JMIR Research Protocols最新文献

{"title":"Social Transfers for Exclusive Breastfeeding in Brazil: Protocol for a Randomized Controlled Trial.","authors":"Stephanie Khoury, Alexandra Brentani, Helena Brentani, Jarlei Fiamoncini, Rossana Francisco, Ana Carolina Onofre, Silvia Elise Rodrigues Henrique, Günther Fink, Jordyn Wallenborn","doi":"10.2196/75796","DOIUrl":"10.2196/75796","url":null,"abstract":"<p><strong>Background: </strong>According to the World Health Organization's infant and young child feeding guidelines, infants should be exclusively breastfed for the first 6 months of life. Despite public health campaigns to increase exclusive breastfeeding (EBF) rates, socioeconomic inequities persist among low-income breastfeeding mothers, especially in countries with large wealth and health gaps, such as Brazil. Social transfer programs are initiatives that provide financial support to individuals or households to improve their well-being and reduce financial burdens. These may be conditional, requiring recipients to meet specific criteria to receive the transfer, or unconditional, in which recipients receive the transfer without prerequisites. Evidence suggests that conditional and unconditional social transfers may help increase EBF rates while addressing the economic challenges breastfeeding mothers face. A randomized controlled trial (RCT) conducted in Vientiane, Lao People's Democratic Republic, found that a social transfer program significantly improved both EBF rates at 6 months and EBF duration. Building on this study, we aim to evaluate the impact of this intervention in a different socioeconomic and cultural context.</p><p><strong>Objective: </strong>This protocol aims to implement an RCT to assess whether conditional and unconditional social transfers improve EBF rates at 6 months postpartum for mothers in low-income communities in São Paulo, Brazil.</p><p><strong>Methods: </strong>A prospective RCT will be conducted among 400 mothers who gave birth in the last 72 hours and plan to exclusively breastfeed. Participants will be recruited in São Paulo at the University Hospital of São Paulo and Amparo Maternal. Participants will be randomly assigned to one of the following groups: (1) control group-no social transfer; (2) intervention group 1-an unconditional social transfer at 6 months postpartum; and (3) intervention group 2-a social transfer at 6 months postpartum, conditional upon mothers' EBF. All groups will receive educational materials supporting EBF. The study will have visits at birth, 1 month, 6 months, 1 year, and 2 years and will include a questionnaire and biological collections of breast milk samples, infant fecal samples, and blood samples (finger pricks) from both the mother and infant. The main study outcomes are the prevalence of EBF at 6 months and the duration of EBF across the 3 groups, where we hypothesize higher rates of EBF among mothers in the conditional group.</p><p><strong>Results: </strong>Recruitment began on March 6, 2024. As of September 2025, we enrolled 204 participants. Our goal is to recruit 400 mother-infant dyads by October 2025, with study visits expected to be completed by October 2027.</p><p><strong>Conclusions: </strong>We hypothesize that the Social Transfers for Exclusive Breastfeeding in Brazil (STEBB) intervention will positively impact breastfeeding mothers in São Paulo. If successful, ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e75796"},"PeriodicalIF":1.5,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12508666/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145137673","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and Safety of Runzaozhiyang Lotion for Chronic Hand Eczema: Protocol for a Randomized Controlled Trial.","authors":"Rui Zang, Chen-Chen Xu, Bing-Nan Cui, Jia-Ning Bi, Ao-Lin Song, Fan Wei, Jiao Yang","doi":"10.2196/76555","DOIUrl":"10.2196/76555","url":null,"abstract":"<p><strong>Background: </strong>Chronic hand eczema (CHE) is a prevalent inflammatory skin disease in clinical practice. Guidelines recommend the use of topical medications, including corticosteroids and calcineurin inhibitors; however, prolonged use of these drugs may result in adverse effects, such as skin atrophy, drug tolerance, and rebound phenomena. Moreover, these medications exhibit limited efficacy in managing chronic hypertrophic hand eczema. Traditional Chinese medicine (TCM) has a long history of treating patients. The Runzaozhiyang lotion (RZZYL) is often used in the Department of Dermatology of Guang'anmen Hospital, China Academy of Chinese Medical Sciences, for these patients, with marked efficacy on symptoms, keratinization, hypertrophy, and pruritus improvements. Nonetheless, there is still no high-quality evidence from evidence-based medicine to prove the effectiveness and safety of CHE treatment.</p><p><strong>Objective: </strong>This study aimed to examine the efficacy and safety of a classic Chinese herbal prescription, RZZYL, for CHE and to provide a different treatment option for patients with hand eczema who are resistant to conventional Western pharmaceutical treatments.