JMIR Research Protocols最新文献

{"title":"Integration of a Patient-Centered mHealth Intervention (Support-Moms) Into Routine Antenatal Care to Improve Maternal Health Among Pregnant Women in Southwestern Uganda: Protocol for a Randomized Controlled Trial.","authors":"Esther Cathyln Atukunda, Godfrey Rwambuka Mugyenyi, Jessica E Haberer, Mark J Siedner, Angella Musiimenta, Josephine N Najjuma, Celestino Obua, Lynn T Matthews","doi":"10.2196/67049","DOIUrl":"https://doi.org/10.2196/67049","url":null,"abstract":"<p><strong>Background: </strong>Mobile health (mHealth) interventions that leverage social support (SS) can improve partner involvement and pregnancy experiences and promote antenatal care (ANC) attendance and skilled births. In our previous studies, we used behavioral frameworks to develop a user-centered mHealth-based, audio SMS text messaging app to support pregnant individuals to use maternity care services in rural Uganda (Support-Moms app). In our pilot study, we observed high intervention uptake, acceptability, and feasibility, as well as increased ANC attendance and skilled births.</p><p><strong>Objective: </strong>With the promising pilot data, we propose a type 1 hybrid implementation-effectiveness trial to test if this novel patient-centered automated and customized mHealth-based SS intervention is effective and cost-effective enough to warrant future large-scale implementation into Uganda's routine maternity care.</p><p><strong>Methods: </strong>We will physically recruit 824 pregnant women at <20 weeks of gestation living in Mbarara and Mitooma districts, southwestern Uganda, and randomize them (1:1) to receive standard of care or the Support-Moms app, with at least 2 of their identified social supporters. Our primary outcome will be the proportion of skilled births. Secondary outcomes will include number of ANC visits<strong>,</strong> institution-based delivery, mode of infant delivery, preterm birth, birth weight, SS, obstetric complications, and deaths (maternal, fetal, and newborn). We will assess other implementation, service, and client outcomes through study records, the mHealth platform, and questionnaires with all women in the intervention, their social supporters, health care providers (HCPs), and managers from participating facilities. We will conduct face-to-face in-depth exit interviews with 30 purposively selected intervention participants and 15 facility HCPs and managers to explore implementation strategies for scale-up. Annual maternity resource allocations, costs, number of ANC visits, and deliveries will be assessed from facility records up to 36 months after implementation. We will estimate incremental cost-effectiveness ratios concerning cost per additional HCP-led delivery, per death averted, and per quality-adjusted life year gained as cost-effectiveness measures.</p><p><strong>Results: </strong>This study was funded in September 2023. Ethics approval was obtained in February 2024, and actual data collection started in March 2024. As of January 2025, 75% (618/824) of all projected study participants provided consent and were recruited into the study. Participants are expected to be followed up until delivery, and 15% (124/824) have so far exited. Data analysis for the trial is expected to start as soon as the last participant exits from the study. The qualitative interviews will start in April 2025, and data will be analyzed and published as soon as data collection is done, which is expected in March 2027.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e67049"},"PeriodicalIF":1.4,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143657081","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":"Evaluation of a Smartphone-Based Weight Loss Intervention with Telephone Support for Merchant Women With Obesity in Côte d'Ivoire: Protocol for a Randomized Controlled Trial.","authors":"Rui Usui, Maki Aomori, Shogo Kanamori, Setsuko Watabe, Bi Tra Jamal Sehi, Kei Kawano, Yuka Kanoya","doi":"10.2196/69264","DOIUrl":"https://doi.org/10.2196/69264","url":null,"abstract":"<p><strong>Background: </strong>The obesity rate among women in Côte d'Ivoire is rising, particularly in urban areas. Merchantry is the leading occupation for women in the country, and merchant women face a high risk of obesity owing to their sedentary lifestyle. A previous survey indicated that the obesity rate among merchant women was 30%, double the national average. Furthermore, 82.2% of merchant women with obesity were unaware of their condition, and 40.1% expressed no interest in losing weight. While most weight loss programs target individuals ready to lose weight, community interventions should also address those with minimal readiness. Additionally, low-cost weight-loss interventions that do not require health professionals are needed in countries with limited medical resources. Smartphones could offer a cost-effective solution as they enable self-monitoring and remote communication.