Actively Recruiting
County Medical Community-based, Cardiovascular Risk Stratified Integrated Care Model: a Pragmatic Cluster Randomised Control Trial
Led by Peking University · Updated on 2025-07-16
2560
Participants Needed
3
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the RISIMA model, an integrated care approach for patients aged 40 to 70 with hypertension and/or type 2 diabetes. This model focuses on cardiovascular disease (CVD) risk assessment, treatment, and management through a community-based healthcare consortium. The trial aims to assess how well this risk-stratified integrated care model works compared to standard care in improving patient outcomes related to cardiovascular risk. The study compares two groups: one receiving usual public health services including quarterly follow-ups and annual physical exams, and the other receiving the RISIMA model. This integrated model includes team-based care by family health teams, a risk-stratified care pathway based on CVD risk scores, enhanced health education sessions, financial incentives for care integration, and a supporting health information system. The intervention is delivered as a package with tailored management plans according to patients' cardiovascular risk levels. Participants will be involved for at least 12 months, during which researchers will monitor outcomes such as the 10-year CVD risk score, blood pressure control, cholesterol, fasting blood sugar, and cardiovascular event rates. The study also evaluates cost-effectiveness. Participants will attend regular follow-ups, education sessions, and risk assessments, with data collected via a health information system that supports care coordination and performance evaluation.
CONDITIONS
Brief Title
County Medical Community-based, Cardiovascular Risk Stratified Integrated Care Model: a Pragmatic Cluster Randomised Control Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 40 and 70 years old
- Patients with hypertension or diabetes
- Permanent residents of the county where the research is conducted
- Already signed up with the family doctor team in the township where the research is located
You will not qualify if you...
- Unable to independently carry out the interventions required for the study
- Residing far from the village or township health center where the research is located, making it difficult to cooperate with visits
- Patients who refuse to participate
- Patients with comorbidities such as cancer that may interfere with the study visits or intervention effects
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive care based on their cardiovascular risk level, including team-based care, risk-stratified management, and strengthened health education.
Quarterly visits for follow-up and monthly health education sessions with individual counseling at month 4 and self-management evaluation at month 8
Trial Site Locations
Total: 3 locations
1
Shaxian County General Hospital
Sanming, Fujian, China
Actively Recruiting
2
Luzhai County People's hospital
Liuzhou, Guangxi, China
Actively Recruiting
3
Luzhai County Traditional Medicine hospital
Liuzhou, China
Actively Recruiting
Research Team
J
Jin Prof. Xu, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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