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Improvement of Motor Imagination and Manual Ability Through Virtual Reality and Selective and Nonselective Functional Electrical Stimulation: Protocol for a Randomized Controlled Trial. 通过虚拟现实以及选择性和非选择性功能性电刺激改善运动想象力和动手能力：随机对照试验方案》。
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES
JMIR Research Protocols
Pub Date : 2024-11-22 DOI: 10.2196/63329
Montserrat Santamaría-Vázquez, J Hilario Ortiz-Huerta, Aitor Martín-Odriozola, Olalla Saiz-Vazquez
<p><strong>Background: </strong>Motor imagery (MI) is a cognitive process that has been shown to be useful in the rehabilitation process after brain injury. Moreover, functional electrical stimulation (FES) and virtual reality (VR) have also been shown to be effective interventions in many parameters, and there is some evidence of their contribution to the improvement of MI capacity.</p><p><strong>Objective: </strong>This study aimed to compare the improvements in MI parameters, grip strength, and manual dexterity obtained using VR, FES, and selective FES based on multifield electrodes in healthy people.</p><p><strong>Methods: </strong>This clinical randomized controlled trial (RCT)with 4 branches will involve 80 healthy university students, with blinded third-party assessment. Participants will be divided into 4 groups: control (no intervention), selective FES (Fesia Grasp), traditional FES (Globus Elite), and Virtual Rehab Hands (Leap Motion sensor). Each group will receive 5 daily sessions, and assessments will be conducted at baseline, postintervention, and follow-up. The Movement Imagery Questionnaire-Revised (MIQ-RS) and chronometry will be used to assess MI, strength will be measured with a digital dynamometer, and manual dexterity will be evaluated with the Nine Hole Peg Test (NHPT) and the Box and Block Test (BBT). Statistical analyses will include 2-way repeated-measures ANOVA with post hoc Bonferroni correction to compare group differences over time, with nonparametric tests (eg, Kruskal-Wallis) being used if normality or variance assumptions are violated. The study will be organized into 3 phases: preparation, data collection, and analysis. The preparation phase will involve finalizing project protocols and obtaining ethical approvals. The data collection phase will consist of recruiting participants, randomizing them into 4 intervention groups, and conducting baseline assessments, followed by intervention sessions. Finally, the analysis phase will focus on evaluating the data collected from all groups and compiling the results for presentation.</p><p><strong>Results: </strong>The study received approval in July 2023, with recruitment and data collection starting in September 2023. The recruitment phase was expected to conclude by July 2024, and the entire study, including the 2-week follow-up, was set to finish in September 2024. As of July 2024, we had enrolled 100% of the sample (N=80 students). We plan to publish the study findings by the end of 2024.</p><p><strong>Conclusions: </strong>Improvements in MI and upper limb functionality are expected, particularly in the selective FES group. This RCT will identify which intervention is most effective in enhancing these skills, with potential benefits for patients with neurological motor disorders.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06109025; https://clinicaltrials.gov/study/NCT06109025.</p><p><strong>International registered report identifier (irrid): </s
背景：运动想象（MI）是一种认知过程，已被证明在脑损伤后的康复过程中非常有用。此外，功能性电刺激（FES）和虚拟现实（VR）在许多参数方面也被证明是有效的干预措施，有证据表明它们有助于提高运动想象能力：本研究旨在比较在健康人群中使用虚拟现实、FES 和基于多场电极的选择性 FES 对 MI 参数、握力和手部灵活性的改善情况：这项临床随机对照试验（RCT）共有 4 个分支，将由 80 名健康大学生参与，并由第三方进行盲法评估。参与者将被分为 4 组：对照组（无干预）、选择性 FES（Fesia Grasp）、传统 FES（Globus Elite）和虚拟康复手（Leap Motion 传感器）。每组每天接受 5 次治疗，并在基线、干预后和随访时进行评估。运动意象问卷-修订版（MIQ-RS）和时间测定法将用于评估运动意象，力量将通过数字测力计进行测量，而手部灵活性将通过九孔钉测试（NHPT）和箱块测试（BBT）进行评估。统计分析将包括双向重复测量方差分析和事后 Bonferroni 校正，以比较不同时间段的组间差异，如果违反正态性或方差假设，将使用非参数检验（如 Kruskal-Wallis）。研究将分为三个阶段：准备、数据收集和分析。准备阶段包括最终确定项目协议和获得伦理批准。数据收集阶段将包括招募参与者、将他们随机分为 4 个干预组、进行基线评估以及随后的干预课程。最后，分析阶段将重点评估从所有小组收集到的数据，并将结果汇编成报告：研究于 2023 年 7 月获得批准，招募和数据收集工作于 2023 年 9 月开始。预计招募阶段将于 2024 年 7 月结束，包括两周随访在内的整个研究将于 2024 年 9 月结束。截至 2024 年 7 月，我们已招募了 100%的样本（N=80 名学生）。我们计划在2024年底公布研究结果：预计 MI 和上肢功能将得到改善，尤其是选择性 FES 组。这项研究将确定哪种干预措施能最有效地提高这些技能，从而为神经系统运动障碍患者带来潜在益处：试验注册：ClinicalTrials.gov NCT06109025；https://clinicaltrials.gov/study/NCT06109025.International 注册报告标识符（irrid）：DERR1-10.2196/63329。
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引用次数: 0
A Mindfulness-Based Lifestyle Intervention for Dementia Risk Reduction: Protocol for the My Healthy Brain Feasibility Randomized Controlled Trial. 降低痴呆症风险的正念生活方式干预：我的健康大脑可行性随机对照试验方案》。
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES
JMIR Research Protocols
Pub Date : 2024-11-21 DOI: 10.2196/64149
Ryan A Mace, Makenna E Law, Joshua E Cohen, Christine S Ritchie, Olivia I Okereke, Bettina B Hoeppner, Judson A Brewer, Stephen J Bartels, Ana-Maria Vranceanu
<p><strong>Background: </strong>Lifestyle behavior change and mindfulness have direct and synergistic effects on cognitive functioning and may prevent Alzheimer disease and Alzheimer disease-related dementias (AD/ADRD). We are iteratively developing and testing My Healthy Brain (MHB), the first mindfulness-based lifestyle group program targeting AD/ADRD risk factors in older adults with subjective cognitive decline. Our pilot studies (National Institutes of Health [NIH] stage 1A) have shown that MHB is feasible, acceptable, and associated with improvement in lifestyle behavior and cognitive outcomes.</p><p><strong>Objective: </strong>We will compare the feasibility of MHB versus an education control (health enhancement program [HEP]) in 50 older adults (aged ≥60 y) with subjective cognitive decline and AD/ADRD risk factors. In an NIH stage 1B randomized controlled trial (RCT), we will evaluate feasibility benchmarks, improvements in cognitive and lifestyle outcomes, and engagement of hypothesized mechanisms.</p><p><strong>Methods: </strong>We are recruiting through clinics, flyers, web-based research platforms, and community partnerships. Participants are randomized to MHB or the HEP, both delivered in telehealth groups over 8 weeks. MHB participants learn behavior modification and mindfulness skills to achieve individualized lifestyle goals. HEP participants receive lifestyle education and group support. Assessments are repeated after the intervention and at a 6-month follow-up. Our primary outcomes are feasibility, acceptability, appropriateness, credibility, satisfaction, and fidelity benchmarks. The secondary outcomes are cognitive function and lifestyle (physical activity, sleep, nutrition, alcohol and tobacco use, and mental and social activity) behaviors. Data analyses will include the proportion of MHB and HEP participants who meet each benchmark (primary outcome) and paired samples 2-tailed t tests, Cohen d effect sizes, and the minimal clinically important difference for each measure (secondary outcomes).