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.
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.
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.
Parallel
Digital Intelligent Integrated Management
BehavioralThis multi-component intervention includes: 1. A digital chronic disease management system for AF screening and intelligent decision-making. 2. Structured multidimensional lifestyle intervention featuring monthly peer-support group cardiac rehabilitation (aerobic, resistance, and flexibility training). 3. Smart wearable device monitoring (HUAWEI Band 6) for heart rate and step counts. 4. Personalized health education delivered via digital articles and videos. 5. Integrated management services providing guideline-directed medical therapy (GDMT) for heart failure and the ABC pathway for AF
Conventional Management
Other interventionParticipants in the control group receive standard diagnosis and treatment for common chronic diseases (hypertension, diabetes, and chronic obstructive pulmonary disease) and Basic Public Health Services (BPHS) provided by primary care physicians. The 14 government-provided BPHS items primarily include quarterly follow-up visits for patients with hypertension, diabetes, and COPD, an annual free physical examination for residents aged 65 years and older, and the distribution of health education materials.
Change in Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC) Risk Score
Risk stratification is performed using the MAGGIC risk score, a validated integer scoring system that integrates 13 key predictors: age, gender, NYHA classification, left ventricular ejection fraction (LVEF), smoking status, diabetes, COPD, heart failure diagnosed within the past 18 months, systolic blood pressure (SBP), body mass index (BMI), serum creatinine level, use of beta-blockers, and use of ACEI/ARB. The cumulative score ranges from 0 to 50. Higher scores indicate a higher risk of mortality and a worse prognosis.
Number of Participants Experiencing a Composite Cardiovascular Endpoint
This is a composite endpoint tracking the first occurrence of any of the following events: cardiovascular death, ischemic or hemorrhagic stroke, hospitalization due to worsening heart failure (HF) or acute coronary syndrome (ACS), and emergency visits for atrial fibrillation (AF).
Number of Participants with Cardiovascular Death at 12 Months
Incidence of cardiovascular death, defined as death due to acute myocardial infarction, heart failure, cardiac arrhythmia, cardiac perforation, cardiac tamponade, or other cardiogenic causes. Deaths caused by ischemic stroke, hemorrhagic stroke, peripheral embolism, and pulmonary embolism are also classified as cardiovascular deaths
Number of Participants with Cardiovascular-Related Hospitalization at 12 Months
Incidence of hospitalization in township-level or higher hospitals caused by cardiovascular diseases (sudden cardiac death, heart failure, cardiac arrhythmia, acute coronary syndrome, hypertensive emergency or hypertensive subemergency, etc.) or neurological diseases (ischemic or hemorrhagic stroke, transient ischemic attack)
Number of Participants with Emergency Visits for Cardiovascular Events at 12 Months
Incidence of emergency visits for cardiovascular events, including exacerbation of heart failure or acute coronary syndrome.
Number of Participants with Stroke at 12 Months
Incidence of stroke, defined as a new onset of neurological deficit symptoms or signs with a duration of at least 24 hours, caused by the sudden rupture of cerebral blood vessels or insufficient cerebral blood perfusion due to vascular occlusion, which is confirmed by cranial CT/MRI evidence or diagnosed by a neurological expert group.
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