Overview
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.
Description
BACKGROUND Atrial fibrillation (AF) and heart failure (HF) frequently coexist and interact with each other, forming a vicious cycle that increases the risks of hospitalization, stroke, cardiovascular death, and all-cause mortality in older patients. Although the Atrial Fibrillation Better Care (ABC) pathway helps improve AF management, older patients with AF and HF in rural China remain vulnerable because of insufficient HF screening, risk stratification, guideline-directed medical therapy, and long-term follow-up. China's rural healthcare system mainly relies on village doctors, but village doctors often lack adequate resources and specialist support to provide optimal management for patients with AF-HF comorbidity. Therefore, a village-doctor led integrated care model based on regular follow-up, medication review, risk monitoring, guideline-based treatment, specialist consultation when needed, and structured patient education may help improve clinical outcomes in this population.
AIM OF THIS STUDY This cluster randomized study aims to compare village-doctor led integrated care versus usual care in improving heart failure risk management, treatment adherence, and clinical outcomes among older patients with atrial fibrillation and heart failure in rural 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 atrial fibrillation and either previously diagnosed or screen-detected heart failure from approximately 50 village clinics in Jiangsu Province. Village clinics will be randomized in a 1:1 ratio to either the intervention group or the control group. Patients in the intervention group will receive village-doctor led integrated care, including monthly follow-up, symptom and vital-sign monitoring, medication review, risk assessment, guideline-based management according to the AF ABC pathway and heart failure guideline-directed medical therapy, specialist consultation when needed, and structured self-management education. Patients in the control group will receive usual chronic disease management according to the National Basic Public Health Service requirements. Follow-up will last up to 36 months.
Eligibility
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) Electrocardiogram (ECG) confirmation of AF or possession of a diagnostic certificate for AF issued by a specialist. 3) A documented history of HF or a diagnosis of HF based on echocardiography and/or NT-proBNP screening, defined by the presence of typical HF symptoms and/or signs, together with one of the following: 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 changes (HFpEF; LVEF ≥ 50%, meeting at least one of the following criteria: LAV 40 ml/m², E/e' ≥ 15, or TRV \> 2.8 m/s). 4) Management by a village clinic near the participant's place of residence. 5) Ability to understand the study procedures and provide written informed consent.
Exclusion Criteria:
- Expected life expectancy of less than 12 months.
- Severe renal insufficiency (Ccr \< 30ml/min) or ongoing dialysis treatment.
- Cardiac insufficiency secondary to correctable causes, including hyperthyroid heart disease, anemic heart disease, or uncorrected congenital heart disease.
- Indications for pacemaker implantation without having undergone implantation.
- Chronic obstructive pulmonary disease (COPD) complicated by type II respiratory failure.
- Special populations, including patients with mental illnesses.
