Tang Yangyang, Jiang Chao, Guo Jiakun, Li Yueyuan, Wang Chi, Chu Shuk Han, Wang Zhiyan, Wu Yanfang, Hua Chang, Lu Yanmei, Zhang Shuai, Song Yanna, Han Rong, Dong Jianzeng, Ma Changsheng, Cai Jun, Anderson Craig S, Du Xin
Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; National Clinical Research Center for Cardiovascular Diseases, Beijing, China.
Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China; National Clinical Research Center for Cardiovascular Diseases, Beijing, China; Heart Health Research Center, Beijing, China.
Am Heart J. 2025 May;283:70-80. doi: 10.1016/j.ahj.2025.01.014. Epub 2025 Jan 28.
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the 6-month intervention, support from the study coordination center and the distribution of low-sodium salt will be withdrawn, and all participants will be followed up until 12 months.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.
The Healthy Family Program will provide critically important data on the effectiveness of a novel BP management strategy in rural China.
The study is registered at ClinicalTrials.gov (NCT06427096).
我们旨在确定与常规护理相比，以社区为基础、由健康指导员主导的多方面家庭干预措施对中国农村居民（无论有无高血压）血压管理的有效性。
方法/设计：“健康家庭计划”是一项整群随机对照试验，在80个村庄（每个村庄约有100名居民）开展，目标是共纳入8000名年龄在40至80岁之间的老年人。村庄以1:1的比例随机分配到干预组，接受多方面策略，或对照组，继续采用常规标准护理。多方面干预策略的主要组成部分包括：（1）建立以家庭健康指导员为首的血压管理团队，团队成员包括家庭负责人和乡村医生；（2）实施一项侧重于6个方面的干预措施：健康生活方式教育、免费提供钠替代品、体重管理、体育锻炼、血压监测以及为高血压患者提供适当的降压治疗。主要结局是所有参与者从基线到6个月时收缩压的变化，以干预组和对照组之间的绝对差值报告。6个月干预结束后，将撤销研究协调中心的支持和低钠盐的发放，所有参与者将随访至12个月。截至2024年12月31日，干预组的24个村庄已完成6个月的干预。
“健康家庭计划”将为中国农村一种新型血压管理策略的有效性提供至关重要的数据。
该研究已在ClinicalTrials.gov（NCT06427096）注册。
