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乡村诊所基于远程医疗的房颤综合管理:一项整群随机试验

Telemedicine-based integrated management of atrial fibrillation in village clinics: a cluster randomized trial.

作者信息

Chu Ming, Zhang Shimeng, Gong Jinlong, Yang Shu, Yang Gang, Sun Xingxing, Wu Dan, Xia Yaodongqin, Jiao Jincheng, Peng Xiafeng, Peng Zhihang, Hong Li, Wang Zhirong, Li Mingfang, Lip Gregory Y H, Chen Minglong

机构信息

Division of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.

Division of Cardiology, Jiangdu People's Hospital Affiliated to Yangzhou University, Yangzhou, China.

出版信息

Nat Med. 2025 Apr;31(4):1276-1285. doi: 10.1038/s41591-025-03511-2. Epub 2025 Feb 21.

Abstract

In rural China, where healthcare relies on village doctors (nonspecialized practitioners who work exclusively in their village clinics), delivering integrated atrial fibrillation (AF) management poses challenges. We developed a telemedicine-based, village doctor-led integrated care model and conducted a cluster randomized clinical trial to assess its efficacy compared to usual care. A total of 30 village clinics were randomly assigned (1:1) to the intervention or control group, with 1,039 village residents aged ≥65 years with AF (44.3% women) recruited. The primary outcome in stage 1 is adherence to integrated AF care at 12 months. In stage 2, the primary outcome is a composite of cardiovascular death, all strokes, heart failure or acute coronary syndrome hospitalization, and AF emergency visits over 36 months. Both primary outcomes were met. At 12 months, 33.1% in the telemedicine-based, village doctor-led care group and 8.7% in the usual care group met all criteria for integrated AF care (between-group difference, 24.4% (95% confidence interval (CI), 18.3-30.5%); P < 0.001). Over 34.0 months, 41.8% in the telemedicine-based, village doctor-led care group and 10.3% in the usual care group met all criteria for integrated AF care (P < 0.001). The rate of the composite cardiovascular event outcome was lower in the telemedicine-based, village doctor-led care group than in the usual care group (6.2% versus 9.6% per year; hazard ratio, 0.64 (95% CI, 0.50-0.82); P < 0.001). Our trial intervention by this telemedicine-based integrated care delivery model of AF care in rural villages demonstrates better adherence and improved clinical outcomes compared to usual care. ClinicalTrials.gov registration: NCT04622514 .

摘要

在中国农村地区,医疗保健依赖于乡村医生(仅在其所在乡村诊所工作的非专科医生),提供心房颤动(AF)综合管理面临挑战。我们开发了一种以远程医疗为基础、由乡村医生主导的综合护理模式,并进行了一项整群随机临床试验,以评估其与常规护理相比的疗效。总共30个乡村诊所被随机分配(1:1)到干预组或对照组,招募了1039名年龄≥65岁的患有AF的乡村居民(女性占44.3%)。第一阶段的主要结局是12个月时对AF综合护理的依从性。在第二阶段,主要结局是心血管死亡、所有中风、心力衰竭或急性冠状动脉综合征住院以及36个月内AF急诊就诊的综合情况。两个主要结局均达到。在12个月时,以远程医疗为基础、由乡村医生主导的护理组中有33.1%的患者和常规护理组中有8.7%的患者符合AF综合护理的所有标准(组间差异为24.4%(95%置信区间(CI),18.3 - 30.5%);P < 0.001)。在34.0个月期间,以远程医疗为基础、由乡村医生主导的护理组中有41.8%的患者和常规护理组中有10.3%的患者符合AF综合护理的所有标准(P < 0.001)。以远程医疗为基础、由乡村医生主导的护理组中心血管事件综合结局的发生率低于常规护理组(每年6.2%对9.6%;风险比为0.64(95%CI,0.50 - 0.82);P < 0.001)。我们通过这种基于远程医疗的农村AF护理综合服务模式进行的试验干预表明,与常规护理相比,其依从性更好且临床结局得到改善。ClinicalTrials.gov注册号:NCT04622514 。

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