County Medical Community-based, Cardiovascular Risk Stratified Integrated Care Model: a Pragmatic Cluster Randomised Control Trial

Not Applicable

Recruiting

• Conditions: Hypertension; Cardiovascular Diseases; Diabetes Mellitus Type 2

• Registration Number: NCT06302127
• Lead Sponsor: Peking University

Brief Summary

The goal of this cluster randomized trial is to evaluate the effectiveness of the RISIMA model based on an integrated county healthcare consortium implemented by multi-level family health teams (FHTs)on patients with diabetes and/or hypertension, including CVD risk assessment, treatment, and management.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-04
• Study First Submitted QC: 2024-03-04
• Study First Posted: 2024-03-08
• Study Start: 2024-05-20
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-13
• Last Update Posted: 2025-07-16
• Primary Completion: 2025-10-20
• Study Completion: 2025-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2560

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
10-year CVD risk score	12 months	This study intervention is designed to address CVD risk by introducing an integrated care package. Therefore, a validated risk score is required to properly evaluate the effect of interventions. The WHO/ISH score is a tool to estimate the risk of CVD development based on age, sex, BP, total cholesterol, smoking and diabetes. The primary objective of this study is to evaluate whether or not the intervention can substantially lower the risk at 1 year. The primary outcome is the mean difference in WHO/ISH risk score change from baseline to 12 months between the intervention and control townships. The WHO/ISH risk score will be calculated using the lab-based measurements, but if there are missing, a nonlaboratory measurements will be used.

Secondary Outcome Measures

Name	Time	Method
10-year CVD risk score changes	6 months	change in 10-year CVD risk score changes between the intervention and control FDTs at 6 months
blood pressure control rate	12 months	change in blood pressure control rate between the intervention and control FDTs at 12 months
systolic blood pressure	6 months	change in SBP between the intervention and control FHTs at 6 months
total cholesterol	12 months	change in total cholesterol between the intervention and control FHTs at 12 months.
fasting blood glucose	12 months	change in fasting blood glucose between the intervention and control FDTs at 12 months
CVD incidence rate	12 months	difference of incidence rate of major adverse cardiovascular events (including acute myocardial infarction, stroke, angina, and sudden cardiac death) between the intervention and control FDTs at 12 months
cost-effectiveness outcome	12 months	a health economic evaluation to assess the cost-effectiveness of the intervention compared with usual care at 12 months

Trial Locations

Locations (3)

Shaxian County General Hospital; 🇨🇳 Sanming, Fujian, China

Luzhai County People's hospital; 🇨🇳 Liuzhou, Guangxi, China

Luzhai County Traditional Medicine hospital; 🇨🇳 Liuzhou, China