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中国老年住院患者衰弱现状调查及其健康结局研究
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注册号:

Registration number:

ChiCTR1800017682 

最近更新日期:

Date of Last Refreshed on:

2018-08-09 

注册时间:

Date of Registration:

2018-08-09 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

中国老年住院患者衰弱现状调查及其健康结局研究 

Public title:

Investigation on the frailty status and health outcomes of elderly hospitalized patients in China  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中国老年住院患者衰弱现状调查及其健康结局研究 

Scientific title:

Investigation on the frailty status and health outcomes of elderly hospitalized patients in China  

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:

焦静 

研究负责人:

焦静 

Applicant:

Jing Jiao 

Study leader:

Jing Jiao 

申请注册联系人电话:

Applicant telephone:

+86 010-69155719 

研究负责人电话:

Study leader's telephone:

+86 010-69155719 

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:

jiaojing.2006@aliyun.com 

研究负责人电子邮件:

Study leader's E-mail:

jiaojing.2006@aliyun.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:

北京市东城区帅府园1号 

研究负责人通讯地址:

北京市东城区帅府园1号 

Applicant address:

1 Shuaifuyuan, Wangfujing Street, Dongcheng District, Beijing, China 

Study leader's address:

1 Shuaifuyuan, Wangfujing Street, Dongcheng District, Beijing, China 

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:

北京协和医院 

Applicant's institution:

Peking Union Medical College Hospital 

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:

S-K540 

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:

北京协和医院伦理审查委员会 

Name of the ethic committee:

The Institutional Review Board of Peking Union Medical College Hospital  

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

徐辉 

Contact Name of the ethic committee:

Hui Xu 

伦理委员会联系地址:

北京协和医院科研处 

Contact Address of the ethic committee:

Research Department of Peking Union Medical College Hospital, 1 Shuaifuyuan, Wangfujing Street, Dongcheng District, Beijing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

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:

北京协和医院 

Primary sponsor:

Peking Union Medical College Hospital 

研究实施负责(组长)单位地址:

北京市东城区帅府园1号 

Primary sponsor's address:

1 Shuaifuyuan, Wangfujing Street, Dongcheng District, Beijing, China 

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):

东城区

Country:

China

Province:

Beijing

City:

Dongcheng District

单位(医院):

北京协和医院

具体地址:

帅府园1号

Institution
hospital:

Peking Union Medical College Hospital

Address:

1 Shuaifuyuan, Wangfujing Street, Dongcheng District, Beijing, China

经费或物资来源:

中国医学科学院中央级公益性科研院所基本科研业务费 

Source(s) of funding:

Fundamental Research Funds for the Central Universities 

研究疾病:

衰弱 

Target disease:

frailty 

研究疾病代码:

 

Target disease code:

 

研究类型:

病因学/相关因素研究 

Study type:

Cause/Relative factors study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

本研究拟通过开展全国多中心的前瞻性研究,描述我国三级医院住院老年人群衰弱现况,系统探讨影响我国老年患者衰弱的危险因素,探究我国老年住院患者衰弱与健康结局的关系。 

Objectives of Study:

To describe the frailty status of hospitalized elders in tertiary hospitals in China through a multi-center prospective study and to systematically analysis the risk factors of elderly patients with frailty in China, and explore the relationship between frailty and health outcomes of elderly hospitalized patients in China. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

1.年龄≥65岁 2.知情同意,愿意参与本研究 

Inclusion criteria

1. Aged ≥65 years old; 2. Voluntary participation and completion of consent. 

排除标准:

1.患者持续意识障碍或沟通障碍,无法进行有效交流且其照顾者无法提供有效信息 2.重度失能,长期卧床(≥4周) 

Exclusion criteria:

1. Patients with disorder of consciousness or communication and can not provide valid information; 2. Severe disability or immobility(≥4 weeks). 

研究实施时间:

Study execute time:

From2018-01-01To 2019-02-28 

征募观察对象时间:

Recruiting time:

From2018-09-01To 2018-12-31 

干预措施:

Interventions:

组别:

住院老年人群

样本量:

8400

Group:

hospitalized elders population

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

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):

东城区 

Country:

China 

Province:

Beijing 

City:

Dongcheng District 

单位(医院):

北京协和医院 

单位级别:

三级甲等 

Institution
hospital:

Peking Union Medical College Hospital  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

四川省 

市(区县):

 

Country:

China 

Province:

Sichuan Province 

City:

 

单位(医院):

四川省人民医院 

单位级别:

三级甲等 

Institution
hospital:

Sichuan Province People's Hospital  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

浙江省 

市(区县):

 

Country:

China 

Province:

Zhejiang Province 

City:

 

单位(医院):

浙江大学医学院附属第二医院 

单位级别:

三级甲等 

Institution
hospital:

The Second Affiliated Hospital Zhejiang University School of Medicine  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

青海省 

市(区县):

 

Country:

China 

Province:

Qinghai Province 

City:

 

单位(医院):

青海省人民医院 

单位级别:

三级甲等 

Institution
hospital:

Qinghai Province People's Hospital  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

黑龙江省 

市(区县):

 

Country:

China 

Province:

Heilongjiang Province 

City:

 

单位(医院):

哈尔滨医科大学附属第二医院 

单位级别:

三级甲等 

Institution
hospital:

The Second Affiliated Hospital of Harbin Medical University  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

湖北省 

市(区县):

 

Country:

China 

Province:

Hubei Province 

City:

 

单位(医院):

华中科技大学同济医学院附属同济医院 

单位级别:

三级甲等 

Institution
hospital:

Tongji Hospital Tongji Medical College of HUST  

Level of the institution:

Tertiary Hospital 

测量指标:

Outcomes:

指标中文名:

Frail衰弱评分

指标类型:

主要指标 

Outcome:

Frail score

Type:

Primary indicator 

测量时间点:

测量方法:

Frail score

Measure time point of outcome:

Measure method:

指标中文名:

抑郁状态

指标类型:

主要指标 

Outcome:

Depression

Type:

Primary indicator 

测量时间点:

测量方法:

Geriatric Depression Scale

Measure time point of outcome:

Measure method:

指标中文名:

日常生活活动能力

指标类型:

主要指标 

Outcome:

Activity of Daily Living

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

出院后再就医情况

指标类型:

主要指标 

Outcome:

Re-hospitalization record

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良事件发生情况

指标类型:

主要指标 

Outcome:

Adverse event

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量

指标类型:

主要指标 

Outcome:

Quality of life

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

谵妄

指标类型:

主要指标 

Outcome:

delirium

Type:

Primary 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:

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 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):

非随机研究

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

Non-randomized trial

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

邮件咨询

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

E-mail

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:

病例报告表 电子采集和管理系统

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

Case Record Form, CRF Electronic Data Capture, EDC

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2018-08-09
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