Novel Model of Integrated Care of Older Patients With Atrial Fibrillation and Heart Failure in Rural China (MIRACLE-AFHF)
NCT07492524 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 942
Last updated 2026-07-28
Summary
This cluster randomization study aims to compare village-doctor led integrated care versus usual care to improve heart failure risk management, guideline-directed medical therapy, self-management adherence, and clinical outcomes for older patients with atrial fibrillation and heart failure in rural China.
Conditions
Interventions
- OTHER
-
Village-Doctor Led Integrated Care
1. Village doctors will conduct monthly follow-up, including clinical assessment, vital-sign monitoring, medication review, risk screening, health education, and referral when needed. 2. For patients with clinical deterioration or treatment difficulties, village doctors may use a remote care platform to obtain specialist consultation and individualized recommendations. 3. Village doctors will receive standardized training based on the AF ABC pathway and heart failure GDMT principles. 4. Patients will receive structured education on medication adherence, symptom monitoring, lifestyle modification, and recognition of warning signs.
- OTHER
-
Usual Care
Usual care includes routine follow-up, general health education, medication registration, and standard referral procedures provided by local primary care providers. Participants will not receive the structured village-doctor led integrated care program.
Sponsors & Collaborators
-
The First Affiliated Hospital with Nanjing Medical University
collaborator OTHER -
Jiangsu Taizhou People's Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 65 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-01
- Primary Completion
- 2029-12-30
- Completion
- 2029-12-30
Countries
- China
Study Locations
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