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

Cardiovascular Diseases Clinical Trial

— SMARTER  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05645640
• Other study ID #: 2022-GSP-GG-4
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 16, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: March 2024
• Source: China National Center for Cardiovascular Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4538
• Est. completion date: June 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Primary Prevention
• Risk Reduction

Intervention

Combination Product:
• Village doctor-led tailored health management
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.

Locations

Country	Name	City	State
China	Fuwai Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Outcome: Medication adherence	Changes in proportion of subjects who report taking the full dose of prescribed medications =6 days per week among all necessary subjects from baseline to 12 months	12 months
Other	Exploratory Outcome: MACEs	Major adverse cardiovascular events, including occurrence of death, myocardial infarction, stroke, and cardiovascular hospitalization	12 months
Primary	10-year ASCVD risk score	Changes in 10-year ASCVD risk score from baseline to 12 months	12 months
Secondary	Lifetime ASCVD risk score	Changes in lifetime ASCVD risk score from baseline to 12 months	12 months
Secondary	Blood pressure	Changes in systolic and diastolic blood pressure from baseline to 12 months	12 months
Secondary	Fasting plasma glucose (FPG)	Changes in fasting plasma glucose (FPG) from baseline to 12 months	12 months
Secondary	Non-HDL cholesterol	Changes in Non-HDL cholesterol from baseline to 12 months	12 months
Secondary	Weight change	Changes in proportion of subjects who are overweight and obesity from baseline to 12 months	12 months
Secondary	Smoke abstinence	Changes in proportion of daily smoking persons from baseline to 12 months	12 months
Secondary	Physical activity	Changes in proportion of subjects with insufficient physical activity (<3000 MET min/wk) from baseline to 12 months	12 months