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乡村共同体视域下农村老年人跌倒关键风险识别与干预策略优化研究
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注册号：

Registration number：

 ChiCTR2400087834 

最近更新日期：

Date of Last Refreshed on：

 2026-03-31 08:15:31 

注册时间：

Date of Registration：

 2024-08-05 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

乡村共同体视域下农村老年人跌倒关键风险识别与干预策略优化研究

Public title：

Identifying key risk factors and optimizing intervention strategies of falls for rural older people from a "rural community" perspective

注册题目简写：

“稳步乡间-速递安康”

English Acronym：

EXPRESS-SAFER

研究课题的正式科学名称：

依托物流网络在中国农村实施人工智能赋能的跌倒预防：一项混合型效能-实施整群随机对照试验

Scientific title：

Leveraging Logistics Networks for AI-Enabled Fall Prevention in Rural China: A Hybrid Effectiveness-Implementation Cluster Randomized Trial

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

李少杰 

研究负责人：

姚尧 

Applicant：

Shaojie Li 

Study leader：

Yao Yao 

申请注册联系人电话：

Applicant telephone：

 +86 178 6419 1208

研究负责人电话：

Study leader's
telephone：

+86 156 0011 3336

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 li_shaojie@hsc.pku.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

 yao.yao@bjmu.edu.cn

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 agelab.pku.edu.cn

申请注册联系人通讯地址：

北京市海淀区学院路38号

研究负责人通讯地址：

北京市海淀区学院路38号

Applicant address：

No. 38 Xueyuan Road, Haidian District, Beijing

Study leader's address：

No. 38 Xueyuan Road, Haidian District, Beijing

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

北京大学中国卫生发展研究中心

Applicant's institution：

China Center for Health Development Studies, Peking University

研究负责人所在单位：

北京大学中国卫生发展研究中心

Affiliation of the Leader：

China Center for Health Development Studies, Peking University

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 IRB00001052-24070

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

北京大学生物医学伦理委员会

Name of the ethic committee：

Biomedical Ethics Committee of Peking University

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-08-03 00:00:00

伦理委员会联系人：

刘珍慧

Contact Name of the ethic committee：

Zhenhui Liu

伦理委员会联系地址：

北京市海淀区学院路38号

Contact Address of the ethic committee：

No. 38 Xueyuan Road, Haidian District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 10 8280 5751

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 llwyhgy@bjmu.edu.cn

研究实施负责（组长）单位：

北京大学中国卫生发展研究中心

Primary sponsor：

China Center for Health Development Studies, Peking University

研究实施负责（组长）单位地址：

北京市海淀区学院路38号

Primary sponsor's address：

No. 38 Xueyuan Road, Haidian District, Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

北京大学中国卫生发展研究中心

具体地址：

北京市海淀区学院路38号

Institution
hospital：

China Center for Health Development Studies, Peking University

Address：

No. 38 Xueyuan Road, Haidian District, Beijing

经费或物资来源：

国家自然科学基金

Source(s) of funding：

National Natural Science Foundation of China

研究疾病：

跌倒  

Target disease：

falls

研究疾病代码：

W00-W19

Target disease code：

W00-W19

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

整群随机分组 

Study design：

Cluster randomization 

研究目的：

针对全球人口老龄化与农村医疗人力资源短缺的双重挑战，EXPRESS 试验旨在验证一种创新性的“AI-物流-医疗”融合的基层卫生治理模式。本研究采用混合 II 型设计，评估将人工智能驱动的精准跌倒风险分级与基于物流网络（快递员）的任务分担相结合，提供个性化、循证的跌倒预防服务是否能有效降低资源匮乏地区老年人的跌倒及相关伤害发生率（12个月的干预服务），同时确立该模式在真实世界中的实施效能、成本效益与可持续性（12个月干预期后停止干预服务，继续观察12个月），为中低收入国家实现健康老龄化提供可扩展的政策范本。  

