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Effect of Helpers Stay Quit Online Training on Preventing Smoking Relapse and Personal Networks: Protocol for a Pragmatic Randomized Controlled Trial and Embedded Mixed Methods Personal Network Study. 在线帮助者戒烟培训对预防复吸和个人网络的影响：一项实用的随机对照试验协议和嵌入式混合方法个人网络研究。
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES
JMIR Research Protocols
Pub Date : 2026-01-27 DOI: 10.2196/82140
Myra Muramoto, Allison Hopkins, Christopher McCarty, Alicia Allen, L Miriam Dickinson, Timothy Connolly, Janet Spradley, Jun Ying
<p><strong>Background: </strong>Despite major gains in smoking cessation treatment, over half of those who recently quit will relapse within one year. Two systematic reviews of relapse prevention studies reached differing conclusions on the effectiveness of behavioral interventions. Existing relapse prevention evidence is limited by study designs, methodology, and conceptual approaches to behavioral interventions. Personal networks exert powerful effects on initiating and maintaining smoking behavior and can facilitate maintaining abstinence or trigger relapse. To date, relapse prevention interventions have focused on those who are newly abstinent ("abstainers") and have not attempted to influence the abstainer's personal network. The Helpers Stay Quit (Helpers Stay Quit) online training is a conceptually novel "help others" intervention to increase abstainers' public identification as a nonsmoker and their ability to influence those in their personal network to also quit smoking-thereby creating a personal network social environment supportive of long-term abstinence.</p><p><strong>Objective: </strong>This study is a 2-arm, pragmatic randomized controlled trial (pRCT) testing the hypothesis that quitline abstainers receiving the Helpers Stay Quit intervention will have higher 30-day and 7-day point prevalence of abstinence than those receiving quitline follow-up usual care, and that outcomes may be mediated by characteristics of abstainers' personal networks. The embedded mixed methods study examines the effects of the Helpers Stay Quit intervention on the abstainers' personal network interactions related to smoking and smoking cessation.</p><p><strong>Methods: </strong>The study design is a 2-group pRCT (N=940) comparing the Helpers Stay Quit online training intervention with a quitline usual care condition. Baseline, 3-, 6-, and 12-month surveys collect data on cognitive and emotional factors potentially influencing relapse. Text messages survey tobacco use status and participants' use of the Helpers Stay Quit training content. The composition and structure of participants' personal networks are assessed at baseline and 12 months. We interviewed 60 participants (both relapsed and abstinent) at differing intervals in the last 6 months of study participation to qualitatively assess personal network influences on relapse or abstinence.</p><p><strong>Results: </strong>A total of 9 state quitlines are participating by referring potentially eligible clients for screening and potential enrollment. Recruitment began in December 2022. Enrollment of 940 participants was completed in September 2025. When the manuscript was submitted, as of August 31, 2025, 337 participants (65%) had completed the study with 12-month follow-up surveys.</p><p><strong>Conclusions: </strong>This pRCT tests whether exposure to the Helpers Stay Quit intervention decreases relapse rates of newly abstinent smokers enrolled in state quitline coaching treatment. The embedded perso
背景：尽管戒烟治疗取得了重大进展，但最近戒烟的人中有一半以上会在一年内复吸。两项预防复发研究的系统综述对行为干预的有效性得出了不同的结论。现有的复发预防证据受限于研究设计、方法和行为干预的概念方法。人际网络在开始和维持吸烟行为方面发挥着强大的作用，可以促进保持戒烟或引发复发。到目前为止，预防复发的干预措施主要集中在那些刚刚戒酒的人身上（“戒酒者”），并没有试图影响戒酒者的个人网络。“帮助戒烟者”（Helpers Stay Quit）在线培训是一种概念新颖的“帮助他人”干预，旨在提高戒烟者作为非吸烟者的公众认同，以及他们影响个人网络中其他人戒烟的能力，从而创造一个支持长期戒烟的个人网络社会环境。目的：本研究是一项两组、实用的随机对照试验（pRCT），旨在检验戒断线上接受帮助者戒烟干预的戒断者30天和7天点戒断率高于接受戒断线上随访常规护理的戒断者的假设，并且结果可能受戒断者个人网络特征的调节。本研究采用嵌入式混合方法，探讨协助戒烟干预对戒烟者与吸烟及戒烟有关的个人网络互动的影响。方法：研究设计为2组pRCT (N=940)，比较助手在线戒烟培训干预与戒烟常规护理条件。基线、3个月、6个月和12个月的调查收集了可能影响复发的认知和情绪因素的数据。短信调查烟草使用状况和参与者使用帮助者戒烟培训内容的情况。在基线和12个月时评估参与者个人网络的组成和结构。在过去6个月的研究中，我们以不同的间隔采访了60名参与者（包括复发和戒断），以定性地评估个人网络对复发或戒断的影响。结果：共有9个州的戒烟热线通过推荐潜在的合格客户进行筛选和潜在的登记参与。招聘于2022年12月开始。2025年9月完成940名参与者的登记。论文提交时，截至2025年8月31日，337名参与者（65%）完成了为期12个月的随访调查。结论：本pRCT测试了是否暴露于助手戒烟干预会降低参加国家戒烟指导治疗的新戒烟者的复发率。嵌入式个人网络混合方法研究旨在检查新戒烟者个人网络的特征，这些特征可能影响复发以及通过个人网络传播戒烟相关信息和行为的潜在可能性。该研究的设计和测量将提供对个人网络的影响，以及影响那些刚刚戒断的人复发或维持戒断的可能性的认知和情感因素的见解。
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引用次数: 0
Real-World Effectiveness and Noninferiority Evaluation and Comparison of Messenger RNA-Based and Protein-Based COVID-19 Vaccines: Protocol for the BEEHIVE Randomized Study With a Hybrid Effectiveness Design. 基于信使rna和基于蛋白质的COVID-19疫苗的实际有效性和非劣效性评价与比较：BEEHIVE随机研究方案与混合有效性设计
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES
JMIR Research Protocols
Pub Date : 2026-01-27 DOI: 10.2196/80858
Sarang K Yoon, German L Ellsworth, Steph Battan-Wraith, Andrew L Phillips, Rebecca V Fink, Joshua Griffin, Elizabeth A K Rowley, Jacob McKell, Ashley S Smith, Riley Campbell, Jesse Williams, Sarah W Ball, Hongwei Zhao, Brandy Warren, Matthew D Rousculp, Matthew S Thiese
