JMIR Research Protocols最新文献

{"title":"An Everyday Patient-Centered Discussion Model for Primary Care: Protocol for a Feasibility and Acceptability Study of the Zeroing in on Individualized, Patient-Centered Decisions (ZIP) Approach.","authors":"Sarah Skurla Dorin, Frances B Schulenberg, Stephanie Visnic, Bradley Youles, Rob Holleman, Jeremy B Sussman, Tanner J Caverly","doi":"10.2196/64998","DOIUrl":"https://doi.org/10.2196/64998","url":null,"abstract":"<p><strong>Background: </strong>The Zeroing in on Individualized, Patient-Centered Decisions (ZIP) approach was developed to be a feasible, everyday shared decision-making (SDM) approach to personalizing decisions in primary care. Current SDM models, which require 5 to 10 minutes just to present initial information, are impractical in primary care, highlighting the need for more concise, patient-centered approaches. The ZIP approach preserves core aspects of SDM while offering a more pragmatic framework suited to real-world clinical constraints. This approach includes three key elements: (1) making a personalized recommendation, (2) qualitatively presenting trade-offs, and (3) supporting patient decisional autonomy. Previous work has found this approach to be acceptable. However, little is known about how feasible and acceptable the ZIP approach is during an actual primary care visit.</p><p><strong>Objective: </strong>This paper aims to describe the protocol for a pilot test of the feasibility and acceptability to both patients and primary care physicians (PCPs) of using a paper-based deployment of the ZIP approach in a primary care clinic.</p><p><strong>Methods: </strong>Two case studies were examined: lung cancer screening (LCS) and blood pressure (BP) treatment decisions. This study was a multicomponent pilot implementation study involving training PCPs in the ZIP approach and providing them with an encounter-based decision aid supporting the ZIP approach during clinic visits. Eligible patients were either candidates for an initial LCS conversation or a conversation about intensifying BP medication. The patient-PCP medical encounters were audio recorded. Following the appointment, the patient completed a short survey and underwent a semistructured interview. After PCPs completed 2 to 3 study appointments, they underwent a semistructured interview reflecting on their experience with the ZIP approach. Surveys and interviews sought to understand the overall ZIP components presented during the appointment (ie, feasibility) and the extent to which patients and physicians found the approach appropriate (ie, acceptability). Survey data were analyzed to provide an overview of patient and physician demographics. Interviews were transcribed and analyzed through qualitative coding and thematic analysis to identify high-level takeaways of the feasibility and acceptability of this approach.</p><p><strong>Results: </strong>This study was funded in October 2022 by the Department of Veterans Affairs. We recruited 10 PCPs and 23 patients (n=4, 17% patients undergoing LCS and n=19, 83% patients involved in BP treatment decision-making). Data collection took place from October 2023 to April 2024. Data analysis concluded in December 2024. Planned paper submission will occur in June 2025.</p><p><strong>Conclusions: </strong>The results from this pilot implementation study will contribute to the ongoing efforts toward integrating a practical approach to SDM into pr","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e64998"},"PeriodicalIF":1.5,"publicationDate":"2025-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145251139","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Comprehensive and Structured Follow-Up for Persons With Multiple Sclerosis (CoreDISTparticipation) to Optimize Physical Functions, Health, and Employment: Protocol for a Prospective, Single-Blinded Randomized Controlled Trial and Health Economic Evaluation.","authors":"Britt Normann, Marianne Sivertsen, Tonje B Braaten, Hans Olav Melberg, Hanne Kristin Fikke, Marianne Elvik, Ellen Christin Arntzen","doi":"10.2196/74988","DOIUrl":"https://doi.org/10.2196/74988","url":null,"abstract":"<p><strong>Background: </strong>Multiple sclerosis (MS) is a chronic neurological disease of the central nervous system, primarily affecting young adults. Common challenges in MS include fatigue, physical impairments, and cognitive impairments, associated with low levels of physical activity, unemployment, reduced health-related quality of life (HRQoL), and substantial personal and societal costs. Many leave the workforce or reduce hours even when disability is low and despite a desire to increase work hours if the job is adjusted to their needs. Existing services aiming to optimize physical functions and work participation only initiate retrospectively, and there is a lack of knowledge regarding the possible effect of more proactive services.</p><p><strong>Objective: </strong>The objective of this study is to investigate the effects of a comprehensive multidisciplinary intervention, CoreDISTparticipation, delivered across health care levels (hospitals and municipalities) and sectors (health and employment/welfare), on barriers to work, physical activity, and physical functions; fatigue; and HRQoL for employed people with multiple sclerosis (pwMS) and to perform a health economic evaluation.</p><p><strong>Methods: </strong>This prospective, single-blinded randomized controlled trial (RCT) will include 115 pwMS with Expanded Disability Status Scale (EDSS) scores of 0-4 randomly allocated to either a CoreDISTparticipation intervention group or usual care (control group). The CoreDISTparticipation intervention includes (1) information videos, hospital outpatient physiotherapist assessments, and meetings with employment consultants; (2) group-based physiotherapy in municipalities for 60 minutes over 6 weeks, one indoor CoreDIST balance session, one outdoor CoreDIST balance and high-intensity interval session, and tailored work follow-up; and (3) 6 weeks of digitally supported independent training, twice weekly. Assessments will be conducted at baseline, week 9, and week 16. Primary outcomes include Multiple Sclerosis Work Difficulties Questionnaire-23 - Norwegian version (MSWDQ-23NV) and ActiGraph wGT3x-BT monitor scores. Secondary outcomes include Trunk Impairment Scale - modified Norwegian Version (TIS-modNV), Mini Balance Evaluation Systems Test (MiniBESTest), AccuGait Optimized force platform, 6-minute walk test (6MWT), Multiple Sclerosis Walking Scale-12, Multiple Sclerosis Impact Scale-29 - Norwegian version, EQ-5D-5L, and Fatigue Severity Scale - Norwegian version scores. The study will identify effects of CoreDISTparticipation versus usual care on work barriers, physical activity, balance, walking, fatigue, and quality of life, along with a health economic evaluation. Descriptive statistics and repeated measures mixed models will be performed using IBM SPSS version29.</p><p><strong>Results: </strong>We completed the enrolment phase and enrolled and randomized 115 participants in two phases by August 1, 2024. The 15-week retests were completed","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e74988"},"PeriodicalIF":1.5,"publicationDate":"2025-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145251136","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating the Efficacy of a Mobile Phone App in Enhancing Menopause Knowledge and Shared Decision-Making: Protocol for a Randomized Controlled Trial.","authors":"Jana Karam, Maggie M Paul, Chrisandra Shufelt, Prajna Ravikumar, Amy M Fratianni, Sey Oloyede, Erin M Pagel, Mary S Hedges, Ekta Kapoor, Juliana M Kling, Kristin Cole, Rajeev Chaudhry, Stephanie S Faubion","doi":"10.2196/76536","DOIUrl":"https://doi.org/10.2196/76536","url":null,"abstract":"<p><strong>Background: </strong>Menopause symptoms are common but often inadequately addressed by primary care clinicians due to limited time for discussions and resources. Mobile health apps can play a crucial role in symptom identification and management; yet, many existing menopause-focused apps lack evidence-based content and medical expertise.</p><p><strong>Objective: </strong>The aim of this study is to describe the protocol study design and methodology of a randomized controlled trial to evaluate the effectiveness of the emmii mobile app for improving menopause-related knowledge and shared decision-making compared to a traditional menopause education pamphlet.</p><p><strong>Methods: </strong>This randomized controlled trial will recruit women aged 45-55 years with upcoming primary care appointments at Mayo Clinic within 3 weeks of the date of initial outreach. Eligible patients must be English-speaking, able to provide informed consent, and report a Menopause Rating Scale score ≥5, which indicates that they are experiencing significant menopause-related symptoms. Patients will be randomized to have access to either the emmii app (intervention, n=200) or an evidence-based menopause education pamphlet (control, n=200). The emmii app is developed with direct input from primary care clinicians certified by The Menopause Society and offers symptom tracking, personalized treatment recommendations based on a protocol, and a discussion guide to support communication between patients and their primary care clinicians. Outcomes will include a postappointment survey sent to the patients and their primary care clinicians within 1-3 weeks of the appointment, and assessment of patient knowledge, clinical treatment plans, and both the patient and clinician experience. The study will also compare prescribing rates of hormonal and nonhormonal therapies for menopause symptoms between the emmii intervention and control groups to assess for influence on treatment patterns. Data will be analyzed using descriptive statistics, including chi-square tests, Wilcoxon rank sum tests, and multivariable modeling.</p><p><strong>Results: </strong>Data collection is scheduled to begin in April 2025.</p><p><strong>Conclusions: </strong>This protocol outlines the design and methodology of a randomized controlled trial that aims to assess the impact of the emmii app in facilitating menopause care through primary care clinician-patient communication and shared decision-making.