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

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)

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Primary Prevention; Risk Reduction
• Intervention / Treatment: Combination product: Village doctor-led tailored health management

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.

• Study Type: Interventional
• Enrollment (Actual): 4533
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Fuwai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	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.
No Intervention: Control; Subjects in the control group will receive usual care (advice on lifestyle change, medication, and rehabilitation).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
10-year ASCVD risk score	Changes in 10-year ASCVD risk score from baseline to 12 months	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lifetime ASCVD risk score	Changes in lifetime ASCVD risk score from baseline to 12 months	12 months
Blood pressure	Changes in systolic and diastolic blood pressure from baseline to 12 months	12 months
Fasting plasma glucose (FPG)	Changes in fasting plasma glucose (FPG) from baseline to 12 months	12 months
Non-HDL cholesterol	Changes in Non-HDL cholesterol from baseline to 12 months	12 months
Weight change	Changes in proportion of subjects who are overweight and obesity from baseline to 12 months	12 months
Smoke abstinence	Changes in proportion of daily smoking persons from baseline to 12 months	12 months
Physical activity	Changes in proportion of subjects with insufficient physical activity (<3000 MET min/wk) from baseline to 12 months	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Exploratory Outcome: MACEs	Major adverse cardiovascular events, including occurrence of death, myocardial infarction, stroke, and cardiovascular hospitalization	12 months

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Investigators: Principal Investigator: Xi Li, Fuwai Hospital, CAMS & PUMC

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2023
• Primary Completion (Actual): May 16, 2024
• Study Completion (Actual): May 16, 2024

Study Registration Dates

• First Submitted: November 23, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Actual): December 9, 2022

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 2022-GSP-GG-4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No