety disorder (SAD) and agoraphobia are common, impairing conditions often treated with cognitive behavioral therapy (CBT) conducted in groups. In CBT, exposure therapy is a core element. However, in-vivo exposure therapy is logistically challenging and aversive for both patient and therapist, especially in a group context, often leading to exposure being skipped all together in clinical practice. Virtual reality exposure (VRE), in which phobic stimuli is presented through immersive virtual reality technology, has shown promise as a flexible alternative to in-vivo exposure. We thus hypothesized that using VRE would result in more overall exposure and more individualized exposure, resulting in statistically significant symptom reduction compared with a group using in-vivo exposure. Objective: Objectives: This trial evaluated the efficacy of group CBT with VRE (VR-CBT) versus CBT with in-vivo exposure for treating SAD and agoraphobia in clinical settings. Methods: Methods: In this randomized, parallel-group, assessor-blinded trial, 177 participants with SAD (N =150) or agoraphobia (N=27) as a primary diagnosis were assigned to either VR-CBT (N =81) or traditional CBT (N=96) across five Danish mental health outpatient clinics. Both groups received 14 weekly group sessions. The difference between the two treatments was, that the VR-CBT group received exposure therapy via head-mounted displays (HMDs) displaying 360-degree videos of anxiogenic situations for individuals with SAD (E.g., presenting at work) and agoraphobia (E.g., faulty elevator), while the CBT group conducted traditional in-vivo exposure exercises (E.g., presenting to the group, using the clinic elevator). Primary outcomes were phobic anxiety reductions, measured by the Liebowitz Social Anxiety Scale (LSAS) and the Mobility Inventory for Agoraphobia (MIA) at baseline, post-treatment, and 1 year-follow up (from baseline). Secondary outcomes included work and social functioning, depressive symptoms, and quality of life. Results: Results: Both groups showed significant reductions in primary, secondary, and exploratory outcomes, with no significant differences between groups at post-treatment (d= -0.026) and 1 year follow-up (d=0.097). Baseline characteristics and attrition rates were balanced across groups. Conclusions: Conclusion: Due to insufficient recruitment and substantial missing data, no definitive conclusions can be drawn regarding group differences between VR-CBT and traditional CBT in group settings. The feasibility issues encountered suggest that careful consideration of the benefits and limitations of VR technology is essential before implementation in clinical practice. Clinical Trial: Clinicaltrials.gov NCT03845101; https://clinicaltrials.gov/study/NCT03845101?term=NCT03845101&rank=1

    Benjamin Arnfred, Fatime Zeka, Carsten Hjorthøj, Clas Winding Christensen, Kirsten Stengaard Moeller, Mette Øllgaard Pedersen, Nicole Rosenberg, Lars Clemmensen, Louise Birkedal Glenthøj, Merete Nordentoft·2025·JMIR Mental Health
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  • Implementing Remote Patient Monitoring for Patients During Systemic Cancer Therapy

    stage 1

    Mobile monitoring of outpatients during cancer therapy becomes possible through technological advancements. This study leveraged a new remote patient monitoring app for in-between systemic therapy sessions. Patients' evaluation showed that the handling is feasible. Clinical implementation must consider an adaptive development cycle for reliable operations.

    Maria Hägglund, Madeleine Blusi, Stefano Bonacina, Lina Nilsson, Inge Cort Madsen, Sylvia Pelayo, Anne Moen, Arriel Benis, Lars Lindsköld, Parisis Gallos, Lara Kohn, Anita Mueller, Veit Scheble, Philip Storz, Hanna Borlinghaus, Selcan Behiye Ulas, Nisar Malek, Christian Thies·2023·Studies in Health Technology and Informatics
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  • A Mobile Phone App Intervention to Promote Healthy Salt Intake Among Adults: Protocol for a Randomized Controlled Study

    stage 1

    Background: There is sound evidence associating high salt intake and a greater risk of cardiovascular and noncardiovascular diseases. High salt intake has been observed in several populations worldwide. Therefore, promoting healthier salt consumption has been encouraged as a low-cost strategy to reduce this risk factor. However, these strategies need to be sound, built on theoretical and methodological bases, and consider the target population’s context. Objective: This protocol aims to describe a mobile phone app intervention to promote healthy salt intake among adults. Methods: This is an experimental and longitudinal study protocol conducted in three modules. Module 1 refers to the planning of the intervention based on the Behaviour Change Wheel framework. Module 2 is the development of the mobile phone app intervention based on the date of module 1. In module 3, the intervention will be evaluated using a randomized controlled study, with three steps of data collection in a 2-month follow-up in a sample of 86 adults (43 participants for each group: the control group and intervention group) recruited from the primary health care centers of a Brazilian town. The discretionary salt intake questionnaire will assess salt consumption, the app usability will be assessed using the System Usability Scale, and psychosocial variables (habit, intention, and self-efficacy) will also be measured. Results: Recruitment began in October 2021, and the follow-up will end in August 2022. The results of this study are expected to be published in 2023. Conclusions: Results from this study will help people to control salt intake when cooking at home, will stimulate self-care, will work as an alternative or supportive method in the relationship between health care professionals and patients, and will contribute to implementing the app intervention to promote healthy salt intake on a large scale. Trial Registration: The Brazilian Clinical Trials Registry RBR-4s8qyyq; https://ensaiosclinicos.gov.br/rg/RBR-4s8qyyq

    Milena Sia Perin, Thais São-João, Maria Cecília Bueno Jayme Gallani, Titilayo Tatiana Agbadje, Roberta Cunha Matheus Rodrigues, Marilia Estevam Cornélio·2022·JMIR Research Protocols
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  • Physical Activity Mobile App (CareFit) for Informal Carers of People With Dementia: Protocol for a Feasibility and Adaptation Study

    stage 1

    Background: Physical activity is a critical component of both well-being and preventative health, reducing the risk of both chronic mental and physical conditions and early death. Yet, there are numerous groups in society who are not able to undertake as much physical activity as they would like to. This includes informal (unpaid) carers, with the United Kingdom national survey data suggesting that 81% would like to do more physical activity on a regular basis. There is a clear need to develop innovations, including digital interventions that hold implementation potential to support regular physical activity in groups such as carers. Objective: This study aims to expand and personalize a cross-platform digital health app designed to support regular physical activity in carers of people with dementia for a period of 8 weeks and evaluate the potential for implementation. Methods: The CareFit for dementia carers study was a mixed methods co-design, development, and evaluation of a novel motivational smartphone app to support home-based regular physical activity for unpaid dementia carers. The study was planned to take place across 16 months in total (September 1, 2022, to December 31, 2023). The first phase included iterative design sprints to redesign an initial prototype for widespread use, supported through a bespoke content management system. The second phase included the release of the “CareFit” app across Scotland through invitations on the Apple and Google stores where we aimed to recruit 50 carers and up to 20 professionals to support the delivery in total. Partnerships for the work included a range of stakeholders across charities, health and social care partnerships, physical activity groups, and carers’ organizations. We explored the implementation of CareFit, guided by both Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) and the Complex Intervention Frameworks. Results: Project processes and outcomes were evaluated using mixed methods. The barriers and enablers for professional staff to signpost and use CareFit with clients were assessed through interviews or focus groups and round stakeholder meetings. The usability of CareFit was explored through qualitative interviews with carers and a system usability scale. We examined how CareFit could add value to carers by examining “in-app” data, pre-post questionnaire responses, and qualitative work, including interviews and focus groups. We also explored how CareFit could add value to the landscape of other online resources for dementia carers. Conclusions: Results from this study will contribute new knowledge including identifying (1) suitable pathways to identify and support carers through digital innovations; (2) future design of definitive studies in carer populations; and (3) an improved understanding of the Reach, Effectiveness, Adoption, Implementation, and Maintenance across a range of key stakeholders.

