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

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.