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Effectiveness of a Cardiovascular Management System on Triple Risk Factor Control in High-Risk Older Adults: Protocol
Yan Wang1, Lei Su2, Jingyi Xiao1
1Centre of Health Management, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.
JMIR Research Protocols
|December 9, 2025
Summary
This randomized trial will assess the CardioCare system for managing cardiovascular disease risk factors in high-risk adults. It aims to improve triple risk factor control, enhancing patient outcomes and healthcare strategies.
Area of Science:
- Cardiovascular disease (CVD) research
- Digital health interventions
- Public health management
Background:
- Cardiovascular disease (CVD) is a major health concern in China.
- Current public health programs offer limited post-screening management for CVD risk factors.
- The CardioCare system offers a digital solution for cardiovascular risk management.
Purpose of the Study:
- To evaluate the CardioCare system's effectiveness in achieving triple risk factor control (blood pressure, lipids, glycemia) in high-risk adults.
- To assess secondary outcomes including CVD risk, clinical parameters, medication adherence, lifestyle changes, and system usability.
- To determine the cost-effectiveness of the CardioCare intervention.
Main Methods:
- A single-center, superiority randomized controlled trial with 1:1 allocation.
- 300 adults aged ≥50 years with >10% 10-year CVD risk will be recruited.
- Intervention group receives CardioCare system (risk stratification, personalized messages, cardiologist oversight); control group receives usual care for 12 months.
Main Results:
- Primary outcome: proportion achieving triple risk factor control at 12 months.
- Secondary outcomes: changes in clinical, behavioral, usability, and economic measures.
- Analysis will follow intention-to-treat principles with multiple imputation for missing data.
Conclusions:
- The trial will provide evidence on the clinical and cost-effectiveness of the CardioCare system.
- Findings may support scaling the intervention in health checkup centers.
- Results could inform national strategies for chronic disease management.
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