</p><p><strong>Results: </strong>Recruitment began in January 2024. We received 225 inquiries. Of these 225 individuals, 40 (17.8%) were eligible. Of the 40 eligible participants, 21 (52.5%) were enrolled in 2 group cohorts, 17 (42.5%) were on hold for future group cohorts, and 2 (5%) withdrew before enrollment. All participants have completed before the intervention assessments. All cohort 1 participants (9/21, 43%) have completed either MHB or the HEP (≥6 of 8 sessions) and after the intervention assessments. The intervention for cohort 2 (12/21, 57%) is ongoing. Adherence rates for the Garmin Vivosmart 5 (128/147, 87.1% weeks) and daily surveys (105/122, 86.1% weeks) are high. No enrolled participants have dropped out. Enrollment is projected to be completed by December 2024.</p><p><strong>Conclusions: </strong>The RCT will inform the development of a larger efficacy RCT (NIH stage 2) of MHB versus the HEP in a more diverse sample of
背景：改变生活方式和正念对认知功能有直接的协同作用，可预防阿尔茨海默病和阿尔茨海默病相关痴呆症（AD/ADRD）。我们正在反复开发和测试 "我的健康大脑"（MHB），这是首个以正念为基础的生活方式团体项目，针对主观认知能力下降的老年人的阿兹海默症/阿兹海默症相关痴呆症（AD/ADRD）风险因素。我们的试点研究（美国国立卫生研究院[NIH]1A 阶段）表明，MHB 是可行的、可接受的，并且与生活方式行为和认知结果的改善相关：我们将比较 MHB 与教育对照组（健康增强计划 [HEP]）在 50 位主观认知能力下降且存在注意力缺失症/注意力缺失性痴呆症风险因素的老年人（年龄≥60 岁）中的可行性。在一项美国国立卫生研究院（NIH）1B阶段随机对照试验（RCT）中，我们将评估可行性基准、认知和生活方式结果的改善情况以及假设机制的参与情况：我们正在通过诊所、传单、网络研究平台和社区合作等方式进行招募。参与者将被随机分配到 MHB 或 HEP 项目中，两者均以远程医疗小组的形式进行，为期 8 周。MHB 参与者学习行为矫正和正念技能，以实现个性化的生活方式目标。HEP 参与者则接受生活方式教育和小组支持。干预结束后和 6 个月的随访期间将重复进行评估。我们的主要结果是可行性、可接受性、适当性、可信度、满意度和忠诚度基准。次要结果是认知功能和生活方式（体育活动、睡眠、营养、烟酒使用、精神和社交活动）行为。数据分析将包括符合各项基准（主要结果）的 MHB 和 HEP 参与者的比例，以及配对样本 2-tailed t 检验、Cohen d 效果大小和各项指标的最小临床重要性差异（次要结果）：招募工作于 2024 年 1 月开始。我们收到了 225 份咨询。在这 225 人中，有 40 人（17.8%）符合条件。在这 40 名符合条件的参与者中，有 21 人（52.5%）参加了 2 个小组，17 人（42.5%）暂缓参加未来的小组，2 人（5%）在参加前退出。所有参与者均已完成干预评估。第一组的所有参与者（9/21，43%）都完成了 "健康之路 "或 "健康教育计划"（8 个疗程中≥6 个疗程），并完成了干预评估。第二组参与者（12/21，57%）的干预仍在进行中。Garmin Vivosmart 5（128/147，87.1% 周）和每日调查（105/122，86.1% 周）的坚持率很高。没有参加者退出。预计将于 2024 年 12 月完成注册：该研究将为在更多样化的老年人样本中开展更大规模的 MHB 与 HEP 的疗效研究（美国国立卫生研究院第二阶段）提供信息，并通过理论驱动的中介和调节因素测试改善机制。在 MHB 中将正念与生活方式行为改变相结合，有可能成为一种有效且可持续的方法，提高老年人对减少注意力缺失/注意力缺失性痴呆风险策略的接受度：ClinicalTrials.gov NCT05934136; https://www.clinicaltrials.gov/study/NCT05934136.International 注册报告标识符 (irrid)：DERR1-10.2196/64149。
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引用次数: 0
Digital Homework Support Program for Children and Adolescents With Attention-Deficit/Hyperactivity Disorder: Protocol for a Randomized Controlled Trial. 针对注意力缺陷/多动障碍儿童和青少年的数字家庭作业支持计划：随机对照试验方案》。
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES
JMIR Research Protocols
Pub Date : 2024-11-21 DOI: 10.2196/44553
Fanny Gollier-Briant, Laurence Ollivier, Pierre-Hugues Joalland, Stéphane Mouchabac, Philippe Leray, Olivier Bonnot
<p><strong>Background: </strong>Attention-deficit/hyperactivity disorder (ADHD) affects 4% to 5% of the general population. Homework sessions are frequent conflictual moments characterized by increased anxiety in children and stress in their parents, contributing to a lower family quality of life. Children with ADHD experience more severe homework problems than typically developing peers. Poor academic performance in individuals with ADHD is partly attributed to challenging homework. Psychoeducational and school-based approaches are time-consuming and not fully accessible to professionals. Digital tools, such as smartphone and tablet apps, might offer an interesting alternative. We present our digital homework support program for children and adolescents, known as "Programme d'Aide Numérique aux Devoirs pour Enfant avec TDA-H" (PANDAH), along with the study protocol of our ongoing randomized controlled trial.</p><p><strong>Objective: </strong>This study aims to test PANDAH's efficacy in improving homework performance and family quality of life.</p><p><strong>Methods: </strong>Individuals aged 9-16 years with an ADHD diagnosis and no comorbid psychiatric disorders are included. This is a multicenter study involving 9 reference centers for ADHD in France. The study comprises (1) a 3-month period with a randomized controlled trial design, where participants are divided into 2 parallel groups (group 1: care as usual or waiting list; group 2: PANDAH app), followed by (2) an extension period of 3 months (months 3-6), during which all participants will have access to the app. This second phase serves as a crucial incentive for patients initially randomly assigned to group 1. Assessments will be conducted at baseline, month 3, and month 6 for each patient by trained psychologists. The primary end point will be the global Homework Performance Questionnaire (HPQ), Parent version score at 6 months. The main analysis will adhere to the "intent-to-treat principle" (all patient data will be analyzed according to their initial group determined by randomization). We expect (1) HPQ score improvement in individuals using the app during the first 3-month period compared to individuals not using the app; (2) greater HPQ score improvement for individuals using the app for 6 months compared to those using the app for 3 months only; and (3) adherence to the PANDAH program, measured with in-app metrics.</p><p><strong>Results: </strong>Recruitment began in January 2024, and the trial is ongoing.</p><p><strong>Conclusions: </strong>This study contributes to the digital transformation of health care. The use of smartphone apps in self-care and self-management is a societal phenomenon, and its implementation in the field of psychiatry is of particular interest. The app might serve as both valuable support for patients and an opportunity for parents to distance themselves from conflict-laden homework sessions. Since the market for smartphone apps in the health care and well-
背景介绍注意力缺陷/多动症（ADHD）的患病率占总人口的 4% 至 5%。家庭作业是经常发生冲突的时刻，其特点是增加儿童的焦虑和父母的压力，导致家庭生活质量下降。与发育正常的同龄人相比，多动症儿童的家庭作业问题更为严重。多动症儿童学习成绩差的部分原因是家庭作业具有挑战性。心理教育和以学校为基础的方法耗费时间，专业人员也无法完全掌握。智能手机和平板电脑应用程序等数字工具或许能提供一种有趣的替代方案。我们介绍了针对儿童和青少年的数字家庭作业支持计划，即 "Programme d'Aide Numérique aux Devoirs pour Enfant avec TDA-H"（PANDAH），以及我们正在进行的随机对照试验的研究方案：本研究旨在检验 PANDAH 在提高作业成绩和家庭生活质量方面的有效性：研究对象包括年龄在 9-16 岁、被诊断为多动症且未合并精神疾病的儿童。这是一项多中心研究，涉及法国的 9 个多动症参考中心。研究包括：（1）为期 3 个月的随机对照试验设计，将参与者分为 2 个平行组（第 1 组：常规护理或候补名单；第 2 组：PANDAH 应用程序）；（2）为期 3 个月的延长期（第 3-6 个月），在此期间，所有参与者均可使用该应用程序。训练有素的心理学家将在基线、第 3 个月和第 6 个月对每位患者进行评估。主要终点是 6 个月时的家庭作业表现问卷（HPQ）家长版的总分。主要分析将遵循 "意向治疗原则"（所有患者数据都将根据随机确定的初始组别进行分析）。我们期望：（1）与未使用该应用程序的患者相比，在前 3 个月使用该应用程序的患者的 HPQ 得分有所提高；（2）与仅使用该应用程序 3 个月的患者相比，使用该应用程序 6 个月的患者的 HPQ 得分提高幅度更大；以及（3）通过应用程序内的指标衡量患者对 PANDAH 计划的依从性：结果：招募工作于 2024 年 1 月开始，试验仍在进行中：这项研究有助于医疗保健的数字化转型。在自我保健和自我管理中使用智能手机应用程序是一种社会现象，在精神病学领域的应用尤其值得关注。该应用程序既可以为患者提供有价值的支持，也可以让家长远离充满冲突的家庭作业。由于医疗保健和福利领域的智能手机应用程序市场主要由行业驱动，因此对此类数字工具进行学术构思和评估至关重要：ClinicalTrials.gov NCT04857788; https://clinicaltrials.gov/ct2/show/NCT04857788.International registered report identifier (irrid)：PRR1-10.2196/44553。
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引用次数: 0
Development and Implementation of an Online Patient Education Program for Children and Adolescents With Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, Their Parents, Siblings, and School Personnel: Protocol for the Prospective BAYNET FOR ME/CFS Study. 为患有肌痛性脑脊髓炎/慢性疲劳综合征的儿童和青少年、他们的父母、兄弟姐妹和学校工作人员开发和实施在线患者教育计划：前瞻性 BAYNET FOR ME/CFS 研究协议》。
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES
JMIR Research Protocols
Pub Date : 2024-11-21 DOI: 10.2196/54679
Franca Keicher, Julia Thomann, Jana Erlenwein, Mara Schottdorf, Nils Lennart Reiter, Nadine Patricia Scholz-Schwärzler, Barbara Vogel, Cordula Warlitz, Silvia Stojanov, Silvia Augustin, Lola Goldbrunner, Linda Schanz, Veronika Dodel, Charlotte Zipper, Nicole Schiweck, Robert Jaeschke, Milica Saramandic, Karolina Wiejaczka, Maria Eberhartinger, Kristina Dettmer, Daniel Bruno Ricardo Hattesohl, Stephanie Englbrecht, Uta Behrends, Juliane Spiegler
<p><strong>Background: </strong>Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) presents significant challenges for affected children and adolescents, their social environment, and treating physicians, due to its profound impact on quality of life and the lack of causal therapeutic approaches. One crucial aspect of care that has been missing for these patients is comprehensive education for both them and their social circles.</p><p><strong>Objective: </strong>This study protocol aims to outline the goals, study design, execution, and evaluation of the subproject within the BAYNET FOR ME/CFS project. The focus is on developing online education programs for children and adolescents with ME/CFS, as well as for their parents, siblings, and school staff. These programs are designed to improve independent disease management, increase knowledge, and promote interaction with other affected individuals.</p><p><strong>Methods: </strong>In phase I, the group-based online education programs were developed by a multidisciplinary team based on the ModuS concept created by the Competence Network for Patient Education (KomPaS). These programs were then piloted and finalized. Phase II involved recruiting participants and implementing the finalized programs. Given the restricted physical and cognitive capacities of the affected individuals, the patient education programs were exclusively designed in a digital format to facilitate participation. In phase III, the programs will be evaluated for acceptance, completeness, and participant satisfaction. The qualitative assessment will focus on individual expectations and benefits derived from the training. Phase IV will further assess the programs in terms of improvements in disease knowledge, health-related quality of life, life satisfaction, and family burden.</p><p><strong>Results: </strong>The programs were developed, piloted, and finalized during phase I, which ran from December 2022 to May 2023. The pilot phase, from March to May 2023, led to adaptations in the program concept. In total, 8 patients and their parents, 5 siblings, and 59 school staff participated in the piloting. Adjustments were made to the format, content, duration, and schedule to better meet the needs of the affected individuals and their social circles. In phase II, participant recruitment for the patient education program took place from January to July 2023. The study successfully recruited 24 young patients with ME/CFS and their parents, along with 8 siblings and 51 school staff. Two program blocks for patients and parents and 2-3 blocks for siblings and school staff commenced in May 2023 and were completed within the same year. Phase III began after phase II and involves the evaluation of the programs, with the process expected to conclude by the end of 2024. Phase IV, planned for 2025-2026, will involve the rollout of the program to 150 children and their caretakers. This phase will focus on evaluating disease knowledge, health
背景：肌痛性脑脊髓膜炎/慢性疲劳综合征（ME/CFS）对生活质量影响深远，且缺乏因果治疗方法，这给受影响的儿童和青少年、他们的社会环境以及治疗医生带来了巨大挑战。对这些患者的护理一直缺少一个重要方面，那就是对他们及其社交圈的全面教育：本研究方案旨在概述 BAYNET FOR ME/CFS 项目子项目的目标、研究设计、执行和评估。重点是为患有 ME/CFS 的儿童和青少年，以及他们的父母、兄弟姐妹和学校工作人员开发在线教育项目。这些项目旨在改善独立的疾病管理，增加知识，并促进与其他患者的互动：在第一阶段，多学科团队根据患者教育能力网络（KomPaS）提出的 ModuS 概念开发了基于小组的在线教育项目。然后对这些程序进行试点并最终确定。第二阶段包括招募参与者和实施最终确定的方案。鉴于患者的身体和认知能力有限，患者教育项目专门设计成数字格式，以方便参与。在第三阶段，将对项目的接受度、完整性和参与者满意度进行评估。定性评估将侧重于个人期望和从培训中获得的益处。第四阶段将从疾病知识、与健康相关的生活质量、生活满意度和家庭负担的改善方面对项目进行进一步评估：在 2022 年 12 月至 2023 年 5 月的第一阶段中，这些计划得到了开发、试点和最终确定。试点阶段（2023 年 3 月至 5 月）对项目理念进行了调整。共有 8 名患者及其家长、5 名兄弟姐妹和 59 名学校教职员工参与了试点工作。为了更好地满足患者及其社交圈的需求，我们对活动的形式、内容、持续时间和日程安排进行了调整。在第二阶段，患者教育项目的参与者招募工作于 2023 年 1 月至 7 月进行。研究成功招募了24名年轻的ME/CFS患者及其父母，以及8名兄弟姐妹和51名学校教职员工。针对患者和家长的两个项目组以及针对兄弟姐妹和学校教职员工的2-3个项目组于2023年5月启动，并于同年完成。第 III 阶段在第 II 阶段之后开始，涉及项目评估，预计在 2024 年底结束。第四阶段计划于 2025-2026 年进行，将向 150 名儿童及其看护人推广该计划。该阶段将重点评估疾病知识、与健康相关的生活质量、生活满意度和家庭负担，并包括纵向评估：这些数据旨在支持为患有 ME/CFS 的儿童和青少年开发一种全面的跨专业护理模式：DERR1-10.2196/54679。
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引用次数: 0
Development of a Web Platform to Facilitate the Implementation and Evaluation of Health Promoting Schools: Protocol for a Double Diamond Design Approach. 开发网络平台，促进健康促进学校的实施和评估：双钻石设计方法协议》。
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES
JMIR Research Protocols
Pub Date : 2024-11-20 DOI: 10.2196/52110
Gemma Bermejo-Martínez, José Antonio Julián, Víctor José Villanueva-Blasco, Alberto Aibar, Ana Corral-Abós, Alberto Abarca-Sos, Eduardo Generelo, Melania Mur, Manuel Bueno, Elisa Ferrer, Isabel Artero, Luis García-González, Berta Murillo-Pardo, Roberto Ferriz, Susana Menal-Puey, Iva Marques-Lopes, Marta Fajó-Pascual, Eduardo Ibor-Bernalte, Javier Zaragoza Casterad

Background: Health Promoting Schools (HPS) have emerged as a powerful framework to promote healthy behaviors in many countries. However, HPS still present several challenges, highlighting the excessive workload involved in the accreditation, design, implementation, and evaluation processes. In this sense, a resource to facilitate the implementation processes may have a positive impact on the support of HPS.

Objective: The aim of this study was to describe the co-design processes undertaken and resulting learnings to develop the Red Escuelas Promotoras de Salud (network of health promoting schools; REDEPS)-Gestion platform to facilitate the accreditation, design, implementation procedures, and evaluation processes of the Aragon's Health-Promoting School Network.

Methods: The Double Diamond Design Approach was used to co-design this web-platform. The different stakeholders that participated in this co-design, progressed through a 4-stage reflective phase, to discover, define, develop, and deliver the REDEPS-Gestion platform.

Results: Participants agreed that the functions of the REDEPS-Gestion platform should permit the management of both the educational centers and the administration such as accreditation processes, definition and review intervention projects, and preparation and review of the different progress reports to evaluate the HPS. Despite co-design being a well-established approach to creative practice, especially within the public sector, some challenges emerged during the co-design process, such as engaging and facilitating stakeholders' participation or the complexity of combining the interests of all stakeholders. This approach allowed us to identify the main barriers for future users and implement platform improvements.

Conclusions: We hope that the REDEPS-Gestion platform will therefore be able to contribute to facilitating the implementation of HPS. The Double Diamond Design Approach used to co-design this web platform was an efficient and feasible methodological design approach. The REDEPS-Gestion platform will facilitate HPS implementation in Aragon as well as all the processes involving HPS. Future work will determine its effectiveness in improving HPS implementation.

International registered report identifier (irrid): DERR1-10.2196/52110.

背景：在许多国家，健康促进学校（HPS）已成为促进健康行为的有力框架。然而，"健康促进学校 "仍然面临着一些挑战，特别是在认证、设计、实施和评估过程中工作量过大。从这个意义上说，促进实施过程的资源可能会对支持保健计划产生积极影响：本研究的目的是描述共同设计过程以及由此产生的学习成果，以开发健康促进学校网络（REDEPS）-管理平台，促进阿拉贡健康促进学校网络的认证、设计、实施程序和评估过程：方法：采用 "双钻设计法 "共同设计了这一网络平台。参与共同设计的各利益相关方通过 4 个阶段的反思来发现、定义、开发和提供 REDEPS-Gestion 平台：与会者一致认为，REDEPS-Gestion 平台的功能应允许对教育中心和行政部门进行管理，如认证程序、定义和审查干预项目，以及编写和审查不同的进展报告，以评估保健计划。尽管共同设计是一种行之有效的创新实践方法，尤其是在公共部门，但在共同设计过程中也出现了一些挑战，如吸引和促进利益相关者的参与，或将所有利益相关者的利益结合起来的复杂性。这种方法使我们能够确定未来用户的主要障碍，并对平台进行改进：因此，我们希望 REDEPS-Gestion 平台能够为促进 HPS 的实施做出贡献。共同设计该网络平台所采用的 "双钻设计法 "是一种高效可行的方法论设计方法。REDEPS-Gestion 平台将促进在阿拉贡实施 HPS 以及涉及 HPS 的所有流程。未来的工作将确定该平台在改进 HPS 实施方面的有效性：DERR1-10.2196/52110。
{"title":"Development of a Web Platform to Facilitate the Implementation and Evaluation of Health Promoting Schools: Protocol for a Double Diamond Design Approach.","authors":"Gemma Bermejo-Martínez, José Antonio Julián, Víctor José Villanueva-Blasco, Alberto Aibar, Ana Corral-Abós, Alberto Abarca-Sos, Eduardo Generelo, Melania Mur, Manuel Bueno, Elisa Ferrer, Isabel Artero, Luis García-González, Berta Murillo-Pardo, Roberto Ferriz, Susana Menal-Puey, Iva Marques-Lopes, Marta Fajó-Pascual, Eduardo Ibor-Bernalte, Javier Zaragoza Casterad","doi":"10.2196/52110","DOIUrl":"https://doi.org/10.2196/52110","url":null,"abstract":"<p><strong>Background: </strong>Health Promoting Schools (HPS) have emerged as a powerful framework to promote healthy behaviors in many countries. However, HPS still present several challenges, highlighting the excessive workload involved in the accreditation, design, implementation, and evaluation processes. In this sense, a resource to facilitate the implementation processes may have a positive impact on the support of HPS.</p><p><strong>Objective: </strong>The aim of this study was to describe the co-design processes undertaken and resulting learnings to develop the Red Escuelas Promotoras de Salud (network of health promoting schools; REDEPS)-Gestion platform to facilitate the accreditation, design, implementation procedures, and evaluation processes of the Aragon's Health-Promoting School Network.</p><p><strong>Methods: </strong>The Double Diamond Design Approach was used to co-design this web-platform. The different stakeholders that participated in this co-design, progressed through a 4-stage reflective phase, to discover, define, develop, and deliver the REDEPS-Gestion platform.</p><p><strong>Results: </strong>Participants agreed that the functions of the REDEPS-Gestion platform should permit the management of both the educational centers and the administration such as accreditation processes, definition and review intervention projects, and preparation and review of the different progress reports to evaluate the HPS. Despite co-design being a well-established approach to creative practice, especially within the public sector, some challenges emerged during the co-design process, such as engaging and facilitating stakeholders' participation or the complexity of combining the interests of all stakeholders. This approach allowed us to identify the main barriers for future users and implement platform improvements.</p><p><strong>Conclusions: </strong>We hope that the REDEPS-Gestion platform will therefore be able to contribute to facilitating the implementation of HPS. The Double Diamond Design Approach used to co-design this web platform was an efficient and feasible methodological design approach. The REDEPS-Gestion platform will facilitate HPS implementation in Aragon as well as all the processes involving HPS. Future work will determine its effectiveness in improving HPS implementation.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/52110.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"13 ","pages":"e52110"},"PeriodicalIF":1.4,"publicationDate":"2024-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142681378","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
Community Versus Facility-Based Services to Improve the Screening of Active Hepatitis C Virus Infection in Cambodia: The ANRS 12384 CAM-C Cluster Randomized Controlled Trial-Protocol for a Mixed Methods Study. 在柬埔寨，社区服务与基于设施的服务如何改善活动性丙型肝炎病毒感染的筛查？ANRS 12384 CAM-C 群组随机对照试验--混合方法研究方案》。
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES
JMIR Research Protocols
Pub Date : 2024-11-20 DOI: 10.2196/63376
Emilie Mosnier, Olivier Ségéral, Sansothy Neth, Luis Sagaon-Teyssier, Dyna Khuon, Chan Leakhena Phoeung, Sovatha Mam, Chhingsrean Chhay, Kimeang Heang, Jean Charles Duclos-Vallée, Vonthanak Saphonn

Background: In Cambodia, hepatitis C constitutes a significant public health challenge, particularly among older adults (>45 years) for whom prevalence is estimated to be 5%. To facilitate the elimination of hepatitis C among the general population, enhancing access to screening and treatment is imperative. In this regard, the evaluation of community-based screening programs emerges as a crucial step toward improving health care accessibility.

Objective: This study aims to assess the comparative efficacy of a community-based versus a facility-based approach in enhancing the uptake of hepatitis C antibody testing among the general population older than 40 years of age in Cambodia.

Methods: The CAM-C (Community Versus Facility-Based Services to Improve the Screening of Active Hepatitis C Virus Infection in Cambodia) study uses a cluster-randomized controlled trial design across two Cambodian provinces to compare community-based and facility-based hepatitis testing interventions. Sampling involves a multistage cluster approach, targeting individuals older than 40 years of age due to their higher prevalence and risk of chronic hepatitis complications. This study incorporates a qualitative analysis of acceptability and a cost-effectiveness comparison. Interventions include facility-based testing with subsequent referral and community-based testing with direct in-home assessments. Follow-up for positive cases involves comprehensive management and potential direct-acting antiviral treatment. This study aims to identify a significant increase in testing uptake, requiring the screening of 6000 individuals older than 40 years of age, facilitated by a structured sampling and intervention approach to minimize contamination risks.

Results: The final protocol including the quantitative, qualitative, and cost-effectiveness part of the study was registered and was approved in 2019 by the National Ethical Cambodian for Health Research. Inclusions were completed by mid-2024, with analyses starting in May 2024.

Conclusions: Using a mixed methods approach that combines a robust methodology (cluster-randomized controlled trial) with a cost-effectiveness analysis and qualitative research, such a study should provide invaluable information to guide the Ministry of Health in its hepatitis C virus screening strategy and move toward elimination.

Trial registration: ClinicalTrials.gov NCT03992313; https://clinicaltrials.gov/study/NCT03992313.

International registered report identifier (irrid): DERR1-10.2196/63376.