</p><p><strong>Objective: </strong>This study will evaluate a low-cost smartphone-based intervention that targets individuals who are not ready to lose weight without the involvement of health professionals.</p><p><strong>Methods: </strong>The intervention will run for 6 months, and its efficacy will be assessed in an unblinded, parallel-group, randomized controlled trial with 108 participants per group. All direct interventions for participants in this study will be carried out by staff without medical qualifications. The intervention group will receive weighing scales and be encouraged to record their weight with a smartphone app. Health education will be provided via weekly group messages and monthly phone calls. The evaluation will be conducted face-to-face. The primary outcome will be the weight change, and the secondary outcome will be differences in body fat percentage, abdominal circumference, and stage of behavioral change in weight loss behaviors from baseline to 3, 6, and 12 months.</p><p><strong>Results: </strong>In accordance with this protocol, the recruitment of participants started on August 26, 2024. A total of 216 participants were allocated, with 108 in the intervention group and 108 in the control group. The baseline survey began on November 15, 2024, and is currently ongoing as of the end of November 2024.</p><p><strong>Conclusions: </strong>This study will be the first in sub-Saharan African countries to implement a smartphone app-based weight loss program in sub-Saharan Africa that does not require direct intervention by health care professionals but specifically targets communities. Furthermore, if the effectiveness of this program is confirmed, it has the potential to serve as a low-cost sustainable weight loss model at the policy level.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/69264.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e69264"},"PeriodicalIF":1.4,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143657076","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 Multicomponent Strategy to Improve HIV Pre-Exposure Prophylaxis in a Southern US Jail: Protocol for a Type 3 Hybrid Implementation-Effectiveness Trial.","authors":"Ank E Nijhawan, Jana Kholy, Julia L Marcus, Timothy P Hogan, Robin T Higashi, Jacqueline Naeem, Laura Hansen, Brynn Torres, Barry-Lewis Harris, Song Zhang, Douglas Krakower","doi":"10.2196/64813","DOIUrl":"https://doi.org/10.2196/64813","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Pre-exposure prophylaxis (PrEP) is an effective approach for preventing HIV infection, but it is underutilized by populations who may benefit the most, including people living in the Southern United States and those involved in the criminal legal (CL) system. Improving the access and use of PrEP for these groups could decrease HIV-related health disparities. Beyond individual outcomes, HIV prevention for CL-involved people can have a significant public health impact on HIV incidence due to a high turnover between jails and the community.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;We will develop, implement, and evaluate a multicomponent PrEP implementation strategy for the Dallas County Jail (DCJ) to increase the initiation of this HIV-preventive intervention for CL-involved individuals.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This is a type 3 hybrid implementation-effectiveness study that takes a combined approach by assessing the implementation of a strategy to identify candidates for PrEP at the DCJ and linking them to PrEP providers upon community re-entry while also gathering information about clinical outcomes. The approach is guided by the EPIS (exploration, preparation, implementation, sustainment) framework. Initial formative work (exploration) involves qualitative interviews of diverse key stakeholders to identify factors that may influence linkage to PrEP after jail release. These findings will undergo rapid qualitative analysis (preparation) to inform the adaptation of a multicomponent jail PrEP implementation strategy protocol. This approach, which will include an electronic health record (EHR) prediction model and integration of a PrEP patient navigator into the jail health team, will allow medical providers and the navigator at the DCJ to engage individuals most likely to benefit in shared decision-making about PrEP and navigate them to community PrEP care (implementation) in a process that begins before release from jail and ends with successful care linkage. Regular quantitative and qualitative evaluations of this approach will allow for ongoing stakeholder input, refinement of the implementation strategy, and maintenance of the program (sustainment).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Findings from 26 qualitative interviews (9 formerly incarcerated individuals, 9 county jail staff, and 8 employees of community organizations) have been obtained, analyzed, and mapped to an implementation strategy formalized in a jail PrEP protocol. An HIV risk prediction model based on EHR data to identify individuals most likely to benefit from PrEP has been developed and internally validated and is ready to be deployed. We anticipate the availability of preliminary study findings in 2026.