</p><p><strong>Methods: </strong>This study is a clinical trial characterized as randomized, double-blind, double-dummy, and positive drug-controlled. A total of 122 patients diagnosed with CHE have been randomized and allocated in a 1:1 ratio into 2 distinct groups, with one receiving the intervention and the other serving as the control. Participants in the intervention group will receive RZZYL granules along with a placebo cream of mometasone furoate, whereas the control group will get mometasone furoate cream in combination with a placebo for RZZYL granule. Both groups will be treated with either the active drug or a placebo for 4 weeks. The primary outcome metrics are the Hand Eczema Severity Index (HECSI) and the Numerical Rating Scales (NRS). Secondary outcome metrics consist of the target lesion area score, the Patient-Oriented Eczema Measure (POEM), the Dermatology Life Quality Index (DLQI), and the Investigator Global Assessment (IGA). The outcomes will be assessed at the start of the study and again at 2 and 4 weeks after the treatment period.</p><p><strong>Results: </strong>The study will be conducted according to the guidelines and regulations approved by the participating institutions. Recruitment is expected to commence in March 2025 and conclude in March 2026. Data collection is anticipated to be completed by June 2026, with the study expected to conclude in August 2026.</p><p><strong>Conclusions: </strong>This protocol addresses the limitations of previous research and aims to explore the efficacy and safety of RZZYL in treating CHE through a higher-quality clinical study. It seeks to provide additional treatment options for patients with CHE who are resistant to or have poor responses to current therapies.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e76555"},"PeriodicalIF":1.5,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12459855/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145137678","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Improving the Reporting Quality of Studies on Information Extraction From Clinical Texts: Protocol for the Development of a Consensus-Based Reporting Guideline.","authors":"Daniel Reichenpfader, Henning Müller, Kerstin Denecke","doi":"10.2196/76776","DOIUrl":"10.2196/76776","url":null,"abstract":"<p><strong>Background: </strong>Information extraction (IE) from clinical texts is increasingly important in health care; yet, reporting practices remain inconsistent. Existing guidelines do not fully address the unique challenges of IE studies. IE methods vary widely in their design, ranging from rule-based systems to advanced large language models, contributing to heterogeneity in reporting. While several reporting frameworks exist for applications of artificial intelligence in health care, they primarily focus on prediction modeling or clinical trials and associated protocols rather than text-based IE.</p><p><strong>Objective: </strong>This study aims to develop the Clinical Information Extraction (CINEX) guideline, a consensus-based reporting guideline for studies on clinical IE.</p><p><strong>Methods: </strong>The CINEX guideline is developed following an established guideline methodology, including a 3-round electronic Delphi (eDelphi) study with domain experts and a final in-person consensus meeting. The eDelphi process includes feedback loops and predefined consensus thresholds, with items rated on a 10-point scale for both relevance and maturity. The final consensus meeting is held as a hybrid workshop at the MEDINFO 2025 conference and focuses on finalizing the items that reached consensus.</p><p><strong>Results: </strong>Our results will provide a validated reporting guideline for studies on clinical IE. A preliminary set of 28 reporting items was drafted from a scoping review and existing frameworks. The draft guidelines include 5 key dimensions: information model, architecture, data, annotation, and outcome. This draft guideline will be refined through the eDelphi process. It is designed to be technology-agnostic and applicable across diverse IE approaches, including not only large language models but also traditional machine learning methods and rule-based and hybrid systems.</p><p><strong>Conclusions: </strong>The CINEX guideline provides structured, expert-validated guidance for reporting clinical IE studies, improving transparency, reproducibility, and comparability. The final guideline will be disseminated alongside an explanatory document to support adoption and implementation.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e76776"},"PeriodicalIF":1.5,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12459736/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145137622","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An Iteratively Adapted Transdiagnostic Prevention Program for Diverse High School Settings (U-PEACE): Protocol for a Randomized Controlled Trial.","authors":"Clarissa Victoria Velez, Mileini Campez-Pardo, Jennifer Mariam Canovas, Paloma Maria Pedronzo, Yeojin Amy Ahn, Chelsea Faye Dale, Sannisha K Dale, Lisa Gwynn, Amanda Jensen-Doss, Elizabeth R Pulgaron, Sara Mijares St George, Jill Ehrenreich-May","doi":"10.2196/74080","DOIUrl":"10.2196/74080","url":null,"abstract":"<p><strong>Background: </strong>Despite many adolescents experiencing mental health concerns, a substantial portion lack access to evidence-based treatments (EBTs) for psychopathology; this issue is magnified for adolescents belonging to communities considered marginalized. One way to ameliorate this is by adapting existent EBTs-typically delivered in research settings-so that they are feasible and scalable in adolescent settings, such as high schools. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents may be particularly suited for this purpose due to its transdiagnostic, modular approach and its focus on adolescent clients.</p><p><strong>Objective: </strong>This study aimed to iteratively adapt and implement the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents in 3 Title 1 high schools, with a focus on feasibility and scalability of the intervention in diverse high school settings.</p><p><strong>Methods: </strong>For initial adaptation, members of participating high school communities will be presented with original, unadapted intervention materials and asked to provide qualitative feedback on how to make the program more appropriate and feasible for their schools (aim 1). After initial adaptations are implemented, an open-trial pilot case series will assess the appropriateness and feasibility of the resulting program: the Unified Protocol for Emotional and Academic Challenges in Education (aim 2). Initial outcome data and qualitative feedback from pilot case series participants will then inform final adaptations for the randomized controlled trial-in which the adapted program will be compared to high schools' mental health services as usual (aim 3). The adapted program's effectiveness will be evaluated by using a mixed methods approach, and feasibility will be preliminarily assessed through cost-effectiveness analyses (aim 4).</p><p><strong>Results: </strong>Data collection for the study was concluded in May 2025, with primary outcome analyses anticipated to be completed by August 2025.</p><p><strong>Conclusions: </strong>This protocol may serve as a promising guide for adapting youth EBTs in more accessible, diverse settings, as well as result in a useful prevention program for youth with emotional concerns.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06056674; https://clinicaltrials.gov/study/NCT06056674.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/74080.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e74080"},"PeriodicalIF":1.5,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12508673/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145130860","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Machine Learning in Health Economic Evaluations: Protocol for a Scoping Review.","authors":"Hanan Daghash, Ashleigh Kernohan, Rosiered Brownson-Smith, Rohan Pandey, Ananya Ananthakrishnan, Cen Cong, Victoria Riccalton, Edward Meinert, Gurdeep S Sagoo","doi":"10.2196/77494","DOIUrl":"10.2196/77494","url":null,"abstract":"<p><strong>Background: </strong>In recent years, the development of machine learning (ML) applications has increased substantially, indicating the potential role of ML in transforming health care. However, the integration of ML approaches into health economic evaluations is underexplored and has several challenges.</p><p><strong>Objective: </strong>This scoping review aims to explore the applications of ML in health economic evaluations. This review will also seek to identify some potential challenges to the use of ML in health economic evaluations.</p><p><strong>Methods: </strong>This review will use PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) methods. The search will be conducted on MEDLINE (Ovid), Embase (Ovid), IEEE Xplore, and Cochrane Library databases. The eligibility criteria of the selection process will be based on the study types, data sources, methods, and outcomes (SDMO) framework approach.</p><p><strong>Results: </strong>The database search yielded 4141 records after removal of retractions and duplicates. Title and abstract screening of 3718 records has been completed, resulting in 30 reports retrieved for eligibility assessment. Data extraction and charting are currently in progress. The results will be published in peer-reviewed journals by the end of 2025.</p><p><strong>Conclusions: </strong>This review will help to build up the current understanding of how ML applications are integrated in health economics evaluations. This will also explore the potential barriers to and challenges of using ML in health economics evaluations.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/77494.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e77494"},"PeriodicalIF":1.5,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12508662/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145137695","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effectiveness and Related Factors of Narrative Messages in Correcting Health-Related Misinformation: Protocol for a Systematic Review.","authors":"Tsuyoshi Okuhara, Hiroko Okada, Rie Yokota","doi":"10.2196/69414","DOIUrl":"10.2196/69414","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;The internet and social media have become essential sources of health information for patients and citizens; however, they often disseminate misinformation that lacks scientific evidence. Health-related misinformation can undermine evidence-based treatment, weaken patient-provider relationships, and contribute to adverse health outcomes. Although narratives have been proposed as a promising approach to countering misinformation, their effectiveness remains inconsistent and influenced by various factors.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The aim of this study is to assess the effectiveness of narrative messages in correcting health-related misinformation compared to nonnarrative messages. It also seeks to identify message-, sender-, and recipient-related factors that influence the effectiveness of narrative-based corrections.