Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06302127

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shaxian County General Hospital, Sanming, Fujian, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

team-based care

Other

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.

Risk-stratified care pathway

Procedure

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.

Strengthened health education

Behavioral

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.

Financial incentives for integration of care

Other

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.

Supporting health information system

Other

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.

Primary outcomes

  1. 10-year CVD risk score

    Time frame: 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 outcomes

  1. 10-year CVD risk score changes

    Time frame: 6 months

    change in 10-year CVD risk score changes between the intervention and control FDTs at 6 months

  2. blood pressure control rate

    Time frame: 12 months

    change in blood pressure control rate between the intervention and control FDTs at 12 months

  3. systolic blood pressure

    Time frame: 12 months

    change in SBP between the intervention and control FHTs at 12 months

  4. systolic blood pressure

    Time frame: 6 months

    change in SBP between the intervention and control FHTs at 6 months

  5. total cholesterol

    Time frame: 12 months

    change in total cholesterol between the intervention and control FHTs at 12 months.

  6. fasting blood glucose

    Time frame: 12 months

    change in fasting blood glucose between the intervention and control FDTs at 12 months

  7. CVD incidence rate

    Time frame: 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

  8. cost-effectiveness outcome

    Time frame: 12 months

    a health economic evaluation to assess the cost-effectiveness of the intervention compared with usual care at 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Jin Prof. Xu, PhD

CONTACT

[email protected]

0086-82805701

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Acronym: C-RISIMA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 8, 2024
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.