Clinical trial NCT06984978: EXpress Prevent Rural oldEr Adults' fallS, fractureS and Dependency (EXPRESS)
Official title: AI-assisted, Village Doctors and Express Services-Involved, Community-Based Multicenter Cluster Randomized Controlled Trial for Fall Prevention Among Rural Older Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 1881
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: The overall goal of EXPRESS is to develop an effective and sustainable fall prevention strategy suitable for rural China (AI-assisted, village doctors and express services-involved, personalized fall prevention strategy based on multidimensional risk profiling) to reduce the incidence of falls and fall-related injuries among older people in rural areas. The intervention strategy for the EXPRESS project is grounded in high-level evidence recommended by the guidelines, including the Technical Guidelines for Fall Prevention and Control in Community-Dwelling Older Adults published by China's National Health Commission. It aims to overcome the shortage of medical and human resources in rural China, leveraging social infrastructure to implement coherent interventions.

EXPRESS adopts a cluster-randomized multicenter design, recruiting older adults aged 65 and above from four provinces-Beijing, Hubei, Shanxi, and Anhui-selecting four villages from each province. The 16 villages are randomly assigned to the intervention or control group. The EXPRESS intervention is structured around five key components-SAFER, each designed to address rural health resource limitations, enhance accessibility, and provide personalized fall prevention services through AI technology and community integration.

S - Screening: Fall risk screening and assessment tailored to rural older adults. All participants undergo comprehensive fall risk assessments through a dual approach. First, village doctors administer a 10-item rural-adapted fall risk scale, developed by the research team for ease of use and specificity to the rural aging population. The scale captures key indicators such as mobility, balance, and prior fall history, offering a structured yet practical tool for frontline healthcare workers in resource-limited settings. Second, participants are instructed to complete sit-to-stand and 6-meter walking task (3 meters out and back) at their natural pace on a marked 3-meter mat. The smartphone is mounted on a specialized tripod on the opposite side, 2 meters from the endpoint of the mat, with a 30° downward angle to optimize the motion capture field of view. These recordings are analyzed using deep learning model and AI-powered motion analysis to extract five objective dimensions associated with fall risk: (1) balance (via sway and bilateral symmetry), (2) gait speed, (3) stride length, (4) trunk rotation (via turning motion), and (5) lower limb strength (via sit-to-stand movement). This combined subjective-objective assessment ensures accurate risk assessment and supports tailored interventions. Importantly, this risk screening and tailored health counseling process has been designed to be embedded within China's National Essential Public Health Service (EPHS) framework, particularly under the older adult health management program, which requires village doctors to conduct an annual physical examination for all residents aged 65 and above. As part of this initiative, the EXPRESS project incorporates the fall risk assessment and individualized consultation into the existing annual check-up workflow, allowing the service to be delivered efficiently during the routine health visit. To further support integration and incentivize adoption, the EXPRESS project offers a performance-based subsidy of RMB 6 per older adult to village doctors who complete both the fall risk screening and individualized counseling during the EPHS check-up. This approach not only promotes the institutionalization of fall prevention services, but also enhances sustainability and alignment with national health priorities in rural China.

A - AI-assisted recommendations: Personalized, AI-assisted falls prevention suggestions and health education. Collected assessment data are integrated into a decision-support system powered by artificial intelligence, which synthesizes evidence-based guidelines, expert consensus, and real-world data. The AI system generates personalized fall prevention plans tailored to each participant's risk profile and rural lifestyle. These plans assist village doctors in making informed, evidence-based decisions and provide actionable recommendations suitable for local implementation. Through the "1+1" transmission mechanism, village doctors conduct one-on-one risk assessments and explain the plan's key content, improving older people's health literacy and awareness of fall prevention. Meanwhile, a risk assessment and health recommendation report combining text and images will be issued to participants, using large fonts and including risk warning icons to ensure they are age and cultural appropriate.

F - Fitness: Tailored balance and strength training via Health Intervention Cartoon Brochure and Action Demonstration Video. Based on the risk assessment results, each older person will receive an individualized training recommendation customized by rehabilitation experts, which includes targeted training movements (such as balance training, lower limb strength training, etc.), supporting graphic and textual list (large font, easy to understand), and operation demonstration videos. Additionally, exercise rehabilitation experts develop a manual with 10 low-barrier exercises suitable for rural life scenarios, such as "bench balance training" and "big arm swings." Instructional videos are distributed to village doctors and participants. Village doctors are encouraged to lead group exercise sessions at village clinics, creating a community-driven atmosphere for physical activity.