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This systematic review will follow the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Comprehensive searches will be conducted across databases, including PubMed, MEDLINE, CINAHL, PsycINFO, and Web of Science, using keywords related to narratives and correction of health-related misinformation. This review will include quantitative studies evaluating narrative-based corrections for health-related misinformation in experimental and quasi-experimental studies. Studies unrelated to health misinformation or where the full text is unavailable will be excluded. No restrictions on publication year will apply. Only papers written in English will be included. Two independent reviewers will screen the papers using Rayyan QCRI software, with disagreements resolved by a third reviewer. Data extraction will cover health topics (eg, vaccination, tobacco), study characteristics (eg, author, publication year), narrative characteristics (eg, definition of narrative, theoretical foundation), participant characteristics (eg, sociodemographic), methodology (eg, study design, content of interventions and comparators, outcomes and measures, moderating and mediating factors), main results, and discussion. The quality of the eligible studies will be assessed using the Cochrane Risk of Bias 2 tool and the Risk of Bias In Non-randomized Studies - of Interventions tool.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The results will be summarized in tables and presented as a descriptive review addressing the effectiveness of narrative corrections in health-related misinformation and the factors influencing their success. The implications of these results for future studies and practices will be elucidated. The findings of this review will be presented at a relevant conference and submitted to a peer-reviewed journal for publication. The aim is to complete the submission process by the northern summer of 2025.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Narrative messages represent a theoretically promising strategy for countering health-related misinformation; however, th","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e69414"},"PeriodicalIF":1.5,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12508667/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145137690","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Extension of the Consolidated Criteria for Reporting Qualitative Research Guideline to Large Language Models (COREQ+LLM): Protocol for a Multiphase Study.","authors":"Leonard Fehring, Julian Frings, Paul Rust, Christian Kempny, Petra A Thürmann, Sven Meister","doi":"10.2196/78682","DOIUrl":"10.2196/78682","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Qualitative research provides essential insights into human behaviors, perceptions, and experiences in health sciences. The COREQ (Consolidated Criteria for Reporting Qualitative Research) checklist, published in 2007 and endorsed by the Enhancing the Quality and Transparency of Health Research Network, advanced transparency of qualitative research reporting. However, the recent integration of large language models (LLMs) into qualitative research introduces novel opportunities and methodological challenges that existing guidelines do not address. LLMs are increasingly applied to research design as well as processing, analysis, interpretation, and even direct interaction (\"conversing\") with qualitative data. However, their probabilistic nature, dependence on underlying training data, and susceptibility to hallucinations necessitate dedicated reporting to ensure transparency, reproducibility, and methodological validity.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This protocol outlines the methodological development process of COREQ+LLM, an extension to the COREQ checklist, to support transparent reporting of LLM use in qualitative research. The three main objectives are to (1) identify and categorize current applications of LLMs used as qualitative research tools, (2) assess how LLM use in qualitative studies in health care is reported in published studies, and (3) develop and refine reporting items for COREQ+LLM through a structured consensus process among international experts.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Following the Enhancing the Quality and Transparency of Health Research Network guidance for reporting guideline development, this study comprises 4 main phases. Phase 1 is a systematic scoping review of peer-reviewed literature from January 2020 to April 2025, examining the use and reporting of LLMs in qualitative research. The scoping review protocol was registered with the Open Science Framework on June 6, 2025, and will adhere to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) guidelines. Phase 2 will use a Delphi process to reach consensus on candidate items for inclusion in the COREQ+LLM checklist among an interdisciplinary international panel of experts. Phase 3 includes pilot testing, and phase 4 involves publication and dissemination.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;As of September 2025, the steering committee has been established, and the initial search strategy for the scoping review has identified 5049 records, with 4201 (83.20%) remaining after duplicate removal. Title and abstract screening is underway and will inform the initial draft of candidate checklist items. The COREQ+LLM extension is scheduled for completion by December 2025.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The integration of LLMs in qualitative research requires dedicated reporting guidelines to ensure methodological rigor, transparency, and interpretability. COREQ+LLM will a","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e78682"},"PeriodicalIF":1.5,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12508663/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145137697","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of Adherence to Oral Semaglutide on Glycemic Control in People With Type 2 Diabetes Treated With Metformin: Protocol for an Open-Label Clinical Trial.","authors":"Nynne Sophie Holdt-Caspersen, Claus Dethlefsen, Ole Hejlesen, Erik Christiansen, Stine Hangaard, Peter Vestergaard, Morten Hasselstrøm Jensen","doi":"10.2196/64899","DOIUrl":"10.2196/64899","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Treatment adherence by people with type 2 diabetes (T2D) is overall suboptimal, which can hinder glycemic control. Multiple adherence barriers have been identified, such as the dislike and fear of injections. Several of the recommended antidiabetic drugs are available in oral formulations, which may be a good alternative to injection therapy when possible. However, strict dosing instruction could pose adherence barriers; for example, oral semaglutide requires predose and postdose fasting and restricted water intake at dosing time. Currently, oral semaglutide is the only oral glucagon-like peptide-1 receptor agonist and has only been available for a few years; therefore, limited knowledge exists on adherence to it.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The aim of this study is to investigate the effect of adherence to oral semaglutide dosing instructions on glycemic control in people with T2D who are dysregulated on metformin and optionally a sodium-glucose cotransporter-2 inhibitor and naïve to oral semaglutide.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This prospective, noninterventional, open-label, clinical trial with a duration of 12 weeks will be conducted in Denmark. Eligible participants are adults (aged ≥18 years) with dysregulated T2D (hemoglobin A1c of 53-75 mmol/mol) currently treated with metformin and optionally a sodium-glucose cotransporter-2 inhibitor for whom the next natural step in the treatment is to add an antidiabetic drug to the treatment regimen. Potential participants are recruited through announcements on social media and digital mail sent to their official digital mailbox (e-boks). During the trial, 20 participants will be initiated on oral semaglutide and escalated in dosage in accordance with the label. Information on the participants' behavior related to the dosing instructions will be collected using the following devices: a smartwatch to track activity and sleep time, a smart pill bottle to track dosing time, a smart bottle to track time and volume of water intake at dosing time, and a smartphone to take a photo of their breakfast to log time of breakfast. Glycemic control will be assessed using an unblinded continuous glucose monitoring sensor that the participants will wear. Participants are asked to report any cases of nausea or vomiting in terms of time of occurrence, duration, and severity. The primary endpoint is change from baseline to end-of-study time-in-range derived from continuous glucose monitoring data.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The first participant visit was in April 2024. Three months of high frequency temporal data on adherence behavior will be collected, despite the relatively few expected participants included.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Participants may change their behavior due to awareness of being observed. Regardless, the knowledge gained from this trial might be integrated into a decision support system, providing people with diabetes with guidance on how t","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e64899"},"PeriodicalIF":1.5,"publicationDate":"2025-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12504889/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145130900","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Home-Based Exercise to Improve Functional Outcomes in Veterans With a Recently Healed Diabetic Foot Ulcer: Protocol for a Pilot Randomized Controlled Trial.","authors":"Gwen L Robinson, Jake Drumheller, Alison D Lydecker, Bailey Rammling, Elizabeth A Dennis, Odessa Addison, Steven J Prior, Brock A Beamer, John D Sorkin, H David Gottlieb, Kiana Trent, Mary-Claire Roghmann","doi":"10.2196/71237","DOIUrl":"10.2196/71237","url":null,"abstract":"<p><strong>Background: </strong>Foot ulcers are a common complication of diabetes, often resulting from peripheral neuropathy and inadvertent trauma. Poor healing is exacerbated by peripheral arterial disease and poor glycemic control. Off-loading, a key treatment, leads to prolonged immobility. Patients rarely regain baseline mobility. Mobility is crucial to improve glycemia, promote vascular health, and improve immobility as it leads to nursing home admissions. There is limited research on exercise during ulcer remission.</p><p><strong>Objective: </strong>This pilot study will assess the feasibility and acceptability of a home-based exercise regimen aimed at safely increasing mobility and function, focusing on improving lower extremity strength, tissue perfusion, and glycemic control.