    Kieren Egan, Bradley Macdonald, William Hodgson, Alison Kirk, Barbara Fawcett, Mark D. Dunlop, Roma Maguire, Greg Flynn, Joshua Stott, Gill Windle·2024·JMIR Research Protocols
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  • A Medicoeconomic Evaluation of a Telehealth Platform for Elective Outpatient Surgeries: Protocol for a Randomized Controlled Trial

    stage 1

    Background: The number of elective outpatient surgeries in Canada has increased markedly in the last 10 years. However, unanticipated cancellations on the day of surgery and adverse postoperative events are frequent. Modern technologies have been shown to be of great help in the medical field in improving patient care. Thus, it is likely that dedicated technologies could also significantly improve surgical outpatients’ pathways. Therefore, the department of anesthesiology at the University of Montreal Medical Center, in collaboration with LeoMed, a telemedicine platform, has developed a telehealth solution to offer more efficient perioperative support and follow-up for patients undergoing ambulatory surgery. Objective: The objective is to evaluate the medicoeconomic benefit of a dedicated perioperative telehealth platform for patients undergoing day surgery. Our hypothesis is that this dedicated telecare solution will allow more efficient patient care, which will reduce all types of medical costs related to day surgery pathways. Methods: This study is a single-center, single-blinded, 2-group randomized controlled trial. One thousand patients aged over 18 years with internet access who are scheduled to undergo ambulatory surgery will be enrolled and randomized either to follow a perioperative path that includes a patient-tailored perioperative digital app via the LeoMed telecare platform for 1 month or to follow the standard of care, which does not offer personalized digital support. The primary outcome will be to evaluate the cost-effectiveness of the telecare platform, assessing direct costs from factors such as unanticipated cancellations on the day of surgery due to preoperative instructions not being followed, calls to the local health information line, calls to the provincial health information line, emergency department consultations, unplanned readmissions, or medical visits for problems related to the surgical procedure within the first 30 days after the intervention. The secondary outcome will be to evaluate cost utility using a questionnaire assessing quality-adjusted life years. A blinded independent research team will analyze outcomes. All data will be analyzed according to the intention-to-treat principle. A sample size of 500 subjects in each group was calculated to detect a 21% reduction in postoperative complications with a power of 90%. This study has been approved by the ethics board of Centre hospitalier de l’Université de Montréal (University of Montreal Health Centre). No employee of LeoMed was involved in the study conception, and none will be involved in either data collection or analysis. Results: Results of this trial will be useful to determine the economic benefit of a telecare platform specifically developed for surgical outpatient pathways. Conclusions: We believe that the deployment of a dedicated perioperative telehealth app will lead to better patient care and fewer postoperative complications, which will lower all types of costs related to surgical outpatient care. Trial Registration: ClinicalTrials.gov NCT04948632; https://ClinicalTrials.gov/ct2/show/NCT04948632

    Florian Robin, Maxim Roy, Alexandre Kuftedjian, Laurelie Perret, Frédéric Lavoie, Alexandre Castonguay, Marie-Pascale Pomey, Cedrick Zaouter, Guy Pare·2023·JMIR Research Protocols
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  • Does gender diversity on boards improve bank financial performance in a bank-based financial system? A pre-registered report

    stage 1

    This pre-registered report aims to reveal whether board gender diversity enhance bank performance in a bank-based (financial) system. Using publicly listed banks in the period (2010 2021), we plan to measure bank performance and adopt a difference in difference method for the analysis. We focus on whether Japan’s Corporate Governance (CG) code strengthens the advisory or monitoring roles of women on board (WOB) in the banking industry. We shed light on the effectiveness of Japan’s CG code, which aims to increase the number of female directors. Furthermore, we contribute to the discussion of “Who monitors the monitors?” in a bank-based system.

    Hideaki Sakawa, Naoki Watanabel, Yoshio Kuroki·2025·Pacific-Basin Finance Journal
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  • Effects of a Collective Family-Based Mobile Health Intervention Called “SMARTFAMILY” on Promoting Physical Activity and Healthy Eating: Protocol for a Randomized Controlled Trial

    stage 1

    Background: Numerous smartphone apps are targeting physical activity and healthy eating, but empirical evidence on their effectiveness for initialization and maintenance of behavior change, especially in children and adolescents, is still limited. Objective: The aim of this study was to conceptualize a theory-based and evidence-based mHealth intervention called SMARTFAMILY (SF) that targets physical activity and healthy eating in a collective family-based setting. Subsequently, the app will be refined and re-evaluated to analyze additional effects of just-in-time adaptive interventions (JITAIs) and gamification features. Methods: A smartphone app based on behavior change theories and behavior change techniques was developed and implemented and will be evaluated with family members individually and cooperatively (SF trial). Existing evidence and gained results were used to refine and will be used to re-evaluate the app (SF2.0 trial). Both trials are cluster randomized controlled trials with 3 measurement occasions. The intervention group uses the app for 3 consecutive weeks, whereas the control group receives no treatment. Baseline measurements (T0) and postintervention measurements (T1) include physical activity (ie, self-reported and accelerometry) and healthy eating measurements (ie, self-reported fruit and vegetable intake) as the primary outcomes. The secondary outcomes (ie, self-reported) are intrinsic motivation, behavior-specific self-efficacy, and the family health climate, complemented by an intentional measure in SF2.0. Four weeks following T1, a follow-up assessment (T2) is completed by the participants, consisting of all questionnaire items to assess the stability of the intervention effects. Mixed-method analysis of covariance will be used to calculate the primary intervention effects (ie, physical activity, fruit and vegetable intake) while controlling for covariates, including family health climate, behavior-specific self-efficacy, and intrinsic motivation. Results: This study is funded by the German Federal Ministry of Education and Research and ethically approved by the Karlsruhe Institute of Technology. For both trials, it is hypothesized that the apps will positively influence physical activity and healthy eating in the whole family. Furthermore, SF2.0 is expected to produce stronger effects (ie, higher effect sizes) compared to SF. SF app development and piloting are completed. Data acquisition for the SF trial is terminated and discontinued due to the COVID-19 pandemic. SF2.0 app development and piloting are completed, while data acquisition is ongoing. Participant recruitment for the SF 2.0 trial started in February 2020. The results for SF are expected to be published in mid-2021, and the results of SF2.0 are expected to be published in mid-2022. Conclusions: In this study, it is hypothesized that targeting the whole family will facilitate behavior change at the individual level and the family level, as the implemented strategies address changes in daily family life. Furthermore, subsequent app development (SF2.0) with supplementary addition of motivation-enhancing features and a JITAI approach is expected to enhance positive intervention effects. Trial Registration: German Clinical Trials Register DRKS00010415; https://tinyurl.com/yyo87yyu

    Kathrin Wunsch, Tobias Eckert, Janis Fiedler, Laura Cleven, Christina Niermann, Harald Reiterer, Britta Renner, Alexander Woll·2020·JMIR Research Protocols
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  • Do creditors value board ownership representativeness? Evidence from trade credit: A pre-registered report

    stage 1

    This pre-registered study aims to explore the interaction between internal board structure arrangements and external stakeholder reactions. Specifically, we focus on how customers and suppliers respond to board ownership representativeness, which measures the alignment of interests between the board and the shareholders. We investigate the following questions in this study: (1) Does board ownership representativeness impact corporate trade credit? (2) If so, what is the mechanism underlying this effect? (3) What impact does the legal environment and information asymmetry have on this relationship? (4) How does board ownership representativeness interact with the role of independent directors? (5) How does the change in trade credit driven by board ownership representativeness ultimately influence a firm's performance? This study expands the research on the economic consequences of board structure from the perspective of board ownership representativeness and provides a new lens for enhancing firms' access to trade credit.

    Fuxiu Jiang, Jia Ma·2025·Pacific-Basin Finance Journal
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  • Evaluating the Feasibility and Acceptability of a Digital Pre-Exposure Prophylaxis Navigation and Activation Intervention for Racially and Ethnically Diverse Sexual and Gender Minority Youth (PrEPresent): Protocol for a Pilot Randomized Controlled Trial

    stage 1
    Jacob B Stocks, Sam Calvetti, Matthew T Rosso, Lindsay Slay, Michele Kipke, Manuel Puentes, Lisa B Hightow-Weidman·2023·JMIR Research Protocols
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  • Data Visualization Support for Tumor Boards and Clinical Oncology: Protocol for a Scoping Review

    stage 1

    Background: Complex and expanding data sets in clinical oncology applications require flexible and interactive visualization of patient data to provide the maximum amount of information to physicians and other medical practitioners. Interdisciplinary tumor conferences in particular profit from customized tools to integrate, link, and visualize relevant data from all professions involved. Objective: The scoping review proposed in this protocol aims to identify and present currently available data visualization tools for tumor boards and related areas. The objective of the review will be to provide not only an overview of digital tools currently used in tumor board settings, but also the data included, the respective visualization solutions, and their integration into hospital processes. Methods: The planned scoping review process is based on the Arksey and O’Malley scoping study framework. The following electronic databases will be searched for articles published in English: PubMed, Web of Knowledge, and SCOPUS. Eligible articles will first undergo a deduplication step, followed by the screening of titles and abstracts. Second, a full-text screening will be used to reach the final decision about article selection. At least 2 reviewers will independently screen titles, abstracts, and full-text reports. Conflicting inclusion decisions will be resolved by a third reviewer. The remaining literature will be analyzed using a data extraction template proposed in this protocol. The template includes a variety of meta information as well as specific questions aiming to answer the research question: “What are the key features of data visualization solutions used in molecular and organ tumor boards, and how are these elements integrated and used within the clinical setting?” The findings will be compiled, charted, and presented as specified in the scoping study framework. Data for included tools may be supplemented with additional manual literature searches. The entire review process will be documented in alignment with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) flowchart. Results: The results of this scoping review will be reported per the expanded PRISMA-ScR guidelines. A preliminary search using PubMed, Web of Knowledge, and Scopus resulted in 1320 articles after deduplication that will be included in the further review process. We expect the results to be published during the second quarter of 2024. Conclusions: Visualization is a key process in leveraging a data set’s potentially available information and enabling its use in an interdisciplinary setting. The scoping review described in this protocol aims to present the status quo of visualization solutions for tumor board and clinical oncology applications and their integration into hospital processes. Trial Registration:

    Dominik Boehm, Cosima Strantz, Jan Christoph, Hauke Busch, Thomas Ganslandt, Philipp Unberath·2024·JMIR Research Protocols
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  • Engagement With Conversational Agent–Enabled Interventions in Cardiometabolic Disease Management: Protocol for a Systematic Review

    stage 1

    Background: Cardiometabolic diseases (CMDs) are a group of interrelated conditions, including heart failure and diabetes, that increase the risk of cardiovascular and metabolic complications. The rising number of Australians with CMDs has necessitated new strategies for those managing these conditions, such as digital health interventions. The effectiveness of digital health interventions in supporting people with CMDs is dependent on the extent to which users engage with the tools. Augmenting digital health interventions with conversational agents, technologies that interact with people using natural language, may enhance engagement because of their human-like attributes. To date, no systematic review has compiled evidence on how design features influence the engagement of conversational agent–enabled interventions supporting people with CMDs. This review seeks to address this gap, thereby guiding developers in creating more engaging and effective tools for CMD management. Objective: The aim of this systematic review is to synthesize evidence pertaining to conversational agent–enabled intervention design features and their impacts on the engagement of people managing CMD. Methods: The review is conducted in accordance with the Cochrane Handbook for Systematic Reviews of Interventions and reported in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Searches will be conducted in the Ovid (Medline), Web of Science, and Scopus databases, which will be run again prior to manuscript submission. Inclusion criteria will consist of primary research studies reporting on conversational agent–enabled interventions, including measures of engagement, in adults with CMD. Data extraction will seek to capture the perspectives of people with CMD on the use of conversational agent–enabled interventions. Joanna Briggs Institute critical appraisal tools will be used to evaluate the overall quality of evidence collected. Results: This review was initiated in May 2023 and was registered with the International Prospective Register of Systematic Reviews (PROSPERO) in June 2023, prior to title and abstract screening. Full-text screening of articles was completed in July 2023 and data extraction began August 2023. Final searches were conducted in April 2024 prior to finalizing the review and the manuscript was submitted for peer review in July 2024. Conclusions: This review will synthesize diverse observations pertaining to conversational agent–enabled intervention design features and their impacts on engagement among people with CMDs. These observations can be used to guide the development of more engaging conversational agent–enabled interventions, thereby increasing the likelihood of regular intervention use and improved CMD health outcomes. Additionally, this review will identify gaps in the literature in terms of how engagement is reported, thereby highlighting areas for future exploration and supporting researchers in advancing the understanding of conversational agent–enabled interventions. Trial Registration: PROSPERO CRD42023431579; https://tinyurl.com/55cxkm26

    Nick Kashyap, Ann Tresa Sebastian, Chris Lynch, Paul Jansons, Ralph Maddison, Tilman Dingler, Brian Oldenburg·2024·JMIR Research Protocols
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  • Mental Health Apps Available in App Stores for Indian Users: Protocol for a Systematic Review

    stage 1

    Background: There has been a surge in mental health apps over the past few years. While these have great potential to address the unmet mental health needs of the population, the recent proliferation of mental health apps in the commercial marketplace has raised several concerns, such as privacy, evidence-based, and quality. Although there is mounting research on the effectiveness of mental health apps, the majority of these are not accessible to the public and most of those available have not been researched. Despite the rapid growth of the digital health market in India, there are no comprehensive reviews of publicly available mental health apps for Indian users. Hence it becomes important to review mental health apps freely available to potential end users in terms of their scope, functions, and quality. Objective: This study aims to systematically evaluate mental health apps available to Indian users in app stores. Methods: This systematic review of mental health apps will be performed following the Target user, Evaluation focus, Connectedness and Health domain approach and the PASSR (Protocol for App Store Systematic Reviews) checklist. Fifteen key search terms covering various mental health conditions and therapies will be used on the Android and iOS stores. The identified apps will be further screened and reviewed based on the inclusion and exclusion criteria. The pool of eligible apps will be downloaded for detailed review. The following steps will be adopted to streamline the review process and interrater consistency. Six apps will be randomly selected from the downloaded apps, for joint discussion and review by a team of 4 primary reviewers and 2 mentors. Following this, a new set of 6 randomly selected apps will be rated independently by the primary reviewers and the differences in ratings will be jointly discussed for generating consensus. Subsequently, the primary reviewers will individually review the remaining apps in the list. Data will be extracted based on predecided parameters such as privacy policy, basic purpose, type of developer, nature of intervention strategies, and guided versus unguided nature. Additionally, the apps will be reviewed for quality using the Mobile Application Rating Scale. The data analysis and synthesis strategy will incorporate descriptive statistics based on quality evaluation using the Mobile Application Rating Scale and examining the content of the apps for generating descriptive information. Results: The initial screening of mental health apps available for Indian users on the Google Play Store and Apple App Store was initiated in October 2024. We expect to complete the detailed systematic review by April 2025. Conclusions: This study will offer a comprehensive review of mental health apps available in digital marketplaces for Indian users and has implications for end users, policy makers, developers, and mental health professionals. Trial Registration: International Platform of Registered Systematic Review and Meta-analysis Protocols INPLASY2024100035; https://inplasy.com/inplasy-2024-10-0035/

    Seema Mehrotra, Ravikesh Tripathi, Pramita Sengupta, Abhishek Karishiddimath, Angelina Francis, Pratiksha Sharma, Paulomi Sudhir, Srikanth Tk, Girish N. Rao, Rajesh Sagar·2025·JMIR Research Protocols
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  • AI-Supported Digital Microscopy Diagnostics in Primary Health Care Laboratories: Protocol for a Scoping Review

    stage 1

    Background: Digital microscopy combined with artificial intelligence (AI) is increasingly being implemented in health care, predominantly in advanced laboratory settings. However, AI-supported digital microscopy could be especially advantageous in primary health care settings, since such methods could improve access to diagnostics via automation and lead to a decreased need for experts on site. To our knowledge, no scoping or systematic review had been published on the use of AI-supported digital microscopy within primary health care laboratories when this scoping review was initiated. A scoping review can guide future research by providing insights to help navigate the challenges of implementing these novel methods in primary health care laboratories. Objective: The objective of this scoping review is to map peer-reviewed studies on AI-supported digital microscopy in primary health care laboratories to generate an overview of the subject. Methods: A systematic search of the databases PubMed, Web of Science, Embase, and IEEE will be conducted. Only peer-reviewed articles in English will be considered, and no limit on publication year will be applied. The concept inclusion criteria in the scoping review include studies that have applied AI-supported digital microscopy with the aim of achieving a diagnosis on the subject level. In addition, the studies must have been performed in the context of primary health care laboratories, as defined by the criteria of not having a pathologist on site and using simple sample preparations. The study selection and data extraction will be performed by 2 independent researchers, and in the case of disagreements, a third researcher will be involved. The results will be presented in a table developed by the researchers, including information on investigated diseases, sample collection, preparation and digitization, AI model used, and results. Furthermore, the results will be described narratively to provide an overview of the studies included. The proposed methodology is in accordance with the JBI methodology for scoping reviews. Results: The scoping review was initiated in January 2023, and a protocol was published in the Open Science Framework in January 2024. The protocol was completed in March 2024, and the systematic search will be performed after the protocol has been peer reviewed. The scoping review is expected to be finalized by the end of 2024. Conclusions: A systematic review of studies on AI-supported digital microscopy in primary health care laboratories is anticipated to identify the diseases where these novel methods could be advantageous, along with the shared challenges encountered and approaches taken to address them.

