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

NCT06984978 | Active Not Recruiting DMC

• 2 other identifiers: 2024080572374013
• Study Type: interventional
• Target: 1,881
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Falls; Falls Injury; Fall Prevention

Keywords

AI-assisted fall prevention; Multicenter cluster randomized controlled trial; Fall-related injuries; Community-based intervention; Fall risks screening and assessment; Fall prevention; Rural older adults; Task shifting and sharing; Express

Outcome Measures

Primary Outcomes (3)

• Fall incidence within 12 months (rate of falls per person-year)

  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.

  Months 3, 6, 9, 12 after baseline survey

• Proportion of participants with ≥1 fall within 12 months

  A dichotomous outcome (fallers vs. non-fallers) that reflects risk reduction at the individual level. The measurement method is consistent with the fall incidence.

  Months 3, 6, 9, 12 after baseline survey

• Fall-related injuries incidence within 12 months

  Fall-related injuries included fractures, head injuries, hospitalizations, other events requiring medical attention. The measurement method is consistent with the fall incidence.

  Months 3, 6, 9, 12 after baseline survey

Secondary Outcomes (14)

• Fall health literacy

  Months 12 after baseline survey

• Activities of daily living

  Months 12 after baseline survey

• Health-related Quality of life

  Months 12 after baseline survey

• Depressive symptoms

  Months 12 after baseline survey

• Cognitive function

  Months 12 after baseline survey

Study Arms (2)

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

EXPERIMENTAL

EXPRESS intervention is structured around five key components-SAFER.

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

Control group

NO INTERVENTION

The control group will receive standard health management through primary public health services and will be provided with a basic calendar to record fall events.

Interventions

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

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.

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

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Age 65 years or older.
• Resides in the village for at least 12 months.
• Provides informed consent and is willing to voluntarily participate.
• 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.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

China Center for Health Development Studies, Peking University

Haidian, Beijing Municipality, China

Location

Study Officials

• Yao Yao, MD

  Peking University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research professor

Study Record Dates

• First Submitted: May 11, 2025
• First Posted: May 22, 2025
• Study Start: August 6, 2024
• Primary Completion: August 30, 2025
• Study Completion (Estimated): August 30, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)