<p><strong>Background: </strong>Surveillance of COVID-19 vaccine effectiveness (VE) was extensive upon vaccine introduction; however, it declined after the withdrawal of pandemic status in May 2023. Continued monitoring of updated vaccine formulations is needed to ensure the maintenance of VE in the face of evolving viral strains.</p><p><strong>Objective: </strong>The Booster Epidemiological Evaluation of Health, Illness and Vaccine Efficacy (BEEHIVE) study (NCT06065176), a randomized trial with a hybrid design, was developed to assess the real-world VE of the 2023-2024 Pfizer-BioNTech and Novavax COVID-19 vaccine formulations targeting the XBB.1.5 SARS-CoV-2 variant.</p><p><strong>Methods: </strong>This study was designed to enroll approximately 1500 participants aged ≥18 years from the Salt Lake City, Utah, area who had previously received ≥2 doses of an authorized messenger RNA (mRNA)-based COVID-19 vaccine but had not received a dose of the 2023-2024 formulation. The study used a randomized, hybrid design comprising 2 blinded groups assigned to receive the 2023-2024 formula of either the Novavax COVID-19 vaccine or the Pfizer-BioNTech COVID-19 vaccine and a nonrandomized, observational control group of volunteers who chose not to receive a 2023-2024 vaccine dose during the study. Follow-up lasted 24 weeks and included symptom surveys and self-administered COVID-19 antigen testing, both occurring weekly. The primary aim was to compare VE (defined as prevention of symptomatic SARS-CoV-2 infection) between study-vaccinated participants and the control group. The secondary aim was to determine the relative VE of the Pfizer-BioNTech mRNA and Novavax 2023-2024 COVID-19 vaccines. Secondary objectives included assessing how the number of previous COVID-19 vaccinations impacted VE of the 2023-2024 COVID-19 vaccines; identifying predictors and associated factors for asymptomatic versus symptomatic infection and/or prolonged or severe illness; examining factors associated with post-COVID-19 conditions; and evaluating participants' knowledge, attitudes, and practices related to COVID-19 vaccination. Participant engagement was maintained via online and text-based reminders and surveys, as well as researcher follow-up.</p><p><strong>Results: </strong>Participants were recruited from November 2023 through March 2024, with 452 and 457 participants randomized to the Novavax and Pfizer-BioNTech vaccine groups, respectively, and 279 participants enrolled in the control group. SARS-CoV-2 variants from the XBB, JN.1, KP.2, and KP.3 lineages were in circulation in the United States and the Utah region during data collection. The study ended on September 9, 2024, with results expected to be published in 2026.</p><p><strong>Conclusions: </strong>Data from this study will provide valuable real-world VE data for a dose of the Novavax COVID-19 vaccine or the Pfizer-BioNTech COVID-19 vaccine after an mRNA-based COVID-19 primary series.</p><p><strong>Trial registration:
背景：在疫苗引入后，对COVID-19疫苗有效性（VE）进行了广泛监测；然而，在2023年5月取消大流行地位后，它有所下降。需要继续监测更新的疫苗配方，以确保在面对不断演变的病毒毒株时维持疫苗免疫。目的：开展健康、疾病和疫苗功效强化流行病学评估（BEEHIVE）研究（NCT06065176），该研究是一项混合设计的随机试验，旨在评估2023-2024年辉瑞- biontech和Novavax针对XBB.1.5 SARS-CoV-2变体的COVID-19疫苗配方的实际VE。方法：本研究旨在招募来自犹他州盐湖城地区的约1500名年龄≥18岁的参与者，他们之前接受过≥2剂基于信使RNA （mRNA）的授权COVID-19疫苗，但未接受过2023-2024制剂。该研究采用随机混合设计，包括2个盲法组，分别接受2023-2024配方的Novavax COVID-19疫苗或辉瑞- biontech COVID-19疫苗，以及一个非随机观察性对照组，志愿者在研究期间选择不接受2023-2024疫苗剂量。随访24周，包括症状调查和自我给予的COVID-19抗原检测，均为每周进行一次。主要目的是比较接种研究疫苗的参与者和对照组之间的VE（定义为预防症状性SARS-CoV-2感染）。次要目的是确定辉瑞- biontech mRNA和Novavax 2023-2024 COVID-19疫苗的相对VE。次要目标包括评估既往COVID-19疫苗接种次数如何影响2023-2024年COVID-19疫苗的VE；确定无症状与有症状感染和/或长期或严重疾病的预测因素和相关因素；检查与covid -19后疾病相关的因素；评估参与者对COVID-19疫苗接种的知识、态度和做法。通过在线和基于文本的提醒和调查以及研究人员的随访来保持参与者的参与度。研究人员从2023年11月至2024年3月招募了参与者，其中452和457名参与者分别被随机分配到Novavax和Pfizer-BioNTech疫苗组，279名参与者被纳入对照组。在数据收集期间，来自XBB、JN.1、KP.2和KP.3谱系的SARS-CoV-2变体在美国和犹他州地区流行。该研究于2024年9月9日结束，预计将于2026年公布结果。结论：本研究的数据将为基于mrna的COVID-19初级系列后的Novavax COVID-19疫苗或辉瑞- biontech COVID-19疫苗剂量提供有价值的真实VE数据。试验注册：ClinicalTrials.gov NCT06065176；https://www.clinicaltrials.gov/study/NCT06065176.International注册报表标识符（irrid）： RR1-10.2196/80858。
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引用次数: 0
Effectiveness of an Educational and Counseling Program (the Green Mother Project Phase 2) to Enhance Breastfeeding and Improve Mothers' Diets From an Environmental Perspective: Protocol for a Cluster Randomized Controlled Trial. 从环境角度加强母乳喂养和改善母亲饮食的教育和咨询项目（绿色母亲项目第二阶段）的有效性：一项聚类随机对照试验方案。
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES
JMIR Research Protocols
Pub Date : 2026-01-26 DOI: 10.2196/80358
Rosa Maria Cabedo-Ferreiro, Liudmila Liutsko, Judit Cos-Busquets, Rosa García-Sierra, Margalida Colldeforns-Vidal, Azahara Reyes-Lacalle, Pere Torán-Monserrat, M Mercedes Vicente-Hernández, Miriam Gómez-Masvidal, Concepció Violán, Laura Montero-Pons, Gemma Falguera-Puig, Gemma Cazorla-Ortiz
<p><strong>Background: </strong>Exclusive breastfeeding is recommended as healthier and more sustainable than formula feeding. It produces less waste, requires fewer resources, and has a smaller environmental impact. Breastfeeding has some environmental impact related to increased maternal dietary needs and the use of feeding accessories. In light of the global climate emergency and suboptimal breastfeeding rates, targeted interventions are urgently needed to promote sustainable infant feeding practices. There are few studies that evaluate sustainability interventions in the postpartum period.</p><p><strong>Objective: </strong>The objective of this study is to evaluate the effectiveness of an educational and counseling intervention on breastfeeding and healthy maternal nutrition from an environmental perspective.</p><p><strong>Methods: </strong>A multicenter prospective intervention study is being conducted in 2 cohorts in primary care centers and hospitals in the north metropolitan area of Barcelona. The control group received standard obstetric care. The experimental group additionally received an educational intervention and health care support on breastfeeding and healthy and sustainable maternal nutrition. Pregnant women were monitored from 24 weeks of gestation to 6 months post partum. The rates of different types of breastfeeding, the women's diet, and the associated environmental impacts (climate change and water footprint) will be analyzed to assess the effectiveness of the intervention.