E - Events-based engagement: Seasonal prevention activities and prevention materials integrated with traditional festivals and solar terms of the traditional Chinese calendar. To improve community engagement and intervention sustainability, the EXPRESS trial designed three round of intervention leveraging seasonal intervention packages that align with key traditional cultural events: the Chongyang Festival (October), the Spring Festival (January/February), and the Qingming Festival (April). These packages include culturally relevant and visually engaging materials, such as fall prevention calendars, fans printed with safety messages, and weather-specific tips. In addition, each package includes seasonal fall prevention tips, such as staying indoors during snowy weather, wearing non-slip shoes in winter, and being cautious during spring farming activities, thereby strengthening fall prevention awareness among older adults. The distribution of these packages aims to strengthen and consolidate the knowledge, beliefs, and behaviors of fall prevention among participants at different time points, leveraging local traditions to promote adherence, enhancing their sense of participation and sustainability in the intervention.

R - Reach-home delivery: The final and most important intervention strategy is home delivery of fall prevention services by express service. To alleviate the burden on village doctors and address the shortage of healthcare personnel in rural areas, the EXPRESS trial inspired by the Task Shifting/Sharing Theory and incorporates local couriers as community health support agents. Fall prevention intervention materials are remotely prepared by the technical team and distributed through a task-sharing platform. These couriers did their routine job and delivered intervention materials-including personalized health reports, educational calendars, and seasonal care packages-directly to participants' homes. This delivery model ensures the timeliness and coverage of fall prevention services to the doorsteps of older adults in rural and other regions with limited health care personnel.

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.

The intervention will last for one year, with participants being followed up on fall and injury incidents every three months. The primary outcome is the incidence of falls and fall-related injuries during the year of intervention. To reduce recall bias, fall and injury records will be collected using multiple methods: first, self-reporting by older adults on the calendar; second, a quarterly check-up by the couriers; and third, an endpoint assessment in the twelfth month of the study. Secondary outcomes include changes in activity of daily living, quality of life, fall-related health literacy, depressive symptoms, cognitive function, and dementia. The baseline data collection for this study was completed in August 2024, and the intervention effectiveness and health economic evaluation are expected to be completed by August 2025.

Eligibility criteria: 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 outcomes:
measure: Fall incidence within 12 months (rate of falls per person-year)
timeFrame: Months 3, 6, 9, 12 after baseline survey
measure: Proportion of participants with ≥1 fall within 12 months
timeFrame: Months 3, 6, 9, 12 after baseline survey
measure: Fall-related injuries incidence within 12 months
timeFrame: Months 3, 6, 9, 12 after baseline survey
Secondary outcomes:
measure: Fall health literacy
timeFrame: Months 12 after baseline survey
measure: Activities of daily living
timeFrame: Months 12 after baseline survey
measure: Health-related Quality of life
timeFrame: Months 12 after baseline survey
measure: Depressive symptoms
timeFrame: Months 12 after baseline survey
measure: Cognitive function
timeFrame: Months 12 after baseline survey
measure: Dementia
timeFrame: Months 12 after baseline survey
measure: Incidence of chronic non-communicable diseases
timeFrame: Months 12 after baseline survey
measure: Frailty
timeFrame: Months 12 after baseline survey
measure: Sleep Quality
timeFrame: Months 12 after baseline survey
measure: Gait Speed
timeFrame: Months 12 after baseline survey
measure: Stride Length
timeFrame: Months 12 after baseline survey
measure: Center of Pressure Sway Area
timeFrame: Months 12 after baseline survey
measure: Lower Limb Strength (Estimated Peak Force)
timeFrame: Months 12 after baseline survey
measure: Trunk Rotation Range
timeFrame: Months 12 after baseline survey
Other outcomes:
Locations:
city: Haidian
country: China
facility: China Center for Health Development Studies, Peking University
state: Beijing
Study officials:
affiliation: Peking University
name: Yao Yao, MD
role: PRINCIPAL_INVESTIGATOR
References: