Effectiveness of an Integrated Engagement Support System to Facilitate Patient Use of Digital Diabetes Prevention Programs: Protocol for a Randomized Controlled Trial.
Effectiveness of an Integrated Engagement Support System to Facilitate Patient Use of Digital Diabetes Prevention Programs: Protocol for a Randomized Controlled Trial.
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DOI：
10.2196/26750
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发表时间：
2021-02-09
影响因子：
1.7
通讯作者：
Mann DM
中科院分区：
文献类型：
--
作者：
Lawrence K;Rodriguez DV;Feldthouse DM;Shelley D;Yu JL;Belli HM;Gonzalez J;Tasneem S;Fontaine J;Groom LL;Luu S;Wu Y;McTigue KM;Rockette-Wagner B;Mann DM
数字糖尿病预防计划（dDPPs）是有效的行为改变工具，可预防糖尿病风险患者的疾病进展。目前，这些计划与现有的卫生信息技术基础设施和临床工作流程整合得很差，导致提供者对使用dDPP的患者的了解、互动和支持存在障碍。可以促进围绕dDPP的患者-提供者互动的工具可能有助于改善患者参与和遵守这些计划以及改善健康结果。本研究旨在使用严格的，以用户为中心的设计（UCD）方法来开发一个理论驱动的系统，支持患者与dDPP及其初级保健提供者的参与。本研究将分3个阶段进行。在第一阶段，我们将使用系统的UCD，敏捷软件开发和定性研究方法来确定关键用户（患者，提供者，临床工作人员，数字健康技术专家和内容专家）的要求，限制和高影响力功能的优先级，以设计，开发和完善参与系统的可行干预原型。在第二阶段，我们将在糖尿病前期患者及其初级保健提供者中进行参与系统的单臂可行性试点。在第3阶段，我们将使用参与系统进行一项2组随机对照试验。主要结局为6个月和12个月时的体重、BMI和A1 c。次要结局将是dDPP中的患者参与度（使用和活动）。中介变量（自我效能，数字健康素养和医患关系）将被测量。该项目于2018年启动，并于2019年9月获得资助。根据2019年7月授予的机构审查委员会质量改进豁免，第1阶段的入组和数据收集于2019年9月开始。截至2020年12月，已招募27名患者，预计首批结果将于2021年初提交发表。该研究于2020年12月获得机构审查委员会批准进行第2期和第3期，预计第2期招募将于2021年初开始。我们的研究结果将为技术的设计和开发提供指导，以将dDPP平台整合到现有的临床工作流程中。这将促进患者参与数字行为改变干预措施以及提供者参与患者使用dDPP。可以促进围绕dDPP的患者-提供者互动的综合临床工具可能有助于改善患者对这些计划的依从性，并通过解决患者和提供者面临的障碍来改善健康结果。通过试点测试和临床试验进行的进一步评估将评估这些工具的有效性和实施情况。ClinicalTrials.gov NCT 04049500; https://clinicaltrials.gov/ct2/show/NCT04049500 DERR 1 -10.2196/26750
Digital diabetes prevention programs (dDPPs) are effective behavior change tools to prevent disease progression in patients at risk for diabetes. At present, these programs are poorly integrated into existing health information technology infrastructure and clinical workflows, resulting in barriers to provider-level knowledge of, interaction with, and support of patients who use dDPPs. Tools that can facilitate patient-provider interaction around dDPPs may contribute to improved patient engagement and adherence to these programs and improved health outcomes. This study aims to use a rigorous, user-centered design (UCD) methodology to develop a theory-driven system that supports patient engagement with dDPPs and their primary care providers with their care. This study will be conducted in 3 phases. In phase 1, we will use systematic UCD, Agile software development, and qualitative research methods to identify key user (patients, providers, clinical staff, digital health technologists, and content experts) requirements, constraints, and prioritization of high-impact features to design, develop, and refine a viable intervention prototype for the engagement system. In phase 2, we will conduct a single-arm feasibility pilot of the engagement system among patients with prediabetes and their primary care providers. In phase 3, we will conduct a 2-arm randomized controlled trial using the engagement system. Primary outcomes will be weight, BMI, and A1c at 6 and 12 months. Secondary outcomes will be patient engagement (use and activity) in the dDPP. The mediator variables (self-efficacy, digital health literacy, and patient-provider relationship) will be measured. The project was initiated in 2018 and funded in September 2019. Enrollment and data collection for phase 1 began in September 2019 under an Institutional Review Board quality improvement waiver granted in July 2019. As of December 2020, 27 patients have been enrolled and first results are expected to be submitted for publication in early 2021. The study received Institutional Review Board approval for phases 2 and 3 in December 2020, and phase 2 enrollment is expected to begin in early 2021. Our findings will provide guidance for the design and development of technology to integrate dDPP platforms into existing clinical workflows. This will facilitate patient engagement in digital behavior change interventions and provider engagement in patients’ use of dDPPs. Integrated clinical tools that can facilitate patient-provider interaction around dDPPs may contribute to improved patient adherence to these programs and improved health outcomes by addressing barriers faced by both patients and providers. Further evaluation with pilot testing and a clinical trial will assess the effectiveness and implementation of these tools. ClinicalTrials.gov NCT04049500; https://clinicaltrials.gov/ct2/show/NCT04049500 DERR1-10.2196/26750
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