比较社区心房颤动患者的初级-三级多学科合作护理与常规护理：一项聚类随机对照试验的方案

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-05-19 DOI:10.1016/j.cct.2025.107957

Yongqi Wang , Jun Huang , Dexing Zhang , Junrong Jiang , Yumei Xue , Wenjing Zhao , Hai Deng , Shulin Wu , Xudong Liu

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引用次数: 0

摘要

社区卫生服务中心（CHCs）正在成为中国预防和治疗心房颤动（AF）等慢性心脑血管疾病的主要机构。本研究的目的是评估一种标准化的初级-三级多学科协作治疗模式（PTCC）与常规治疗模式对社区房颤患者的影响。方法本研究为两组、前瞻性、多中心、聚类随机对照、非劣效性试验。从中国广州越秀区16个CHCs中招募220名年龄在65岁及以上的房颤患者。16例CHCs随机分为PTCC干预组和常规护理对照组（1:1）。干预将持续两年，调查将在基线、3个月、6个月、12个月和24个月进行。通过标准化问卷面对面访谈或检索健康记录和医疗记录收集房颤患者的基线信息，每次随访时通过定期电话或门诊面对面访谈收集随访数据。主要终点是抗凝率，次要终点包括心房纤颤相关不良事件（心血管死亡率、心血管和非心血管住院、主要心血管不良事件、中风、大出血、临床相关非大出血）、健康相关生活质量和成本效益。讨论PTCC项目在房颤患者中的实施可为房颤患者的管理提供依据，促进房颤患者的预后。试验注册号：本研究已在中国临床试验注册中心注册（ChiCTR2200057242）。

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Comparing primary-tertiary multidisciplinary collaborative care with usual care in community patients with atrial fibrillation: The protocol for a cluster randomized controlled trial

Background

The community health service centers (CHCs) are becoming the major undertakers in China in the prevention and treatment of chronic cardiovascular and cerebrovascular diseases such as atrial fibrillation (AF). The objective of this study was to evaluate the effect of a standardized model of primary-tertiary multidisciplinary collaborative care (PTCC) compared to usual care on AF patients in the community settings.

Methods

This study is a two-arm, prospective, multicenter, cluster randomized controlled, non-inferiority trial. A total of 220 AF patients aged 65 years or more will be recruited from 16 CHCs in the Yuexiu District of Guangzhou, China. The 16 CHCs will be randomly assigned to the PTCC intervention group and usual care control groups (1:1). The interventions will last for two years, and the survey will be conducted at baseline, 3-month, 6-month, 12-month, and 24-month. The baseline information from AF patients will be collected through face-to-face interviews with a standardized questionnaire or retrieval of health records and medical treatment records, and the following-up data will be collected by regular telephone calls or outpatient face-to-face interviews at each follow-up. The primary endpoint is the anticoagulation rate and the secondary outcomes include AF-related adverse events (cardiovascular mortality, cardiovascular and non-cardiovascular hospitalizations, major adverse cardiovascular events, stroke, major bleeding, clinically relevant non-major bleeding), health-related quality of life, and cost-effectiveness.

Discussion

The implementation of the PTCC program in AF patients may provide evidence for the management of AF patients and promote their prognosis in community.

Trial registration number: This study is registered at the Chinese Clinical Trial Registry (ChiCTR2200057242).

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.