AI-assisted, Village Doctors and Express Services-Involved, Community-Based Multicenter Cluster Randomized Controlled Trial for Fall Prevention Among Rural Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 1,881
- 试验地点
- 1
- 主要终点
- Fall-related injuries incidence within 12 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 95 Years(Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Fall-related injuries incidence within 12 months
时间窗: 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.
Fall incidence within 12 months (rate of falls per person-year)
时间窗: 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
时间窗: 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.
次要结局
- Dementia(Months 12 after baseline survey)
- Frailty(Months 12 after baseline survey)
- Sleep Quality(Months 12 after baseline survey)
- Gait Speed(Months 12 after baseline survey)
- Stride Length(Months 12 after baseline survey)
- Center of Pressure Sway Area(Months 12 after baseline survey)
- Lower Limb Strength (Estimated Peak Force)(Months 12 after baseline survey)
- Trunk Rotation Range(Months 12 after baseline survey)
- 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)
- Incidence of chronic non-communicable diseases(Months 12 after baseline survey)
研究者
Yao Yao
Research professor
Peking University