</p><p><strong>Results: </strong>The development of the educational and counseling intervention has been completed, including the creation of the Guide to Good Practices in Breastfeeding, Nutrition, and Sustainability. Health care professionals received targeted training. Recruitment of pregnant women was conducted from December 2023 to December 2024. Prenatal education sessions and specialized care pathways were designed and implemented. Breastfeeding-friendly spaces were adapted to support the participating centers. Data collection for monitoring breastfeeding practices, maternal diet, and environmental impact indicators (carbon footprint and water footprint), with the follow-up period of 6 months post partum, was extended until September 2025, with a complementary missing data collection in October 2025. Data cleaning for final analysis is expected to conclude by January 2026. This study hypothesizes that mothers who receive higher levels of education and counseling support will (1) breastfeed for a longer duration, (2) adopt healthier and more sustainable dietary practices, and (3) reduce environmental impacts associated with both infant feeding accessories and dietary choices.</p><p><strong>Conclusions: </strong>We expect an increase in the incidence and prevalence rates of breastfeeding and a shift toward a healthy and sustainable diet with low environmental impact.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05729581; https://c
背景：纯母乳喂养被认为比配方奶喂养更健康、更可持续。它产生的废物更少，需要的资源更少，对环境的影响也更小。母乳喂养对环境有一定的影响，这与产妇饮食需求的增加和喂养器具的使用有关。鉴于全球气候紧急情况和母乳喂养率不理想，迫切需要有针对性的干预措施，以促进可持续的婴儿喂养做法。很少有研究评估产后可持续性干预措施。目的：本研究的目的是评估从环境角度对母乳喂养和母亲健康营养的教育和咨询干预的有效性。方法：在巴塞罗那北部大都市区初级保健中心和医院的2个队列中进行了一项多中心前瞻性干预研究。对照组接受标准产科护理。实验组还接受了关于母乳喂养和健康和可持续的产妇营养的教育干预和保健支持。从妊娠24周到产后6个月对孕妇进行监测。将分析不同类型的母乳喂养率、妇女的饮食和相关的环境影响（气候变化和水足迹），以评估干预措施的有效性。结果：教育和咨询干预措施的发展已经完成，包括母乳喂养、营养和可持续性良好做法指南的创建。保健专业人员接受了有针对性的培训。孕妇招募于2023年12月至2024年12月进行。设计并实施了产前教育课程和专门护理途径。对母乳喂养友好空间进行了改造，以支持参与中心。监测母乳喂养做法、产妇饮食和环境影响指标（碳足迹和水足迹）的数据收集工作延长至2025年9月，随访期为产后6个月，并于2025年10月补充了缺失的数据收集工作。最终分析的数据清理预计将于2026年1月结束。本研究假设，接受更高水平教育和咨询支持的母亲将(1)母乳喂养时间更长，(2)采用更健康和更可持续的饮食习惯，以及(3)减少与婴儿喂养配件和饮食选择相关的环境影响。结论：我们预计母乳喂养的发生率和流行率会增加，并向健康和可持续的低环境影响饮食转变。试验注册：ClinicalTrials.gov NCT05729581；https://clinicaltrials.gov/study/NCT05729581.International注册报告标识符（irrid）： DERR1-10.2196/80358。
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引用次数: 0
Combining Noninvasive Brain Stimulation and Physiotherapy to Improve the Management of Chronic Low Back Pain in Veterans: Protocol for a Multi-Arm Randomized Controlled Trial. 结合无创脑刺激和物理治疗改善退伍军人慢性腰痛的管理：一项多臂随机对照试验方案。
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES
JMIR Research Protocols
Pub Date : 2026-01-26 DOI: 10.2196/78952
Frederique Dupuis, Yannick Tousignant-Laflamme, Pascale Marier Deschênes, Philippe Fournier, Ildephonse Nduwimana, Orlane Ballot, Loris Loisel, Anne Marie Pinard, Luc Lacombe, Pierre Langevin, Alain Gaumond, Jean-Sébastien Roy, Hugo Massé-Alarie
<p><strong>Background: </strong>Low back pain (LBP) is the most common chronic pain condition in veterans, but the effectiveness of standard management approaches is modest. Addressing the psychological risk factors of chronic pain that are often observed in this population (eg, anxiety, depression, stress and mood disorders) may be important to enhance outcomes. Psychologically informed physiotherapy (PiP) identifies and mitigates the negative impacts of emotional and cognitive factors alongside the biomedical aspects of chronic LBP to improve physical functioning and has shown promising results in this population. However, residual pain and disability often persist in veterans. The combination of PiP with repetitive transcranial magnetic stimulation (rTMS) to the prefrontal cortex may enhance its effectiveness by modulating cognition, emotion, and pain perception.</p><p><strong>Objective: </strong>The aim of this study is to compare the effects of (1) combining active rTMS with PiP, (2) combining sham rTMS with PiP, and (3) usual physiotherapy (UP) on physical functioning in veterans with chronic LBP and comorbid psychological risk factors. Secondary objectives include comparing their effect on pain intensity, quality of life, depression symptoms, pain catastrophizing, movement pain-related fear, self-efficacy, medication use, and posttraumatic stress disorder symptoms.</p><p><strong>Methods: </strong>Ninety-six veterans with chronic LBP and comorbid psychological risks factors of pain will be enrolled in this 3-arm parallel randomized controlled trial. Individuals will be allocated to receive an 8-week intervention of (1) active rTMS + PiP, (2) sham rTMS + PiP, or (3) UP. Online self-administered questionnaires will be completed at baseline, 2, 8, and 26 weeks after the first treatment session. A linear mixed model will be used to assess the treatment effects by using intention-to-treat analyses. We hypothesize that active rTMS + PiP will be more effective than sham rTMS + PiP and that active PiP + rTMS or sham rTMS will be more effective than UP.</p><p><strong>Results: </strong>Ethics approval was obtained in January 2025, and participating physiotherapists completed the 2-day PiP training in May 2025. Participants have been recruited since June 2025. As of December 2025, 28 participants have been included, and recruitment is expected to continue up to June 2027, targeting the inclusion of approximately 4 new participants per month. Follow-up should be completed by December 2027, and results will be analyzed. The results of this randomized controlled trial should be published and available in June 2028.</p><p><strong>Conclusions: </strong>It is paramount to identify innovative and effective interventions for the management of chronic LBP in veterans. This study will provide new evidence on the effectiveness of two innovative interventions targeting cognitive and emotional factors of pain (ie, PiP and rTMS). If our hypothesis is confirmed, it
