The iCARE trial is an ongoing randomized controlled study designed to assess whether an individualized mobile health intervention reduces the incidence of major cardiovascular events in patients with coronary heart disease.
RCT (n=2,820)
Open-label
Stratified block randomization
Yes
Does an individualized, visualized mobile health intervention (iCARE) reduce the incidence of major cardiovascular events in patients with coronary heart disease compared to text-only or routine care?
This study protocol outlines a large-scale randomized controlled trial to evaluate whether a visualized, individualized mobile health intervention can reduce major cardiovascular events in patients with coronary heart disease.
BACKGROUND: Mobile health-based individualized interventions have shown potential effects in managing cardiovascular risk factors. This study aims to assess whether or not mHealth based individualized interventions delivered by an Individualized Cardiovascular Application system for Risk Elimination (iCARE) could reduce the incidence of major cardiovascular events in individuals with coronary heart disease. METHODS: This study is a large-scale, multi-center, parallel-group, open-label, randomized controlled clinical trial. This study will be conducted from September 2019 to December 2025. A total of 2820 patients with coronary heart disease will be recruited from two clinical sites and equally randomized into three groups: the intervention group and two control groups. All participants will be informed of six-time points (at 1, 3, 6, 12, 24, and 36 months after discharge) for follow-up visits. Over a course of 36 months, patients who are randomized to the intervention arm will receive individualized interventions delivered by a fully functional iCARE that using various visualization methods such as comics, videos, pictures, text to provide individualized interventions in addition to standard care. Patients randomized to control group 1 will receive interventions delivered by a modified iCARE that only presented in text in addition to routine care. Control group 2 will only receive routine care. The primary outcome is the incidence of major cardiovascular events within 3 years of discharge. Main secondary outcomes include changes in health behaviors, medication adherence, and cardiovascular health score. DISCUSSION: If the iCARE trial indeed demonstrates positive effects on patients with coronary heart disease, it will provide empirical evidence for supporting secondary preventive care in this population. Results will inform the design of future research focused on mHealth-based, theory-driven, intelligent, and individualized interventions for cardiovascular risk management. TRIAL REGISTRATION: Trial registered 24th December 2016 with the Chinese Clinical Trial Registry (ChiCTR-INR-16010242). URL: http://www.chictr.org.cn/showproj.aspx?proj=17398 .
Chen et al. (2021) conducted an RCT in Coronary heart disease (n=2,820). iCARE system (Individualized Cardiovascular Application system for Risk Elimination) vs. Modified iCARE (text only) plus routine care, or routine care alone was evaluated on Incidence of major cardiovascular events (MACEs). The iCARE trial is an ongoing randomized controlled study designed to assess whether an individualized mobile health intervention reduces the incidence of major cardiovascular events in patients with coronary heart disease.
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