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This study will provide key insights into the feasibility and effectiveness of a PrEP implementation strategy among people at increased risk of HIV acquisition in an urban jail in Southern United States. This prac","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e64813"},"PeriodicalIF":1.4,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143657034","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":"Preventing Premature Family Maladjustment: Protocol for a Multidisciplinary eHealth Study on Preterm Parents' Well-Being.","authors":"Alessandra Decataldo, Federico Paleardi, Giacomo Lauritano, Maria Francesca Figlino, Concetta Russo, Mino Novello, Brunella Fiore, Giulia Ciuffo, Chiara Ionio","doi":"10.2196/63483","DOIUrl":"https://doi.org/10.2196/63483","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;The consequences of preterm birth extend beyond the clinical conditions of the newborn, profoundly impacting the functioning and well-being of families. Parents of preterm infants often describe the experience of preterm birth and subsequent admission to the neonatal intensive care unit (NICU) as a disruptive event in their lives, triggering feelings of guilt, helplessness, and fear. Although various research examines changes in parents' well-being and perception of self-efficacy during the stay in the NICU, there is a lack of research analyzing what happens in the transition phase at home after the baby's discharge. Recently, scholars have advocated for the use of web-based support programs to monitor and prevent preterm family maladjustment and assist parents.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This interdisciplinary research will develop a sociopsychological model focused on assessing the well-being of parents of premature infants during and after their stay in a NICU. Specifically, the study aims to (1) monitor the mental health of parents of premature infants both at the time of the child's discharge from the NICU and in the first 6 months after discharge to prevent family maladjustment, (2) deepen our understanding of the role of digital tools in monitoring and supporting preterm parents' well-being, and (3) study the potential impact of the relationship with health care professionals on the overall well-being of parents.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This project combines mixed methods of social research and psychological support with an eHealth approach. The well-being of parents of premature infants will be assessed using validated scales administered through a questionnaire to parents of preterm infants within 6 NICUs at the time of the child's discharge. Subsequently, a follow-up assessment of parental well-being will be implemented through the administration of the validated scales in a web application. In addition, an ethnographic phase will be conducted in the NICUs involving observation of the interaction between health care professionals and parents as well as narrative interviews with health care staff. Finally, interactions within the digital environment of the web application will be analyzed using a netnographic approach. We expect to shed light on the determinants of well-being among parents of premature infants in relation to varying levels of prematurity severity; sociodemographic characteristics such as gender, age, and socioeconomic status; and parental involvement in NICU care practices. With the follow-up phase via web application, this project also aims to prevent family maladjustment by providing psychological support and using an eHealth tool.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The results are expected by October 2025, the expiration date of the Project of Relevant National Interest.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The eHealth Study on Preterm Parents' Well-Being aims to improve pret","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e63483"},"PeriodicalIF":1.4,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143657088","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":"Acceptability and Preliminary Efficacy of a Novel Web-Based Physical Activity for the Heart (PATH) Intervention Designed to Promote Physical Activity in Adults With Obesity: Protocol for a Pilot Randomized Controlled Trial.","authors":"Jacob Kariuki, Lora Burke, Kirk Erickson, Susan Sereika, Sudeshna Paul, Jessica Cheng, Heran Biza, Amjad Abdirahman, Katherine Wilbraham, Heather Milton, Cornelius Brown, Matthew Sells, Foster Osei Baah, Jessica Wells, Rasheeta Chandler, Bethany Barone Gibbs","doi":"10.2196/67972","DOIUrl":"https://doi.org/10.2196/67972","url":null,"abstract":"<p><strong>Background: </strong>Even in the absence of weight loss, any level of physical activity (PA) can reduce the risk of cardiovascular disease among individuals with obesity. However, these individuals face multifaceted barriers that reduce their motivation and engagement in PA. They prefer programs that are convenient, fun to engage in, and feature people who they can relate to. Yet, there is a paucity of PA interventions that are designed to incorporate these preferences. We designed the web-based PA for The Heart (PATH) intervention to address this gap.</p><p><strong>Objective: </strong>This study aimed to describe the protocol of a study that aims to examine the acceptability and preliminary efficacy of PATH intervention among insufficiently active adults with obesity aged at least 18 years.</p><p><strong>Methods: </strong>This is a 6-month pilot randomized controlled trial (RCT), using a parallel design with 1:1 allocation to intervention or control group. The PATH intervention group is given access to the PATH platform, but the resources each participant can access are tailored according to their baseline fitness level. Control group receives a self-help PA handout. Both groups self-monitor their PA using Fitbit (Google) and have Zoom (Zoom Video Communications) meetings twice a month with either the health coach (intervention) or study coordinator (control). The outcomes at 6-months include acceptability, changes in PA, and cardiometabolic risk from baseline to 6-months.</p><p><strong>Results: </strong>We screened 763 individuals for eligibility and 89 participants were enrolled and randomized to the intervention (45/504, 50.6%) and control arms (44/504, 49.4%). The average age was 48.7 (SD 12.17) years, and most participants were female (81/504, 90.1%), Black (45/504, 50.6%), and non-Hispanic (83/504, 93.3%). No systematic differences in baseline characteristics were observed between the study arms. The 6-month intervention is currently underway, and the completion of follow-up data collection is expected in February 2025, with results to be published soon after.</p><p><strong>Conclusions: </strong>The PATH intervention offers a promising, evidence-based approach to overcoming the barriers that have hindered previous PA programs for adults with obesity. It can support new and existing programs to foster long-term maintenance of health-enhancing PA.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05803304; https://clinicaltrials.gov/study/NCT05803304.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/67972.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e67972"},"PeriodicalIF":1.4,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656957","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":"Sustainable Implementation of Digital Assistive Technologies in Health Care Through a Simplified Interaction and Control Platform: Protocol for a Cocreative Feasibility Study.","authors":"Pascal Müller, Sebastian Hofstetter, Patrick Jahn","doi":"10.2196/63089","DOIUrl":"https://doi.org/10.2196/63089","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;With the expected increase in the number of people needing care and the increasing shortage of skilled care workers, new care concepts are required. Therefore, digital assistive technologies (DATs), especially robotics, can improve the situation of people with different needs and create opportunities for participation. For a human-technology interaction to have a high level of usability, DAT's meaningfulness and effectiveness must be accessible to end users. Significant barriers to the use of DATs in health care are the lack of controllability and adaptivity, as well as control functions that are too complex.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The objective of this paper is to develop an interaction and control platform that is understandable to a layperson and has a programming interface for DAT interactions. The innovation consists of the expansion of usage and interaction options for carers of existing DAT in a more individual manner. This is to be achieved by combining modern interactive media, a modular software architecture, and already available DAT.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The project is planned as a mixed methods study with a longitudinal design, with multiple user involvements and measurement times in collaboration with 3 care facilities in Germany. When assessing technologies, the satisfaction of the basic human needs of competence, connection, and autonomy plays an important role in the actual use of the technology. These needs can be measured in the form of usability (System Usability Scale), intention to use (Technology Usage Inventory), and satisfaction with the carers' needs (Technology-Based Experience of Need Satisfaction). In the qualitative assessment, user experience is recorded using the think-aloud method and focus groups in order to obtain information about potential improvements of the platform.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The EduXBot (Educational Exploration Robot Application Platform) project was initiated in January 2023 and is scheduled to conclude in December 2025, at which point the project's final results are expected to be available. The initial results were attained in the summer of 2024 when the final concept for the platform prototype was developed. In November 2024, an initial prototype of a functional platform for the simplified interaction and control of DAT was evaluated.