Novel Model of Integrated Care of Older Patients With Atrial Fibrillation to Prevent Heart Failure in Rural China

Sponsor
Jiangsu Taizhou People's Hospital
Study ID
NCT07492498
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 symptom assessment, vital-sign monitoring, medication adherence support, cardiovascular risk-factor management, health education, and referral when needed. 2. Village doctors will provide AF management based on the ABC pathway and simplified home-based exercise rehabilitation education. 3. When clinical deterioration or management difficulties occur, village doctors may use a remote care platform to obtain cardiology specialist consultation and treatment recommendations within 24 hours. 4. Village doctors will receive standardized training on AF management, anticoagulation, rate/rhythm control, and cardiovascular risk-factor management. 5. Patients will receive structured education on medication adherence, symptom monitoring, lifestyle modification, exercise rehabilitation, and recognition of warning signs.
  • Usual Care — OTHER
    Participants in the control group will receive usual chronic disease management according to the National Basic Public Health Service requirements. 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 randomized study aims to compare village doctor-led integrated care versus usual care to improve cardiovascular health, atrial fibrillation management, self-management adherence, and heart failure prevention among older rural patients with atrial fibrillation in China.

Key Dates

First listed
Mar 25, 2026
Start date
Aug 1, 2026
Status verified
Jun 2026
Primary completion
Jul 1, 2030
Completion
Jul 1, 2030

Study Design

Enrollment
1,356 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention Group
    The intervention group will receive a village doctor-led integrated management program supported by telemedicine, guideline-based training, and a simplified exercise-based cardiac rehabilitation component, aiming to prevent incident heart failure in elderly rural patients with atrial fibrillation who have preserved cardiac function.
  • 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 Life's Essential 8 Cardiovascular Health Score [ Time Frame: Baseline to 12 months ]

Central Contacts

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