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06919887; https://clinicaltrials.gov/ct2/show/NCT06919887.</p><p><strong>International registered report identifier (irrid): </strong>PRR1-10.2196/76536.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e76536"},"PeriodicalIF":1.5,"publicationDate":"2025-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145251175","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Quantifying Maternal Health Using Digital Phenotyping: Protocol for a Longitudinal Observational Study.","authors":"Amanda Glime, Taysir Mahmoud, Soni Rusagara, Alysa St Charles, Devika Lekshmi, Ashley Peterson, Aarti Sathyanarayana","doi":"10.2196/77175","DOIUrl":"https://doi.org/10.2196/77175","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;We present a digital phenotyping protocol designed to continuously and objectively measure behavioral, physiological, and contextual data during pregnancy and the postpartum period using passive sensing from Garmin smartwatches and smartphones, along with active ecological momentary assessments (EMAs). This novel protocol uniquely adapts to the unpredictable timing of childbirth, spanning from the third trimester through 6 weeks post partum, to accurately capture critical temporal changes and maternal-infant outcomes. By providing high-frequency real-time data, this methodology offers comprehensive insights into pregnancy-related behaviors and physiological processes, overcoming the limitations of traditional retrospective self-report methods.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;We aim to develop a protocol for longitudinal data collection supporting digital phenotyping that is optimized for pregnancy and the postpartum period. This protocol leverages the pregnant population's heightened interest in health and tracking. It aims to minimize the burden on the participants, increase retention, and assess the value of wearables compared to smartphones to determine the appropriate data collection methods.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Data will be collected from 30 nulliparous participants from the start of the third trimester through 6 weeks post partum. This protocol uses 3 distinct 1-time surveys, alongside daily and weekly EMAs, to capture real-time maternal experience data. Passive maternal data-such as activity, vitals, sleep, and location-are collected via smartphones and Garmin smartwatches. Participants are expected to log data about the newborn after delivery through the mobile app Huckleberry. This protocol was developed in collaboration with the Northeastern University Sath Laboratory, which focuses on digital phenotyping and longitudinal data collection, and the Tufts Medical Center's obstetrics and gynecology department, which has expertise in working with the pregnant population.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;This study was funded in August 2024. Data collection is projected to run from October 2025 to July 2026. As of September 2025, the study has been approved, and recruitment and data collection are to begin. The results are expected to be published by August 2026. We plan to assess the retention rates, survey and EMA completion rates, wear time of the smartwatch without intervention, and data volume logged in the Huckleberry app. In addition, we will perform digital phenotyping to determine whether the data collected during pregnancy can be used to predict breastfeeding outcomes, delivery outcomes, and maternal-infant well-being.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This protocol integrates the use of digital phenotyping in pregnancy and postpartum research, providing a novel method for capturing real-time indicators of maternal well-being. It will determine the expected rates of data completion and ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e77175"},"PeriodicalIF":1.5,"publicationDate":"2025-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145251189","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Interventions to Prevent Sexual Harassment Against Nurses-StopSH: Protocol for an Intervention Development Study.","authors":"Milena Marta Bruschini, Maria Schubert","doi":"10.2196/71425","DOIUrl":"https://doi.org/10.2196/71425","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Patients' sexual harassment against nurses is a worldwide phenomenon. Some forms occur on a daily to weekly basis. Despite the known high prevalence and its negative consequences, there is still a lack of evidence-based measures to prevent patients' sexual harassment against nurses. Given the complexity of the problem, multidimensional interventions are required.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The main objective of the StopSH project is to develop an evidence-based, complex intervention package to prevent patients' sexual harassment against nurses and minimize its negative consequences for the acute care sector in the German-speaking part of Switzerland.