Objectives of Study：

To address the dual global crises of rapid population aging and critical rural health workforce shortages, the EXPRESS trial evaluates a transformative "AI-Logistics-Health" convergence model. Utilizing a Hybrid Type II effectiveness-implementation design, this study aims to determine whether integrating AI-driven precision risk stratification with logistics-based task-sharing (local couriers) and evidence-based fall prevention model can significantly reduce the incidence of falls and fall-related injuries among older adults in resource-constrained settings (12 months of intervention). Furthermore, the trial seeks to elucidate the implementation fidelity, cost-effectiveness, sustainability, and scalability of repurposing commercial logistics infrastructure for public health delivery (after a 12-month intervention period, the intervention ceased, followed by an additional 12-month observation period), providing a model to guide national policy reforms for aging-in-place in rural China and similar global settings.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

研究现场排除标准： 行政偏倚：乡镇人民政府所在地的行政村（部分村医与乡镇卫生院混用人力资源，且医疗资源可及性显著高于普通村，引入偏倚）。 人口规模限制：村内常住65岁及以上老年人口数少于50人（统计效能不足）或多于200人（大型村导致干预实施“稀释”效应或超出单个村医/快递员负荷）。 既往干预史：过去3年内曾参与过政府或科研机构组织的跌倒预防、骨骼健康或类似的大规模健康行为干预项目。 行政稳定性：已列入政府拆迁、合并等计划，无法保证干预（12个月）和随访期（12个月）的稳定性。 研究对象排除标准： 预期寿命受限：患有晚期恶性肿瘤、终末期器官衰竭等严重疾病，经临床医生评估预期寿命<24个月。 严重活动受限：长期卧床、完全依赖轮椅生活或肢体瘫痪，无法进行跌倒风险步态评估者。 认知功能障碍：既往确诊为痴呆，或存在严重认知障碍（如无法理解简单指令），无法配合干预措施或提供可靠的跌倒回忆数据。 严重感官障碍：存在未经矫正的双目失明或严重听力损失，无法接收快递员/村医的健康教育信息或无法使用干预工具。 不稳定的健康状况：近3个月内新发急性心肌梗死、脑卒中或进行重大手术，目前处于急性康复期，不适宜进行运动干预者。

Exclusion criteria：

Exclusion Criteria for Study Sites Administrative Bias: Villages serving as the seat of the township government (to avoid bias arising from shared workforce with township health centers and superior baseline healthcare access). Population Size Constraints: Administrative villages with a permanent resident population of aged ≥ 65 years numbering fewer than 50 (insufficient statistical power) or more than 200 (potential for intervention dilution or workforce overload). Prior Exposure: Participation in fall prevention, bone health, or similar large-scale health behavioral intervention programs within the past 3 years. Instability: Villages scheduled for demolition, relocation, or administrative merger within the study period, compromising follow-up retention. Exclusion Criteria for Study Participants Life Expectancy: Diagnosis of terminal illness (e.g., advanced malignancy, end-stage organ failure) with a life expectancy of < 24 months as assessed by a clinician. Severe Immobility: Bedridden status, complete wheelchair dependence, or limb paralysisower preventing participation in gait assessment and exercise interventions. Cognitive Impairment: Diagnosis of dementia or severe cognitive impairment (e.g., inability to follow simple instructions) that precludes cooperation with interventions or reliable reporting of fall events. Sensory Deficits: Severe, uncorrected visual or hearing impairment (e.g., blindness or profound deafness) preventing the reception of health education or use of intervention materials. Acute Instability: Recent history (within the past 3 months) of acute myocardial infarction, stroke, or major surgery, currently in an unstable recovery phase where exercise intervention is contraindicated.