背景：腰痛（LBP）是退伍军人中最常见的慢性疼痛，但标准管理方法的有效性是适度的。解决在这一人群中经常观察到的慢性疼痛的心理风险因素（例如，焦虑、抑郁、压力和情绪障碍）可能对提高结果很重要。心理知情物理疗法（PiP）识别和减轻情绪和认知因素的负面影响，以及慢性腰痛的生物医学方面，以改善身体功能，并在这一人群中显示出有希望的结果。然而，残余的疼痛和残疾往往在退伍军人中持续存在。PiP联合前额皮质重复经颅磁刺激（rTMS）可能通过调节认知、情绪和疼痛感知来增强其有效性。目的：本研究旨在比较(1)主动rTMS联合PiP、(2)假rTMS联合PiP、(3)常规物理治疗（UP）对慢性腰痛退伍军人身体功能及共病心理危险因素的影响。次要目标包括比较它们对疼痛强度、生活质量、抑郁症状、疼痛灾难化、运动疼痛相关恐惧、自我效能、药物使用和创伤后应激障碍症状的影响。方法：96名患有慢性腰痛并伴有疼痛共病心理危险因素的退伍军人进行三组平行随机对照试验。个体将被分配接受为期8周的干预(1)激活rTMS + PiP，(2)假rTMS + PiP，或(3)UP。在线自我管理问卷将在第一次治疗后的基线、2周、8周和26周完成。将使用一个线性混合模型，通过意向-治疗分析来评估治疗效果。我们假设主动rTMS + PiP比假rTMS + PiP更有效，主动PiP + rTMS或假rTMS比UP更有效。结果：2025年1月获得伦理批准，参与的物理治疗师于2025年5月完成为期2天的PiP培训。参与者从2025年6月开始招募。截至2025年12月，已纳入28名参与者，预计招募将持续到2027年6月，目标是每月纳入约4名新参与者。随访应在2027年12月之前完成，并对结果进行分析。这项随机对照试验的结果将于2028年6月公布。结论：在退伍军人慢性腰痛的治疗中，寻找创新和有效的干预措施至关重要。本研究将为两种针对疼痛认知和情绪因素的创新干预措施（即PiP和rTMS）的有效性提供新的证据。如果我们的假设被证实，它可以激励临床实践的改变，并改善退伍军人慢性腰痛的生活质量。试验注册：ClinicalTrials.gov NCT06999772；https://clinicaltrials.gov/study/NCT06999772.International注册报表标识符（irrid）： PRR1-10.2196/78952。
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引用次数: 0
Acceptance and Commitment to Empowerment Intervention to Reduce HIV Stigma and Promote Community Resilience: Protocol for an Implementation Study. 接受和承诺授权干预，以减少艾滋病毒耻辱和促进社区复原力：实施研究的协议。
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES
JMIR Research Protocols
Pub Date : 2026-01-26 DOI: 10.2196/80669
Josephine Pui-Hing Wong, Alan Tai-Wai Li, Carla T Hilario, Mandana Vahabi, Egbe Etowa, Isaac Luginaah, Aniela M Dela Cruz, Miya Narushima, Kenneth Po-Lun Fung
<p><strong>Background: </strong>Racialized immigrants are disproportionately impacted by HIV in Canada. In 2022, 69.5% of first-time HIV cases, where race and/or ethnicity was reported, were among racialized individuals: Indigenous (22.6%), Black (18.0%), Asian and Arab (16.3%), and Latinx (10.1%). HIV vulnerability in racialized communities is reinforced by HIV stigma intersecting with prejudice and discrimination associated with racism, gendered oppression, homophobia, and economic marginalization. Stigma and discrimination impede public health efforts in HIV prevention, testing, treatment, and care.</p><p><strong>Objective: </strong>The goal of the study is to reduce HIV-related stigma in racialized immigrant communities in 6 Canadian cities in Alberta (Calgary, Edmonton) and Ontario (London, Niagara, Ottawa, Toronto). We will implement an evidence-based 6-session online intervention, Acceptance and Commitment to Empowerment (ACE), to promote skills for psychological flexibility (mindfulness, acceptance, cognitive defusion, values clarification, and committed action) and collective empowerment (critical reflection, dialogue, interconnectedness, and collective action). The objectives are to (1) assess community contexts and needs to inform the refinement of ACE; (2) build community capacity in stigma reduction; (3) evaluate the facilitators and barriers of implementing stigma reduction programs; and (4) disseminate knowledge to advance research, policy, and practice.</p><p><strong>Methods: </strong>Guided by the principles of social justice and health equity, we will apply the context-based PRISM (Practical Robust Implementation and Sustainability Model) and outcome-based RE-AIM (reach, effectiveness, adoption, implementation, maintenance) frameworks to inform the contextual adaptation, implementation, and evaluation of the ACE intervention. In phase 1 (year 1), we aim to survey 12 local organizations on their existing stigma reduction programs; engage 30 service providers and 60 community members to explore the local contexts and needs of stigma reduction. In phase 2 (year 2), phase 1 results will be used to refine the ACE intervention and apply a train-the-trainer (TTT) approach to engage 48 service providers or community leaders in the ACE training. ACE TTT graduates will be mentored to become ACE Community Facilitators. In phase 3 (years 3-4), project staff and ACE Community Facilitators will work in small 3-member teams to deliver the online ACE intervention to qualified participants (n=288) in 6 cities. Mixed methods will be used to examine the contextual factors on implementation processes and intervention effectiveness. Data analyses will include reflexive thematic analysis of qualitative data, inferential statistics, and analyses of variance to determine the effectiveness of the intervention over time.</p><p><strong>Results: </strong>The implementation of project ACE was delayed by 2 years due to the COVID-19 pandemic. The requirement
背景：在加拿大，种族化的移民受到艾滋病毒的影响不成比例。2022年，报告种族和/或民族的首次艾滋病毒病例中，有69.5%是种族化的个体：土著（22.6%），黑人（18.0%），亚洲和阿拉伯人（16.3%），拉丁裔（10.1%）。种族化社区的艾滋病毒易感性因艾滋病毒污名与与种族主义、性别压迫、同性恋恐惧症和经济边缘化相关的偏见和歧视交织在一起而加剧。污名化和歧视阻碍了艾滋病毒预防、检测、治疗和护理方面的公共卫生工作。目的：本研究的目的是减少阿尔伯塔省（卡尔加里、埃德蒙顿）和安大略省（伦敦、尼亚加拉、渥太华、多伦多）6个加拿大城市种族化移民社区中艾滋病毒相关的耻辱感。我们将实施基于证据的6期在线干预，接受和承诺赋权（ACE），以促进心理灵活性（正念、接受、认知融合、价值观澄清和承诺行动）和集体赋权（批判性反思、对话、相互联系和集体行动）的技能。目的是(1)评估社区的情况和需要，为改善社区教育提供信息；(2)建立社区减少污名的能力；(3)评估实施减少耻辱感项目的促进因素和障碍；(4)传播知识以推进研究、政策和实践。方法：在社会公正和健康公平原则的指导下，我们将应用基于情境的PRISM（实用稳健实施和可持续性模型）和基于结果的RE-AIM（覆盖范围、有效性、采用、实施、维护）框架，为ACE干预的情境适应、实施和评估提供信息。在第一阶段（第一年），我们的目标是调查12个当地组织现有的减少耻辱项目；与30个服务提供者和60个社区成员合作，探讨减少耻辱的当地情况和需求。在第二阶段（第二年），第一阶段的结果将用于完善ACE干预措施，并采用培训师培训（TTT）方法，让48家服务提供商或社区领导人参与ACE培训。ACE TTT毕业生将被指导成为ACE社区协调员。在第三阶段（第3-4年），项目工作人员和ACE社区协调员将以三人小组为单位，向6个城市的合格参与者（288人）提供在线ACE干预。混合方法将用于检查实施过程和干预有效性的背景因素。数据分析将包括对定性数据的反思性专题分析、推论统计和方差分析，以确定干预措施随时间的有效性。结果：由于COVID-19大流行，ACE项目的实施推迟了2年。获得所有附属大学（n=8）的研究伦理批准的要求进一步推迟了涉及参与者的研究活动的启动，直到2023年9月。在2023年10月至2024年8月期间，项目组从6个项目点招募了8位社区领导组成项目咨询委员会（PAC），并与PAC成员一起确定了第一阶段的外联和招募策略，并招募并确保了19个社区组织作为第二阶段的项目合作者。截至2025年3月，第一阶段数据收集已经完成，数据分析和知识转化正在进行中。结论：基于先前的研究结果，我们期望通过集体赋权，对ACE在减少内化和制定的耻辱方面的有效性，以及在现实环境中种族化移民中实施ACE的促进因素/障碍，产生关键的知识。
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引用次数: 0
Comparative Evaluation of Push-Out Bond Strength of Glass Fiber Posts and Carbon Fiber Posts in Root Canals Treated With Calcium Hydroxide-Based, Resin-Based, and Bioceramic-Based Root Canal Sealers: Protocol for an In Vitro Study. 玻璃纤维桩和碳纤维桩在氢氧化钙基、树脂基和生物陶瓷基根管密封剂治疗根管中推出结合强度的比较评估：一项体外研究方案
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES
JMIR Research Protocols
Pub Date : 2026-01-26 DOI: 10.2196/76621
Vinus Shivlani, Manoj Chandak, Sanika Damle

Background: For root canal procedures to be successful, adequate bond strength between endodontic sealer and post material is necessary. For postendodontic restorations, glass fiber posts and carbon fiber posts are frequently used. Depending on the type of root canal sealer used, such posts may work differently. The chemical composition and characteristics of calcium hydroxide-based, resin-based, and bioceramic-based sealers vary, which may have an impact on the posts' binding strength. Therefore, optimizing rehabilitative results requires an understanding of these connections.

Objective: This study aims to evaluate and compare the push-out bond strength of glass fiber posts and carbon fiber posts in root canals treated with calcium hydroxide-based, resin-based, and bioceramic-based endodontic sealers.

Methods: A total of 60 extracted human premolars will be used in this in vitro investigation. After canal preparation, specimens will be separated into 3 groups according to the type of sealer used (bioceramic-based, resin-based, and calcium hydroxide-based). The type of post (carbon fiber or glass fiber) will be used to further split each group into 2 subgroups. A universal testing machine will be used to exert a compressive force on each post to test its push-out bond strength. Bond strength data will be recorded in megapascals and analyzed using ANOVA and post hoc tests.

Results: The results are expected to demonstrate significant differences in push-out bond strength among different post and sealer combinations. Glass fiber posts are expected to have higher bond strength values than carbon fiber posts across all sealer groups, with the highest bond strength anticipated in the bioceramic-based sealer group. Resin-based sealers are expected to exhibit intermediate bond strength values, whereas calcium hydroxide-based sealers are expected to show the lowest bond strength values across both types of post.

Conclusions: Glass fiber posts are expected to offer superior push-out bond strength in comparison to carbon fiber posts, especially when used with bioceramic-based sealers. The type of root canal sealer significantly affects bond strength, with bioceramic-based sealers providing the most reliable bond. Findings are expected that will suggest that careful selection of both post material and sealer type is necessary to enhance the long-term success of root canal restorations.

International registered report identifier (irrid): DERR1-10.2196/76621.

背景：为了根管治疗的成功，根管密封剂和桩材料之间有足够的粘结强度是必要的。牙髓后修复多采用玻璃纤维桩和碳纤维桩。根据所使用的根管密封器的类型，这些桩的工作可能不同。氢氧化钙基密封剂、树脂基密封剂和生物陶瓷基密封剂的化学成分和特性各不相同，这可能会影响桩的结合强度。因此，优化康复效果需要了解这些联系。目的：比较氢氧化钙基根管密封剂、树脂基根管密封剂和生物陶瓷根管密封剂对玻璃纤维根管和碳纤维根管的推出强度。方法：用60颗提取的人前磨牙进行体外研究。根管预备完成后，根据使用的封闭剂类型将标本分为3组（生物陶瓷基、树脂基、氢氧化钙基）。柱子的类型（碳纤维或玻璃纤维）将用于进一步将每组分成2个子组。将使用万能试验机对每个桩施加压缩力，以测试其推出粘结强度。粘结强度数据将以兆帕斯卡为单位记录，并使用方差分析和事后测试进行分析。结果：结果预计将证明在推出粘结强度显著差异在不同的桩和封口剂组合。在所有密封剂组中，玻璃纤维桩的粘结强度值预计高于碳纤维桩，其中生物陶瓷基密封剂组的粘结强度预计最高。树脂基封口剂预计会表现出中等的结合强度值，而氢氧化钙基封口剂预计会在两种类型的桩中表现出最低的结合强度值。结论：与碳纤维桩相比，玻璃纤维桩有望提供更好的推出结合强度，特别是当与生物陶瓷基密封剂一起使用时。根管密封剂的类型会显著影响根管的粘结强度，生物陶瓷基密封剂提供最可靠的粘结。研究结果表明，为了提高根管修复的长期成功率，需要仔细选择桩材料和密封器类型。国际注册报告标识符（irrid）： DERR1-10.2196/76621。
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引用次数: 0
Effectiveness and Safety of Kangjia Decoction Granules for the Treatment of Hashimoto Thyroiditis: Protocol for a Randomized, Double-Blinded, Placebo-Controlled, Multicenter Clinical Trial. 康佳汤颗粒治疗桥本甲状腺炎的有效性和安全性：一项随机、双盲、安慰剂对照、多中心临床试验方案。
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES
JMIR Research Protocols
Pub Date : 2026-01-26 DOI: 10.2196/80993
Duanchun Zhang, Dan Zhang, Xiaoxiao Qu, Huihong Cao, Yanming He
<p><strong>Background: </strong>Hashimoto thyroiditis (HT) is a chronic inflammation of the thyroid gland mediated by autoimmune disorders, often leading to hypothyroidism and a significant reduction in a patient's quality of life. At the time of this writing, there is a lack of effective clinical treatments for early-stage HT. Kangjia decoction granules (KDGs) were developed based on clinical experience and results analysis, showing promising outcomes in improving antibody levels and quality of life in patients with HT. However, there is a lack of further evaluation of the efficacy and safety of KDGs.</p><p><strong>Objective: </strong>This pilot study aims to further understand and validate the efficacy and safety of KDGs for treating HT through clinical research and comprehensively assess the benefits of this intervention for patients.</p><p><strong>Methods: </strong>This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. Participants meeting the HT diagnostic criteria will be randomly allocated to the intervention and control groups (n1=n2=70). The intervention group will receive KDG treatment, whereas the control group will receive a placebo treatment. All participants will undergo treatment for 3 months. Changes in antithyroid peroxidase antibody (TPOAb) levels will be the primary outcome. Secondary outcomes include antithyroglobulin antibodies (TGAb), thyrotropin, also known as thyroid stimulating hormone (TSH), triiodothyronine (T3), thyroid hormone (T4), serum free triiodothyronine (FT3), serum free thyroxine (FT4), thyroid ultrasonography, IL17 mRNA and FOXP3 mRNA, traditional Chinese medicine (TCM) syndrome efficacy scores, and quality of life scale scores. Throughout the treatment and follow-up periods, safety indicators, such as routine blood and urine tests, hepatic and renal function, electrocardiography, and major adverse reactions, will be monitored.</p><p><strong>Results: </strong>The research protocol and informed consent form received approval from the Clinical Research Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, affiliated with Shanghai University of Traditional Chinese Medicine, on December 14, 2022 (Approval No. 2022-123). Participant recruitment commenced in June 2023. All intervention and concurrent data collection activities were scheduled for completion by October 2025. Data management is still ongoing; therefore, data analysis has not yet been performed.</p><p><strong>Conclusions: </strong>This study's findings will offer initial clinical evidence regarding the efficacy of the TCM compound KDGs in modulating peripheral immunity in patients with HT, decreasing autoimmune antibody levels, ameliorating TCM syndromes, and enhancing quality of life. These results will serve as a basis for future large-scale trial designs.</p><p><strong>Trial registration: </strong>China Clinical Trials Registry ChiCTR2300070184; https://www.chictr.org.cn/showp
桥本甲状腺炎（桥本甲状腺炎）是一种由自身免疫性疾病介导的甲状腺慢性炎症，常导致甲状腺功能减退，并显著降低患者的生活质量。在撰写本文时，对早期HT缺乏有效的临床治疗。根据临床经验和结果分析，康佳汤颗粒（KDGs）在改善HT患者抗体水平和生活质量方面显示出良好的效果。然而，缺乏对kdg的有效性和安全性的进一步评价。目的：本先导研究旨在通过临床研究进一步了解和验证kdg治疗HT的有效性和安全性，全面评估该干预措施对患者的益处。方法：本研究为多中心、随机、双盲、安慰剂对照临床试验。符合HT诊断标准的参与者将被随机分配到干预组和对照组（n1=n2=70）。干预组将接受KDG治疗，而对照组将接受安慰剂治疗。所有参与者将接受为期3个月的治疗。抗甲状腺过氧化物酶抗体（TPOAb）水平的变化将是主要结果。次要结局包括抗甲状腺球蛋白抗体（TGAb）、促甲状腺素（又称促甲状腺激素（TSH））、三碘甲状腺原氨酸（T3）、甲状腺激素（T4）、血清游离三碘甲状腺原氨酸（FT3）、血清游离甲状腺素（FT4）、甲状腺超声检查、il - 17 mRNA和FOXP3 mRNA、中医证候疗效评分、生活质量量表评分。在整个治疗和随访期间，将监测安全指标，如血常规和尿常规、肝肾功能、心电图和主要不良反应。结果：研究方案和知情同意书于2022年12月14日获得上海中医药大学附属岳阳中西医结合医院临床研究伦理委员会批准（批准号：2022-123）。参与者招募于2023年6月开始。所有干预和同步数据收集活动计划于2025年10月完成。数据管理仍在进行中；因此，尚未进行数据分析。结论：本研究结果将为中药复方KDGs在调节HT患者外周免疫、降低自身免疫抗体水平、改善中医证候、提高生活质量等方面的疗效提供初步临床证据。这些结果将作为未来大规模试验设计的基础。试验注册：中国临床试验注册中心ChiCTR2300070184；https://www.chictr.org.cn/showprojEN.html?proj=189169.International注册报告标识符（irrid）： DERR1-10.2196/80993。
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引用次数: 0
Traditional Chinese Medicine Syndrome Differentiation of Adult Patients With Type 2 Diabetes and Metabolic Syndrome: Protocol for a Cross-Sectional Study. 成人2型糖尿病合并代谢综合征的中医辨证：一项横断面研究方案
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES
JMIR Research Protocols
Pub Date : 2026-01-23 DOI: 10.2196/86217
Jialing Zhang, Hoi Ki Wong, Zhilin Lin, Shuyan Zhong, Minxia Ma, Xuejiao Wang

Background: The global burden of type 2 diabetes mellitus (T2DM) and metabolic syndrome (MetS) continues to rise, with these conditions significantly increasing risks of cardiovascular disease, disability, and mortality. Traditional Chinese Medicine (TCM) syndrome differentiation, a cornerstone of TCM practice, guides diagnosis and treatment by identifying patterns of disharmony. However, large-scale studies investigating TCM syndrome patterns in T2DM comorbid with MetS remain scarce.

Objective: This cross-sectional study aims to characterize TCM syndrome profiles in a population diagnosed with T2DM and MetS and evaluate their diagnostic relevance.

Methods: This cross-sectional study will enroll a cohort of 470 participants diagnosed with T2DM and MetS. All participants will undergo comprehensive assessments, including the Syndrome Differentiation Questionnaire for T2DM and MetS, demographic and anthropometric measurements, biochemical profiling (eg, fasting glucose, glycosylated hemoglobin, and lipid panel), dietary measurement (Food Frequency Questionnaire), physical activity measurement (International Physical Activity Questionnaire Short Form), sleep quality evaluation (Pittsburgh Sleep Quality Index), quality-of-life assessment (Audit of Diabetes-Dependent Quality of Life), stroke risk estimation (Framingham Stroke Risk Score), and retinal imaging. Latent class analysis will be used to identify the TCM syndrome patterns. Factor analysis will be employed to identify core TCM syndrome factors. Hierarchical cluster analysis will be performed to classify TCM syndrome elements, and logistic regression will examine associations between syndrome differentiation, metabolic parameters, lifestyle factors, and disease progression.

Results: This trial was registered on November 17, 2024. Participant recruitment for this study was initiated in November 2024. As of October 2025, more than 450 eligible participants have been enrolled and have completed data collection. Recruitment is scheduled to conclude on December 31, 2025.

Conclusions: As the first large-scale clinical study to systematically characterize TCM syndrome differentiation in T2DM-MetS comorbidity, this research will establish syndrome profiles associated with metabolic parameters, lifestyle factors, and disease progression. The findings are expected to provide a framework for integrating TCM syndrome differentiation into chronic disease management, ultimately contributing to personalized treatment strategies and improved patient outcomes in integrative medicine.

Trial registration: ClinicalTrials.gov NCT06703684; https://clinicaltrials.gov/study/NCT06703684.

International registered report identifier (irrid): DERR1-10.2196/86217.

背景：2型糖尿病（T2DM）和代谢综合征（MetS）的全球负担持续上升，这些疾病显著增加了心血管疾病、残疾和死亡的风险。中医辨证论治是中医实践的基石，通过辨证论治来指导诊断和治疗。然而，关于T2DM合并MetS的中医证候模式的大规模研究仍然很少。目的：本横断面研究旨在描述T2DM和MetS人群的中医证候特征，并评估其诊断相关性。方法：这项横断面研究将招募470名诊断为T2DM和MetS的参与者。所有参与者都将接受全面的评估，包括T2DM和MetS的证候调查问卷、人口统计学和人体测量、生化分析（如空腹血糖、糖化血红蛋白和脂质面板）、饮食测量（食物频率调查问卷）、体育活动测量（国际体育活动问卷简表）、睡眠质量评估（匹兹堡睡眠质量指数）。生活质量评估（糖尿病依赖生活质量审计），卒中风险评估（Framingham卒中风险评分）和视网膜成像。潜在类分析将用于识别中医证型。采用因子分析方法识别核心中医证候因子。分层聚类分析将对中医证候要素进行分类，逻辑回归将检验辨证、代谢参数、生活方式因素和疾病进展之间的关系。结果：该试验于2024年11月17日注册。本研究的参与者招募于2024年11月开始。截至2025年10月，已招募了450多名符合条件的参与者并完成了数据收集。招聘计划于2025年12月31日结束。结论：作为第一个系统表征T2DM-MetS合并症中医辨证的大规模临床研究，本研究将建立与代谢参数、生活方式因素和疾病进展相关的证候谱。该研究结果有望为中医辨证纳入慢性病管理提供一个框架，最终有助于个性化治疗策略和改善中西医结合患者的预后。试验注册：ClinicalTrials.gov NCT06703684；https://clinicaltrials.gov/study/NCT06703684.International注册报告标识符（irrid）： DERR1-10.2196/86217。
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引用次数: 0
Developing the Link-me+EMPHN Mental Health Model of Care to Improve General Practitioner Capacity for Mental Health Care in Australian Primary Care: Protocol for a Mixed Methods Formative Study. 发展Link-me+ empn心理健康护理模式以提高澳大利亚初级保健的全科医生心理健康护理能力：混合方法形成性研究的协议。
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES
JMIR Research Protocols
Pub Date : 2026-01-23 DOI: 10.2196/79560
Amy Coe, Jane London, Anne-Marie Martin, Aaron van Ree, Kirsty Lembke, Caroline Johnson, Bridget Bassilios, Catherine Kaylor-Hughes
<p><strong>Background: </strong>The rising prevalence of mental health conditions continues to place significant pressure on general practitioners (GPs) and general practice. Despite their critical role in managing mental health conditions, GPs and practice staff face substantial barriers in providing effective mental health care, such as time and financial constraints. A new mental health model of care (Link-me+EMPHN) aimed at engaging and building capacity in GPs and practice staff for the provision of mental health services is being designed and implemented in a Primary Health region in Victoria, Australia.</p><p><strong>Objective: </strong>This protocol describes formative research that aims to support the implementation of the Link-me+EMPHN Mental Health Model of Care in general practice, focusing on identifying current gaps in GP mental health training, assessing barriers and facilitators to implementation, exploring stakeholder perceptions and experiences, and determining needs and priorities for successful integration into routine practice.</p><p><strong>Methods: </strong>The formative research involves a multimethod approach comprising (1) a desktop audit of currently available mental health training and guidelines for GPs; (2) up to 20 semistructured interviews with GPs and practice nurses; (3) an online survey exploring current mental health care practice of GPs and practice nurses; (4) two co-design workshops with people with lived experience of mental health care help-seeking in general practice and four expert working group workshops with a multidisciplinary primary-care team; and (5) testing of the model of care in a simulated practice setting with GPs, patients, and Care Navigators. The desktop audit, online survey, and interviews will be mapped to the Theoretical Domains Framework to systematically identify gaps in GP knowledge and skills in providing mental health care. Thematic analysis of the interviews will provide context for the gaps found in current mental health care and training so that we can begin to address these. Findings from each of the co-design, expert working group, and simulation sessions will be thematically analyzed and will include key themes, insights, and any practical implications.</p><p><strong>Results: </strong>The formative research received funding in May 2024, with the formative research components taking place from May 2024 to July 2025. As of June 24, 2025, a total of 5 people participated in co-design, 14 in semistructured interviews, 28 in simulation sessions, 30 completed the online survey, and 4 working groups have been held. The desktop audit yielded 270 results. The findings of the formative research are tentatively planned for publication in 2026.</p><p><strong>Conclusions: </strong>This formative research will generate a robust understanding of the factors influencing GP and practice engagement in mental health care and will provide practical solutions to improve implementation of the menta
背景：心理健康状况的患病率不断上升，继续给全科医生（gp）和全科实践带来巨大压力。尽管全科医生和执业人员在管理精神健康状况方面发挥着关键作用，但他们在提供有效的精神卫生保健方面面临着重大障碍，例如时间和资金限制。在澳大利亚维多利亚州的一个初级保健区，正在设计和实施一种新的精神卫生保健模式（Link-me+ epn），目的是使全科医生和执业人员参与并建立提供精神卫生服务的能力。目的：本协议描述了旨在支持在全科实践中实施Link-me+ empn心理健康护理模式的形成性研究，重点是确定全科医生心理健康培训的当前差距，评估实施的障碍和促进因素，探索利益相关者的看法和经验，并确定成功融入日常实践的需求和优先事项。方法：形成性研究涉及多方法方法，包括：(1)当前可用的心理健康培训和全科医生指南的桌面审计；(2)与全科医生和执业护士进行多达20次半结构化访谈；(3)开展全科医生和执业护士心理卫生服务现状在线调查；(4) 2次与有精神卫生保健全科求助生活经历的人共同设计工作坊，4次与多学科初级保健团队共同设计专家工作组工作坊；(5)在全科医生、患者和护理导航员的模拟实践环境中测试护理模型。桌面审计、在线调查和访谈将映射到理论领域框架，以系统地确定全科医生在提供精神卫生保健方面的知识和技能差距。对访谈进行专题分析将为当前精神卫生保健和培训中发现的差距提供背景，以便我们能够开始解决这些问题。每个共同设计、专家工作组和模拟会议的结果将进行主题分析，并将包括关键主题、见解和任何实际意义。结果：形成性研究于2024年5月获得资助，形成性研究组成部分在2024年5月至2025年7月进行。截至2025年6月24日，共5人参与协同设计，14人参与半结构化访谈，28人参与模拟会话，30人完成在线调查，4个工作组。桌面审计产生了270个结果。形成性研究的结果暂定于2026年发表。结论：这项形成性研究将对影响全科医生和精神卫生保健实践参与的因素产生强有力的理解，并将为改善精神卫生保健模式的实施提供切实可行的解决方案。这些发现将有助于创建一个可持续的、可扩展的模式，以改善患者的心理健康结果，并支持全科医生。国际注册报告标识符（irrid）： DERR1-10.2196/79560。
{"title":"Developing the Link-me+EMPHN Mental Health Model of Care to Improve General Practitioner Capacity for Mental Health Care in Australian Primary Care: Protocol for a Mixed Methods Formative Study.","authors":"Amy Coe, Jane London, Anne-Marie Martin, Aaron van Ree, Kirsty Lembke, Caroline Johnson, Bridget Bassilios, Catherine Kaylor-Hughes","doi":"10.2196/79560","DOIUrl":"https://doi.org/10.2196/79560","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;The rising prevalence of mental health conditions continues to place significant pressure on general practitioners (GPs) and general practice. Despite their critical role in managing mental health conditions, GPs and practice staff face substantial barriers in providing effective mental health care, such as time and financial constraints. A new mental health model of care (Link-me+EMPHN) aimed at engaging and building capacity in GPs and practice staff for the provision of mental health services is being designed and implemented in a Primary Health region in Victoria, Australia.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This protocol describes formative research that aims to support the implementation of the Link-me+EMPHN Mental Health Model of Care in general practice, focusing on identifying current gaps in GP mental health training, assessing barriers and facilitators to implementation, exploring stakeholder perceptions and experiences, and determining needs and priorities for successful integration into routine practice.