Study protocol for the healthy family program on population blood pressure: A multicenter, parallel group, cluster randomized, controlled trial in rural China

IF 3.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal Pub Date : 2025-01-28 DOI:10.1016/j.ahj.2025.01.014

Yangyang Tang MD , Chao Jiang MD , Jiakun Guo MSc , Yueyuan Li MAE , Chi Wang PhD , Shuk Han Chu MPH , Zhiyan Wang MD , Yanfang Wu MD , Chang Hua MD , Yanmei Lu PhD , Shuai Zhang BS , Yanna Song BS , Rong Han ME , Jianzeng Dong MD , Changsheng Ma MD , Jun Cai MD , Craig S. Anderson MD PhD , Xin Du MD PhD

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引用次数: 0

Abstract

Background

We aim to determine the effectiveness of a community-based, health instructor led, multifaceted family intervention, as compared with usual care, on blood pressure (BP) management among Chinese rural residents, with or without hypertension.

Methods/Design

The Healthy Family Program is a cluster randomized controlled trial being undertaken in 80 villages (each with approximately 100 residents) with a target to enroll a total of 8000 older adults (aged 40-80 years). Villages were randomly assigned in a 1:1 ratio to either an intervention group to receive multifaceted strategies or a control group to continue with usual standard of care. The main components of the multifaceted intervention strategies include: (1) Establishing a BP management team led by family health instructors, with team members including family leaders and village doctors, and (2) Implementing an intervention that focused on 6 areas: education for a healthy lifestyle, free provision of sodium substitute, weight management, physical exercise, BP monitoring, and appropriate antihypertensive treatment for individuals with hypertension. The primary outcome is change in systolic BP from baseline to 6 months in all participants, reported as the absolute difference between intervention and control groups. After the 6-month intervention, support from the study coordination center and the distribution of low-sodium salt will be withdrawn, and all participants will be followed up until 12 months. As of December 31, 2024, 24 villages in the intervention group have completed the 6-month intervention.

Conclusion

The Healthy Family Program will provide critically important data on the effectiveness of a novel BP management strategy in rural China.

Trial Registration

The study is registered at ClinicalTrials.gov (NCT06427096).

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健康家庭计划对人口血压的研究方案：中国农村多中心、平行组、聚类随机对照试验

背景：我们的目的是确定以社区为基础的、健康指导员引导的、多方面的家庭干预，与常规护理相比，对有或无高血压的中国农村居民的血压（BP）管理的有效性。方法/设计：健康家庭方案是一项在80个村庄（每个村庄约有100名居民）进行的集群随机对照试验，目标是总共招募8000名老年人（40-80岁）。村庄以1:1的比例随机分配到接受多方面策略的干预组或继续常规标准护理的对照组。综合干预策略的主要内容包括：1)建立以家庭健康指导员为领导，由家庭领导和乡村医生组成的血压管理团队；2)实施以健康生活方式教育、免费提供钠替代品、体重管理、体育锻炼、血压监测和高血压患者适当降压治疗为重点的干预措施。主要结果是所有参与者从基线到6个月的收缩压变化，报告为干预组和对照组之间的绝对差异。干预6个月后，将停止研究协调中心的支持和低钠盐的分发，并对所有参与者进行随访至12个月。截至2024年12月31日，干预组共有24个村完成了为期6个月的干预。结论：健康家庭项目将为中国农村新型BP管理策略的有效性提供至关重要的数据。试验注册：该研究在ClinicalTrials.gov注册（NCT06427096）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

American heart journal 医学-心血管系统

CiteScore

8.20

自引率

2.10%

发文量

214

审稿时长

38 days

期刊介绍： The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.