Strategy for Cardiovascular Disease Prevention Through Tailored Health Management in Individuals With Elevated Risk (SMARTER)

National Center for Cardiovascular Diseases

Status: Completed

Conditions: Primary Prevention; Cardiovascular Diseases; Risk Reduction

Treatments: Combination Product: Village doctor-led tailored health management

Study type: Interventional

Funder types: Other

Identifiers

NCT05645640

2022-GSP-GG-4

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 4,533 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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4,533 participants in 2 patient groups

Intervention

Active Comparator group

Description:

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).

Treatment:

Combination Product: Village doctor-led tailored health management

Control

No Intervention group

Description:

Subjects in the control group will receive usual care (advice on lifestyle change, medication, and rehabilitation).