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The formative research involves a multimethod approach comprising (1) a desktop audit of currently available mental health training and guidelines for GPs; (2) up to 20 semistructured interviews with GPs and practice nurses; (3) an online survey exploring current mental health care practice of GPs and practice nurses; (4) two co-design workshops with people with lived experience of mental health care help-seeking in general practice and four expert working group workshops with a multidisciplinary primary-care team; and (5) testing of the model of care in a simulated practice setting with GPs, patients, and Care Navigators. The desktop audit, online survey, and interviews will be mapped to the Theoretical Domains Framework to systematically identify gaps in GP knowledge and skills in providing mental health care. Thematic analysis of the interviews will provide context for the gaps found in current mental health care and training so that we can begin to address these. Findings from each of the co-design, expert working group, and simulation sessions will be thematically analyzed and will include key themes, insights, and any practical implications.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The formative research received funding in May 2024, with the formative research components taking place from May 2024 to July 2025. As of June 24, 2025, a total of 5 people participated in co-design, 14 in semistructured interviews, 28 in simulation sessions, 30 completed the online survey, and 4 working groups have been held. The desktop audit yielded 270 results. The findings of the formative research are tentatively planned for publication in 2026.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This formative research will generate a robust understanding of the factors influencing GP and practice engagement in mental health care and will provide practical solutions to improve implementation of the menta","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e79560"},"PeriodicalIF":1.5,"publicationDate":"2026-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146040816","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}
引用次数: 0
Development of a Mobile App (MyLepto App) to Improve Knowledge, Attitude, and Practice Regarding Leptospirosis Among Wet Market Workers in Selangor, Malaysia: Protocol for a Quasi-Experimental Study. 开发一款移动应用程序（MyLepto App），以提高马来西亚雪兰莪州菜市场工作人员对钩端螺旋体病的知识、态度和实践：一项准实验研究方案。
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES
JMIR Research Protocols
Pub Date : 2026-01-23 DOI: 10.2196/75809
Mas Norehan Merican Aljunid Merican, Zaleha Md Isa, Rozita Hod, Roszita Ibrahim, Zamtira Seman, Rusdi Abd Rashid
<p><strong>Background: </strong>Leptospirosis is the most common zoonotic cause of mortality, with most of its burden occurring in tropical regions and low-income countries. It is endemic in Southeast and South Asian nations. Leptospirosis outbreaks occur after natural disasters. In Malaysia, the e-notification system of the Communicable Diseases Control Information System recorded 5217 leptospirosis cases in 2019 with 32 fatalities. The incidence rate was 15.61 per 100,000 people. Male individuals comprised 67% of leptospirosis cases, while people aged 25 to 55 years accounted for 45% of the cases. Information and perception are crucial in influencing positive behavior. Nonetheless, information on urban and rural people's knowledge, attitude, and practice (KAP) regarding the incidence of leptospirosis is limited.</p><p><strong>Objective: </strong>We aimed to develop a mobile app with information on leptospirosis and measure its effectiveness in improving KAP regarding leptospirosis among wet market workers in Selangor, Malaysia.</p><p><strong>Methods: </strong>A 3-phase study will be conducted and includes development of a mobile app containing information about leptospirosis, analysis of its acceptability, and application of the intervention. Participants will be recruited based on specific inclusion criteria by using purposive sampling. Four wet markets in Hulu Langat district, Selangor, will be selected according to a list provided by local municipal councils. The respondents from each selected wet market will be workers aged 18 years and older. Mobile app development will begin with an idea description, storyboard creation, and content approval through the nominal group technique. The mobile app content will be constructed using the Health Belief Model theory. Subsequently, the usability of the mobile app prototype will be evaluated using the validated Malay version of the System Usability Scale questionnaire for the evaluation of mobile apps. This protocol entails a 12-week intervention stage, in which the baseline assessment is regarded as a pretest evaluation and the follow-up assessment as a posttest evaluation. Participant selection will be based on the inclusion and exclusion criteria. This study will incorporate a set of validated questionnaires created by a group of leptospirosis experts. The validated questionnaire will comprise 9 sections with open-ended questions on sociodemographic data, KAP, and mobile app requirements.</p><p><strong>Results: </strong>Mobile app development and usability testing were completed between January 2024 and March 2025. Participant recruitment is scheduled in April to May 2025 after submission of this manuscript, with the 12-week intervention and data collection running from May to July 2025. As of manuscript submission, recruitment, data collection, and data analysis have not yet begun. Data analysis is expected to be completed by September 2025, and results are anticipated for publication in late 202
背景：钩端螺旋体病是最常见的人畜共患死亡原因，其负担大多发生在热带地区和低收入国家。它是东南亚和南亚国家的地方病。钩端螺旋体病发生在自然灾害之后。在马来西亚，传染病控制信息系统的电子通报系统在2019年记录了5217例钩端螺旋体病病例，其中32例死亡。发病率为每10万人15.61人。男性占钩端螺旋体病病例的67%，而年龄在25至55岁之间的人占45%。信息和感知是影响积极行为的关键。然而，关于城乡居民对钩端螺旋体病发病率的知识、态度和行为（KAP）的信息是有限的。目的：我们旨在开发一个带有钩端螺旋体病信息的移动应用程序，并衡量其在改善马来西亚雪兰莪州菜市场工作人员钩端螺旋体病的KAP方面的有效性。方法：将进行一项三期研究，包括开发包含钩端螺旋体病信息的移动应用程序，分析其可接受性和干预措施的应用。参与者将根据特定的纳入标准，采用有目的的抽样方法招募。雪兰莪州Hulu Langat区的四个菜市场将根据当地市政委员会提供的名单进行选择。每个选定菜市场的受访者都是年满18岁的工人。移动应用程序开发将从想法描述、故事板创建和通过名义上的小组技术的内容批准开始。使用健康信念模型理论构建移动应用程序内容。随后，将使用经过验证的马来语版本的系统可用性量表问卷来评估移动应用程序原型的可用性。该方案包括为期12周的干预阶段，其中基线评估被视为测试前评估，随访评估被视为测试后评估。参与者的选择将基于纳入和排除标准。这项研究将包括一组由钩端螺旋体病专家创建的有效问卷。经过验证的问卷将包括9个部分，其中包括关于社会人口统计数据、KAP和移动应用程序要求的开放式问题。结果：手机应用开发和可用性测试在2024年1月至2025年3月完成。本文提交后，计划于2025年4月至5月招募参与者，并于2025年5月至7月进行为期12周的干预和数据收集。截至稿件提交，招募、数据收集和数据分析尚未开始。数据分析预计将于2025年9月完成，结果预计将于2025年底公布。结论：由于雪兰莪州Hulu Langat地区报告的钩端螺旋体病病例较多，本干预研究将在那里进行。移动应用程序的开发可能有助于提高菜市场工作人员对钩端螺旋体病的认知。国际注册报告标识符（irrid）： PRR1-10.2196/75809。
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