County-based integrated cardiovascular care program using risk-stratified pathways
County Medical Community-based, Cardiovascular Risk Stratified Integrated Care Model: a Pragmatic Cluster Randomised Control Trial
NA · Peking University · NCT06302127
This project will test whether a county-based team care program that uses cardiovascular risk levels, stronger education, financial incentives, and shared health records helps adults 40–70 with hypertension or type 2 diabetes get better treatment and control.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 2560 (estimated) |
| Ages | 40 Years to 70 Years |
| Sex | All |
| Sponsor | Peking University (other) |
| Locations | 3 sites (Sanming, Fujian and 2 other locations) |
| Trial ID | NCT06302127 on ClinicalTrials.gov |
What this trial studies
This pragmatic cluster randomized trial implements the RISIMA integrated care model through multi-level family health teams within county healthcare consortia. Clusters of township-level family doctor teams are randomized to deliver team-based care, risk-stratified care pathways, strengthened health education, financial incentives for care integration, and a supporting health information system versus usual care. The trial enrolls permanent county residents aged 40–70 with hypertension and/or type 2 diabetes who are already signed up with local family doctor teams. Outcomes include cardiovascular risk assessment, treatment adherence, control of blood pressure and glucose, and management processes during routine follow-up.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40–70 with hypertension or type 2 diabetes who live in the participating counties and are registered with a local family doctor team.
Not a fit: Patients with serious comorbidities that interfere with visits (for example active cancer), pregnant or lactating women, those unable to attend township or village health centers, or those not registered with a local family doctor team are unlikely to benefit.
Why it matters
Potential benefit: If successful, this model could improve blood pressure and glucose control, streamline care coordination, and reduce cardiovascular risk for participants.
How similar studies have performed: Similar team-based and risk-stratified primary care programs have improved blood pressure and diabetes control in several settings, although results vary by healthcare system and study design.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged between 40 and 70 years old; 2. Patients with hypertension or diabetes; 3. Permanent residents of the county where the research is conducted; 4. Already signed up with the family doctor team in the township where the research is located. Exclusion Criteria: 1. Unable to independently carry out the interventions required for the study; 2. Residing far from the village or township health center where the research is located, making it difficult to cooperate with visits; 3. Patients who refuse to participate; 4. Patients with comorbidities such as cancer that may interfere with the study visits or intervention effects; 5. Pregnant or lactating women
Where this trial is running
Sanming, Fujian and 2 other locations
- Shaxian County General Hospital — Sanming, Fujian, China (RECRUITING)
- Luzhai County People's hospital — Liuzhou, Guangxi, China (RECRUITING)
- Luzhai County Traditional Medicine hospital — Liuzhou, China (RECRUITING)
Study contacts
- Study coordinator: Jin Prof. Xu, PhD
- Email: xujin@hsc.pku.edu.cn
- Phone: 0086-82805701
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypertension, Diabetes Mellitus Type 2, Cardiovascular Diseases