Village-Doctor Led Integrated Care: 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: 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 summary
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.
Eligibility
Sex
ALL
Min age
65 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1\. The village clinics need to be willing and able to provide integrated care to their patients with atrial fibrillation; 2. The village doctors from one village clinic serves all AF patients from 3-5 nearby villages; 3. The village doctors are trained to have a fundamental understanding of telemedicine; 4. Patients are eligible for participation if 1)they aged 65-80 years.
2)Availability of an electrocardiogram confirming atrial fibrillation, or an official diagnosis certificate of atrial fibrillation issued by a specialist.
3)Receiving healthcare management from a primary medical institution near the place of residence.
4)Able to understand and sign the informed consent form.
Exclusion Criteria:
1. A definite history of heart failure, or confirmed cardiac dysfunction or heart failure based on echocardiography and/or NT-proBNP screening. Diagnostic criteria include typical heart failure symptoms or signs with reduced left ventricular ejection fraction (HFrEF, LVEF \<40%), mildly reduced left ventricular ejection fraction (HFmrEF, LVEF 40-49%), or preserved left ventricular ejection fraction with elevated NT-proBNP and structural heart disease evidence (HFpEF, LVEF ≥50%, with at least one of the following: LAVI \>40 mL/m², E/e' ≥15, or TRV \>2.8 m/s).
2. Expected survival of less than 12 months.
3. Severe renal insufficiency, defined as creatinine clearance \<30 mL/min, or currently receiving dialysis treatment.
4. Cardiac dysfunction caused by reversible secondary causes, including hyperthyroid heart disease, anemic heart disease, or uncorrected congenital heart disease.
5. Indication for pacemaker implantation but without pacemaker placement.
6. Chronic obstructive pulmonary disease complicated by type II respiratory failure.
7. Special populations, such as patients with mental illness.
Primary outcome measure(s)
Change in Life's Essential 8 Cardiovascular Health Score — Baseline to 12 months Mean change in Life's Essential 8 cardiovascular health score from baseline to 12 months. The score includes diet, physical activity, nicotine exposure, sleep health, body mass index, non-HDL cholesterol, blood glucose, and blood pressure.
Composite Cardiovascular Outcome — Baseline to 36 months Composite cardiovascular endpoint, including cardiovascular death, ischemic or hemorrhagic stroke, hospitalization for worsening heart failure or acute coronary syndrome, and emergency visits due to atrial fibrillation.
Incidence of Asymptomatic Left Ventricular Dysfunction With or Without Heart Failure — Baseline to 48 months Incidence of asymptomatic left ventricular dysfunction with or without heart failure, assessed by clinical evaluation, NT-proBNP, and echocardiographic evidence of cardiac dysfunction.
Trial sites (3)
Facility
City
Region
Status
Village Clinics in Dongtai City, Jiangsu Province
Yancheng
Dongtai
Recruiting
Village Clinics in Jiangdu District, Jiangsu Province
Yangzhou
Jiangdu
Recruiting
Village Clinics in Suining County, Jiangsu Province
Xuzhou
Suining
Recruiting
More Jiangsu Taizhou People's Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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