Novel Model of Integrated Care of Older Patients With Atrial Fibrillation and Heart Failure in Rural China (MIRACLE-AFHF)

Sponsor
Jiangsu Taizhou People's Hospital
Study ID
NCT07492524
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Village-Doctor Led Integrated Care — OTHER
    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.
  • Usual Care — OTHER
    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.

Study Details

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.

Key Dates

First listed
Mar 25, 2026
Start date
Aug 1, 2026
Status verified
Jun 2026
Primary completion
Dec 30, 2029
Completion
Dec 30, 2029

Study Design

Enrollment
942 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention Group
    Participants in this arm will receive village-doctor led integrated care for atrial fibrillation and heart failure. Village doctors will receive standardized training based on the AF ABC pathway and heart failure GDMT principles. Patients will receive structured self-management education focused on medication adherence, symptom monitoring, lifestyle modification, and recognition of warning signs.
  • Active Comparator: Control Group
    Participants in this arm will receive usual chronic disease management according to the National Basic Public Health Service requirements.

Primary Outcome Measure

Change in MAGGIC Heart Failure Risk Score [ Time Frame: Baseline to 12 months ]

Central Contacts

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