Effectiveness of a cardiovascular management system on triple risk-factor control in high-risk older adults: protocol for a randomized controlled trial (Preprint)

<sec> <title>BACKGROUND</title> Cardiovascular disease (CVD) remains a leading cause of morbidity and mortality in China. Although the National Basic Public Health Service Program provides annual health check-ups for older adults, post-screening management of CVD risk factors such as hypertension, dyslipidemia, and diabetes is often inadequate. The CardioCare System is a digital cardiovascular management platform that integrates risk prediction, personalized health interventions, and continuous engagement to address these gaps. </sec> <sec> <title>OBJECTIVE</title> This trial aims to evaluate the effectiveness of the CardioCare System in improving triple risk-factor control, simultaneous control of blood pressure, lipids, and glycemia, at 12 months among high-risk adults. Secondary objectives include assessing changes in estimated 10-year CVD risk, individual clinical parameters, medication adherence, lifestyle modification, system engagement, usability, satisfaction, and cost-effectiveness. </sec> <sec> <title>METHODS</title> This is a single-center, parallel-group, superiority randomized controlled trial with a 1:1 allocation ratio. A total of 300 adults aged ≥50 years, with an estimated 10-year CVD risk &gt;10% and no prior CVD diagnosis, will be recruited from the Health Management Centre of the First Affiliated Hospital of Sun Yat-sen University in Guangzhou, China. Participants will be randomized to receive either the CardioCare System intervention or standard care for 12 months. The intervention includes risk stratification and communication, weekly personalized SMS or WeChat messages, and cardiologist oversight. The primary outcome is the proportion of participants achieving triple risk-factor control at 12 months. Secondary outcomes include clinical, behavioral, usability, and economic measures. Analyses will follow the intention-to-treat principle, with multiple imputation for missing data. </sec> <sec> <title>RESULTS</title> This trial was funded on 28 October 2024. Recruitment is scheduled to begin in January 2026 and conclude in April 2026, with follow-up completed by June 2027. Data analysis will commence in mid-2027, and the main findings are expected to be published in end-2027. As of manuscript submission, recruitment has not yet started. </sec> <sec> <title>CONCLUSIONS</title> This trial will provide robust evidence on the clinical effectiveness and cost-effectiveness of the CardioCare System in managing multiple cardiovascular risk factors among high-risk adults. Findings will inform the potential for scaling this intervention within health check-up centers and integrating it into national chronic disease management strategies. </sec> <sec> <title>CLINICALTRIAL</title> ChiCTR2500103369 </sec>