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This project is an intervention development study with a multimethod design. It involves the participative development and testing of a complex intervention package in one to two Swiss hospitals as practice partners. The project is carried out in four project phases. First, a systematic scoping review will be conducted to identify and map existing interventions aimed at preventing sexual harassment of nurses or minimizing its consequences. The review will include interventions at the individual, organizational, and network levels of nurses. The problem and needs analysis form the second phase, where a cross-sectional web-based survey will be carried out among nurses in one to two partner hospitals. The aim is to assess the prevalence, forms, and perceived consequences of sexual harassment, as well as existing and desired strategies or support structures. The results will inform the development of the intervention package. As a third phase, a complex intervention package will be codeveloped using a participatory action research approach, based on the findings from the first two phases. This process will involve nurses, hospital management, human resources, and other relevant stakeholders to ensure contextual relevance and feasibility. Finally, during a feasibility assessment, the developed intervention package will be implemented and tested on two to three test wards within the partner hospitals. The mixed methods feasibility study will assess the acceptability, practicality, and preliminary effects of the intervention. Survey data, as well as contextual and observational data, will be collected.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The project was launched in February 2024 and is scheduled to last for 5 years. As of August 2025, this project is in phase 2. Data collection is ongoing. The StopSH project is expected to develop and test a complex intervention package for the prevention of patients' sexual harassment against nurses. This intervention package is predicted to reduce the prevalence and negative effects of sexual harassment against nurses.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The results of this project will provide important guidance for nurses, but also for their employers, and as such can contribute to the long-term reductio","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e71425"},"PeriodicalIF":1.5,"publicationDate":"2025-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145251165","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Taabo Multigenerational Birth Cohort in Côte d'Ivoire: Protocol for Establishing a Longitudinal Multigenerational Birth Cohort to Guide Health Policy.","authors":"Siaka Koné, Nicole Probst-Hensch, Daouda Dao, Jürg Utzinger, Martial Laubet, Abou Marie-Chantal Tobo, Günther Fink","doi":"10.2196/70771","DOIUrl":"10.2196/70771","url":null,"abstract":"<p><strong>Background: </strong>A large number of sociodemographic, economic, environmental, and psychosocial changes have contributed to the epidemiological transition of African countries and fundamentally shifted the primary drivers of health. Cohort studies are essential for understanding and improving population health but remain scarce in sub-Saharan Africa.</p><p><strong>Objective: </strong>The main objective of the Taabo Multigenerational Cohort (MGC) project is to establish a large, regionally representative multigenerational cohort. The cohort will be established within the Taabo Health and Demographic Surveillance System (HDSS) and used for studying the life course and intergenerational dynamics of disease in the south-central part of Côte d'Ivoire.</p><p><strong>Methods: </strong>The Taabo MGC project focuses on children born between January 1, 2024, and December 31, 2025, in the Taabo HDSS, as well as their parents, grandparents, and great-grandparents. Eligible women and their children are enrolled during pregnancy, and women who do not report during pregnancy are enrolled after the birth. After enrollment of pregnant women, biological ancestors of the index child who are still alive and living in the study area are recruited into the cohort. The cohort is expected to enroll at least 3000 pregnant women and their children, as well as the infants' fathers, grandparents, and great-grandparents, with an expected sample size of approximately 15,000 individuals. To ensure the entire local population is covered in this study, we will also include 100 adults without children. The baseline assessments cover data on demographics, household wealth, tobacco and alcohol consumption, diet, physical activity, health history, quality of life, environmental exposures, depression, anxiety, stress, resilience, obstetric history, birth outcomes, cognitive function, and, for older adults, physical performance. We will also collect anthropometric measurements, blood pressure, and hemoglobin levels and check for Plasmodium infection (the causative agent of malaria) among all participants.