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;It is expected that the open DAT system architecture enables caregivers without any previous technical knowledge to assemble their individual DAT functional portfolio. The results of the project will provide low-threshold access to interaction options for existing DAT as well as expand the usage of such technologies in an individual and patient-centered way.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration: &lt;/strong&gt;Deutsches Register Klinischer Studien DRKS00034195; https://drks.de/search/de/trial/DRKS00034195.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;International registered report identifier (irrid): ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e63089"},"PeriodicalIF":1.4,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143657093","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":"Methadone patient access to collaborative treatment (MPACT): Protocol for a pilot and a randomized controlled trial to establish feasibility of adoption and impact on methadone treatment delivery and patient outcomes.","authors":"Beth E Meyerson, Allissa Davis, Richard A Crosby, Linnea B Linde-Krieger, Benjamin R Brady, Gregory A Carter, Arlene N Mahoney, David Frank, Janet Rothers, Zhanette Coffee, Elana Deuble, Jonathan Ebert, Mary F Jablonsky, Marlena Juarez, Barbara Lee, Heather M Lorenz, Michael D Pava, Kristen Tinsely, Sana Yousaf","doi":"10.2196/69829","DOIUrl":"https://doi.org/10.2196/69829","url":null,"abstract":"<p><strong>Background: </strong>Access to methadone treatment can reduce opioid overdose death by up to 60%, but U.S. patient outcomes are suboptimal. Federally-allowed methadone treatment accommodations during the COVID public health emergency were not widely adopted. It is likely that staff-level characteristics such as trauma symptoms influence adoption of treatment innovation.</p><p><strong>Objective: </strong>Methadone Patient Access to Collaborative Treatment (MPACT) is a two-phased project (pilot and field trial) to develop and test a staff-level, multimodal intervention to increase staff adoption of methadone treatment innovation and ultimately improve patient outcomes of treatment retention.</p><p><strong>Methods: </strong>A pilot and national trial will measure implementation feasibility, acceptability and effects of the MPACT intervention on treatment practice change, clinic culture, patient retention, and patient Posttraumatic stress symptoms (PTSS). The pilot will be a single-arm 5.5-month pilot study of MPACT conducted in two Arizona methadone treatment clinics (rural and urban) among 100 patients and 22 staff. The national trial will be a 20-month cluster randomized trial conducted among 40 clinics, 800 patients (20 per clinic) and 520 staff (13 per clinic). Data will be gathered by staff and patient survey and patient chart review. The primary study outcome is increased patient methadone treatment retention measured as: 1) time to first treatment interruption from study enrollment, 2) active in treatment at enrollment, day 30, 60, 90, and 120, 3) continuous days in treatment during the study period. Secondary study outcomes include reductions in vicarious trauma (VT) and PTSS among enrolled opioid treatment program staff and PTSS among enrolled patients.</p><p><strong>Results: </strong>This study is funded (currently) by the National Institute on Drug Abuse under Award Number R61DA059889, funded September 2023. As of November 30, 2025, we recruited all pilot participants and are in the second month of the pilot study. The pilot study will conclude in March of 2025 at which time we will initiate data analysis. The randomized controlled trial will begin in December 2025.</p><p><strong>Conclusions: </strong>The MPACT study will provide a foundation for an evidence-based, staff-level intervention aimed at improving patient retention in methadone treatment. Future studies should examine the individual components of MPACT to determine their differential contributions to the primary outcome of patient methadone treatment retention, and to secondary outcomes of staff and patient reduction in stress symptoms.</p><p><strong>Clinicaltrial: </strong>Clinicaltrials.gov NCT06513728, pilot and NCT06556602 for trial.