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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Hypertension; Diabetes Mellitus Type 2
• Intervention / Treatment: Other: Team-based care; Procedure: Risk-stratified care pathway; Behavioral: Strengthened health education; Other: Financial incentives for integration of care; Other: Supporting health information system

• Study Type: Interventional
• Enrollment (Estimated): 2560
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jin Prof. Xu, PhD; Phone Number: 0086-82805701; Email: xujin@hsc.pku.edu.cn

Study Locations

• China
  • Liuzhou, China
    • Recruiting
    • Luzhai County Traditional Medicine hospital
    • Contact: Pengfei Liu; Phone Number: +86 18177251898; Email: lzxygb@126.com
  • Fujian
    • Sanming, Fujian, China
      • Recruiting
      • Shaxian County General Hospital
      • Contact: Xiaohong Xie; Phone Number: +86 13860506137; Email: lilylwj@live.com
  • Guangxi
    • Liuzhou, Guangxi, China
      • Recruiting
      • Luzhai County People's hospital
      • Contact: Pengfei Liu; Phone Number: +86 18177251898; Email: lzxygb@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; During the study, control participant will be provided with existing essential public health service including quarterly follow-ups and annual physical examination, and be advised to see their usual provider for care, as appropriate.
Experimental: Intervention; Intervention group will receive the risk-stratified integrated CVD management (RISIMA) model consisting of 5 core elements provided as a package: (1) Team-based care; (2) Risk-stratified care pathway; (3) Strengthened health education; (4) Financial incentives for integration of care; (5) Supporting health information system.	Other: Team-based care; The RISIMA model is provided by a family healthcare team composed of one village doctor, one general physician at township health centers and one specialist including cardiologists, neurologists or endocrinologists from county hospital. For villages without village doctor, public health professionals from township health centers would join the service team as the supplement. Within the team, three team members carry the different function. Village doctor is responsible for regular home visits, CVD risk measurement and organizing health education course. GP as the core service provider in the team is responsible for CVD risk monitoring, providing health education course for middle-high risk participants, and generating integrated care plans for each participant. Specialist is responsible for providing guidance particularly for high-risk population management to township and village doctors within the team.; Procedure: Risk-stratified care pathway; Based on WHO/ISH score, baseline population will be divided into three groups-low risk (10-year CVD risk: <10%), middle risk (10-year CVD risk: 10%~20%) and high risk (10-year risk: >20%). With the support from experts and health care professionals, study had developed a risk-stratified care pathway on the basis of clinical guidance. According to the pathway, participants at different risk tertile are provided with differentiated management plan especially in terms of health education, follow-up frequency and treatment plan.; Behavioral: Strengthened health education; The education comprised 8 monthly sessions developed by GP and village doctors. At the 4th month, individual health counseling by village doctors will be done to encourage the imitation and maintenance of self-management behaviors, and to identify any potential problems in the program. It took half an hour per each participant. At the 8th month, self-management evaluation will be done to assess personal self-management ability. High risk participants are required to take the education course, and middle risk participants are only encouraging to take. All participants would receive the education messages twice a month, which introduce tips about the management of hypertension, diabetes and CVD risk factors.; Other: Financial incentives for integration of care; Specialists receive reimbursement for case discussion and high risk population management; GP receive reimbursement for providing education program and risk monitoring; Village doctor receive reimbursement for assisting education program, risk measurement and home visits. And overall services quality will be measured, and taken into account for annual performance evaluation.; Other: Supporting health information system; A dynamic patient risk monitoring information system is established for simplifying the risk data collection and entry for village doctors, meanwhile, GP and specialist can receive the updates of risk scores simultaneously. Apart from the function of risk monitoring, this system also incorporates the e-records of home visits, health education attendance as well as medical records including outpatient visits and hospitalizations. The upgraded information systems not only can support the healthcare professionals with comprehensive and real-time data, but also provide the performance evaluation data for policymakers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
10-year CVD risk score	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
systolic blood pressure	change in SBP between the intervention and control FHTs at 12 months	12 months
total cholesterol	change in total cholesterol between the intervention and control FHTs at 12 months.	12 months
10-year CVD risk score changes	change in 10-year CVD risk score changes between the intervention and control FDTs at 6 months	6 months
blood pressure control rate	change in blood pressure control rate between the intervention and control FDTs at 12 months	12 months
systolic blood pressure	change in SBP between the intervention and control FHTs at 6 months	6 months
fasting blood glucose	change in fasting blood glucose between the intervention and control FDTs at 12 months	12 months
CVD incidence rate	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	12 months
cost-effectiveness outcome	a health economic evaluation to assess the cost-effectiveness of the intervention compared with usual care at 12 months	12 months

Collaborators and Investigators

• Sponsor: Peking University

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2024
• Primary Completion (Estimated): October 20, 2025
• Study Completion (Estimated): December 20, 2025

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): July 16, 2025
• Last Update Submitted That Met QC Criteria: July 13, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 2; Cardiovascular Diseases
• Other Study ID Numbers: CCHDS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No