Abstract
BackgroundDigital 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.ObjectiveThis 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.MethodsThis 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.ResultsThe 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.ConclusionsOur 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.Trial RegistrationClinicalTrials.gov NCT04049500; https://clinicaltrials.gov/ct2/show/NCT04049500International Registered Report Identifier (IRRID)DERR1-10.2196/26750
Highlights
BackgroundMore than 80 million US adults are considered prediabetic
Enrollment and data collection for phase 1 began in September 2019 under an Institutional Review Board quality improvement waiver granted in July 2019
Integrated clinical tools that can facilitate patient-provider interaction around Digital diabetes prevention programs (dDPPs) may contribute to improved patient adherence to these programs and improved health outcomes by addressing barriers faced by both patients and providers
Summary
BackgroundMore than 80 million US adults are considered prediabetic. Without treatment, an estimated 15% to 30% will develop diabetes over the 5 years [1]. Evidence-based interventions to prevent DM2 have focused on behavior change therapies including weight loss, dietary changes, and exercise This focus on behavior change was in response to findings from seminal research in Finland and the United States, which demonstrated that intensive lifestyle changes (including a low-fat diet, 150 min per week of moderate exercise, and a target 7% weight reduction) were as effective as medication in preventing the progression to DM2 in at-risk patients [4]. In response to these findings, the Centers for Disease Control and Prevention (CDC) developed a national diabetes prevention program (DPP) in 2010 that was aimed at providing patients with comprehensive, research-based, cost-effective programs to help prevent diabetes. Tools that can facilitate patient-provider interaction around dDPPs may contribute to improved patient engagement and adherence to these programs and improved health outcomes
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