研究实施时间：

Study execute time：

从 From 2024-08-03 00:00:00至 To 2026-09-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-08-05 00:00:00 至 To 2024-09-01 00:00:00

干预措施：

Interventions：

组别：

干预组

样本量：

 945

Group：

Intervention Group

Sample size：

干预措施：

干预组实施"筛查+AI辅助健康指导+不倒翁健康操+基于节庆的参与+健康到家"的干预策略（SAFER），持续12个月，具体包括： S (Screening) - 双模态跌倒风险分级：实施“量表+数字”混合筛查模式，由乡村医生执行，结合适配乡村的跌倒风险量表（主观）与基于智能手机计算机视觉的步态平衡分析技术（客观），对老年人进行精准的跌倒风险分级。 A (AI-assisted Recommendations) ：开发基于大语言模型和云端算法的跌倒预防支持系统。系统自动解析多维筛查数据，生成个性化、循证的跌倒预防处方（涵盖生活方式、锻炼、环境改造建议等提示），辅助乡村医生提供个性化的健康指导。 F (Fitness) - 定制化运动处方: 康复专家开发一套适合乡村居家锻炼的“不倒翁健康操”。这是一套渐进式下肢力量与平衡训练方案，可基于AI评估结果量身定制。针对个体跌倒风险（如肌少症或核心不稳），通过视频和图册提供家庭版的锻炼和康复指导。 E (Events-based Engagement) - 文化嵌入式行为助推：采用行为助推策略，将干预时间轴与中国传统节气及节日（如重阳、春节、清明节）深度融合。按季节发放具有文化适应性的“不倒翁健康礼包”（涵盖跌倒风险的健康体检报告和涵盖跌倒预防核心信息的跌倒预防月历），利用传统文化和仪式感来强化干预内容的行为依从性。 R (Reach-home Delivery) - 物流赋能的任务分担：利用当地物流基础设施如中国邮政解决跌倒预防“最后一公里”服务难题。建立任务分担（Task-sharing）机制，由经过培训的快递员作为非专业卫生工作者，定期将干预材料（报告、礼包）投递至参与者家中，并提供基础的社会支持。

干预措施代码：

Intervention：

The 12 months intervention is "SAFER" strategy, a hybrid effectiveness-implementation intervention that operationalizes precision prevention through existing rural infrastructure. SAFER denotes five synergistic, evidence-based components: S - Screening (Dual-Modality Risk Stratification): Implementation of a hybrid assessment protocol where rural doctors utilize a smartphone-based AI computer vision application alongside rural-validated fall-risk scales. This dual-modality approach precisely stratify individual fall risk phenotypes. A - AI-Empowered Recommendations: Deployment of a cloud-based, AI empowered fall prevention supporting system. The algorithm processes screening data to generate personalized, guideline-based prevention prescriptions and actionable risk modification strategies across resource-constrained settings. F - Fitness (Tailored Exercise Prescription): Engagement in the rehabilitation physician–designed "Tumbler" (Bu-Dao-Weng) Exercise Program, a tailored regimen focusing on progressive low-limb strength and balance training. Exercise intensity and modality are individualized based on the participant’s specific risk phenotypes identified by the AI assessment (e.g., sarcopenia or postural instability). E - Events-Based Engagement (Culturally-Adaptive Behavioral Nudging): A sustainable engagement strategy that synchronizes intervention delivery with traditional cultural festivals and solar terms (e.g., Double Ninth Festival, Lunar New Year, and Ching Ming Festival). Seasonal "Fall Prevention Packages" (a health examination report covering fall risk and a monthly fall-prevention calendar highlighting core prevention messages) utilize temporal behavioral nudges and cultural cues to sustain long-term adherence. R - Reach-Home Delivery (Logistics-Enabled Task Sharing): Operationalization of a task-sharing framework utilizing the local logistics network. Trained couriers are repurposed as lay health workers to execute the "last-mile" delivery of intervention materials directly to participants' homes, bridging the access gap in geographically dispersed rural areas.

Intervention code：

组别：

对照组

样本量：

 936

Group：

Control Group

Sample size：

干预措施：

基本公共卫生服务中常规老年健康管理（包括每年一次的免费健康体检和和常规健康指导），配送与干预组同样外包装和递送频率的包裹（涵盖血压、BMI等常规查体体检报告和常规月历）。

干预措施代码：

Intervention：

Standard of Care with Attention Control: routine older adult health management under the Basic Public Health Services program (including an annual free health examination and routine health guidance), with packages delivered at the same frequency and in identical packaging as the intervention group, containing standard health examination reports (e.g., blood pressure and BMI) and a regular monthly calendar.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

 北京市密云区 

Country：

China

Province：

Beijing

City：

Miyun District, Beijing

单位(医院)：

 密云区不老屯乡镇卫生院 

单位级别：

 社区卫生服务中心 

Institution
hospital：

Bulaotun Township Health Center in Miyun District

Level of the institution：

Community Health Service Center

国家：

 中国

省(直辖市)：

 安徽 

市(区县)：

 六安市霍邱县 

Country：

China

Province：

Anhui

City：

Huoqiu County, Lu'an

单位(医院)：

 六安市霍邱县城关镇乡镇卫生院 

单位级别：

 社区卫生服务中心 

Institution
hospital：

Township Health Center in Chengguan Town, Huoqiu County, Lu'an City

Level of the institution：

Community Health Service Center

国家：

 中国

省(直辖市)：

 湖北 

市(区县)：

 潜江市积玉口镇 

Country：

China

Province：

Hubei

City：

Jiyukou County, Qianjiang

单位(医院)：

 潜江市积玉口镇卫生院 

单位级别：

 社区卫生服务中心 

Institution
hospital：

Jiyukou Town Health Center, Qianjiang City

Level of the institution：

Community Health Service Center

国家：

 中国

省(直辖市)：

 山西 

市(区县)：

 吕梁市方山县 

Country：

China

Province：

Shanxi

City：

Fangshan County, Lvliang

单位(医院)：

 吕梁市方山县积翠镇乡镇卫生院 

单位级别：

 社区卫生服务中心 

Institution
hospital：

Jicui Township Health Center, Fangshan County, Lvliang City

Level of the institution：

Community Health Service Center

测量指标：

Outcomes：

指标中文名：

12个月内跌倒发生率(每人年发生的跌倒总次数)

指标类型：

主要指标

Outcome：

Rate of Falls (Falls per Person-Year) within 12 months

Type：

Primary indicator

测量时间点：

基线调查及第3个月、6个月、9个月、12个月、18个月和24个月的随访

测量方法：

受访者自报,跌倒日历,季度快递员随访和疑似事件电话核实

Measure time point of outcome：

Baseline and Month 3, 6, 9, 12 (Primary analysis), 18, and 24 during the follow-ups

Measure method：

self-reported by participants, fall calendars, quarterly courier follow-up, and telephone verification of suspected events

指标中文名：

12个月内跌倒发生比例(发生>=1次跌倒的参与者比例）

指标类型：

主要指标

Outcome：

Fall incidence proportion of participants experiencing >= 1 fall

Type：

Primary indicator

测量时间点：

基线调查及第3个月、6个月、9个月、12个月、18个月和24个月的随访

测量方法：

受访者自报,跌倒日历,季度快递员随访和疑似事件电话核实

Measure time point of outcome：

Baseline and Month 3, 6, 9, 12 (Primary analysis), 18, and 24 during the follow-ups

Measure method：

self-reported by participants, fall calendars, quarterly courier follow-up, and telephone verification of suspected events

指标中文名：

12个月内需医疗处置的致伤性跌倒(骨折、脑外伤、软骨损伤)发生率

指标类型：

主要指标

Outcome：

Incidence of Medically Attended Injurious Falls (fractures, traumatic brain injury, dislocations, or severe soft tissue injuries requiring hospitalization)

Type：

Primary indicator

测量时间点：

基线调查及第6个月、12个月、18个月和24个月的随访

测量方法：

受访者自报，病例和就医记录

Measure time point of outcome：

Baseline and Months 6, 12 (Primary analysis), 18, and 24 during the follow-ups

Measure method：

self reports by participants, health records, and encounter data obtained from trial sites

