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中国农村老年人初级卫生保健中的跌倒预防项目:家庭整群随机临床试验

A Fall Prevention Program Integrated in Primary Health Care for Older People in Rural China: The FAMILY Cluster Randomized Clinical Trial.

作者信息

Peng Junyi, Ye Pengpeng, Nan Boya, Yan Shichun, Li Zhifang, Li Qian, Meng Ruilin, Li Yangchun, Hao Tianyou, Zhang Lan, Peng Dandan, Xu Zijian, Wang Yanni, Si Lei, Yang Minghui, Yao Yao, Zhang Jing, Tian Wei, Wang Yongchen, Ivers Rebecca, Tian Maoyi

机构信息

School of Public Health, Harbin Medical University, Harbin, China.

National Center for Chronic and Non-Communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.

出版信息

JAMA. 2025 Aug 25. doi: 10.1001/jama.2025.12724.

DOI:10.1001/jama.2025.12724
PMID:40853561
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12379124/
Abstract

IMPORTANCE

With rapidly aging populations globally, there is a lack of evidence on effective fall prevention strategies among community-dwelling older people in resource-constrained areas.

OBJECTIVE

To assess the effectiveness of a fall prevention program integrated in primary health care systems on the risk of falls among Chinese rural older adults.

DESIGN, SETTING, AND PARTICIPANTS: A 12-month, open-label, cluster randomized clinical trial, conducted in 128 rural villages from 4 Chinese provinces, involving adults 60 years or older at risk of falls (recruitment from September 19, 2023, to November 15, 2023; last follow-up, January 15, 2025).

INTERVENTIONS

The fall prevention intervention, consisting of balance and functional exercises and community-engaged health education, was integrated with the rural primary health care system. The control group received usual care, health education alone, without active involvement with the communities.

MAIN OUTCOMES AND MEASURES

The primary outcome was the proportion of participants who reported at least 1 fall in 12 months following the intervention. Six secondary outcomes included the rate of falls, 3 measures of functional mobility, the proportion of participants who reported fall-related injury, and health-related quality of life. Fall-related data were collected via quarterly participant self-reports supported by a calendar; functional mobility was measured at baseline and 12-month follow-up using validated measures.

RESULTS

Of the 2616 participants recruited, 6 died before randomization and 2610 (median age, 70.0 years [IQR, 66.4-74.2]; 1553 female [59.5%]) were randomized either to the intervention group (1311 from 64 villages) or to the control group (1299 from 64 villages). During a mean follow-up of 358.0 (SD, 31.3) days, 388 participants (29.7%) in the intervention group reported falling at least once during the 12-month follow-up compared with 497 (38.3%) in the control group (odds ratio, 0.67; 95% CI, 0.48-0.91; P = .01). All secondary outcomes favored the intervention except the Timed Up and Go Test (for functional mobility), which showed no significant difference.

CONCLUSIONS AND RELEVANCE

This cluster randomized trial found that integrating a fall prevention program in a primary health care system was associated with a significant reduction in the risk of self-reported falls among Chinese rural older people. This intervention, comprising balance and functional exercises and community-engaged health education, has the potential to be scaled-up in China and other low- and middle-income countries with rapidly growing aging populations.

TRIAL REGISTRATION

Chinese Clinical Trial Registry Identifier: ChiCTR2300075879.

摘要

重要性

随着全球人口迅速老龄化,在资源有限地区,针对社区居住的老年人,缺乏有效预防跌倒策略的相关证据。

目的

评估纳入初级卫生保健系统的预防跌倒项目对中国农村老年人跌倒风险的有效性。

设计、地点和参与者:一项为期12个月的开放标签整群随机临床试验,在中国4个省份的128个乡村开展,纳入60岁及以上有跌倒风险的成年人(2023年9月19日至2023年11月15日招募;末次随访时间为2025年1月15日)。

干预措施

预防跌倒干预措施包括平衡和功能锻炼以及社区参与的健康教育,并与农村初级卫生保健系统相结合。对照组接受常规护理及仅健康教育,未积极融入社区。

主要结局和测量指标

主要结局是干预后12个月内报告至少发生1次跌倒的参与者比例。六个次要结局包括跌倒发生率、3项功能活动能力测量指标、报告有跌倒相关损伤的参与者比例以及健康相关生活质量。通过季度参与者自我报告并辅以日历收集跌倒相关数据;使用经过验证的测量方法在基线和12个月随访时测量功能活动能力。

结果

在招募的2616名参与者中,6人在随机分组前死亡,2610人(中位年龄70.0岁[四分位间距,66.4 - 74.2];1553名女性[59.5%])被随机分为干预组(来自64个村庄的1311人)或对照组(来自64个村庄的1299人)。在平均358.0(标准差,31.3)天的随访期间,干预组388名参与者(29.7%)在12个月随访期间报告至少跌倒1次,而对照组为497名(38.3%)(比值比,0.67;95%置信区间,0.48 - 0.91;P = 0.01)。除了计时起立行走测试(用于功能活动能力)无显著差异外,所有次要结局均有利于干预组。

结论及意义

这项整群随机试验发现,将预防跌倒项目纳入初级卫生保健系统与中国农村老年人自我报告的跌倒风险显著降低相关。这项包括平衡和功能锻炼以及社区参与的健康教育的干预措施,有可能在中国以及其他老龄化人口快速增长的低收入和中等收入国家扩大推广。

试验注册

中国临床试验注册标识符:ChiCTR2300075879。

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Falls prevention in community-dwelling older adults and implementation of world falls guidelines: a call for action across Europe by the European Geriatric Medicine Society Special Interest Group on Falls and Fractures.社区居住老年人的跌倒预防及全球跌倒指南的实施:欧洲老年医学学会跌倒与骨折特别兴趣小组呼吁全欧洲采取行动
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