背景：在柬埔寨，丙型肝炎是一项重大的公共卫生挑战，尤其是在老年人（年龄大于 45 岁）中，其发病率估计为 5%。为促进在普通人群中消除丙型肝炎，当务之急是提高筛查和治疗的可及性。在这方面，对社区筛查项目进行评估是提高医疗服务可及性的关键一步：本研究旨在评估以社区为基础的方法与以医疗机构为基础的方法在提高柬埔寨 40 岁以上人群接受丙型肝炎抗体检测率方面的比较效果：CAM-C（柬埔寨基于社区和医疗机构的丙型肝炎病毒感染筛查服务）研究采用分组随机对照试验设计，在柬埔寨的两个省份比较基于社区和医疗机构的肝炎检测干预措施。抽样采用多阶段群集法，目标人群为 40 岁以上的老年人，因为他们的发病率较高，而且慢性肝炎并发症的风险也较高。这项研究包括对可接受性的定性分析和成本效益比较。干预措施包括基于设施的检测和随后的转诊，以及基于社区的检测和直接的家庭评估。阳性病例的后续治疗包括综合管理和潜在的直接作用抗病毒治疗。这项研究旨在确定检测接受率的显著提高，需要对 6000 名 40 岁以上的人进行筛查，并通过结构化采样和干预方法将污染风险降至最低：最终方案包括研究的定量、定性和成本效益部分，已于 2019 年注册并获得柬埔寨国家健康研究伦理委员会批准。2024 年年中完成纳入工作，2024 年 5 月开始进行分析：这项研究采用混合方法，将稳健的方法学（分组随机对照试验）与成本效益分析和定性研究相结合，应能提供宝贵的信息，指导卫生部制定丙型肝炎病毒筛查战略并逐步消除丙型肝炎：试验注册：ClinicalTrials.gov NCT03992313；https://clinicaltrials.gov/study/NCT03992313.International 注册报告标识符 (irrid)：DERR1-10.2196/63376。
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引用次数: 0
The Young Adult Centered Healthforce Training (YACHT) Program to Increase HIV Testing and Pre-Exposure Prophylaxis Referrals Among Young Sexual Minority Men in Florida: Protocol for a Type 2 Implementation-Effectiveness Hybrid Trial With a Stepped Wedge Design. 以年轻成年人为中心的健康力量培训 (YACHT) 计划，旨在增加佛罗里达州年轻男性性少数群体中的 HIV 检测和暴露前预防转介：采用阶梯式楔形设计的第 2 类实施-效果混合试验方案》（Protocol for a Type 2 Implementation-Effectiveness Hybrid Trial with a Stepped Wedge Design）。
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES
JMIR Research Protocols
Pub Date : 2024-11-20 DOI: 10.2196/63191
Rebecca Giguere, Maria Isabel Fernandez, Jose A Bauermeister, Iván C Balán, Subhash Aryal, Andrea Cheshure, Sara Green, Willey Lin, Jonathan Morgan, Sylvie Naar
<p><strong>Background: </strong>There is a high incidence of HIV among young sexual minority men in Florida. Many are unaware of their status due to low testing rates. Counseling, testing, and referral (CTR) services are essential for diagnosis and prevention of HIV and are integral to the Ending the HIV Epidemic (EHE) strategic plan. However, efforts to increase CTR among young sexual minority men have not been successful.</p><p><strong>Objective: </strong>The Young Adult Centered Healthforce Training (YACHT) program promotes developmentally sensitive, culturally appropriate, and evidence-based CTR services for young sexual minority men. This study tests whether the YACHT program increases HIV testing among young sexual minority men and fidelity to evidence-based CTR among testing providers.</p><p><strong>Methods: </strong>Agencies in Florida EHE counties that tested at least 24 young sexual minority men aged 18 to 29 years in 2021 will be invited to participate. The sites (N=42) will be randomized in blocks of 6 to participate in the YACHT program, following a stepped wedge design. Through YACHT, all sites will receive visits from mystery shoppers (MSs), who are trained to evaluate HIV testing services and complete postvisit quality monitoring assessments. Sites will be offered the opportunity to review their MS feedback and to receive tailored motivational interviewing training and evidence-based technical assistance to address areas of need identified through MS assessments. The study will evaluate whether YACHT leads to increased HIV testing by comparing numbers of young sexual minority men testing for HIV before versus after YACHT's implementation. The Exploration, Preparation, Implementation and Sustainment framework will help understand the barriers to and facilitators of the program's implementation and sustainment.</p><p><strong>Results: </strong>YACHT was funded in August 2022. Data collection began in June 2023. As of June 2024, 194 MS visits have taken place at 42 sites; 4 (67%) sites from the first block and 1 (33%) site from the second block have engaged with the study. At baseline, sites exhibited the lowest competencies in relationship context, counseling sessions, and safer sex education and the highest competency in privacy and confidentiality. Data collection will continue through May 2027, with results published by the end of 2027.</p><p><strong>Conclusions: </strong>To address the high incidence of HIV among young sexual minority men in Florida, YACHT aims to support testing sites with tailored motivational interviewing training and technical assistance to address needs identified by MS assessments. The program seeks to improve delivery of evidence-based CTR services, thereby increasing HIV testing, counseling, and pre-exposure prophylaxis referrals and reducing HIV incidence among this population.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06015581; https://classic.clinicaltrials.gov/ct2/show/NCT060155
背景：在佛罗里达州，性少数群体的年轻男性中艾滋病毒感染率很高。由于检测率低，许多人并不知道自己的状况。咨询、检测和转介 (CTR) 服务对于诊断和预防 HIV 至关重要，也是终结 HIV 流行 (EHE) 战略计划不可或缺的一部分。然而，在性少数群体年轻男性中增加 CTR 的努力并不成功：以年轻人为中心的健康力量培训（YACHT）计划提倡为年轻的性少数群体男性提供发展敏感性、文化适宜性和以证据为基础的 CTR 服务。本研究测试了 YACHT 计划是否增加了性少数群体年轻男性的 HIV 检测，以及检测提供者是否忠实于循证 CTR：将邀请佛罗里达州 EHE 县在 2021 年至少检测过 24 名 18 至 29 岁年轻性少数群体男性的机构参与。这些机构（N=42）将按照阶梯式楔形设计，以 6 个为一组随机参与 YACHT 计划。通过 YACHT，所有医疗点都将接受神秘顾客（MSs）的访问，这些神秘顾客接受过评估 HIV 检测服务和完成访问后质量监控评估的培训。医疗点将有机会审查神秘顾客的反馈意见，并接受量身定制的动机访谈培训和循证技术援助，以解决神秘顾客评估中发现的需求领域。该研究将通过比较实施 YACHT 之前和之后性少数群体年轻男性接受 HIV 检测的人数，评估 YACHT 是否会增加 HIV 检测。探索、准备、实施和持续框架将有助于了解计划实施和持续的障碍和促进因素：YACHT 于 2022 年 8 月获得资助。数据收集工作于 2023 年 6 月开始。截至 2024 年 6 月，已对 42 个项目点进行了 194 次 MS 访问；4 个项目点（67%）（第一阶段）和 1 个项目点（33%）（第二阶段）参与了研究。在基线阶段，医疗点在关系背景、咨询课程和安全性教育方面的能力最低，而在隐私和保密方面的能力最高。数据收集工作将持续到 2027 年 5 月，并于 2027 年底公布结果：为了解决佛罗里达州性少数群体年轻男性艾滋病高发的问题，YACHT 旨在为检测点提供量身定制的动机访谈培训和技术援助，以满足 MS 评估所确定的需求。该计划旨在改善循证 CTR 服务的提供，从而增加 HIV 检测、咨询和暴露前预防转介，降低该人群的 HIV 感染率：试验注册：ClinicalTrials.gov NCT06015581；https://classic.clinicaltrials.gov/ct2/show/NCT06015581.International 注册报告标识符 (irrid)：DERR1-10.2196/63191。
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引用次数: 0
Effects of Interprofessional Education on Readiness for Interprofessional Learning in Rehabilitation Science Students From Professional Health Care Programs: Protocol for a Systematic Review. 跨专业教育对专业医疗保健课程康复科学学生跨专业学习准备的影响：系统回顾协议》。
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES
JMIR Research Protocols
Pub Date : 2024-11-20 DOI: 10.2196/60830
Eric Dixon, Jayden Pannu, Kabir Dhaliwal, Rachel Cheng, Gurpal Deol, Sophie Frangos, Emma Tawil, Ana Oliveira, Sarah Wojkowski, Shirley Quach
<p><strong>Background: </strong>The World Health Organization defines interprofessional education (IPE) as a process in which students from different health care programs work together to provide effective care while deepening their knowledge of each other's roles. Previous literature shows a strong argument for early exposure to IPE as a facilitator for high quality patient care. The goal of IPE is to improve interprofessional collaboration (IPC), the "gold standard" of care to enhance patients' quality of life, functional ability, and health status, especially for patients who require expertise from a variety of health care professionals. IPC has shown improvements in quality of life, functional ability, and health status. IPE can occur in the form of structured interventions or spontaneously in student placements. Literature has demonstrated that IPE facilitates skill, knowledge development, teamwork, communication skills, and mutual respect among health care professional students.</p><p><strong>Objective: </strong>This systematic review aims to examine IPE outcomes, including readiness for IPC, IPE perceptions, attitudes toward collaborative learning, student confidence, practice efficiency, and team dynamics after IPE interventions in rehabilitation science students.</p><p><strong>Methods: </strong>The study will be conducted as outlined by the Cochrane Handbook for Systematic Reviews and will be reported per the PRISMA (Preferred Reporting of Items for Systematic Reviews and Meta-Analyses) 2015 guidelines. Students have performed literature searches across the databases MEDLINE, Embase, CINAHL, ERIC, Web of Science, and AMED. Studies will be included if their IPE intervention included multiple prelicensure health care professional students in a health care or health care education setting. Based on timelines presented in the Institute of Medicine's report on the impacts of IPE, relevant studies from 2016 to the present will be included. The Risk of Bias 2 tool will be used to study sources of bias. The GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) working group's methods will be used to evaluate the quality of the evidence presented. The final 3 authors are assisting as supervisors, providing oversight and feedback as needed. Any deviations from this protocol will be reported in the final paper.</p><p><strong>Results: </strong>The search strategy was finalized and searched across the databases by March 8, 2024. The systematic review was registered with PROSPERO on March 31, 2024. A total of 10,692 citations were retrieved for abstract and title screening, beginning in March 2024, and 756 were eligible for full-text screening in April 2024. Six articles were considered for inclusion and data extraction, which began in July 2024. Finalization of the extracted data and paper will occur in September 2024.</p><p><strong>Conclusions: </strong>This systematic review will provide a summary of the effects of IPE interve
背景：世界卫生组织将跨专业教育（IPE）定义为一个过程，在这个过程中，来自不同医疗保健专业的学生共同合作，提供有效的护理，同时加深对彼此角色的了解。以往的文献表明，尽早接触 IPE 有助于提供高质量的病人护理。IPE 的目标是改善跨专业协作（IPC），这是提高患者生活质量、功能能力和健康状况的 "黄金标准"，尤其是对于需要不同医护专业人员提供专业知识的患者而言。IPC 已显示出对生活质量、功能能力和健康状况的改善。IPE 可以以结构化干预的形式进行，也可以在学生实习中自发进行。文献表明，IPE 促进了医护专业学生的技能、知识发展、团队合作、沟通技巧和相互尊重：本系统性综述旨在研究 IPE 的成果，包括康复科学专业学生在 IPE 干预后对 IPC 的准备程度、对 IPE 的认知、对协作学习的态度、学生的信心、实践效率和团队活力：本研究将按照《Cochrane 系统综述手册》的规定进行，并将按照 PRISMA（系统综述和 Meta 分析首选报告项目）2015 指南进行报告。学生们在 MEDLINE、Embase、CINAHL、ERIC、Web of Science 和 AMED 等数据库中进行了文献检索。如果研究中的 IPE 干预措施包括了医疗保健或医疗保健教育环境中的多名执照前医疗保健专业学生，则将被纳入研究范围。根据医学研究所关于 IPE 影响的报告中提出的时间表，将纳入 2016 年至今的相关研究。偏倚风险 2 工具将用于研究偏倚来源。GRADE（建议、评估、发展和评价分级）工作组的方法将用于评估所提交证据的质量。最后 3 位作者将作为指导者提供协助，在需要时提供监督和反馈。任何偏离该协议的内容都将在最终论文中报告：在 2024 年 3 月 8 日之前完成了检索策略并在各数据库中进行了检索。系统综述于 2024 年 3 月 31 日在 PROSPERO 注册。从 2024 年 3 月开始，共检索到 10,692 篇引文进行摘要和标题筛选，2024 年 4 月有 756 篇符合全文筛选条件。有 6 篇文章被考虑纳入并提取数据，提取工作于 2024 年 7 月开始。提取的数据和论文将于 2024 年 9 月完成：本系统综述将总结 IPE 干预对执照前康复科学学生的影响。它将为教育工作者、医疗保健提供者和学生提供宝贵的信息，帮助他们了解 IPE 的相关性。它还将揭示研究差距，并强调有待进一步研究的领域：PROSPERO CRD42024506081；https://tinyurl.com/3tf2h9er.International 注册报告标识符 (irrid)：PRR1-10.2196/60830。
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引用次数: 0
The Effect of Interventions Based on the Information-Motivation-Behavioral Skills Model on the Human Papillomavirus Vaccination Rate Among 11-13-Year-Old Girls in Central and Western China: Protocol for a Randomized Controlled Trial. 基于 "信息-动机-行为技能模型 "的干预措施对中国中西部地区 11-13 岁女孩人乳头瘤病毒疫苗接种率的影响：随机对照试验方案》。
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES
JMIR Research Protocols
Pub Date : 2024-11-19 DOI: 10.2196/58873
Shu Jing, Yijin Wu, Zhenwei Dai, Shenglan Tang, Xiaoyou Su, Youlin Qiao

