Wang Ruoxi, Rouleau Geneviève, Booth Gillian Lynn, Brazeau Anne-Sophie, El-Dassouki Noor, Taylor Madison, Cafazzo Joseph A, Greenberg Marley, Nakhla Meranda, Shulman Rayzel, Desveaux Laura
Institute for Better Health, Trillium Health Partners, Mississauga, ON, Canada.
Institute for Health System Solutions and Virtual Care, Women's College Hospital, Toronto, ON, Canada.
JMIR Res Protoc. 2023 Sep 13;12:e46115. doi: 10.2196/46115.
BACKGROUND: Emerging adults living with type 1 diabetes (T1D) face a series of challenges with self-management and decreased health system engagement, leading to an increased risk of acute complications and hospital admissions. Effective and scalable strategies are needed to support this population to transfer seamlessly from pediatric to adult care with sufficient self-management capability. While digital health interventions for T1D self-management are a promising strategy, it remains unclear which elements work, how, and for which groups of individuals. OBJECTIVE: This study aims to evaluate the design and implementation of a multicomponent SMS text message-based digital health intervention to support emerging adults living with T1D in real-world settings. The objectives are to identify the intervention components and associated mechanisms that support user engagement and T1D health care transition experiences and determine the individual characteristics that influence the implementation process. METHODS: We used a realist evaluation embedded alongside a randomized controlled trial, which uses a sequential mixed methods design to analyze data from multiple sources, including intervention usage data, patient-reported outcomes, and realist interviews. In step 1, we conducted a document analysis to develop a program theory that outlines the hypothesized relationships among "individual-level contextual factors, intervention components and features, mechanisms, and outcomes," with special attention paid to user engagement. Among them, intervention components and features depict 10 core characteristics such as transition support information, problem-solving information, and real-time interactivity. The proximal outcomes of interest include user engagement, self-efficacy, and negative emotions, whereas the distal outcomes of interest include transition readiness, self-blood glucose monitoring behaviors, and blood glucose. In step 2, we plan to conduct semistructured realist interviews with the randomized controlled trial's intervention-arm participants to test the hypothesized "context-intervention-mechanism-outcome" configurations. In step 3, we plan to triangulate all sources of data using a coincidence analysis to identify the necessary combinations of factors that determine whether and how the desired outcomes are achieved and use these insights to consolidate the program theory. RESULTS: For step 1 analysis, we have developed the initial program theory and the corresponding data collection plan. For step 2 analysis, participant enrollment for the randomized controlled trial started in January 2023. Participant enrollment for this realist evaluation was anticipated to start in July 2023 and continue until we reached thematic saturation or achieved informational power. CONCLUSIONS: Beyond contributing to knowledge on the multiple pathways that lead to successful engagement with a digital health intervention as well as target outcomes in T1D care transitions, embedding the realist evaluation alongside the trial may inform real-time intervention refinement to improve user engagement and transition experiences. The knowledge gained from this study may inform the design, implementation, and evaluation of future digital health interventions that aim to improve transition experiences. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/46115.
背景:患有1型糖尿病(T1D)的青年成年人在自我管理和医疗系统参与度降低方面面临一系列挑战,这导致急性并发症和住院风险增加。需要有效且可扩展的策略来支持这一人群在具备足够自我管理能力的情况下无缝地从儿科护理过渡到成人护理。虽然用于T1D自我管理的数字健康干预措施是一种很有前景的策略,但尚不清楚哪些要素有效、如何有效以及适用于哪些个体群体。 目的:本研究旨在评估一种基于短信文本的多组件数字健康干预措施在现实环境中支持患有T1D的青年成年人的设计与实施情况。目标是确定支持用户参与以及T1D医疗保健过渡体验的干预组件和相关机制,并确定影响实施过程的个体特征。 方法:我们采用了一种与随机对照试验相结合的现实主义评估方法,该试验采用序贯混合方法设计来分析来自多个来源的数据,包括干预使用数据、患者报告的结果以及现实主义访谈。在第一步中,我们进行了文献分析,以制定一个项目理论,概述“个体层面的背景因素、干预组件和特征、机制以及结果”之间的假设关系,并特别关注用户参与度。其中,干预组件和特征描述了10个核心特征,如过渡支持信息、问题解决信息和实时交互性。感兴趣的近端结果包括用户参与度、自我效能感和负面情绪,而感兴趣的远端结果包括过渡准备情况、自我血糖监测行为和血糖水平。在第二步中,我们计划对随机对照试验干预组的参与者进行半结构化现实主义访谈,以测试假设的“背景-干预-机制-结果”配置。在第三步中,我们计划使用一致性分析对所有数据源进行三角测量,以确定决定是否以及如何实现预期结果的因素的必要组合,并利用这些见解巩固项目理论。 结果:对于第一步分析,我们已经制定了初步的项目理论和相应的数据收集计划。对于第二步分析,随机对照试验的参与者招募于2023年1月开始。预计这项现实主义评估的参与者招募将于2023年7月开始,并持续到我们达到主题饱和或获得信息权重。 结论:除了有助于了解导致成功参与数字健康干预以及T1D护理过渡中的目标结果的多种途径外,将现实主义评估与试验相结合可能为实时干预改进提供信息,以提高用户参与度和过渡体验。从本研究中获得的知识可能为未来旨在改善过渡体验的数字健康干预措施的设计、实施和评估提供信息。 国际注册报告识别号(IRRID):PRR1-10.2196/46115。
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