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":" ","pages":""},"PeriodicalIF":1.4,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143657107","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":"Efficacy of DaXianXiong decoction in preventing the progression of severity of acute pancreatitis: Protocol for a Randomized Controlled Trial.","authors":"Dongsheng Ren, Judan Tan, Yuling Zhou, Zhenchun Luo","doi":"10.2196/67392","DOIUrl":"https://doi.org/10.2196/67392","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Developing countries are facing an increase in the incidence of acute pancreatitis (AP) - characterized by rapid onset, fast progression, high rate of severity, and high mortality. Progression of AP into severe acute pancreatitis (SAP) results in a series of complications such as organ dysfunction, local abscesses, pseudocysts, and necrosis. Although the treatment of AP is primarily supportive, including fluid resuscitation and organ support, there is still a lack of consensus on the optimal management regimen for fluid therapy , and strategies to promote gastrointestinal recovery remain limited. As no effective intervention measure has yet been developed, supportive therapy remains the major approach for the early treatment of AP. DaXianXiong decoction is a widely used TCM formulation; however, limited research is conducted on its clinical efficacy. Here, we propose a standardized clinical trial to evaluate the effectiveness and safety of DaXianXiong decoction in preventing the progression of AP to SAP.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to evaluate the efficacy and safety of DaXianXiong decoction in preventing AP from progressing to SAP. Assessing its impact on SAP incidence, clinical severity scores, inflammation markers, and gastrointestinal function, providing evidence for AP management.The primary outcomes will include incidence of SAP, modified CTSI score, APACHE II score, Modified Marshall score, and levels of the inflammation factor. The secondary outcomes will include the effect of the gastrointestinal dysfunction treatment. Evaluations will be conducted at baseline, 24 h after intervention, and days 3, 7, and 28 after intervention in both groups.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This study is a randomized, double-blind, placebo-controlled, single-center clinical trial. Sixty eligible patients will be randomly allocated in a 1:1 ratio to the intervention group and the control group. Both groups will receive standard Western medical treatment for pancreatitis. The intervention group will additionally receive DaXianXiong decoction, while the control group will receive a placebo similar to the decoction.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;This study has been funded by the Performance Incentive Project of Scientific Research Institutions in Chongqing. The trial was registered in April 2024, and data analysis is expected to be completed by April 2025. The study results will be presented at both national and international conferences and published in peer-reviewed journals.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This trial will help us assess the effectiveness and safety of DaXianXiong decoction in patients with AP. This study will provide clinical evidence on the efficacy and safety of DaXianXiong decoction in preventing the progression of AP to SAP. By evaluating its impact, the findings will contribute to the understanding of DaXianXiong decoction as an adjunct therapy in AP management and may offer ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":" ","pages":""},"PeriodicalIF":1.4,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143648755","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":"Demonstrating Tactical Combat Casualty Care in Simulated Environments to Enable Passive, Autonomous Documentation: Protocol for a Prospective Simulation-Based Study.","authors":"Jeanette R Little, Triana Rivera-Nichols, Holly H Pavliscsak, Omar Badawi, James C Gaudaen, Chevas R Yeoman, Todd S Hall, Ethan T Quist, Ericka L Stoor-Burning","doi":"10.2196/67673","DOIUrl":"https://doi.org/10.2196/67673","url":null,"abstract":"<p><strong>Background: </strong>The Telemedicine & Advanced Technology Research Center (TATRC) commenced a new research portfolio specifically addressing Autonomous Casualty Care (AC2) in 2023. The first project within this portfolio addresses the current and historical challenges of capturing tactical combat casualty care (TCCC) data in operational settings.</p><p><strong>Objective: </strong>The initial autonomous casualty care effort, the Passive Data Collection using Autonomous Documentation research project, conducts systematic, simulated patient and casualty care scenarios, leveraging suites of passive sensor inputs to populate a data repository that will automate future combat care.</p><p><strong>Methods: </strong>To obtain the required datasets, TATRC will engage care provider participants who provided consent in one of 6 randomized simulated TCCC scenarios leveraging an institutional review board-approved office protocol (#M-11057). These simulations will leverage mannikins (low and high fidelity) and live simulated patients (eg, human actors who provided consent). All consenting participants (eg, both the care providers and live simulated patients) will be equipped with suites of sensors that will passively collect data on care delivery actions and patient physiology. Simulated data is being collected at Fort Detrick, Maryland; Fort Sam Houston, Texas; Fort Indiantown Gap, Pennsylvania; Fort Liberty, North Carolina; and a commercial site in Greenville, North Carolina.