Abstract
BACKGROUND: An integrated management approach is essential to improving outcomes for patients with atrial fibrillation (AF). China's rural health care system, primarily reliant on village doctors, falls short of providing optimal management of AF in rural populations with limited resources and access to health care. To support village doctors in providing integrated care for AF, we have developed a digital health support platform. OBJECTIVES: This study aims to evaluate the effectiveness of this telemedicine-based, village doctor-led, multifaceted care model. METHODS: The MIRACLE-AF (a novel Model of IntegRAted Care of oLdEr patients with Atrial Fibrillation in rural China) trial is a prospective cluster-randomized clinical trial. Thirty village clinics in Jiangdu County, Jiangsu Province, were randomly assigned to village doctor-led telemedicine integrated care or enhanced usual care in a 1:1 ratio. All the patients diagnosed with AF who resided in this rural area and were aged ≥65 years were eligible for enrollment. The primary outcome in stage 1 was the proportion of patients who met all 3 criteria for the atrial fibrillation better care pathway at 12 months, and in stage 2, a composite of cardiovascular death, all strokes including ischemic stroke and hemorrhagic stroke, worsening of heart failure or acute coronary syndrome, and emergency visits due to AF over 36 months. RESULTS: In total, 1,039 participants were recruited from December 1, 2020, to May 9, 2022, with 524 in the telemedicine care arm and 515 in the enhanced usual care arm. All the enrolled patients are under scheduled follow-up. CONCLUSIONS: The MIRACLE-AF trial will provide evidence for this novel integrated care model for treating rural older patients with AF. (New Model of Integrated Care of Older Patients with Atrial Fibrillation in Rural China; NCT04622514).