基于综合护理方法的心房颤动患者结构化康复治疗:前瞻性观察队列研究方案》。

IF 2.6 Q2 PERIPHERAL VASCULAR DISEASE Vascular Health and Risk Management Pub Date : 2023-07-31 eCollection Date: 2023-01-01 DOI:10.2147/VHRM.S407974
Hui Zhang, Zhigeng Jin, Hao Wang, Yutao Guo, Gregory Y H Lip
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引用次数: 0

摘要

背景:正如我们之前进行的移动心房颤动应用(mAFA)-II 群组随机试验所证实的,基于 ABC(心房颤动更好护理)路径的指南推荐综合护理可改善心房颤动(房颤)"普通 "患者的临床预后。本研究旨在探讨 mAFA III 支持的结构化随访康复套餐是否适合患者的风险特征和不同的治疗模式(例如,仅接受药物治疗、房颤消融或左心房阑尾闭塞[LAAO]的患者),从而提高指南的依从性并降低不良心血管事件的风险:在这项前瞻性、观察性 mAFA III 试点队列研究中,年龄≥ 18 岁的房颤患者将使用 mAFA III App 进行自我管理。假定非ABC路径依从性的 "缺血性中风或全身性栓塞、全因死亡和心血管住院 "综合结果年发生率为29.3%,而ABC路径依从性为20.8%,则至少需要1475名患者才能检测到ABC路径A、B和C部分的结果,并假定第一年的退出率为20%。主要终点是ABC路径中A、B和C部分的指南依从性。还将进行辅助分析,以确定使用智能技术的ABC治疗方案对 "高危 "人群(例如,年龄≥75岁、患有多种疾病、使用多种药物)治疗效果的影响,以及人工智能机器学习房颤风险预测管理在评估房颤复发中的应用。个性化抗凝药物与房颤负担将通过智能设备进行监测。试验注册号:ISRCTN13724416。
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Structured Rehabilitation for Patients with Atrial Fibrillation Based on an Integrated Care Approach: Protocol for a Prospective, Observational Cohort Study.

Background: Guideline-recommended integrated care based on the ABC (Atrial fibrillation Better Care) pathway for "general" patients with atrial fibrillation (AF) improves clinical outcomes, as demonstrated in our prior mobile Atrial Fibrillation Application (mAFA)-II cluster randomized trial. The present study aims to investigate whether mAFA III-supported structured follow-up rehabilitation packages adapted to patient risk profiles and different treatment patterns (eg, for patients receiving drug treatment only, AF ablation, or left atrial appendage occlusion [LAAO]) will improve guideline adherence and reduce the risk of adverse cardiovascular events.

Methods and analysis: In this prospective, observational mAFA III pilot cohort study, patients with AF aged ≥ 18 years will be enrolled using the mAFA III App for self-management. Assuming an annual rate of composite outcome of "ischaemic stroke or systemic embolism, all-cause death and cardiovascular hospitalization" of 29.3% for non-ABC pathway compliance compared with 20.8% for ABC pathway compliance, at least 1475 patients would be needed to detect the outcome of the A, B and C components of the ABC pathway, assuming a withdrawal rate of 20% in the first year. The primary endpoint is adherence to guidelines regarding the A, B and C components of the ABC pathway. Ancillary analyses will be performed to determine the impact of the ABC pathway using smart technologies on the outcomes among the "high-risk" population (eg, ≥75 years old, with multimorbidities, with polypharmacy) and the application of artificial intelligence machine-learning AF risk prediction management in assessing AF recurrence. The individualised anticoagulants with AF burden will be monitored by smart devices.

Trial registration number: ISRCTN13724416.

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来源期刊
Vascular Health and Risk Management
Vascular Health and Risk Management PERIPHERAL VASCULAR DISEASE-
CiteScore
4.20
自引率
3.40%
发文量
109
审稿时长
16 weeks
期刊介绍: An international, peer-reviewed journal of therapeutics and risk management, focusing on concise rapid reporting of clinical studies on the processes involved in the maintenance of vascular health; the monitoring, prevention, and treatment of vascular disease and its sequelae; and the involvement of metabolic disorders, particularly diabetes. In addition, the journal will also seek to define drug usage in terms of ultimate uptake and acceptance by the patient and healthcare professional.
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