</p><p><strong>Results: </strong>Across all research locations, TATRC will collect and annotate approximately 2500 simulation procedures tasks by March 2025. These study data will generate the first machine learning and artificial intelligence algorithms to populate Department of Defense (DD) Form 1380 fields accurately and reliably. Additional data collected past March 2025 will be used to continue to refine and mature the algorithm.</p><p><strong>Conclusions: </strong>The military health care system (MHS) lacks real-world datasets for TCCC care at the point of injury. Developing a data repository of simulated TCCC data is required as an essential step toward automating TCCC care. If TATRC's research efforts result in the ability to automate care delivery documentation, this will alleviate the cognitive burden of TCCC care providers in austere, chaotic environments. By generating a TCCC data repository through this Autonomous Documentation research project, TATRC will have opportunities to leverage this research data to create machine learning and artificial intelligence models to advance passive, automated medical documentation across the health care continuum.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/67673.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e67673"},"PeriodicalIF":1.4,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143648754","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":"Contactless Sleep Monitoring for the Detection of Exacerbations in People With Chronic Obstructive Pulmonary Disease: Protocol for a Longitudinal Observational Study.","authors":"Julie Egmose, Thomas Kronborg, Ole Hejlesen, Stine Hangaard","doi":"10.2196/63230","DOIUrl":"https://doi.org/10.2196/63230","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Exacerbations of chronic obstructive pulmonary disease (COPD) are one of the main causes of mortality, and early detection of exacerbations is thus essential. Telemedicine solutions have shown promising results for the detection of exacerbations in COPD and have increasingly been used. However, the effect of telemedicine is divergent. According to several studies, respiration rate (RR) increases before, during, and after an exacerbation and the change is measurable with several contactless devices. Despite this, RR is rarely measured, and telemedicine solutions only use wearable devices for measuring RR, even though wearable respiratory monitoring devices have been associated with certain drawbacks. Contactless devices are often used during sleep, as measurements conducted during sleep minimize the risk of disturbance from physical activities. However, the potential of measuring RR and heart rate (HR) during sleep for the detection of exacerbations in COPD remains unclear.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The aim of this observational study is to investigate whether contactless measurement of RR, HR, and sleep stages can be used to detect exacerbations in people with COPD.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;An observational study including 50 participants with COPD will be conducted. The participants reside in Aalborg municipality, located in the North Denmark Region. Participants will use a contactless monitor (Sleepiz One+) near their bed during sleep for a period of 4 months. After data collection, descriptive statistics will be used to identify any extremes or variations in RR, HR, or sleep stages in the nights preceding an exacerbation. Correlation analysis will be performed to evaluate the relationship between the number of exacerbations and extremes or variations in RR, HR, or sleep stages. Finally, qualitative interviews will be conducted with 12 participants to explore their experiences of sleeping with the monitor nearby.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Recruitment started at the end of April 2024. A total of 12 participants have been recruited, and the remaining participants are expected to be recruited during March and April 2025. Six out of 12 participants have completed the data collection and qualitative interview stages. Overall data collection is expected to be completed by September 2025. The results are expected to provide insight into the potential for identifying extremes or variations in RR, HR, or sleep stages in the days preceding an exacerbation. Additionally, the results are expected to assess the correlation between the number of exacerbations and extremes or variations in RR, HR, and sleep stages.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The findings from this study may clarify the possibility of using a contactless monitor to detect exacerbations in COPD. Furthermore, the results may have the potential to improve the ability to predict exacerbations in the future.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;International r","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e63230"},"PeriodicalIF":1.4,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143630413","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}