</p><p><strong>Methods: </strong>Veterans aged ≥50 years with a recently healed diabetic plantar foot ulcer receiving care in the US Department of Veterans Affairs (VA) Maryland Health Care System and enrolled in a remote temperature-sensing mat program will be eligible. Potential participants will be identified via administrative codes used for the Prevention of Amputation in Veterans Everywhere directive, as well as using the VA's Podimetrics SmartMat dashboard. In this pilot study, 25 veterans will be randomized (in a 3:1 ratio) to a 12-week home-based exercise regimen or standard of care. Participants will undergo tests for gait speed, knee extension strength, cutaneous perfusion, and community mobility. The intervention group will participate in internet-based videoconference exercise classes twice a week led by the study team and home cycling 3 times a week. The control group will receive standard-of-care guidance. Outcome measures will include feasibility; acceptability; and changes in gait speed, physical activity levels, and strength.</p><p><strong>Results: </strong>This study was funded on July 1, 2024, with data collection planned from October 1, 2024, to March 31, 2026. The protocol was approved by the University of Maryland Institutional Review Board on May 13, 2024, and by the Baltimore VA Research and Development Committee on June 13, 2024. As of June 12, 2025, 12 participants have been enrolled in the study, and 6 (50%) participants have been randomized. Recruitment is expected to continue through December 2025.</p><p><strong>Conclusions: </strong>This project has potential for clinical rehabilitation translation. If it is found to be feasible and acceptable, the exercise intervention will be tested in a future multisite randomized clinical trial to assess its impact on mobility, cardiovascular events, and ulcer recurrence.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06312579; https://clinicaltrials.gov/ct2/show/NCT06312579.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/71237.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e71237"},"PeriodicalIF":1.5,"publicationDate":"2025-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12504896/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145130942","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Group-Based Telehealth Intervention for Birth Trauma: Protocol for a Pilot Feasibility and Waitlist Control Trial.","authors":"Cassandra Sundaraja, Suzanne M Cosh, Amy Dianne Lykins, Hayley Farrell, Hira Masood, Melanie Kelly Williams, Jyoti Chaku, Joseph Turner, Anand Swamy, Phillip J Tully","doi":"10.2196/69051","DOIUrl":"10.2196/69051","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Traumatic childbirth experiences affect almost half of Australian women giving birth and can lead to significant mental health impacts, including postpartum depression, anxiety. and posttraumatic stress disorder (PTSD). Despite evidence supporting psychological interventions for birth trauma, there are prominent gaps in the accessibility of these treatments, particularly for postpartum women in regional or rural areas, who face long waitlists, geographical isolation, and high financial costs. Although narrative approaches hold promise for addressing birth-related trauma, no research study to date has specifically trialed a narrative-informed, group-based telehealth intervention in this space.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to assess the acceptability and feasibility of a narrative-informed, group-based telehealth intervention for postpartum women in reducing the mental health impacts of having experienced a traumatic childbirth.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This pilot feasibility trial with a waitlist control design evaluated a six-session narrative-informed, group-based intervention delivered weekly via telehealth to postpartum women who experienced a traumatic childbirth within the past 6 months. The intervention incorporated narrative therapy techniques, such as externalization, double-listening, and outsider witnessing. Participants from a specific catchment area of predominantly rural towns in New South Wales in Australia were randomly assigned to either an intervention group (IG) or a waitlist control group (WCG). Quantitative measures assessing mental health symptoms of postpartum depression (Edinburgh Postnatal Depression Scale [EPDS]), anxiety (Perinatal Anxiety Screening Scale [PASS]) and posttraumatic stress (City Birth Trauma Scale [City BiTS]) were administered prior to, in between, and at the end of treatment, and measures of client satisfaction (Client Satisfaction Questionnaire [CSQ-8]) and group cohesion (Group Cohesiveness Scale [GCS]) were administered on completion of the intervention.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The project was funded in March 2024. Recruitment was completed between July and August 2024. Eleven pretreatment sessions were held in August 2024. Of the 33 expressions of interest (EOIs) received by August 2024, 9 participants were recruited and randomized to the IG (n=4, 44.4%) and the WCG (n=5, 55.6%). The IG completed the six-session program between September and October 2024, with data collection finalized for pre-, mid-, and postintervention timepoints. The WCG began receiving the intervention mid-October 2024, with the final data collection in December 2024. Key feasibility and acceptability metrics include attendance rates, participant retention, and group cohesion scores. Data analysis is ongoing, with manuscript preparation planned for mid-late 2025.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This study addresses a critical gap in evaluating scalable, acce","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e69051"},"PeriodicalIF":1.5,"publicationDate":"2025-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12504894/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145130769","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}