About this trial
The goal of this cluster-randomized clinical trial is to evaluate a telemedicine-based, village doctor-led integrated management program for older adults (aged 65-80 years) who have both atrial fibrillation (AF) and heart failure (HF) in rural clinics in China. It aims to answer whether the digitally-supported program improves heart failure prognosis, assessed by the MAGGIC score, at 12 months , and reduces the risk of composite endpoint events, such as cardiovascular death, stroke, or heart failure hospitalization, over 36 months compared to conventional routine care. In this study, village clinics will be randomly assigned to either the intervention group or the control group. Participants in the control group will receive conventional routine care and basic public health services , while participants in the intervention group will receive a comprehensive management program led by village doctors. This intervention includes optimized medication treatment guided by a digital health platform with remote expert support , as well as a structured multidimensional lifestyle intervention featuring peer-support group exercises, smart wearable device monitoring, and personalized health education.
Eligibility criteria
Qualifiers
Permanent residents with local household registration at the primary level in Jiangsu Province, aged 65-80 years.
Electrocardiogram (ECG) confirmation of AF or possession of a diagnostic certificate for AF issued by a specialist.
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).
Management by a village clinic near the participant's place of residence.
Disqualifiers
Expected life expectancy of less than 3 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.
Trial design
Treatments tested in this trial
- Digital Intelligent Integrated Management
- Conventional Management