Background: Persistent infection of high-risk human papillomavirus (HPV) can lead to cervical intraepithelial neoplasia, cervical cancer, and even death. HPV vaccination for girls aged 9-14 years can effectively prevent the occurrence of cervical cancer. Some Chinese provinces and cities have launched free HPV vaccination programs for school-age girls; however, due to the lack of supportive government policies, the high price and supply shortage of HPV vaccines, and vaccine hesitancy, some parents refuse to vaccinate their daughters.

Objective: This protocol reports the design of a randomized controlled trial (RCT) aiming to explore the efficacy of a digital HPV vaccination education intervention based on the information-motivation-behavioral skills (IMB) model in improving the HPV vaccination rate among 11-13-year-old girls in central and western China.

Methods: A multicenter intervention study based on an online applet will be conducted in December 2024, and about 750 eligible parents of 11-13-year-old girls will be assigned in a 1:1 ratio to an intervention group receiving 7-day digital HPV vaccination education based on the IMB model or a control group using non-HPV publicity materials. Free HPV vaccination pilot projects will be carried out among this population by our research team in central and western China (some parents might refuse to vaccinate their daughters). All participants will be asked to complete online questionnaires at baseline; postintervention; and 1 week, 1 month, and 3 months after the intervention.

Results: The primary outcome of this study will be receipt of the first HPV vaccination within 3 months. Data will be analyzed based on an intention-to-treat approach, and Stata 16.0 will be used for statistical analysis.

Conclusions: This study aims to improve the HPV vaccination rate among 11-13-year-old girls and will examine the impact of a digital HPV vaccination education intervention based on the IMB model. The findings of this study may offer promising intervention measures for HPV vaccine hesitancy in low-health-resource areas in the future.

Trial registration: Chinese Clinical Trial Registry, ChiCTR2300067402; https://tinyurl.com/v5zt4hc9.

International registered report identifier (irrid): PRR1-10.2196/58873.