指标中文名：

跌倒相关心理、行为与健康素养（跌倒恐惧、跌倒预防健康素养）

指标类型：

次要指标

Outcome：

Fear of Falling and Health Literacy

Type：

Secondary indicator

测量时间点：

基线调查及第12个月、24个月随访

测量方法：

受访者回答问卷

Measure time point of outcome：

Baseline and Months 12 and 24 during the follow-ups

Measure method：

Questionnaire

指标中文名：

日常生活活动自理能力

指标类型：

次要指标

Outcome：

Activities of Daily Living (ADL)

Type：

Secondary indicator

测量时间点：

基线调查及第12个月、24个月随访

测量方法：

受访者回答问卷

Measure time point of outcome：

Baseline and Months 12 and 24 during the follow-ups

Measure method：

Barthel ADL questionnaire

指标中文名：

健康相关生活质量

指标类型：

次要指标

Outcome：

Quality of Life (EQ-5D-5L Utility Score)

Type：

Secondary indicator

测量时间点：

基线调查及第12个月、24个月随访

测量方法：

受访者回答问卷

Measure time point of outcome：

Baseline and Months 12 and 24 during the follow-ups

Measure method：

EQ-5D-5L Utility Score

指标中文名：

客观身体功能（衰弱、起立-行走计时及步速）

指标类型：

次要指标

Outcome：

Objective Physical Function(Frailty, Timed-Up and Go Test, Gait Speed)

