Clinical trial NCT05645640: Strategy for Cardiovascular Disease Prevention Through Tailored Health Management in Individuals With Elevated Risk
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Risk Reduction
Primary Prevention
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2022-12-09
Enrollment: 4533
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 10-year ASCVD risk score
timeFrame: 12 months
Secondary outcomes:
measure: Lifetime ASCVD risk score
timeFrame: 12 months
measure: Blood pressure
timeFrame: 12 months
measure: Fasting plasma glucose (FPG)
timeFrame: 12 months
measure: Non-HDL cholesterol
timeFrame: 12 months
measure: Weight change
timeFrame: 12 months
measure: Smoke abstinence
timeFrame: 12 months
measure: Physical activity
timeFrame: 12 months
Other outcomes:
measure: Exploratory Outcome: Medication adherence
timeFrame: 12 months
measure: Exploratory Outcome: MACEs
timeFrame: 12 months
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Xi Li
role: PRINCIPAL_INVESTIGATOR
References: