Protocol paper: randomized controlled trial of the smart online-to-offline model development for chronic diseases management through digital health in real world setting.

Abstract

Background: Chronic diseases such as diabetes and hypertension pose significant health and economic challenges globally, and South Korea is no 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. This protocol describes a randomized controlled trial that evaluates the effectiveness of an online-to-offline (O2O) digital healthcare service for patients with chronic diseases, specifically diabetes and hypertension, 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 consists of two main groups of participants: those with diabetes and those with hypertension. Participants are randomized into treatment and control arms for each group. The intervention includes personalized digital healthcare support, continuous data monitoring, and online education, with primary care provided by healthcare professionals. To evaluate the primary and secondary outcomes-such as HbA1c, systolic blood pressure, and cholesterol levels-the study applies a range of statistical methods. These include intention-to-treat (ITT) analysis to account for all randomized participants, regression models to estimate the treatment effect, and adjustments for baseline covariates to improve precision. Subgroup analyses will explore variations in treatment effects based on factors such as 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 US National Library of Medicine. The registration number is NCT06150508, and the registered date is 2023-11-29.