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NCT06302127 | RECRUITING | Hypertension

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

Condition or disease

Hypertension

Diabetes Mellitus Type 2

Cardiovascular Diseases

Intervention/treatment

Team-based care

Risk-stratified care pathway

Strengthened health education

Financial incentives for integration of care

Supporting health information system

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 2560 participants
Masking : SINGLE
Masking Description : The follow-up data collection, data entry, and data quality checks will be conducted by researchers unaware of the group assignments. The analysis of results will also be performed by statisticians unaware of the allocation.
Primary Purpose : PREVENTION
Official Title : County Medical Community-based, Cardiovascular Risk Stratified Integrated Care Model: a Pragmatic Cluster Randomised Control Trial
Actual Study Start Date : 2024-05-20
Estimated Primary Completion Date : 2025-10-20
Estimated Study Completion Date : 2025-12-20

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
County Medical Community-based, Cardiovascular Risk Stratified Integrated Care Model: a Pragmatic Cluster Randomised Control Trial

Location Details

NCT06302127

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

China, Fujian

Shaxian County General Hospital

Sanming, Fujian, China,

RECRUITING

China, Guangxi

Luzhai County People's hospital

Liuzhou, Guangxi, China,

RECRUITING

China,

Luzhai County Traditional Medicine hospital

Liuzhou, China,