</p><p><strong>Results: </strong>As of December 2024, the Taabo MGC project has enrolled 3239 women and 6501 family members. The enrollment of pregnant women and their children's biological ancestors will continue until the end of 2025, aiming to reach at least 15,000 adults.</p><p><strong>Conclusions: </strong>The Taabo MGC project is designed to become one of the largest cohort studies in the region. Once established, the Taabo MGC project should become a platform for future observational and interventional studies at the local level and contribute to the much-needed evidence base on lifetime disease risk in this part of Côte d'Ivoire. We hope that our work will stimulate research and guide health policy elsewhere in sub-Saharan Africa.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e70771"},"PeriodicalIF":1.5,"publicationDate":"2025-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12505403/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145251013","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":"Implementation Mapping to Identify Best Practices for Implementing Population-Wide Genomic Screening Programs: Protocol for the FOCUS (Facilitating the Implementation of Population-Wide Genomic Screening) Study.","authors":"Megan Roberts, Jarrod Marable, Kimberly Foss, Cason Whitcomb, Deborah Cragun, Adam Buchanan, Miranda Hallquist, Nathaniel Baker, Rebecca Bosch, Derek W Craig, Ingrid Wagner, Maria Fernandez, Chanita Hughes-Halbert, Caitlin Allen","doi":"10.2196/73718","DOIUrl":"10.2196/73718","url":null,"abstract":"<p><strong>Background: </strong>Population-wide genomic screening (PGS) for genetic conditions such as hereditary breast and ovarian cancer syndrome, Lynch syndrome, and familial hypercholesterolemia presents opportunities to reduce morbidity and mortality among the 1%-2% of the population at elevated risk for these serious, preventable diseases. With decreasing sequencing costs and growing support from national bodies, there are increasing numbers of PGS programs in the United States. However, guidelines and strategies to support implementation are limited, especially regarding equitable access to PGS. Contextual factors, such as organizational structures and processes, impact PGS implementation, often failing to benefit underrepresented populations. To address these challenges, we are completing the Facilitating the Implementation of Population-wide Genomic Screening (FOCUS) project, which will develop and test a freely available, web-based implementation toolkit to guide best practices for implementing PGS.</p><p><strong>Objective: </strong>The FOCUS project aims to (1) examine barriers and facilitators of PGS implementation at diverse health systems, (2) develop implementation strategies with input from an advisory panel and package them into the FOCUS toolkit, and (3) evaluate the toolkit's impact on improving PGS reach, effectiveness, adoption, and maintenance using a hybrid stepped-wedge cluster randomized trial design.</p><p><strong>Methods: </strong>We will complete implementation mapping, guided by the Consolidated Framework for Implementation Research integrated with health equity, and the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework for Health Equity to develop and evaluate an equity-focused PGS implementation toolkit. The study will involve 10 design sites to identify implementation barriers and facilitators and 12 Test Sites to assess the toolkit's effectiveness. Both design and test sites will be representative of the following 4 stages of implementation: exploration or emerging, planning, implementation, and sustainment.</p><p><strong>Results: </strong>The FOCUS project was funded in September 2024 and will conclude in June 2029. The project was funded through the Advancing Genomic Medicine Research Program at the National Human Genome Research Institute (R01HG013851-01). Data collection for aim 1 (qualitative interviews with implementation team members, patients, and laboratory vendors) began January 2024. At the time of reporting, 33 interviews have been completed with implementation team members, 8 with patients, and two with laboratory vendors. Qualitative analyses for aim 1 are underway at the time of reporting.</p><p><strong>Conclusions: </strong>The FOCUS toolkit will establish a standardized approach to scaling PGS programs across diverse populations and settings, ensuring genomics benefits are accessible to all.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e73718"},"PeriodicalIF":1.5,"publicationDate":"2025-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12505404/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145251122","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 Internet-Delivered Sexual Assault Resistance Intervention for Undergraduate Women (The IDEA3 Trial): Protocol for a Multisite Randomized Controlled Efficacy Trial.","authors":"Sarah M Peitzmeier, Charlene Y Senn, Misha Eliasziw, Katie Edwards, Paula Barata, Leanna J Papp, Karen L Hobden","doi":"10.2196/72087","DOIUrl":"10.2196/72087","url":null,"abstract":"<p><strong>Background: </strong>Sexual assault (SA) is a serious problem at universities. It is estimated that 1 in 5 women students will experience SA before they graduate.