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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
4,533
Investigators will "sketch" features of cardiovascular risk factor combinations for the high-risk subjects and accordingly set tailored promotion targets for them. Subjects will receive individualized consultation about their cardiovascular risk profile and tailored health management led by village doctors. They will receive tailored health text messages pushed by village doctors 3 times a week, including contents in physical activity, healthy diet, smoking abstinence, responsible alcohol drinking, sleep, and medication adherence. They will be provided with a smart band, and supposed to daily wear the smart band to collect health data. The progress of tailored promotion targets will be evaluated every 3 months, and feedback will be given in the form of virtual rewards and punishments: completed (a virtual golden egg) and failed (a virtual bomb). According to the number of virtual golden eggs, participants could redeem project gift in real life.
Fuwai Hospital
Beijing, Beijing Municipality, China
10-year ASCVD risk score
Changes in 10-year ASCVD risk score from baseline to 12 months
Time frame: 12 months
Lifetime ASCVD risk score
Changes in lifetime ASCVD risk score from baseline to 12 months
Time frame: 12 months
Blood pressure
Changes in systolic and diastolic blood pressure from baseline to 12 months
Time frame: 12 months
Fasting plasma glucose (FPG)
Changes in fasting plasma glucose (FPG) from baseline to 12 months
Time frame: 12 months
Non-HDL cholesterol
Changes in Non-HDL cholesterol from baseline to 12 months
Time frame: 12 months
Weight change
Changes in proportion of subjects who are overweight and obesity from baseline to 12 months
Time frame: 12 months
Smoke abstinence
Changes in proportion of daily smoking persons from baseline to 12 months
Time frame: 12 months
Physical activity
Changes in proportion of subjects with insufficient physical activity (\<3000 MET min/wk) from baseline to 12 months
Time frame: 12 months
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