Overview
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.
Description
BACKGROUND Atrial fibrillation (AF) is common in older adults and is strongly associated with heart failure (HF), stroke, hospitalization, cardiovascular death, and all-cause mortality. AF and HF frequently interact with each other and may form a vicious cycle, especially in older patients. Although the Atrial Fibrillation Better Care (ABC) pathway has been recommended to improve AF management, older patients with AF in rural China remain vulnerable because of limited access to specialist care, insufficient HF screening, inadequate risk stratification, suboptimal guideline-based treatment, and lack of continuous follow-up. Heart failure is one of the most important, most common, and most prognostically significant complications in patients with AF; therefore, AF management should not focus solely on stroke prevention, but should also move HF screening, prevention, and management to an earlier stage. China's rural healthcare system mainly relies on village doctors, but village doctors often lack adequate resources and specialist support to provide long-term integrated management for patients with AF who are at risk of developing HF. Therefore, a telemedicine-supported, village doctor-led integrated care model based on regular follow-up, medication review, cardiovascular risk monitoring, ABC pathway-based AF management, simplified exercise rehabilitation, specialist consultation when needed, and structured patient education may help improve cardiovascular health and prevent HF in this population.
AIM OF THIS STUDY This cluster randomized study aims to compare village doctor-led integrated care versus usual care in improving cardiovascular health, guideline-based AF management, self-management adherence, clinical outcomes, and prevention of HF among older rural patients with AF in China.
DESIGN This study is a prospective, cluster randomized, open-label, parallel-group clinical trial conducted in rural China. The study aims to enroll older rural residents aged 65 to 80 years with documented AF and without a history or screening evidence of HF or asymptomatic left ventricular dysfunction at baseline. Village clinics in Jiangsu Province will be randomized in a 1:1 ratio to either the intervention group or the control group. Patients in the intervention group will receive telemedicine-supported, village doctor-led integrated care, including monthly follow-up, symptom assessment, vital-sign monitoring, medication adherence support, cardiovascular risk-factor management, ABC pathway-based AF care, simplified home-based exercise rehabilitation education, and remote cardiology consultation when needed. Village doctors will receive standardized training on stroke prevention and anticoagulation, symptom and rate/rhythm management, and management of cardiovascular risk factors and comorbidities. Patients in the control group will receive usual chronic disease management according to the National Basic Public Health Service requirements, including routine follow-up, general health education, medication documentation, and referral when clinically indicated. Follow-up will last up to 48 months. The primary outcome at 12 months is the change in Life's Essential 8 cardiovascular health score from baseline. The primary outcome at 36 months is a composite cardiovascular endpoint including cardiovascular death, ischemic or hemorrhagic stroke, hospitalization for worsening HF or acute coronary syndrome, and emergency department visits due to AF. The primary outcome at 48 months is the incidence of asymptomatic left ventricular dysfunction with or without HF.
Eligibility
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:
- 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).
- Expected survival of less than 12 months.
- Severe renal insufficiency, defined as creatinine clearance \<30 mL/min, or currently receiving dialysis treatment.
- Cardiac dysfunction caused by reversible secondary causes, including hyperthyroid heart disease, anemic heart disease, or uncorrected congenital heart disease.
- Indication for pacemaker implantation but without pacemaker placement.
- Chronic obstructive pulmonary disease complicated by type II respiratory failure.
- Special populations, such as patients with mental illness.