</p><p><strong>Objective: </strong>The primary aim of this randomized controlled trial is to test whether a synchronous web-based facilitated adaptation of an efficacious intervention (the Enhanced Assess, Acknowledge, Act [EAAA] program) can reduce the 1-year incidence of rape among first- and second-year undergraduate women. Secondary aims will assess the impact of the Internet-Delivered EAAA (IDEA³) on other forms of SA (attempted rape, attempted and completed coercion, and nonconsensual sexual contact). Tertiary aims will evaluate effects of the program on (1) survivor self-blame in the event of an assault, (2) 6 known mediators of the intervention effect to guide revision of IDEA³ if necessary, and (3) 2 exploratory outcomes measuring acceptance of sexualized aggression and sexual empowerment.</p><p><strong>Methods: </strong>In this multisite open-label randomized controlled trial, 1920 diverse women students at 2 Canadian and 4 US universities will be randomly assigned to receive either the 12-hour IDEA³ (intervention arm) or standard of care (control arm: 60-minute, web-based, live-facilitated consent workshop). Outcomes are measured at baseline, 1 week, 6 months, and 12 months post intervention. SA will be assessed using the Sexual Experiences Survey-Short Form Version. Survivor self-blame and outcomes known to be mediators of EAAA's reductions in SA will also be measured.</p><p><strong>Results: </strong>Funding was received in October 2022. Recruitment began on October 2, 2023, and the first participant was randomized on October 23, 2023. As of August 2025, a total of 683 participants have been enrolled and randomized. Data collection will end in May 2027.</p><p><strong>Conclusions: </strong>If efficacious, IDEA³ will be made available to universities in Canada and the United States. To date, 6 provinces in Canada and the Campus SaVE Act in the United States require institutions to provide SA prevention programming. An evidence-based, cost-effective option that can be delivered remotely via the internet has the potential to become the gold standard. The research, therefore, has the potential to impact women's health and safety internationally.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06058455, https://clinicaltrials.gov/study/NCT06058455.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/72087.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e72087"},"PeriodicalIF":1.5,"publicationDate":"2025-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145238877","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Effectiveness of the Use of Silver Fluoride and Teledentistry to Manage and Prevent Childhood Caries Among Aboriginal Children in Remote Communities: Protocol for a Cluster Randomized Controlled Trial.","authors":"Peter Arrow, Susan Piggott, Lorraine Anderson, Dawn Bessarab, Lisa Jamieson, David Atkinson, Hien Ngo, Sanjeewa Kularatna, Utsana Tonmukayakul, Soniya Nanda, Jilen Patel, Lorraine Powell, Mohamed Estai","doi":"10.2196/72227","DOIUrl":"https://doi.org/10.2196/72227","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Australian Aboriginal children experience dental decay at more than twice the rate of non-Aboriginal children. The Select Committee into the Provision of and Access to Dental Services in Australia noted that the rate of potentially preventable hospitalizations was the highest among children aged between 5 and 9 years and was higher among Indigenous Australians and those living in remote locations. The application of a silver fluoride (AgF) solution to decayed surfaces has been shown to be effective in stopping the decay process and reducing the occurrence of new decay but has been tested to a limited extent in the Australian context.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to evaluate the feasibility of using the skills of an Aboriginal health practitioner to undertake the application of AgF to carious primary molars to arrest the caries progression and prevent the occurrence of new caries among young Aboriginal children in remote communities.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This study is a cluster-randomized controlled trial with communities randomized and stratified based on caries level and water fluoridation status. The trial will recruit 640 children (aged between 6 months and 7 years) from 30 communities. Informed consent will be obtained. At baseline, each child in the intervention group will be examined by a calibrated examiner and subsequently by an oral health practitioner who will prescribe to an Aboriginal health practitioner the teeth to be treated with AgF. A formulation with 38% AgF will be applied for 1 minute (0.004 mL per tooth). The control group will be provided with standard minimally invasive care. Participants will be followed annually for 2 years to assess caries arrest and prevention by blinded calibrated examiners. Child oral health-related quality of life and dental anxiety will be elicited through validated questionnaires. Tests of proportions will be used to evaluate the proportion of lesions arrested and the proportion of surfaces at risk that decayed over the follow-up. Multiple logistic regression with appropriate control for clustering of teeth and communities will be used to evaluate caries arrest, controlling for potential confounding factors.