China Patient-centered Evaluative Assessment of Cardiac Events (PEACE): Strategy for Cardiovascular Disease Prevention Through Tailored Health Management and Its Effectiveness Assessment Through a Cluster Randomized Trial in Individuals With Elevated Risk (SMARTER)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4,533
- 试验地点
- 1
- 主要终点
- 10-year ASCVD risk score
研究概览
简要总结
The China PEACE SMARTER trial is a cluster ramdomized trial aiming to assess the effectiveness of village doctor-led tailored health management on risk reduction of high-risk individuals for cardiovascular disease.
详细描述
In this study, investigators aim to develop a series of intervention strategies for cardiovascular disease (CVD) prevention through village doctor-led tailored health management in individuals with elevated risk, then assess their effectiveness through a cluster randomized trial. Investigators hypothesize that the village doctor-led tailored health management can reduce the CVD risk and improve risk factor control of the high-risk subjects through 12 months of follow-up. Around 4200 subjects from 120 villages in mainland China who are considered to be eligible according to inclusion and exclusion criteria will be enrolled to the study. The eligibility criteria is: Individuals aged 35 or above who are in high risk for CVD (10-year ASCVD risk ≥10%), able to use smart phone, and contracted with the local family doctor. Patients with history of CVD or severe illnesses, pregnancy, cognition or communication problems are excluded from the study. The selected villages will be assigned (1:1) to either control group (usual care) or intervention group (village doctor-led tailored health management). The primary outcome is the change in 10-year ASCVD risk from baseline to 12 months. Follow up visits will be conducted every 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 35 or above;
- •High CVD risk which defined as 10-year ASCVD risk ≥10% based on China-PAR prediction model;
- •Ownership of a smart phone and being able to use apps;
- •Being contracted with the local family doctor (village doctor);
- •Willing to participate and able to sign informed consent.
排除标准
- •CVD history, including myocardial infarction (MI), stroke, heart failure, severe arrhythmia, or peripheral artery disease, or having received percutaneous coronary intervention (PCI) or coronary artery by-pass grafting operation (CABG);
- •Severe illnesses, such as cancer, or severe hepatic and renal dysfunction;
- •Women during pregnancy, lactation, or plan to have children in the next year;
- •Having problems in cognition or communication, or limited daily activities.
研究组 & 干预措施
Intervention
Subjects in the intervention group will receive village doctor-led tailored health management which includes five main components (marking of individual risk factor profiles, tailored targets for risk factor modification, individualized health education based on Smart Phones, health monitoring and feedback based on Smart Bands, and incentive based on gamification).
干预措施: Village doctor-led tailored health management (Combination Product)
Control
Subjects in the control group will receive usual care (advice on lifestyle change, medication, and rehabilitation).
结局指标
主要结局
10-year ASCVD risk score
时间窗: 12 months
Changes in 10-year ASCVD risk score from baseline to 12 months
次要结局
- Lifetime ASCVD risk score(12 months)
- Blood pressure(12 months)
- Non-HDL cholesterol(12 months)
- Smoke abstinence(12 months)
- Fasting plasma glucose (FPG)(12 months)
- Weight change(12 months)
- Physical activity(12 months)
研究者
Xi Li
Vice Director of National Clinical Research Center for Cardiovascular Diseases
China National Center for Cardiovascular Diseases