中国医疗机构开展跌倒防控现状调查

注册号:

Registration number:

ChiCTR2500107180 

最近更新日期:

Date of Last Refreshed on:

2025-08-05 20:03:22 

注册时间:

Date of Registration:

2025-08-05 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

中国医疗机构开展跌倒防控现状调查

Public title:

Current Practices in Falls Prevention and Management in Chinese Healthcare Institutions

注册题目简写:

English Acronym:

研究课题的正式科学名称:

中国医疗机构开展跌倒防控现状调查

Scientific title:

Current Practices in Falls Prevention and Management in Chinese Healthcare Institutions

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:

姜媛媛 

研究负责人:

武文斌 

Applicant:

Yuanyuan Jiang 

Study leader:

Wenbin Wu 

申请注册联系人电话:

Applicant telephone:

+86 132 1208 3438

研究负责人电话:

Study leader's
telephone:

+86 186 1844 1623

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:

lily0915jyy@163.com

研究负责人电子邮件:

Study leader's E-mail:

firestone1985@126.com

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):

申请注册联系人通讯地址:

北京市东城区东单大华路1号

研究负责人通讯地址:

北京市东城区东单大华路1号

Applicant address:

No. 1 Dongdan Dahua Road, Dongcheng District, Beijing

Study leader's address:

No. 1 Dongdan Dahua Road, Dongcheng District, Beijing

申请注册联系人邮政编码:

Applicant postcode:

100730

研究负责人邮政编码:

Study leader's postcode:

100730

申请人所在单位:

北京医院

Applicant's institution:

Beijing Hospital

研究负责人所在单位:

北京医院

Affiliation of the Leader:

Beijing Hospital

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

2024BJYYEC-KY329-01

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:

北京医院伦理委员会

Name of the ethic committee:

Beijing Hospital Ethics Committee

伦理委员会批准日期:

Date of approved by ethic committee:

2025-01-10 00:00:00

伦理委员会联系人:

侯文静

Contact Name of the ethic committee:

Wenjing Hou

伦理委员会联系地址:

北京市东城区东单大华路1号

Contact Address of the ethic committee:

No. 1 Dongdan Dahua Road, Dongcheng District, Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 85138522

伦理委员会联系人邮箱:

Contact email of the ethic committee:

研究实施负责(组长)单位:

北京医院

Primary sponsor:

Beijing Hospital

研究实施负责(组长)单位地址:

北京市东城区东单大华路1号

Primary sponsor's address:

No. 1 Dongdan Dahua Road, Dongcheng 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

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京医院

具体地址:

北京市东城区东单大华路1号

Institution
hospital:

Beijing Hospital

Address:

No. 1 Dongdan Dahua Road, Dongcheng District, Beijing

经费或物资来源:

2024北京医院临床研究专项指南专项

Source(s) of funding:

2024 Beijing Hospital Clinical Research Program for Practice Guidelines

研究疾病:

跌倒  

Target disease:

Falls

研究疾病代码:

Target disease code:

研究类型:

观察性研究

Study type:

Observational study

研究所处阶段:

其它 

Study phase:

N/A

研究设计:

队列研究 

Study design:

Cohort study 

研究目的:

调查医疗机构基于指南开展跌倒防控的主要瓶颈 (包括医院实施层面和患者需求层面),提出解决策略。  

Objectives of Study:

To investigate major difficulties and dilemmas in falls prevention based on practice guidelines from the perspectives of hospital implementation and patients' needs, and to propose strategic solutions.

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:

1. 因各种原因(如严重认知功能障碍、失能等)无法配合完成测评、访谈及随访;2. 预期生存时间小于1年。

Exclusion criteria:

1. Unable to complete assessments, interviews, or follow‑up due to various reasons (e.g., severe cognitive impairment, disability, etc.); 2. Expected life expectancy of less than one year.

研究实施时间:

Study execute time:

From 2024-07-01 00:00:00 To 2026-01-10 00:00:00  

征募观察对象时间:

Recruiting time:

From 2025-08-15 00:00:00 To 2026-01-09 00:00:00

干预措施:

Interventions:

组别:

高风险组

样本量:

1000

Group:

High falls risk group

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

组别:

低风险组

样本量:

1000

Group:

Low falls risk group

Sample size:

干预措施:

干预措施代码:

Intervention:

None

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 

市(区县):

 

Country:

China

Province:

Beijing

City:

单位(医院):

北京医院 

单位级别:

三甲 

Institution
hospital:

Beijing Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

江苏省 

市(区县):

南通市 

Country:

China

Province:

Jiangsu

City:

Nantong

单位(医院):

上海大学附属南通医院 

单位级别:

三级 

Institution
hospital:

Affiliated Nantong Hospital of Shanghai University

Level of the institution:

Tertiary

国家:

中国

省(直辖市):

山东省 

市(区县):

泰安市 

Country:

China

Province:

Shandong

City:

Taian

单位(医院):

山东省泰山医院 

单位级别:

三级 

Institution
hospital:

Shandong Provincial Taishan Hospital

Level of the institution:

Tertiary

国家:

中国

省(直辖市):

山东省 

市(区县):

青州市 

Country:

China

Province:

Shandong

City:

Qingzhou

单位(医院):

青州市人民医院 

单位级别:

二甲 

Institution
hospital:

Qingzhou People's Hospital

Level of the institution:

Secondary A

国家:

中国

省(直辖市):

河北省 

市(区县):

张家口市 

Country:

China

Province:

Hebei

City:

Zhangjiakou

单位(医院):

涿鹿县医院 

单位级别:

二甲 

Institution
hospital:

Zhuolu County Hospital

Level of the institution:

Secondary A

国家:

中国

省(直辖市):

辽宁省 

市(区县):

沈阳市 

Country:

China

Province:

Liaoning

City:

Shenyang

单位(医院):

中国医科大学附属第一医院 

单位级别:

三甲 

Institution
hospital:

The First Hospital of China Medical University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

甘肃省 

市(区县):

兰州市 

Country:

China

Province:

Gansu

City:

Lanzhou

单位(医院):

甘肃省第三人民医院 

单位级别:

三甲 

Institution
hospital:

Third People's Hospital of Gansu Province

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

贵州省 

市(区县):

贵阳市 

Country:

China

Province:

Guizhou

City:

Guiyang

单位(医院):

贵州省人民医院 

单位级别:

三甲 

Institution
hospital:

Guizhou Provincial People's Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

陕西省 

市(区县):

咸阳市 

Country:

China

Province:

Shaanxi

City:

Xianyang

单位(医院):

陕西省核工业二一五医院 

单位级别:

三甲 

Institution
hospital:

No.215 Hospital of Shaanxi Nuclear Industry

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

河北省 

市(区县):

秦皇岛市 

Country:

China

Province:

Hebei

City:

Qinhuangdao

单位(医院):

秦皇岛市工人医院 

单位级别:

二甲 

Institution
hospital:

Qinhuangdao Worker's Hospital

Level of the institution:

Secondary A

国家:

中国

省(直辖市):

广西 

市(区县):

钦州市 

Country:

China

Province:

Guangxi

City:

Qinzhou

单位(医院):

钦州市第一人民医院 

单位级别:

三甲 

Institution
hospital:

The First People's Hospital of Qinzhou

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

山东省 

市(区县):

诸城市 

Country:

China

Province:

Shandong

City:

Zhucheng

单位(医院):

诸城市人民医院 

单位级别:

三乙 

Institution
hospital:

Zhucheng People's Hospital

Level of the institution:

Tertiary B

国家:

中国

省(直辖市):

陕西省 

市(区县):

西安市 

Country:

China

Province:

Shaanxi

City:

Xi'an

单位(医院):

西安市北方医院 

单位级别:

二甲 

Institution
hospital:

Xi'an North Hospital

Level of the institution:

Secondary B

国家:

中国

省(直辖市):

广东省 

市(区县):

广州市 

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

中山大学附属第三医院 

单位级别:

三甲 

Institution
hospital:

The Third Affiliated Hospital, Sun Yat-sen University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

山东省 

市(区县):

聊城市 

Country:

China

Province:

Shandong

City:

Liaocheng

单位(医院):

莘县人民医院 

单位级别:

二甲 

Institution
hospital:

Shenxian People's Hospital

Level of the institution:

Secondary A

国家:

中国

省(直辖市):

河南省 

市(区县):

洛阳市 

Country:

China

Province:

Henan

City:

Luoyang

单位(医院):

河南科技大学第一附属医院 

单位级别:

三甲 

Institution
hospital:

The First Affiliated Hospital of Henan University of Science & Technology

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

内蒙古 

市(区县):

乌海市 

Country:

China

Province:

Inner Mongolia

City:

Wuhai

单位(医院):

内蒙古乌海市人民医院 

单位级别:

三甲 

Institution
hospital:

The People's Hospital of Wuhai, Inner Mongolia

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

浙江省 

市(区县):

杭州市 

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

杭州市富阳区第一人民医院 

单位级别:

三乙 

Institution
hospital:

The First People's Hospital of Fuyang, Hangzhou

Level of the institution:

Tertiary B

国家:

中国

省(直辖市):

吉林省 

市(区县):

长春市 

Country:

China

Province:

Jilin

City:

Changchun

单位(医院):

吉林省一汽总医院 

单位级别:

三甲 

Institution
hospital:

Jinlin Province FAW General Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

西藏 

市(区县):

拉萨 

Country:

China

Province:

Xizang

City:

Lhasa

单位(医院):

西藏自治区人民医院 

单位级别:

三甲 

Institution
hospital:

People's Hospital of Xizang Autonomous Region

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

6个月内跌倒

指标类型:

主要指标

Outcome:

Falls in 6 months

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

6个月内跌倒致骨折

指标类型:

主要指标

Outcome:

Fracture caused by falls in 6 months

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

6个月的其他不良事件

指标类型:

次要指标

Outcome:

Adverse events in 6 months

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

NA

Tissue:

人体标本去向

其它  

说明

Fate of sample:

0thers  

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 65 years
最大 Max age 85 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):

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法:

Blinding:

None

是否共享原始数据:

IPD sharing

否No

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):

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

None

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:

使用“京颐汇”老年综合评估系统收集数据。数据双人录入,所有原始数据由北京医院进行保存并做到真实性可溯源, 数据进入分析单元时进行脱敏处理,保证患者信息安全。

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

Data is collected using the "Jingyihui Comprehensive Geriatric Assessment System". All original data undergo double-data entry and are preserved by Beijing Hospital with traceable authenticity. When entering the analysis stage, the data are de-identified to ensure patient information security.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2025-08-05 20:03:07