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Download FigureDownload PowerPointAbstractBackgroundAn 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.
下载FigureDownload PowerPointAbstractBackground综合管理方法对于改善心房颤动(AF)患者的预后至关重要。。
To support village doctors in providing integrated care for AF, we have developed a digital health support platform.ObjectivesThis study aims to evaluate the effectiveness of this telemedicine-based, village doctor–led, multifaceted care model.MethodsThe 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.
为了支持乡村医生为房颤提供综合护理,我们开发了一个数字健康支持平台。目的本研究旨在评估这种基于远程医疗的乡村医生主导的多方面护理模式的有效性。方法MIRACLE-AF(中国农村老年房颤患者综合护理的新模式)试验是一项前瞻性整群随机临床试验。
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.ResultsIn 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.
江苏省江都县的30家村卫生室被随机分配到乡村医生主导的远程医疗综合护理或强化常规护理,比例为1:1。居住在该农村地区且年龄≥65岁的所有诊断为房颤的患者均符合入选条件。第一阶段的主要结果是在12个月时符合房颤更好护理途径所有3项标准的患者比例,第二阶段是心血管死亡的综合,包括缺血性中风和出血性中风在内的所有中风,心力衰竭恶化或急性冠状动脉综合征,以及房颤超过36个月的紧急就诊。结果从2020年12月1日至2022年5月9日,共招募了1039名参与者,其中远程医疗护理部门524名,增强型常规护理部门515名。
All the enrolled patients are under scheduled follow-up.ConclusionsThe MIRACLE-AF trial will provide evidence for this novel integrated care model for treating rural older patients with AF. (New Model .
所有登记的患者都在计划的随访中。。
PerspectivesCOMPETENCY IN MEDICAL KNOWLEDGE: Outcomes of the MIRACLE-AF trial are poised to contribute valuable evidence for the effectiveness of a telemedicine-supported village doctor–led model in managing AF in resource-limited rural populations.TRANSLATIONAL OUTLOOK: Future studies are needed to assess the generalizability of the telemedicine-based, village doctor–led integrated care model demonstrated in the MIRACLE-AF trial.Funding Support and Author DisclosuresThis work was funded by the Key Clinical Study Project of Jiangsu Province, China (ID: BE2017750) and the Clinical Medicine Expert Team Project of Xuzhou, China (ID: 2019208002).
医学知识的前瞻性:MIRACLE-AF试验的结果有望为远程医疗支持的乡村医生主导的模式在资源有限的农村人口中管理房颤的有效性提供有价值的证据。转化前景:需要进一步的研究来评估MIRACLE-AF试验中证明的基于远程医疗的乡村医生主导的综合护理模式的普遍性。资金支持和作者披露这项工作由中国江苏省重点临床研究项目(ID:BE2017750)和中国徐州临床医学专家团队项目(ID:2019208002)资助。
Dr Lip has been a consultant and speaker for BMS/Pfizer, Boehringer Ingelheim, Daiichi-Sankyo, and Anthos (no fees are received personally); and is co-principal investigator of the AFFIRMO project on multimorbidity in AF, which has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 899871.
Lip博士曾担任BMS/辉瑞(Pfizer),勃林格殷格翰(Boehringer Ingelheim),第一三共(Daiichi Sankyo)和Anthos(个人不收取任何费用)的顾问和发言人;他是AFFIRMO房颤多发病项目的联合首席研究员,该项目已根据第899871号赠款协议获得欧盟地平线2020研究与创新计划的资助。
Dr Chen has received lecture fee from Biosense Webster, St. Jude Medical, Medtronic, Bayer, and Boehringer Ingelheim; and has received grants from the Clinical Medicine Expert Team Project of Xuzhou and the Key Clinical Study Project of Jiangsu Province, during the conduct of the study (no fees are received personally).
陈博士收到了Biosense Webster,St.Jude Medical,Medtronic,Bayer和勃林格殷格翰的演讲费;并在研究期间获得了徐州临床医学专家团队项目和江苏省重点临床研究项目的资助(个人不收取任何费用)。
All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.Abbreviations and AcronymsABCatrial fibrillation better careAFatrial fibrillationOACoral anticoagulantReferences1. Zhang J., Johnsen S.P., Guo Y., Lip G.Y.H. 'Epidemiology of atrial fibrillation: geographic/ecological risk factors, age, sex, genetics'.
所有其他作者都报告说,他们与本文的内容没有任何关系。缩写和首字母缩略词心房纤颤更好地护理心房纤颤珊瑚抗凝剂参考1。Zhang J.,Johnsen S.P.,Guo Y.,Lip G.Y.H.“心房颤动的流行病学:地理/生态危险因素,年龄,性别,遗传学”。
Card Electrophysiol Clin . 2021;13:1-23. https://doi.org/10.1016/j.ccep.2020.10.010. CrossrefMedlineGoo.
卡电生理临床。2021年;13: 1-23岁。https://doi.org/10.1016/j.ccep.2020.10.010.CrossrefMedlineGoo。
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The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the Author Center.
作者证明,他们符合人类研究委员会和作者机构的动物福利法规以及食品和药物管理局的指南,包括适当的患者同意。。