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Community engagement has commenced, and data collection protocols have been prepared. Staff specific to the study (eg, Aboriginal health practitioners or workers) are in the process of recruitment. Participant recruitment will commence in March 2026 and conclude in December 2026. Study outcomes will be reported at 12- and 24-month follow-ups.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This study will test the effectiveness and feasibility of a non-oral health professional applying AgF to achieve caries arrest and prevention and validate clinical findings against digital imagery acquired on site. This pragmatic study will inform the development of suitable and accessible models of care for dental service pro","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e72227"},"PeriodicalIF":1.5,"publicationDate":"2025-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145244158","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effectiveness, Engagement, and Safety of a Digital Therapeutic (CT-155/BI 3972080) for Treating Negative Symptoms in People With Schizophrenia: Protocol for the Phase 3 CONVOKE Randomized Controlled Trial.","authors":"Shaheen E Lakhan, Cornelia Dorner-Ciossek, Olya Besedina, Faith Dickerson, Claudia Hastedt, Ridwana Isla, René S Kahn, Jean-Pierre Lindenmayer, Ruchi Mehta, Cassandra Snipes, Austin Speier, Wenbo Tang, Bailey Willis, Jamie Winderbaum Fernandez, Christoph von der Goltz, Abhishek Pratap","doi":"10.2196/81293","DOIUrl":"https://doi.org/10.2196/81293","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Negative symptoms of schizophrenia, such as lack of motivation, pleasure, social interest, and expression, are key contributors to functional impairments in people with schizophrenia. While psychosocial interventions have demonstrated efficacy, no Food and Drug Administration-approved pharmacotherapies exist specifically to target these symptoms. Evidence-based digital therapeutics (DTx) may offer novel, scalable treatment options to augment existing treatments.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This article describes the study design and methods of a phase 3, multicenter, double-blind, randomized controlled study (CONVOKE). It aims to evaluate the effectiveness and safety of CT-155/BI 3972080 (CT-155), a smartphone-based DTx, as an adjunct to standard-of-care antipsychotic medication in adults with experiential negative symptoms of schizophrenia.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Eligible participants were 18 years or older with a primary diagnosis of schizophrenia receiving stable antipsychotic medication for ≥12 weeks, scored ≥2 on average in at least 2 Clinical Assessment Interview for Negative Symptoms Motivation and Pleasure subscale (CAINS-MAP) domains, and were smartphone owners. Participants were randomized 1:1 to CT-155 (intervention arm) or a digital control app (control arm). CT-155 integrates aspects of multiple evidence-based psychosocial therapeutic techniques, incorporating principles of in-person psychotherapy aimed at targeting negative symptoms. Development of CT-155 was informed by patients during early clinical learning studies using earlier versions of the app. The digital control included elements of the disease educational components of CT-155 and daily digital check-ins. Participants were blinded to their assigned intervention. A blind-to-hypothesis was used so participants appropriately engaged with both apps. Accordingly, participants were informed that they would receive one of 2 interventions under investigation. Investigators, designated site personnel, and central raters were blinded throughout the study. The study comprised a 2-week screening period, 16-week active period, and a 4-week follow-up period. Change in experiential negative symptoms from baseline to Week 16 (primary end point) was assessed using CAINS-MAP (centrally rated). Other study end points included Clinical Assessment Interview for Negative Symptoms Expressivity, Positive and Negative Syndrome Scale, Personal and Social Performance Scale, Dysfunctional Attitudes Scale, Clinical Global Impressions-Severity, and Patient Global Impression of Improvement Scale. Frequency and severity of adverse events were also assessed, as well as engagement and adherence to either app.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Study enrollment began in March 2023 and was completed in January 2025. Overall, 457 participants were enrolled across 66 clinical study sites in the United States.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;We summarize an innova","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e81293"},"PeriodicalIF":1.5,"publicationDate":"2025-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145243541","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}