背景：高危人乳头瘤病毒（HPV）的持续感染可导致宫颈上皮内瘤变、宫颈癌，甚至死亡。为 9-14 岁女童接种 HPV 疫苗可有效预防宫颈癌的发生。中国部分省市已开展了针对适龄女童的免费 HPV 疫苗接种项目，但由于政府缺乏扶持政策、HPV 疫苗价格昂贵且供应短缺、疫苗接种犹豫不决等原因，部分家长拒绝为女儿接种疫苗：本方案报告了一项随机对照试验（RCT）的设计，旨在探讨基于信息-动机-行为技能（IMB）模型的数字化HPV疫苗接种教育干预对提高中国中西部地区11-13岁女孩HPV疫苗接种率的效果：将于2024年12月开展一项基于在线小程序的多中心干预研究，将约750名符合条件的11-13岁女孩家长按1:1的比例分配到干预组，接受为期7天的基于IMB模式的数字化HPV疫苗接种教育，或分配到使用非HPV宣传材料的对照组。我们的研究团队将在中国中部和西部地区的这一人群中开展免费 HPV 疫苗接种试点项目（部分家长可能会拒绝为女儿接种疫苗）。所有参与者将被要求在基线、干预后、干预后 1 周、1 个月和 3 个月完成在线问卷调查：本研究的主要结果是在 3 个月内接受第一次 HPV 疫苗接种。数据将根据意向治疗方法进行分析，统计分析将使用 Stata 16.0：本研究旨在提高 11-13 岁女孩的 HPV 疫苗接种率，并将研究基于 IMB 模型的数字化 HPV 疫苗接种教育干预措施的影响。本研究的结果可能会为未来低卫生资源地区的HPV疫苗接种犹豫提供有前景的干预措施：中国临床试验注册中心，ChiCTR2300067402；https://tinyurl.com/v5zt4hc9.International 注册报告标识符（irrid）：PRR1-10.2196/58873。
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引用次数: 0
The Integrating Cultural Aspects Into Diabetes Education (INCLUDE) Study to Prevent Diabetes in Chinese Immigrants: Protocol for a Randomized Controlled Trial. 将文化因素纳入糖尿病教育（INCLUDE）以预防中国移民糖尿病的研究：随机对照试验方案》。
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES
JMIR Research Protocols
Pub Date : 2024-11-19 DOI: 10.2196/65455
Lu Hu, Nelson F Lin, Yun Shi, Jiepin Cao, Mary Ann Sevick, Huilin Li, Jeannette M Beasley, Natalie Levy, Kosuke Tamura, Xinyi Xu, Yulin Jiang, Iris Ong, Ximin Yang, Yujie Bai, Liwen Su, Sze Wan Chan, Stella S Yi

Background: Type 2 diabetes (T2D) contributes to significant morbidity and mortality for Chinese immigrants in the United States, exacerbated by social determinants of health (SDOH) barriers such as language barriers, limited access to healthy foods, and low health literacy.

Objective: The goal of the Integrating Cultural Aspects into Diabetes Education (INCLUDE) study is to test a social media-based intervention adapting the Diabetes Prevention Program (DPP) for Chinese immigrants alongside a culturally adapted, community-supported agriculture program. Here, we report the protocol for the INCLUDE study.

Methods: INCLUDE is a 3-year randomized controlled trial (n=150). Participants with prediabetes or at risk for T2D are enrolled and randomized into either the control or intervention group (n=75 each). Participants from the intervention group receive 2-3 culturally tailored, in-language DPP videos weekly for 12 weeks, as well as biweekly phone calls from bilingual study staff to review video content, support goal setting, and assess and address SDOH-related barriers such as food insecurity. Intervention participants will also be given produce for 10 weeks as part of the community-supported agriculture program. Weight (primary outcome), self-efficacy, diet, physical activity, and food insecurity (secondary outcomes) are measured at baseline, 3-month, and 6-month intervals. Splined linear mixed models will be used to examine group differences in longitudinal weight and other secondary outcomes. The INCLUDE study was approved by the Institutional Review Board at the NYU Grossman School of Medicine.

Results: Recruitment started in May 2023, with the first cohort of 75 participants enrolled and randomized into 2 groups in July 2023. The 3-month and 6-month assessment of the first-year cohort has been completed. We have recruited 75 participants for the second cohort as of July 2024.

Conclusions: The INCLUDE study will serve as an innovative model for culturally adapted, multilevel interventions for underserved communities previously unable to access evidence-based diabetes prevention initiatives. Aligning with several national calls for multilevel interventions, the INCLUDE intervention will provide critical data that will inform how researchers and public health professionals address SDOH barriers faced by underserved populations and prevent diabetes.

Trial registration: ClinicalTrials.gov NCT05492916; https://clinicaltrials.gov/study/NCT05492916.

International registered report identifier (irrid): DERR1-10.2196/65455.

背景：在美国，2 型糖尿病（T2D）对中国移民造成了严重的发病率和死亡率，而健康的社会决定因素（SDOH）障碍（如语言障碍、获得健康食品的机会有限以及健康知识水平低）又加剧了这一问题：将文化因素融入糖尿病教育（INCLUDE）研究的目标是测试一项基于社交媒体的干预措施，该措施针对中国移民的糖尿病预防计划（DPP）进行了调整，同时还测试了一项经过文化调整的社区支持农业计划。在此，我们将报告 INCLUDE 研究的方案：INCLUDE 是一项为期 3 年的随机对照试验（n=150）。糖尿病前期或有 T2D 风险的参与者被随机纳入对照组或干预组（各 75 人）。干预组的参与者在 12 周内每周会收到 2-3 个根据文化定制的 DPP 语言视频，以及双语研究人员每两周一次的电话，以审查视频内容、支持目标设定、评估和解决与 SDOH 相关的障碍（如粮食不安全）。作为社区支持农业计划的一部分，干预参与者还将获得为期 10 周的农产品。体重（主要结果）、自我效能感、饮食、体育锻炼和食物不安全（次要结果）将在基线、3 个月和 6 个月间隔期进行测量。将使用分割线性混合模型来检验纵向体重和其他次要结果的组间差异。INCLUDE 研究已获得纽约大学格罗斯曼医学院机构审查委员会的批准：招募工作于 2023 年 5 月开始，首批 75 名参与者于 2023 年 7 月注册并随机分为 2 组。第一年组群的 3 个月和 6 个月评估已经完成。截至 2024 年 7 月，我们已为第二组招募了 75 名参与者：INCLUDE 研究将成为一种创新模式，为以前无法获得循证糖尿病预防措施的服务不足社区提供文化适应性多层次干预措施。INCLUDE 干预项目符合多层次干预的若干国家呼吁，将提供关键数据，为研究人员和公共卫生专业人员如何解决服务不足人群面临的 SDOH 障碍和预防糖尿病提供信息：试验注册：ClinicalTrials.gov NCT05492916；https://clinicaltrials.gov/study/NCT05492916.International 注册报告标识符 (irrid)：DERR1-10.2196/65455。
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引用次数: 0
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