Type：

Secondary indicator

测量时间点：

基线调查及第12个月、24个月随访

测量方法：

基于智能手机计算机视觉的步态平衡分析技术

Measure time point of outcome：

Baseline and Months 12 and 24 during the follow-ups

Measure method：

Smartphone-based computer vision–enabled gait and balance analysis

指标中文名：

实施保真度——供给侧（村医和快递员）

指标类型：

附加指标

Outcome：

Provider Fidelity

Type：

Additional indicator

测量时间点：

基线调查及第12个月、24个月随访

测量方法：

微信和快递APP

Measure time point of outcome：

Baseline and Months 12 and 24 during the follow-ups

Measure method：

WeChat and courier service applications

指标中文名：

实施保真度——需求侧（老年人）

指标类型：

附加指标

Outcome：

Participant Fidelity

Type：

Additional indicator

测量时间点：

基线调查及第12个月、24个月随访

测量方法：

自报和月历记录

Measure time point of outcome：

Baseline and Months 12 and 24 during the follow-ups

Measure method：

Self reports and Calendar record

指标中文名：

采纳率与覆盖面

指标类型：

附加指标

Outcome：

Provider Adoption and Participant Reach

Type：

Additional indicator

测量时间点：

基线调查及第12个月、24个月随访

测量方法：

问卷

Measure time point of outcome：

Baseline and Months 12 and 24 during the follow-ups

Measure method：

Questionnaire

指标中文名：

认知功能

指标类型：

附加指标

Outcome：

cognitive impairment

Type：

Additional indicator

测量时间点：

基线调查及第12个月、24个月随访

测量方法：

MMSE

Measure time point of outcome：

Baseline and Months 12 and 24 during the follow-ups

Measure method：

MMSE

指标中文名：

痴呆

指标类型：

附加指标

Outcome：

Dementia

Type：

Additional indicator

测量时间点：

基线调查及第12个月、24个月随访

测量方法：

CDR, 面部与语义数据视频

Measure time point of outcome：

Baseline and Months 12 and 24 during the follow-ups

Measure method：

CDR, facial record and AI to analyze facial features, asymmetry, and expressions

指标中文名：

抑郁症状

指标类型：

附加指标

Outcome：

Depressive symptoms

Type：

Additional indicator

测量时间点：

基线调查及第12个月、24个月随访

测量方法：

简版老年抑郁症状量表

Measure time point of outcome：

Baseline and Months 12 and 24 during the follow-ups

Measure method：

five-item geriatric depression scale

指标中文名：

死亡

指标类型：

附加指标

Outcome：

Death

Type：

Additional indicator

测量时间点：

基线调查及第12、24个月及之后随访

测量方法：

家属、村医报告，民政档案

Measure time point of outcome：

Baseline and follow-ups at 12 and 24 months and thereafter

Measure method：

family members, village doctors, and civil affairs administrative records

指标中文名：

肌肉减少症

指标类型：

附加指标

Outcome：

Sarcopenia

Type：

Additional indicator

测量时间点：

基线调查及第12个月、24个月随访

测量方法：

肌少症筛查量表、超声、生物电阻抗分析人体成分仪

Measure time point of outcome：

Baseline and Months 12 and 24 during the follow-ups

Measure method：

sarcopenia screening questionnaires, ultrasonography, and BIA (InBody)

指标中文名：

骨密度

指标类型：

附加指标

Outcome：

Bone Mineral Density

Type：

Additional indicator

测量时间点：

基线调查及第12个月、24个月随访

测量方法：

超声骨密度仪

Measure time point of outcome：

Baseline and Months 12 and 24 during the follow-ups

Measure method：

quantitative ultrasound bone densitometer (QUS)

指标中文名：

睡眠质量

指标类型：

附加指标

Outcome：

Sleep quality

Type：

Additional indicator

测量时间点：

基线调查及第12个月、24个月随访

测量方法：

匹兹堡睡眠质量指数

Measure time point of outcome：

Baseline and Months 12 and 24 during the follow-ups

Measure method：

Pittsburgh Sleep Quality Index,PSQI

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

不涉及

组织：

Sample Name：

Not applicable

Tissue：

人体标本去向

 其它  

说明

我们不采集任何人体标本

Fate of sample：

0thers  

Note：

We did not collect sample(s)

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 65 岁 years
最大 Max age 95 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

本项目为整群随机对照试验，采取“分层协变量约束随机化”方法。 随机化在基线数据收集完成且数据库锁定后，由一名不参与本研究招募、数据收集及干预实施的独立第三方统计学家执行。该统计学家来自无利益冲突的机构，对村庄的具体名称保持盲态。 具体步骤如下： 1、分层因素： 以省份（4个）作为分层因子，强制执行各省内 1:1 的分配比例（即每省 2 个干预村，2 个对照村）。 2、约束协变量： 选取影响跌倒结局的关键村级特征作为约束变量，包括：(1) 基线跌倒发生率（主要预后因子）；(2) 村庄常住老年人口规模；(3) 距最近综合医院的距离；(4) 村庄社会经济发展水平。 3、随机化程序： 使用 R 软件 (v4.3.0, cvcrand包) 穷举所有符合分层要求的分配方案（共1296种组合）。计算每种方案的不平衡评分，该评分基于两组间上述协变量的加权马氏距离。设定平衡阈值，筛选出平衡性最优的子集（平衡性最好的10%）构建“有效随机化空间”。最终的分配方案将从该子集中随机抽取产生。 4、去盲： 分配结果将通过加密文件传输给项目经理，随后通知各村启动相应流程。

Randomization Procedure (please state who generates the random number sequence and by what method)：

We employed a Stratified Covariate-Constrained Randomization technique for this Cluster Randomized Trial. The randomization sequence will be generated by an independent statistician who is blinded to village identities and not involved in participant recruitment or outcome assessment. The procedure will be conducted only after the completion of baseline data collection and database locking to prevent recruitment bias. The randomization algorithm is as follows: 1. Stratification: Villages are stratified by province (4 strata) to enforce a strict 1:1 allocation ratio within each province (2 intervention and 2 control villages per site). 2. Covariate Constraint: Within the stratified allocation space, we apply constraints to balance key village-level prognostic covariates, specifically: (1) Baseline fall incidence rate (the strongest predictor of future falls); (2) Population size of older adults; (3) Distance to the nearest referral hospital; and (4) Village socioeconomic status. 3. Procedure: Using R software (v4.3.0, cvcrand package), the statistician will enumerate all possible allocation schemes consistent with the stratification criteria (Total permutations: 6^4 = 1296). An Imbalance Score (B-score) will be calculated for each scheme based on the weighted Mahalanobis distance of the covariate means between arms. The randomization space will be restricted to the subset of schemes with the lowest imbalance scores (e.g., the top 10% most balanced schemes). One allocation scheme will be randomly selected from this restricted "valid" space to determine the final group assignment.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

受试者盲：不知晓分组情况 干预服务提供者盲：不知晓分组情况 结局评价者盲：负责随访评估的现场调查员轮换至非其负责基线的村庄，且禁止查阅分组信息。 临床事件判定委员会盲：设立独立的临床事件判定委员会，在对分组完全盲态的情况下，依据去标识化的问卷、影像和病历资料，对所有致伤性跌倒和骨折事件进行终点裁定。 独立统计分析师盲：不参与干预实施、不参与招募与随访、不接触分组信息。 研究人员和数据安全委员会非盲

Blinding：

This study utilizes a single blind design, Participant Masking (Sham Intervention): To mitigate the Hawthorne effect, the control group receives a "Logistics-Matched Attention Control". This involves the delivery of isomorphic packages (visually identical in branding and size) by uniformed couriers at the same frequency as the intervention arm. Blinding of intervention service providers: Village doctors and local couriers provided identical screening services and delivered packages with the same appearance and delivery frequency, unaware of participants’ group allocation. Blinding of outcome assessors: Field investigators responsible for follow-up assessments were rotated to villages other than those for which they conducted baseline assessments and were prohibited from accessing any information on group allocation. Blinding of the Clinical Event Adjudication Committee: An independent Clinical Event Adjudication Committee was established to adjudicate all injurious falls and fracture events under full blinding to group allocation, based on de-identified questionnaires, imaging, and medical records. The independent statistical analyst was blinded and did not participate in intervention delivery, participant recruitment or follow-up, and had no access to group allocation information. Unblinded personnel: Investigators and the Data Safety Monitoring Committee were not blinded.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

是Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

本研究承诺遵循 FAIR 原则，在研究结果发布后1年，在北京大学老龄健康交叉科学研究网站（agelab.pku.edu.cn）共享去标识化的个体参与者数据。研究人员需向EXPRESS项目学术委员会提交研究计划书及数据使用协议，经审核批准后，在受控环境中访问。

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

The study adheres to FAIR principles and applicable privacy regulations. Data will be available beginning 6 months after publication of the primary results and be accessed at agelab.pku.edu.cn. Access is granted to researchers who submit a methodologically sound proposal and sign a Data Use Agreement (DUA).

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

数据管理遵循 ALCOA+ 原则，采用经过验证的电子数据采集系统。 电子信息采集： 调查员使用移动终端直接录入。系统内置实时逻辑核查，从源头进行异常值质控。针对农村环境，系统支持离线采集功能。 实施质控： 系统自动记录每次访谈的GPS地理位置和时间戳，以验证快递员/调查员入户随访的真实性。 AI数据流： 智能手机采集的步态视频在加密云端即时处理为脱敏参数并反馈至EDC，用于村医健康教育和研究人员制定个性化干预材料，原始视频在云端即刻销毁，仅保留在安全设备中，确保隐私安全。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Data management: Data management adhered to the ALCOA+ principles and was implemented using a validated electronic data capture (EDC) system. Electronic data collection: Investigators entered data directly via mobile devices. The system incorporated real-time logic and consistency checks to identify and control outliers at the point of data entry. To accommodate rural settings, offline data collection functionality was supported. Implementation quality control: The system automatically recorded GPS coordinates and time stamps for each interview to verify the authenticity of home visits conducted by couriers and field investigators. AI-enabled data workflow: Gait videos captured via smartphones were instantaneously processed on an encrypted cloud platform into de-identified parameters and fed back into the EDC system. These outputs were used by village doctors for health education and by researchers to develop personalized intervention materials. The original videos were immediately destroyed on the cloud and retained only on secure devices, thereby ensuring data privacy and security.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2024-08-05 17:31:57
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