Cardiovascular DiseasesSMARTERNCT05645640
Strategy for Cardiovascular Disease Prevention Through Tailored Health Management in Individuals With Elevated Risk
A study testing Village doctor-led tailored health management in people with Cardiovascular Diseases and Risk Reduction, run by China National Center for Cardiovascular Diseases at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Cardiovascular Diseases, Risk Reduction, Primary Prevention
- What is being tested?
- Village doctor-led tailored health management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,533 participants
- Where
- 1 siteChina
- Study dates
- 16 Mar 2023to 16 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Risk Reduction, Primary Prevention
- Being tested
- Village doctor-led tailored health management
- Medical subject headings
- Cardiovascular Diseases, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Village doctor-led tailored health managementCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
10-year ASCVD risk score
Changes in 10-year ASCVD risk score from baseline to 12 months
Measured: 12 months
Secondary outcomes (7)
Lifetime ASCVD risk score
Changes in lifetime ASCVD risk score from baseline to 12 months
Measured: 12 months
Blood pressure
Changes in systolic and diastolic blood pressure from baseline to 12 months
Measured: 12 months
Fasting plasma glucose (FPG)
Changes in fasting plasma glucose (FPG) from baseline to 12 months
Measured: 12 months
Non-HDL cholesterol
Changes in Non-HDL cholesterol from baseline to 12 months
Measured: 12 months
Weight change
Changes in proportion of subjects who are overweight and obesity from baseline to 12 months
Measured: 12 months
Smoke abstinence
Changes in proportion of daily smoking persons from baseline to 12 months
Measured: 12 months
Physical activity
Changes in proportion of subjects with insufficient physical activity (<3000 MET min/wk) from baseline to 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start16 Mar 2023
- Primary completion16 May 2024
- Study completion16 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4,533 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Xi Li, China National Center for Cardiovascular Diseases
- Investigators
- Xi Li, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645640
- Sponsor's protocol ID
- 2022-GSP-GG-4
- Acronym
- SMARTER
- Status last verified
- Aug 2024
- First submitted
- 23 Nov 2022
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40425261
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05645640
- Acronym / sponsor ID
- SMARTER / 2022-GSP-GG-4
- Conditions
- Cardiovascular Diseases, Risk Reduction, Primary Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,533 participants (actual)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 16 May 2024 (actual)
- Study completion
- 16 May 2024 (actual)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Combination Product: Village doctor-led tailored health managementSubjects 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). |
| Control | No intervention | –Subjects in the control group will receive usual care (advice on lifestyle change, medication, and rehabilitation). |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Village doctor-led tailored health managementInvestigators 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. | Combination product | Intervention |
Primary outcome
10-year ASCVD risk score
Time frame: 12 months
Changes in 10-year ASCVD risk score from baseline to 12 months
7 secondary outcomes
Lifetime ASCVD risk score
Time frame: 12 months
Blood pressure
Time frame: 12 months
Fasting plasma glucose (FPG)
Time frame: 12 months
Non-HDL cholesterol
Time frame: 12 months
Weight change
Time frame: 12 months
Smoke abstinence
Time frame: 12 months
Physical activity
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Derived from this study: PubMed 40425261Zhang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xi Li principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Village doctor-led tailored health management in people with Cardiovascular Diseases and Risk Reduction, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10-year ASCVD risk score (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05645640, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.