    Joar von Bahr, Vinod Diwan, Andreas Mårtensson, Nina Linder, Johan Lundin·2024·JMIR Research Protocols
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  • Feasibility and Impact of Integrating an Artificial Intelligence–Based Diagnosis Aid for Autism Into the Extension for Community Health Outcomes Autism Primary Care Model: Protocol for a Prospective Observational Study

    stage 1

    Background: The Extension for Community Health Outcomes (ECHO) Autism Program trains clinicians to screen, diagnose, and care for children with autism spectrum disorder (ASD) in primary care settings. This study will assess the feasibility and impact of integrating an artificial intelligence (AI)–based ASD diagnosis aid (the device) into the existing ECHO Autism Screening Tool for Autism in Toddlers and Young Children (STAT) diagnosis model. The prescription-only Software as a Medical Device, designed for use in children aged 18 to 72 months at risk for developmental delay, produces ASD diagnostic recommendations after analyzing behavioral features from 3 distinct inputs: a caregiver questionnaire, 2 short home videos analyzed by trained video analysts, and a health care provider questionnaire. The device is not a stand-alone diagnostic and should be used in conjunction with clinical judgment. Objective: This study aims to assess the feasibility and impact of integrating an AI-based ASD diagnosis aid into the ECHO Autism STAT diagnosis model. The time from initial ECHO Autism clinician concern to ASD diagnosis is the primary end point. Secondary end points include the time from initial caregiver concern to ASD diagnosis, time from diagnosis to treatment initiation, and clinician and caregiver experience of device use as part of the ASD diagnostic journey. Methods: Research participants for this prospective observational study will be patients suspected of having ASD (aged 18-72 months) and their caregivers and up to 15 trained ECHO Autism clinicians recruited by the ECHO Autism Communities research team from across rural and suburban areas of the United States. Clinicians will provide routine clinical care and conduct best practice ECHO Autism diagnostic evaluations in addition to prescribing the device. Outcome data will be collected via a combination of electronic questionnaires, reviews of standard clinical care records, and analysis of device outputs. The expected study duration is no more than 12 months. The study was approved by the institutional review board of the University of Missouri-Columbia (institutional review board–assigned project number 2075722). Results: Participant recruitment began in April 2022. As of June 2022, a total of 41 participants have been enrolled. Conclusions: This prospective observational study will be the first to evaluate the use of a novel AI-based ASD diagnosis aid as part of a real-world primary care diagnostic pathway. If device integration into primary care proves feasible and efficacious, prolonged delays between the first ASD concern and eventual diagnosis may be reduced. Streamlining primary care ASD diagnosis could potentially reduce the strain on specialty services and allow a greater proportion of children to commence early intervention during a critical neurodevelopmental window. Trial Registration: ClinicalTrials.gov NCT05223374; https://clinicaltrials.gov/ct2/show/NCT05223374

    Kristin Sohl, Rachel Kilian, Alicia Brewer Curran, Melissa Mahurin, Valeria Nanclares-Nogués, Stuart Liu-Mayo, Carmela Salomon, Jennifer Shannon, Sharief Taraman·2022·JMIR Research Protocols
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  • Understanding researchers' perceptions and experiences in finance research replication studies: A pre-registered report

    stage 1

    A fundamental principle of responsible scientific research is replication. Replication provides independent verification of previously reported findings and improves our understanding of observed phenomena by removing researcher bias, strengthening existing evidence and questioning past conclusions. Replication is an essential component of the self-correcting nature of science but, for too long the scientific community has overlooked the benefits of replication due to its perceived lack of novelty. However, a shift in attitudes has been making its way through various scientific disciplines, with finance now having its turn. In this study we survey the authors of Pacific-Basin Finance Journal replication studies to explore their motivations, experiences and seek their feedback on the specific process utilized by the journal to undertake the important task of facilitating the publication of replications.

    Daniel Chai, Searat Ali, Mark Brosnan, Tim Hasso·2024·Pacific-Basin Finance Journal
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  • A Gamified, Social Media–Inspired, Web-Based Personalized Normative Feedback Alcohol Intervention for Lesbian, Bisexual, and Queer-Identified Women: Protocol for a Hybrid Trial

    stage 1

    Background: Sexual minority women are more likely to drink alcohol, engage in heavy drinking, and experience alcohol-related problems than heterosexual women. However, culturally tailored interventions for this population have been slow to emerge. Objective: This type 1 effectiveness-implementation trial examines the feasibility and efficacy of a gamified, culturally tailored, personalized normative feedback (PNF) alcohol intervention for sexual minority women who psychologically identify as lesbian, bisexual, or queer (LBQ). Methods: The core components of a PNF intervention were delivered within LezParlay, a fun, social media–inspired, digital competition designed to challenge negative stereotypes about LBQ women and increase visibility. The competition was advertised on the web through social media platforms and collaboration with LBQ community organizations. After 2 rounds of play by a large cohort of LBQ women, a subsample of 500 drinkers already taking part in the competition were invited to participate in the evaluation study. Study participants were randomized to receive 1 of 3 unique sequences of PNF (ie, alcohol and stigma coping, alcohol and control, or control topics only) over 2 intervention rounds. Randomization was fully automated by the web app, and both researchers and participants were blinded. Results: Analyses will evaluate whether PNF on alcohol use reduces participants’ drinking and negative consequences at 2 and 4 months postintervention; examine whether providing PNF on stigma-coping behaviors, in addition to alcohol use, further reduces alcohol use and consequences beyond PNF on alcohol alone; identify mediators and moderators of intervention efficacy; and examine broader LezParlay app engagement, acceptability, and perceived benefits. Conclusions: This incognito intervention approach is uniquely oriented toward engaging and preventing alcohol-related risks among community populations of LBQ women who may view their heavy drinking as normative and not in need of change because of the visibility of alcohol use in sexual minority community spaces. Thus, this intervention strategy diverges from, and is intended to complement, more intensive programs being developed to meet the needs of LBQ women already motivated to reduce their consumption. Trial Registration: ClinicalTrials.gov NCT03884478; https://clinicaltrials.gov/ct2/show/NCT03884478

    Sarah C. Boyle, Joseph W. LaBrie·2021·JMIR Research Protocols
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  • #4Corners4Health Social Media Cancer Prevention Campaign for Emerging Adults: Protocol for a Randomized Stepped-Wedge Trial

    stage 1

    Background: Many emerging adults (EAs) are prone to making unhealthy choices, which increase their risk of premature cancer morbidity and mortality. In the era of social media, rigorous research on interventions to promote health behaviors for cancer risk reduction among EAs delivered over social media is limited. Cancer prevention information and recommendations may reach EAs more effectively over social media than in settings such as health care, schools, and workplaces, particularly for EAs residing in rural areas. Objective: This pragmatic randomized trial aims to evaluate a multirisk factor intervention using a social media campaign designed with community advisers aimed at decreasing cancer risk factors among EAs. The trial will target EAs from diverse backgrounds living in rural counties in the Four Corners states of Arizona, Colorado, New Mexico, and Utah. Methods: We will recruit a sample of EAs (n=1000) aged 18 to 26 years residing in rural counties (Rural-Urban Continuum Codes 4 to 9) in the Four Corners states from the Qualtrics’ research panel and enroll them in a randomized stepped-wedge, quasi-experimental design. The inclusion criteria include English proficiency and regular social media engagement. A social media intervention will promote guideline-related goals for increased physical activity, healthy eating, and human papillomavirus vaccination and reduced nicotine product use, alcohol intake, and solar UV radiation exposure. Campaign posts will cover digital and media literacy skills, responses to misinformation, communication with family and friends, and referral to community resources. The intervention will be delivered over 12 months in Facebook private groups and will be guided by advisory groups of community stakeholders and EAs and focus groups with EAs. The EAs will complete assessments at baseline and at 12, 26, 39, 52, and 104 weeks after randomization. Assessments will measure 6 cancer risk behaviors, theoretical mediators, and participants’ engagement with the social media campaign. Results: The trial is in its start-up phase. It is being led by a steering committee. Team members are working in 3 subcommittees to optimize community engagement, the social media intervention, and the measures to be used. The Stakeholder Organization Advisory Board and Emerging Adult Advisory Board were formed and provided initial input on the priority of cancer risk factors to target, social media use by EAs, and community resources available. A framework for the social media campaign with topics, format, and theoretical mediators has been created, along with protocols for campaign management. Conclusions: Social media can be used as a platform to counter misinformation and improve reliable health information to promote health behaviors that reduce cancer risks among EAs. Because of the popularity of web-based information sources among EAs, an innovative, multirisk factor intervention using a social media campaign has the potential to reduce their cancer risk behaviors. Trial Registration: ClinicalTrials.gov NCT05618158; https://classic.clinicaltrials.gov/ct2/show/NCT05618158

    David B. Buller, Andrew L. Sussman, Cynthia A. Thomson, Deanna Kepka, Douglas Taren, Kimberly L. Henry, Echo L. Warner, Barbara J. Walkosz, W. Gill Woodall, Kayla Nuss, Cindy K. Blair, Dolores D. Guest, Evelinn A. Borrayo, Judith S. Gordon, Jennifer Hatcher, David W. Wetter, Alishia Kinsey, Christopher F. Jones, Angela K. Yung, Kaila Christini, Julia Berteletti, John A. Torres, Emilia Yessenya Barraza Perez, Annelise Small·2024·JMIR Research Protocols
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  • Randomized clinical trial of a digital integrative medicine intervention among patients undergoing active cancer treatment

    stage 1

    Exercise and mindfulness-based interventions have growing evidence for managing fatigue and comorbid symptoms; however, packaging them in a cohesive digital way for patients undergoing cancer treatment has not been evaluated. We conducted a randomized controlled trial to assess the impact of a 12 week digital integrative medicine program, Integrative Medicine at Home (IM@Home), versus enhanced usual care on fatigue severity (primary outcome), comorbid symptoms and acute healthcare utilization (secondary outcomes), in 200 patients with solid tumors experiencing fatigue during treatment. Fatigue severity decreased more in IM@Home than in the control (1.99 vs. 1.51 points; p = 0.04). IM@Home participants also had reduced symptom distress (p = 0.003), anxiety (p = 0.03), and depression (p = 0.02). Acute healthcare utilization was lower with IM@Home, with fewer emergency department visits (rate ratio 0.49; p = 0.04), hospitalizations (4% vs. 12.9%; p = 0.03), and shorter hospital stays (4.25 vs. 10 days; p < 0.001). These promising findings should be confirmed in phase III clinical trials. “Study registered at clinicaltrials.gov (NCT05053230) on 09-20-2021”.

    Jun J. Mao, Karolina Bryl, Erin F. Gillespie, Angela Green, Tony K. W. Hung, Raymond Baser, Katherine Panageas, Michael A. Postow, Bobby Daly·2025·npj Digital Medicine
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  • Disentangling task conflict and information conflict in the Stroop task

    stage 1

    This study aims to test the interplay between task and information conflicts in the Stroop task. Specifically, we will measure task conflict (RTneutral words − RTneutral shapes) while controlling for frequency and contingency learning effects. By doing so, the current study will resolve inconsistencies and potential confounds that existed in previous studies. We will recruit 500 participants who will perform the color-word Stroop task and will be randomized to one of four different groups: mostly words with congruent trials, mostly symbols with congruent trials, mostly words with incongruent trials, and mostly symbols with incongruent trials and task conflict will be measured in each group. We predict a strong task conflict in the mostly symbols with congruent condition, indicating that task conflict can manifest independently of information conflict. Additionally, we expect an increased task conflict marker in the presence of incongruent trials, indicating that information conflict enhances task control activation.

    Eldad Keha, Eyal Kalanthroff·2025·Consciousness and Cognition
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  • Can praise from peers promote empathy and political inclusion towards racial or ethnic outgroups? [Registered Report Stage 1 Protocol]

    stage 1

    ABSTRACT Outgroup bias is well-documented and pernicious, manifesting in negative attitudes and behavior towards outgroups. Addressing it is a first-order priority for Diversity, Equity and Inclusion programs, as well as society more generally. Empathy---taking the perspective and understanding the experiences of others---holds promise for attenuating outgroup bias, but existing methods are expensive. Through seven pilots, we develop a low-cost, easily scalable ``peer praise” intervention that encourages empathy. In this report, we test whether our intervention promotes empathy and inclusive behavior/attitudes among white U.S. respondents towards Black and Latino/a Americans, a context where outgroup bias is particularly durable. We measure costly choices to engage in empathy, test whether peer praise promotes political and attitudinal inclusion, and if praise specifically from co-partisans can also promote inclusion. Finally, we test if these effects endure over time, vary by partisanship and function through potential mechanisms such as happiness and norms. ITEMS Stage 1 Registered Report Protocol Stage 1 Registered Report Supplementary Information Stage 1 Registered Report Reporting Summary

    Adeline Lo, Jonathan Renshon, Lotem Bassan-Nygate·2025
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  • The Design of a Randomized Clinical Trial to Evaluate a Pragmatic and Scalable eHealth Intervention for the Management of Gestational Weight Gain in Low-Income Women: Protocol for the SmartMoms in WIC Trial

    stage 1

    Background: Less than one-third of women gain an appropriate amount of weight during pregnancy, which can influence the long-term health of both the mother and the child. Economically disadvantaged women are the most vulnerable to maternal obesity, excessive weight gain during pregnancy, and poor birth outcomes. Effective and scalable health care strategies to promote healthy weight gain during pregnancy specifically tailored for these women are lacking. Objective: This paper presents the design and protocol of a biphasic, community-based eHealth trial, SmartMoms in WIC, to increase the adherence to healthy gestational weight gain (GWG) recommendations in low-income mothers receiving women, infant, and children (WIC) benefits. Methods: Phase 1 of the trial included using feedback from WIC mothers and staff and participants from 2 community peer advisory groups to adapt an existing eHealth gestational weight management intervention to meet the needs of women receiving WIC benefits. The health curriculum, the format of delivery, and incentive strategies were adapted to be culturally relevant and at an appropriate level of health literacy. Phase 2 included a pragmatic randomized controlled trial across the 9 health care regions in Louisiana with the goal of enrolling 432 women. The SmartMoms in WIC intervention is an intensive 24-week behavioral intervention, which includes nutrition education and exercise strategies, and provides the technology to assist with weight management, delivered through a professionally produced website application. Results: Phase 1 of this trial was completed in July 2019, and recruitment for phase 2 began immediately thereafter. All data are anticipated to be collected by Spring 2023. Conclusions: The SmartMoms in WIC curriculum was methodically developed using feedback from community-based peer advisory groups to create a culturally relevant, mobile behavioral intervention for mothers receiving WIC benefits. The randomized clinical trial is underway to test the effectiveness of a sustainable eHealth program on the incidence rates of appropriate GWG. SmartMoms in WIC may be able to offer an innovative, cost-effective, and scalable solution for GWG management in women served by WIC. Trial Registration: ClinicalTrials.gov NCT04028843; https://clinicaltrials.gov/ct2/show/NCT04028843

    Emily W. Flanagan, Abby D. Altazan, Natalie R. Comardelle, L. Anne Gilmore, John W. Apolzan, Jessica St Romain, Julie C. Hardee, Renee S. Puyau, Christy L. Mayet, Robbie A. Beyl, S. Ariel Barlow, Sarah Surber Bounds, Kelsey N. Olson, Betty M. Kennedy, Daniel S. Hsia, Leanne M. Redman·2020·JMIR Research Protocols
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  • Study protocol of a clinical randomized controlled trial on the efficacy of an innovative Digital thErapy to proMote wEighT loss in patients with obesity by incReasing their Adherence to treatment: the DEMETRA study

    stage 1

    Despite the increasing use of pharmacological and bariatric surgery to treat obesity, weight-loss lifestyle intervention remains the first-line treatment. Digital health is coming to meet individual needs and makes obesity treatment more accessible, so this work aims to evaluate the safety and performance of a Digital Therapy for Obesity App (DTxO) in improving weight loss and weight-loss maintenance in obese patients exposed to an experimental nonpharmacological treatment program. Here we present the study protocol of a prospective, multicenter, pragmatic, randomized, double-arm, placebo-controlled, parallel, single-blind study on obese patients who will be treated with a new digital therapy to obtain an improvement in their disease condition through the application of different simultaneous strategies (a dietary plan and customized advice program, a customized physical exercise program plan, a cognitive–behavioural assessment and program, alerts and reminders, dedicated section on prescribed drugs intake, and chat and online visits with clinical professionals). We believe that DTxO will offer a promising intervention channel and self-regulation tool holding the potential to reduce treatment burden and reach more people by replacing some in-person contact with phone or digital communication, improving self-engagement and reducing the high demands the “obesity pandemic” for both patients and national health services in terms of time, cost, and effort.

