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Completed

NCT Number: NCT05645640

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

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.

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Key information

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 10-year ASCVD risk score

    Time frame: 12 months

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

Secondary outcomes

  1. Lifetime ASCVD risk score

    Time frame: 12 months

    Changes in lifetime ASCVD risk score from baseline to 12 months

  2. Blood pressure

    Time frame: 12 months

    Changes in systolic and diastolic blood pressure from baseline to 12 months

  3. Fasting plasma glucose (FPG)

    Time frame: 12 months

    Changes in fasting plasma glucose (FPG) from baseline to 12 months

  4. Non-HDL cholesterol

    Time frame: 12 months

    Changes in Non-HDL cholesterol from baseline to 12 months

  5. Weight change

    Time frame: 12 months

    Changes in proportion of subjects who are overweight and obesity from baseline to 12 months

  6. Smoke abstinence

    Time frame: 12 months

    Changes in proportion of daily smoking persons from baseline to 12 months

  7. Physical activity

    Time frame: 12 months

    Changes in proportion of subjects with insufficient physical activity (<3000 MET min/wk) from baseline to 12 months

Other outcomes

  1. Exploratory Outcome: Medication adherence

    Time frame: 12 months

    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

  2. Exploratory Outcome: MACEs

    Time frame: 12 months

    Major adverse cardiovascular events, including occurrence of death, myocardial infarction, stroke, and cardiovascular hospitalization

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Official study 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)

Acronym: SMARTER

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 9, 2022
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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