Li Mingfang, Chu Ming, Shen Youmei, Zhang Shimeng, Yin Xuejun, Yang Shu, Lip Gregory Y H, Chen Minglong
Division of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
School of Population Medicine and Public Health, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
JACC Asia. 2024 Jul 30;4(10):764-773. doi: 10.1016/j.jacasi.2024.07.006. eCollection 2024 Oct.
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.
This study aims to evaluate the effectiveness of this telemedicine-based, village doctor-led, multifaceted care model.
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.
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.
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).
综合管理方法对于改善心房颤动（AF）患者的治疗效果至关重要。中国的农村医疗体系主要依靠乡村医生，在资源有限且医疗服务可及性差的农村人口中，无法提供最佳的房颤管理。为支持乡村医生提供房颤综合护理，我们开发了一个数字健康支持平台。
本研究旨在评估这种以远程医疗为基础、由乡村医生主导的多方面护理模式的有效性。
MIRACLE-AF（中国农村老年房颤患者综合护理新模式）试验是一项前瞻性整群随机临床试验。江苏省江都区的30个乡村诊所被随机分配为乡村医生主导的远程医疗综合护理组或强化常规护理组，比例为1:1。所有居住在该农村地区且年龄≥65岁、被诊断为房颤的患者均符合入组条件。第一阶段的主要结局是在12个月时符合房颤更佳护理路径所有3项标准的患者比例，第二阶段的主要结局是36个月内心血管死亡、包括缺血性卒中和出血性卒中在内的所有卒中、心力衰竭恶化或急性冠状动脉综合征以及因房颤进行急诊就诊的复合结局。
从2020年12月1日至2022年5月9日，共招募了1039名参与者，远程医疗护理组524名，强化常规护理组515名。所有入组患者均在定期随访中。
MIRACLE-AF试验将为这种治疗农村老年房颤患者的新型综合护理模式提供证据。（中国农村老年房颤患者综合护理新模式；NCT04622514）
