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Active, not recruiting Not applicable

EXpress Prevent Rural oldEr Adults' fallS, fractureS and Dependency (EXPRESS)

NCT06984978 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2024-08-06
Last updated
2025-05-22

Condition(s) studied

FallsFalls InjuryFall Prevention

Investigational drug(s) / intervention(s)

AI-assisted, village doctors and express services-involved personalized fall prevention strategy

AI-assisted, village doctors and express services-involved personalized fall prevention strategy: The EXPRESS trial implements a pragmatic, community-based, AI-assisted fall prevention strategy tailored to the needs of older adults in rural China. The intervention is structured around five core components-SAFER: 1. Screening: multidimensional fall risk screening and assessment tailored to rural older adults; 2. AI-assisted recommendations: AI-assisted personalized fall prevention recommendations; 3. Fitness: Tailored balance and strength training via Health Intervention Cartoon Brochure and Action Demonstration Video; 4. Events-based engagement: culturally integrated seasonal intervention packages following the traditional Chinese calendar; 5. Reach-home delivery: home delivery of fall prevention services through local couriers.

Study summary

Falls are the leading cause of injury-related death among individuals aged 65 and above in China. The incidence of falls shows a significant urban-rural disparity in China, with rural areas experiencing a markedly higher rate than urban regions. However, a systematic fall prevention strategy tailored to the needs of older people in rural China has not yet been established.

The EXPRESS study is a multicenter, cluster-randomized controlled trial designed to explore the effectiveness and health economic evaluation of an AI-assisted, village doctors and express services-involved, personalized fall screening and prevention strategy based on multidimensional risk profiling in reducing the incidence of falls and fall-related injuries among older people in rural China.

A total of 1,881 older individuals from 16 villages across four provinces in China (with four villages per province) will be recruited. These 16 rural areas will be randomly assigned to either the intervention group or the control group. The intervention group will receive the AI-assisted, village doctors and express services-involved personalized fall prevention strategy based on multidimensional fall risk screening and assessment, while the control group will follow routine primary health management practices.

The intervention period will last for one year, with randomization taking place after the baseline survey. The primary outcomes are the incidence of falls and fall-related injuries (including falls resulting in hospitalization and fractures, etc). Secondary outcomes include activity of daily living, quality of life, fall-related health literacy, depressive symptoms, cognitive function, dementia, physical function and performance, incidence of chronic non-communicable diseases, frailty, and sleep quality.

Eligibility

Sex
ALL
Min age
65 Years
Max age
95 Years
Healthy volunteers
Accepted
Inclusion Criteria for Villages: The village has a health clinic with at least one full-time village doctor. Village officials and village doctors are actively cooperative and willing to participate in the study. The village is located more than 2 kilometers away from other villages. Exclusion Criteria for Villages: Administrative villages where the township government is located (due to potential bias from centralized use of medical resources). Villages that have previously conducted any form of fall-related knowledge promotion or intervention trials. Inclusion Criteria for Participants: Age 65 years or older. Resides in the village for at least 12 months. Provides informed consent and is willing to voluntarily participate. Exclusion Criteria for Participants: Suffering from major diseases such as cancer or stroke. Disability. Severe cognitive impairment. Severe visual or perceptual impairments. Any other condition preventing participation in the intervention.

Primary outcome measure(s)

  • Fall incidence within 12 months (rate of falls per person-year) — Months 3, 6, 9, 12 after baseline survey
    Defined as the number of falls divided by total person-time of observation. To minimize recall bias in fall measurement, three methods will be employed: self-recording by older adults or their family members on a calendar, quarterly in-person inquiries by delivery personnel, and final evaluation through interviews conducted by an assessment officer.
  • Proportion of participants with ≥1 fall within 12 months — Months 3, 6, 9, 12 after baseline survey
    A dichotomous outcome (fallers vs. non-fallers) that reflects risk reduction at the individual level. The measurement method is consistent with the fall incidence.
  • Fall-related injuries incidence within 12 months — Months 3, 6, 9, 12 after baseline survey
    Fall-related injuries included fractures, head injuries, hospitalizations, other events requiring medical attention. The measurement method is consistent with the fall incidence.

Trial sites (1)

FacilityCityRegionStatus
China Center for Health Development Studies, Peking University Haidian Beijing Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06984978 on ClinicalTrials.gov ↗ ← All trials in China