    Gianluca Castelnuovo, Paolo Capodaglio, Ramona De Amicis, Luisa Gilardini, Sara Paola Mambrini, Giada Pietrabissa, Luca Cavaggioni, Giuseppina Piazzolla, Carlotta Galeone, Giacomo Garavaglia, Simona Bertoli, the DEMETRA Study Group, Amalia Bruno, Antonina Orlando, Alessio Genovese, Federica Sileo, Marta Pellizzari, Marina Croci, Silvia Martinelli·2023·Frontiers in Digital Health
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  • Ethical and Quality of Care-Related Challenges of Digital Health Twins in Older Care Settings: Protocol for a Scoping Review

    stage 1

    Background: Digital health twins (DHTs) have been evolving with their diverse applications in medicine, specifically in older care settings, with the increasing demands of older adults. DHTs have already contributed to improving the quality of dementia and trauma care, cardiac treatment, and health care services for older individuals. Despite its many benefits, the optimum implementation of DHTs has faced several challenges associated with ethical issues, quality of care, management and leadership, and design considerations in older care settings. Since the need for such care is continuously rising and there is evident potential for DHTs to meet those needs, this review aims to map key concepts to address the gaps in the research knowledge to improve DHT implementation. Objective: The review aims to compile and synthesize the best available evidence regarding the problems encountered by older adults and care providers associated with the application of DHTs. The synthesis will collate the evidence of the issues associated with quality of care, the ethical implications of DHTs, and the strategies undertaken to overcome those challenges in older care settings. Methods: The review will follow the Joanna Briggs Institute (JBI) methodology. The published studies will be searched through CINAHL, MEDLINE, JBI, and Web of Science, and the unpublished studies through Mednar, Trove, OCLC WorldCat, and Dissertations and Theses. Studies published in English from 2002 will be considered. This review will include studies of older individuals (aged 65 years or older) undergoing care delivery associated with DHTs and their respective care providers. The concept will include the application of the technology, and the context will involve studies based on the older care setting. A broad scope of evidence, including quantitative, qualitative, text and opinion studies, will be considered. A total of 2 independent reviewers will screen the titles and abstracts and then review the full text. Data will be extracted from the included studies using a data extraction tool developed for this study. Results: The results will be presented in a PRISMA-ScR (Preferred Reporting Items for Systematic Review and Meta-Analysis extension for Scoping Reviews) flow diagram. A draft charting table will be developed as a data extraction tool. The results will be presented as a “map” of the data in a logical, diagrammatic, or tabular form in a descriptive format. Conclusions: The evidence synthesis is expected to uncover the shreds of evidence required to address the ethical and care quality-related challenges associated with applying DHTs. A synthesis of various strategies used to overcome identified challenges will provide more prospects for adopting them elsewhere and create a resource allocation model for older individuals.

    Md Shafiqur Rahman Jabin, Emillia Vann Yaroson, Adaobi Ilodibe, Tillal Eldabi·2024·JMIR Research Protocols
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  • Implementing a Digital HIV Care Navigation Intervention (Health eNav): Protocol for a Feasibility Study

    stage 1

    Background: Young racial and ethnic minority men who have sex with men (MSM) and trans women are disproportionately affected by HIV and AIDS in the United States. Unrecognized infection, due to a low uptake of HIV testing, and poor linkage to care are driving forces of ongoing HIV transmission among young racial and ethnic minority MSM and trans women. Internet and mobile technologies, in combination with social network-based approaches, offer great potential to overcome and address barriers to care and effectively disseminate interventions. Objective: We describe Health eNavigation (Health eNav), a digital HIV care navigation intervention that extends supportive care structures beyond clinic walls to serve youth and young adults living with HIV who are newly diagnosed, not linked to care, out of care, and not virally suppressed, at times when they need support the most. Methods: This study leverages ecological momentary assessments for a period of 90 days and uses person-delivered short message service text messages to provide participants with digital HIV care navigation over a 6-month period. We aim to improve engagement, linkage, and retention in HIV care and improve viral suppression. Digital HIV care navigation includes the following components: (1) HIV care navigation, (2) health promotion, (3) motivational interviewing, and (4) digital social support. Results: Recruitment began on November 18, 2016; enrollment closed on May 31, 2018. Intervention delivery ended on November 30, 2018, and follow-up evaluations concluded on October 31, 2019. In this paper, we present baseline sample characteristics. Conclusions: We discuss real-world strategies and challenges in delivering the digital HIV care navigation intervention in a city-level, public health setting.

    Sean Arayasirikul, Dillon Trujillo, Caitlin M. Turner, Victory Le, Erin C. Wilson·2019·JMIR Research Protocols
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  • A Smartphone App to Promote Healthy Weight Gain, Diet, and Physical Activity During Pregnancy (HealthyMoms): Protocol for a Randomized Controlled Trial

    stage 1

    Background: Excessive gestational weight gain is common and associated with adverse outcomes both in the short and long term. Although traditional lifestyle-based interventions have shown to mitigate excess gestational weight gain, little is known about whether mobile Health (mHealth) apps can promote healthy weight gain, diet, and physical activity during pregnancy. Objective: The primary aim of the HealthyMoms trial is to determine the effectiveness of a smartphone app (HealthyMoms) for mitigating excess gestational weight gain during pregnancy. Secondary aims are to determine the effectiveness of the app on dietary habits, physical activity, body fatness, and glycemia during pregnancy. Methods: HealthyMoms is a two-arm randomized controlled trial. Women are being recruited at routine visits at the maternity clinics in Linköping, Norrköping and Motala, Sweden. Women are randomized to the control or intervention group (n=150 per group). All women will receive standard care, and women in the intervention group will also receive the HealthyMoms smartphone app. Results: Recruitment of participants to the trial was initiated in October 2017, and 190 women have so far completed the baseline measurement. The baseline measures are estimated to be finalized in December 2019, and the follow-up measures are estimated to be completed in June 2020. Conclusions: This project will evaluate a novel smartphone app intervention integrated with existing maternity health care. If successful, it has great potential to be implemented nationally in order to promote healthy weight gain and health behaviors during pregnancy. International Registered Report Identifier (IRRID): DERR1-10.2196/13011

    Pontus Henriksson, Johanna Sandborg, Marie Blomberg, Christina Alexandrou, Ralph Maddison, Kristin Silfvernagel, Hanna Henriksson, Marja H. Leppänen, Jairo H. Migueles, Linnea Widman, Kristin Thomas, Ylva Trolle Lagerros, Marie Löf·2019·JMIR Research Protocols
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  • The effectiveness of using a WeChat account to improve exclusive breastfeeding in Huzhu County Qinghai Province, China: protocol for a randomized control trial

    stage 1

    An exclusive breastfeeding rate in the first 6 months of life of at least 50% is one of the six World Health Organization global nutrition targets for 2025. However, the exclusive breastfeeding rate in China is quite low and decreasing which makes it urgent to explore effective ways to reverse the current downward trend. As mobile technologies have rapidly developed, mobile communication apps such as WeChat (one of the largest social networking platforms in China) are well accepted and have the potential to improve health behaviors in a convenient way. The current paper describes the study protocol of a WeChat intervention that aims to promote breastfeeding in rural areas in China.

