Protocol Paper: Randomized Controlled Trial of the Smart Online-to-Offline Model Development for Chronic Diseases Management through Digital Health in Real World Setting
crossref(2024)
Abstract
Abstract • Background: While chronic diseases, such as diabetes and hypertension, pose significant health and economic challenges globally, and South Korea is not an exception. Innovative digital health services have the potential to revolutionize chronic disease management by providing patients with real-time, personalized care and empowering them to take an active role in their health. There is a critical need to evaluate the effectiveness of such services, and this protocol explicates the randomized controlled trial evaluating the effectiveness of an Online-to-Offline (O2O) digital healthcare service for patients with chronic diseases, specifically diabetes and hypertension patients in Pyeongchang-gun. • Methods: This study presents a comprehensive protocol for the assessment of an Online-to-Offline (O2O) digital health service model aimed at managing chronic diseases. The study comprises two main groups of participants: those with diabetes and those with hypertension. Each group is further randomized into treatment and control arms. The intervention involves personalized digital healthcare support, data monitoring, and online education, with healthcare providers offering primary care. The study employs various statistical approaches, including Intention-to-Treat (ITT), Average Treatment Effect (ATE), and Regression-Adjusted Impact Estimate, to evaluate the primary and secondary outcomes such as HbA1c, systolic blood pressure, and cholesterol levels. Subgroup analyses consider factors like intervention intensity, comorbidity, and healthcare provider. • Discussion: This protocol outlines a novel approach to evaluating the O2O digital health service model for chronic disease management. It offers insights into the nuanced effects of the intervention, highlighting the potential for tailoring future interventions for maximum benefit. By assessing its real-world effectiveness, this study can inform healthcare policies, expand the application scope of O2O service models, and identify additional chronic diseases that can benefit from digital health services. This research bridges the gap between theory and practice, contributing to evidence-based healthcare decision-making and improving patient outcomes in the era of digital health. Trial registration: This study is registered at ClinicalTrials.gov of the United States’s National Library of Medicine. The registration number is NCT06150508, and the registered date is 2023-11-29.
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