Village Doctor-led Telehealth Care vs Usual Care for Older Adults with Atrial Fibrillation and Heart Failure in Rural China The MIRACLE AF-HF Trial

What This Trial Is About

Researchers are evaluating a telemedicine-supported, village doctor-led integrated management model for older adults aged 65 to 80 years living in rural China who have both atrial fibrillation AF and heart failure HF. The study aims to see if this integrated care approach, which follows the AF-HF comorbidity ABC pathway and includes enhanced patient education, improves clinical outcomes compared to usual care. The trial is designed as a cluster-randomized, open-label, parallel-group clinical trial involving village clinics in Jiangsu Province. Participants will be divided into two groups. One group receives village-doctor-led integrated care that includes monthly follow-up visits, symptom and vital sign monitoring, medication reviews, guideline-based management, specialist consultation when needed via telemedicine, and structured patient education. The control group receives usual chronic disease management according to Chinas National Basic Public Health Service. The trial has three phases an initial 12-month phase evaluating changes in the MAGGIC heart failure risk score, a 36-month phase assessing a composite cardiovascular endpoint, and an extended observational follow-up at 6 years to evaluate long-term effects. Throughout the study, participants will have regular assessments including clinical status, vital signs, ECG, medication adherence, and risk factor monitoring. Researchers will track outcomes such as cardiovascular death, stroke, hospitalizations, emergency visits, and adherence to guideline-recommended therapy. Patient education will be reinforced monthly with face-to-face sessions, reminders, and brochures. The total follow-up time for participants can extend up to 72 months, allowing for evaluation of both short- and long-term management of AF with HF in a rural setting.

A Village Doctor-led Telehealth Supported Improvement of Outcomes of AF Patients With Heart Failure Due to Reduced or Preserved Ejection Fraction: The MIRACLE-AF 2 Heart Failure Management Trial (MIRACLE AF-HF)