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

NCT05645640 | Completed

• 1 other identifier: 2022-GSP-GG-4
• Study Type: interventional
• Target: 4,533
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Risk Reduction; Primary Prevention

Outcome Measures

Primary Outcomes (1)

• 10-year ASCVD risk score

  Changes in 10-year ASCVD risk score from baseline to 12 months

  12 months

Secondary Outcomes (7)

• Lifetime ASCVD risk score

  12 months

• Blood pressure

  12 months

• Fasting plasma glucose (FPG)

  12 months

• Non-HDL cholesterol

  12 months

• Weight change

  12 months

Other Outcomes (2)

• Exploratory Outcome: Medication adherence

  12 months

• Exploratory Outcome: MACEs

  12 months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

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

Interventions

Village doctor-led tailored health management COMBINATION_PRODUCT

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.

Intervention

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

Location

Related Publications (1)

• Zhang X, Wang S, Zhou X, Tang Y, Xing L, Ma S, Xu Y, Wu C, Cui J, Yang Y, Lin C, Wu Y, Zhang H, Fan L, Xu C, Li X; SMARTER Collaborative Group. A village doctor-led mobile health intervention for cardiovascular risk reduction in rural China: cluster randomised controlled trial. BMJ. 2025 May 27;389:e082765. doi: 10.1136/bmj-2024-082765.

  PMID: 40425261 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Xi Li

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director of National Clinical Research Center for Cardiovascular Diseases

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 9, 2022
• Study Start: March 16, 2023
• Primary Completion: May 16, 2024
• Study Completion: May 16, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

CN (1)