    Qiong Wu, Yiwen Huang, Michelle Helena van Velthoven, Wei Wang, Suying Chang, Yanfeng Zhang·2019·BMC Public Health
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  • Co-Designing an eHealth Service for the Co-Care of Parkinson Disease: Explorative Study of Values and Challenges

    stage 1

    Background: The need for services to support patient self-care and patient education has been emphasized for patients with chronic conditions. People with chronic conditions may spend many hours per year in health and social care services, but the majority of time is spent in self-care. This has implications in how health care is best organized. The term co-care specifically stresses the combination of health care professionals’ and patients’ resources, supported by appropriate (digital) tools for information exchange, to achieve the best possible health outcomes for patients. Developers of electronic health (eHealth) services need to consider both parties’ specific needs for the service to be successful. Research on participants’ experiences of participating in co-design sessions is scarce. Objective: The aim of this study was to describe different stakeholders’ (people with chronic conditions, health care professionals, and facilitators) overall experiences of participating in co-design workshops aimed at designing an eHealth service for co-care for Parkinson disease, with a particular focus on the perceptions of values and challenges of co-design as well as improvement suggestions. Methods: We conducted 4 half-day co-design workshops with 7 people with Parkinson disease and 9 health care professionals. Data were collected during the workshop series using formative evaluations with participants and facilitators after each workshop, researchers’ diary notes throughout the co-design process, and a Web-based questionnaire after the final workshop. Quantitative data from the questionnaire were analyzed using descriptive statistics. Qualitative data were triangulated and analyzed inductively using qualitative content analysis. Results: Quantitative ratings showed that most participants had a positive general experience of the co-design workshops. Qualitative analysis resulted in 6 categories and 30 subcategories describing respondents’ perceptions of the values and challenges of co-design and their improvement suggestions. The categories concerned (1) desire for more stakeholder variation; (2) imbalance in the collaboration between stakeholders; (3) time investment and commitment paradox; (4) desire for both flexibility and guidance; (5) relevant workshop content, but concerns about goal achievement; and (6) hopes and doubts about future care. Conclusions: Based on the identified values and challenges, some paradoxical experiences were revealed, including (1) a desire to involve more stakeholders in co-design, while preferring to work in separate groups; (2) a desire for more preparation and discussions, while the required time investment was a concern; and (3) the experience that co-design is valuable for improving care, while there are doubts about the realization of co-care in practice. The value of co-design is not mainly about creating new services; it is about improving current practices to shape better care. The choice of methods needs to be adjusted to the stakeholder group and context, which will influence how they experience the process and outcomes of co-design.

    Åsa Revenäs, Helena Hvitfeldt Forsberg, Emma Granström, Carolina Wannheden·2018·JMIR Research Protocols
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  • Preferences for Sun Protection With a Self-Monitoring App: Protocol of a Discrete Choice Experiment Study

    stage 1

    Background: The incidence of sun-exposure-related skin conditions, such as melanoma, is a gradually increasing and largely preventable public health problem. Simultaneously, the availability of mobile apps that enable the self-monitoring of health behavior and outcomes is ever increasing. Inevitably, recent years have seen an emerging volume of electronic patient-generated health data (PGHD), as well as their targeted application across primary prevention areas, including sun protection and skin health. Despite their preventive potential, the actual impact of these apps relies on the engagement of health care consumers, who are primarily responsible for recording, sharing, and using their PGHD. Exploring preferences is a key step toward facilitating consumer engagement and ultimately realizing their potential. Objective: This paper describes an ongoing research project that aims to elicit the preferences of health care consumers for sun protection via app-based self-monitoring. Methods: A discrete choice experiment (DCE) will be conducted to explore how healthy consumers choose between two alternative preventive self-monitoring apps. DCE development and attribute selection were built on extensive qualitative work, consisting of the secondary use of a previously conducted scoping review, a rapid review of reviews, 13 expert interviews, and 12 health care consumer interviews, the results of which are reported in this paper. Following D-optimality criteria, a fractional factorial survey design was generated. The final DCE will be administered in the waiting room of a travel clinic, targeting a sample of 200 participants. Choice data will be analyzed with conditional logit and multinomial logit models, accounting for individual participant characteristics. Results: An ethics approval was waived by the Ethics Committee Zurich. The study started in September 2019 and estimated data collection and completion is set for January 2020. Five two-level attributes have been selected for inclusion in the DCE, addressing (1) data generation methods, (2) privacy control, (3) data sharing with general practitioner, (4) reminder timing, and (5) costs. Data synthesis, analysis, and reporting are planned for January and February 2020. Results are expected to be submitted for publication by February 2020. Conclusions: Our results will target technology developers, health care providers, and policy makers, potentially offering some guidance on how to design or use sun-protection-focused self-monitoring apps in ways that are responsive to consumer preferences. Preferences are ultimately linked to engagement and motivation, which are key elements for the uptake and success of digital health. Our findings will inform the design of person-centered apps, while also inspiring future preference-eliciting research in the field of emerging and complex eHealth services.

    Vasileios Nittas, Margot Mütsch, Milo Alan Puhan·2020·JMIR Research Protocols
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  • The Effectiveness of Technology-Based Strategies to Promote Engagement With Digital Interventions: A Systematic Review Protocol

    stage 1

    Background: Digital interventions provide effective and potentially cost-effective models for improving health outcomes as they deliver health information and services that are widely disseminated, confidential, and can be tailored to needs of the individual user. Digital interventions have been used successfully for health promotion, mental health, and for enabling self-management of long-term conditions. However, their effectiveness is limited by low usage rates, with non-engagement a major challenge. Hence, it is crucial to find effective strategies to increase user engagement with digital interventions. Objective: This systematic review will aim to evaluate the effectiveness of technology-based strategies to promote engagement with digital interventions. Methods: We will follow Cochrane Collaboration guidelines on systematic review methodology. The search strategy will be executed across seven e-databases (including MEDLINE, EMBASE, PsycINFO, CINAHL) using the concepts &#8220;digital intervention&#8221; and &#8220;engagement&#8221;, limited by study type (randomized controlled trial). Grey literature and reference lists of included studies will be searched. Titles and abstracts will be independently screened by 2 authors. Then the full text of potentially eligible papers will be obtained and double screened. Data from eligible papers will be extracted by 1 author and checked for accuracy by another author. Bias will be assessed using the Cochrane bias assessment tool. Narrative synthesis will report on all included studies, and where appropriate, data will be pooled using meta-analysis. All findings will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Sources of heterogeneity will be further investigated if required. Results: Our research is in progress. The final draft of the systematic review is being written and will be submitted before the end of 2015. Conclusions: The review findings will inform researchers and digital intervention providers about optimal use of technology-based strategies to promote engagement with digital interventions. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews: CRD42014010164; http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42014010164#.VTZmmiFViko (Archived by WebCite at http://www.webcitation.org/6XxQC8fT8).

    Ghadah Alkhaldi, Fiona L. Hamilton, Rosa Lau, Rosie Webster, Susan Michie, Elizabeth Murray·2015·JMIR Research Protocols
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  • Study of Methods for Assessing Research Topic Elicitation and pRioritization (SMARTER): Study Protocol to Compare Qualitative Research Methods and Advance Patient Engagement in Research

    stage 1

    Background: Involving patients as partners in research is a defining characteristic of patient-centered outcomes research (PCOR). While patients’ experiential knowledge of a health condition or treatment may yield research priorities not reflected by researchers and policy makers, the methods for identifying and effectively collaborating with patients are still evolving. Patient registries and crowdsourcing may offer ease of access and convenience to both researchers and patients. Surveys and focus groups, including online modalities, have been described for prioritizing research topics. However, little is known about how these different methods compare in producing consistent priorities and similar perceptions of engagement quality among participants. Objective: The aims of this study are (1) to compare how different engagement methods used to elicit patient priorities for research perform as measured by rankings for priorities generated and participant satisfaction; and (2) to determine characteristics of individuals choosing to participate in research prioritization activities.

    Danielle C Lavallee, Bryan Comstock, Mary R Scott, Andrew L Avins, David R Nerenz, Todd C Edwards, Donald L Patrick, Sarah O Lawrence, Zoya Bauer, Anjali R Truitt, Jeffrey G Jarvik·2017·JMIR Research Protocols
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  • Technology-Enhanced Consultations in Diabetes, Cancer, and Heart Failure: Protocol for the Qualitative Analysis of Remote Consultations (QuARC) Project

    stage 1

    Background: Remote videoconsulting is promoted by policy makers as a way of delivering health care efficiently to an aging population with rising rates of chronic illness. As a radically new service model, it brings operational and interactional challenges in using digital technologies. In-depth research on this dynamic is needed before remote consultations are introduced more widely. Objective: The objective of this study will be to identify and analyze the communication strategies through which remote consultations are accomplished and to guide patients and clinicians to improve the communicative quality of remote consultations. Methods: In previous research, we collected and analyzed two separate datasets of remote consultations in a National Institute for Health Research–funded study of clinics in East London using Skype and a Wellcome Trust–funded study of specialist community heart failure teams in Oxford using Skype or FaceTime. The Qualitative Analysis of Remote Consultations (QuARC) study will combine datasets and undertake detailed interactional microanalysis of up to 40 remote consultations undertaken by senior and junior doctors and nurse specialists, including consultations with adults with diabetes, women who have diabetes during pregnancy, people consulting for postoperative cancer surgery and community-based patients having routine heart failure reviews along with up to 25 comparable face-to-face consultations. Drawing on established techniques (eg, conversation analysis), analysis will examine the contextual features in remote consultations (eg, restricted visual field) combined with close analysis of different modes of communication (eg, speech, gesture, and gaze). Results: Our findings will address the current gap in knowledge about how technology shapes the fine detail of communication in remote consultations. Alongside academic outputs, findings will inform the coproduction of information and guidance about communication strategies to support successful remote consultations. Conclusions: Identifying the communication strategies through which remote consultations are accomplished and producing guidance for patients and clinicians about how to use this kind of technology successfully in consultations is an important and timely goal because roll out of remote consultations is planned across the National Health Service.

    Sara E Shaw, Deborah Cameron, Joseph Wherton, Lucas M Seuren, Shanti Vijayaraghavan, Satyajit Bhattacharya, Christine A’Court, Joanne Morris, Trisha Greenhalgh·2018·JMIR Research Protocols
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  • Digital Mental Health Intervention for Paranoia (the STOP App): Qualitative Study on User Acceptability

    Laura Eid, Alexandra Kenny, Rayan Taher, Pamela Jacobsen, Chi Wei Hsu, Jenny Yiend·2025·JMIR Human Factors
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  • Examining ethnic/racial measurement invariance in fourth grade executive function: A registered report of data from the ECLS-K

    stage 1

    Executive function remains one of the most investigated constructs in both cognitive science and education given its high correlation with numerous academic outcomes. Differences appear in executive function skills between children from different racial/ethnic backgrounds, with children from under-resourced and minoritized communities demonstrating lower performance relative to their peers with more resources. However, it remains unclear whether observed differences in performance are a function of biased measures or reflect true differences in executive function capacity. Therefore, using nationally representative data from the Childhood Longitudinal Study (ECLS-K 2010-11), this study examines whether the psychometric properties of executive function are equivalent across race and ethnicity, including Black, White, Latine, and Asian children in the fourth grade. The results of this study will be used to advance our understanding of why differences appear in executive function skills.

    Dana Miller-Cotto, Andrew Ribner, Sammy Ahmed, Alexa Ellis·2024
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  • Within-day associations between affect and intentions to drink alcoho

    stage 1
    Kevin M. King, Jonas Dora, Megan Schultz, Connor J. McCabe, Christine M. Lee, Yuichi Shoda, Anne M. Fairlie, Dana M. Litt, Melissa A. Lewis, Megan E. Patrick, Gregory T. Smith·
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  • OSF _ When and Why Working Together Ben... College Students_ A Registered Report

    stage 1
    Pia Dietze, Andrea G. Dittmann·
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  • manuscriptRRS1.pdf

    stage 1

    Presented by OSF

    Alexandra Ružičková, Lenka Jurkovičová, Julie Páleník, Keith Hutchison, Jiří Chmelík, Kristína Mitterová, Vojtěch Juřík·2024
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  • Development, Validation, and Evaluation of Web-Based Iranian Diabetic Personal Health Record: Rationale for and Protocol of a Randomized Controlled Trial

    stage 1

    Background: Diabetes is one of the four main types of noncommunicable or chronic diseases. Iran is among the countries with the highest incidence of diabetic patients. A study demonstrated that the collection of diabetic data is neither organized nor standardized. There is currently no instance of electronic personal health records particularly used for diabetic patients in Iran, hence the need for one, which will be useful for self-care of diabetic patients. Objective: The objective of the study is to examine the impact of a Web-based diabetic personal health record (DPHR) on the self-care status of diabetic patients as compared with the control group. Methods: This study is a randomized control trial, which involves a systematic review of literature of the preferred data elements regarding a DPHR, and reevaluating the results with the opinions of local endocrinologists. Inclusion criteria were as follows: type 2 diabetic patients between 20-70 of age who live in the Mashhad City and having the disease for at least one year. The sample size is 72 people that were randomly assigned to the control and intervention groups. The participants in the intervention group were allowed access to the Web-based DPHR system, while those in the control group will continue to receive the usual care for 4 months. The study primary outcome measures include self-care status of participants and planned visit adherence. Results: At the moment, there is an ongoing recruitment of participants, and preliminary results will be published in early 2016. Conclusions: We expect the final DPHR model, developed and tested during this study, to help diabetic patients to actively participate in their care management process, and also to empower the physician in providing more quality informed decisions regarding their patients. Trial Registration: irct.ir IRCT2013082914522N1; http://www.irct.ir/searchresult.php?id=14522&#38;number=1 (Archived by WebCite at http://www.webcitation.org/6cC4PCcau).

    Amirabbas Azizi, Robab Aboutorabi, Zahra Mazloum-Khorasani, Monavar Afzal-Aghaea, Mahmood Tara·2016·JMIR Research Protocols
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  • Optimising medication management for polymedicated home-dwelling older adults with multiple chronic conditions: a mixed-methods study protocol

    stage 1

    Introduction Optimal medication management is one of the basic conditions necessary for home-dwelling older adults living with multiple chronic conditions (OAMCC) to be able to remain at home and preserve their quality of life. Currently, the reasons for such high numbers of emergency department visits and the very significant rate of hospitalisations for OAMCC, due to medication-related problems (MRPs), is poorly explored. This study aims to reveal the current state of the medication management practices of polymedicated, home-dwelling OAMCC and to make proposals for improving clinical and medication pathways through an innovative and integrated model for supporting medication management and preventing adverse health outcomes. Methods and analysis A mixed-methods study will address the medication management of polymedicated, home-dwelling OAMCC. Its explanatory sequential design will involve two major phases conducted sequentially over time. The quantitative phase will consist of retrospectively exploiting the last 4 years of electronic patient records from a local hospital (N ≈ 50 000) in order to identify the different profiles—made up of patient-related, medication-related and environment-related factors—of the polymedicated, home-dwelling OAMCC at risk of hospitalisation, emergency department visits, hospital readmission (notably for MRPs), institutionalisation or early death. The qualitative study will involve: (a) obtaining and understanding the medication management practices and experiences of the identified profiles extracted from the hospital data of OAMCC who will be interviewed at home (N ≈ 30); (b) collecting and analysing the perspectives of the formal and informal caregivers involved in medication management at home in order to cross-reference perspectives about this important dimension of care at home. Finally, the mixed-methods findings will enable the development of an innovative, integrated model of medication management based on the Agency for Clinical Innovation framework and Bodenheimer and Sinsky’s quadruple aim. Ethics and dissemination Ethical approval has been obtained from the Human Research Ethics Committee of the Canton Vaud (2018-02196). Findings will be disseminated in peer-reviewed journals, professional conferences and other knowledge transfer activities with primary healthcare providers, hospital care units, informal caregivers’ and patients’ associations. Data are available upon reasonable request.

    Filipa Pereira, Pauline Roux, Marie Santiago-Delefosse, Armin von Gunten, Boris Wernli, Maria Manuela Martins, Henk Verloo·2019
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  • Somatosensory Response Changes During Illusory Finger Stretching

    stage 1
    Kirralise J Hansford, Daniel H Baker, Kirsten J McKenzie, Catherine E J Preston·
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  • On the relation between boredom and social behavior

    stage 1
    Thekla Müller-Boysen, Sergio Pirla, Stefan Pfattheicher·2024
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