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老年中期照护服务流程和标准规范建立的研究
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注册号:

Registration number:

ChiCTR-INR-16009904 

最近更新日期:

Date of Last Refreshed on:

2016-11-17 

注册时间:

Date of Registration:

2016-11-17 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

老年中期照护服务流程和标准规范建立的研究 

Public title:

The elderly care service processes and standards  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

老年中期照护服务流程和标准规范建立的研究 

Scientific title:

The elderly care service processes and standards  

研究课题代号(代码):

Study subject ID:

首发2016-1-2194 

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:

高茂龙 

研究负责人:

陈峥 

Applicant:

Gao Maolong 

Study leader:

Chen Zheng 

申请注册联系人电话:

Applicant telephone:

+86 15110081308 

研究负责人电话:

Study leader's telephone:

+86 01083183988 

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:

gml3447@163.com 

研究负责人电子邮件:

Study leader's E-mail:

paul_c99@sina.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:

北京市海淀区温泉路118号 

研究负责人通讯地址:

北京市海淀区温泉路118号 

Applicant address:

118 Spring Road, Haidian District, Beijing 

Study leader's address:

118 Spring Road, Haidian District, Beijing 

申请注册联系人邮政编码:

Applicant postcode:

100095 

研究负责人邮政编码:

Study leader's postcode:

100095 

申请人所在单位:

北京老年医院 

Applicant's institution:

Beijing Geriatric 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:

2015-001 

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:

北京老年医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Beijing Geriatric Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2015-04-03 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

北京老年医院 

Primary sponsor:

Beijing Geriatric Hospital 

研究实施负责(组长)单位地址:

北京市海淀区温泉路118号 

Primary sponsor's address:

118 Spring 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

市(区县):

海淀区

Country:

China

Province:

Beijing

City:

Haidian District

单位(医院):

北京老年医院

具体地址:

北京市海淀区温泉路118号

Institution
hospital:

Beijing Geriatric Hospital

Address:

118 Spring Road, Haidian District, Beijing

经费或物资来源:

北京市卫生和计划生育委员会 

Source(s) of funding:

Beijing Municipal Commission of Health and Family Planning 

研究疾病:

慢性病 

Target disease:

chronic disease 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

通过本项目的研究,分析我国现有老年医学服务的现状与弊端,提出构建我国老年中期照护服务模式的理论依据和数据支持,逐步建立我国老年中期照护的服务流程和标准规范,更好地满足老年人日益增长的健康服务需求,不断提升老年患者的生存质量和健康期望寿命。 

Objectives of Study:

Through this project research, analysis of the current situation and shortcomings of Chinese existing medical service, construct the middle aged care service model theoretical basis and data support, the gradual establishment of China's elderly intermediate care service processes and standards, to better meet the growing demand for health services for the elderly, improve elderly patients the quality of life and health life expectancy 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

符合急性期医院出院条件但需转诊入住中期照护机构的老年患者,愿意参与本项目的研究,并能够接受为期一年的跟踪随访;在急性疾病住院期间出现功能下降,但生命征象稳定,不需要做密集医疗介入、医学检验或氧气使用者;经老年照护团队进行老年综合评估认定具有康复潜能。 

Inclusion criteria

With acute hospital conditions but elderly patients need referral for intermediate care institutions, research is willing to participate in the project, and be able to accept the follow-up for one year; in the acute disease hospitalized function decline, but the vital signs are stable, do not require intensive medical intervention, medical examination or oxygen users; the elderly care team to carry out comprehensive geriatric assessment identified as having potential for rehabilitation. 

排除标准:

从急性期医院出院的老年患者,身体基本康复或基本没有康复可能,且不愿意参与本项目研究者;确定做特定手术或特殊检查者(人工关节置换除外);末期疾病之急病状况;癌症病患需化疗或放疗;患者经治疗团队判定需转介长期照护机构者。 

Exclusion criteria:

Elderly patients discharged from acute hospital, basic physical rehabilitation or no chance of recovery, and unwilling to participate in the project research; make specific operation or special inspection (except artificial joint replacement); emergency condition of end-stage renal disease; cancer patients need chemotherapy or radiotherapy; patients after treatment team to be transferred to the judge long-term care institut 

研究实施时间:

Study execute time:

From2016-01-01To 2017-12-31 

征募观察对象时间:

Recruiting time:

From2016-11-17To 2017-12-31 

干预措施:

Interventions:

组别:

试验组

样本量:

800

Group:

Experience group

Sample size:

干预措施:

中期照护

干预措施代码:

Intervention:

Intermediate care

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):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京老年医院 

单位级别:

三级 

Institution
hospital:

Beijing Geriatric Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京小汤山医院 

单位级别:

三级 

Institution
hospital:

Beijing Xiao Tang Shan Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京市隆福医院 

单位级别:

二级 

Institution
hospital:

Beijing Longfu Hospital  

Level of the institution:

Secondary hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京市西城区广外医院 

单位级别:

二级 

Institution
hospital:

Beijing city Xicheng Guangwai hospital  

Level of the institution:

Secondary hospital 

测量指标:

Outcomes:

指标中文名:

生活能力

指标类型:

主要指标 

Outcome:

ADL

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

死亡率

指标类型:

主要指标 

Outcome:

mortality

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

认知功能

指标类型:

次要指标 

Outcome:

cognitive function

Type:

Secondary 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:

次要指标 

Outcome:

quality of life

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院次数

指标类型:

次要指标 

Outcome:

hospitalization times

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:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 60 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):

统计学人员用电脑程序生成随机数字表

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

Random number table was generated throug a computer program

盲法:

Blinding:

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:

即时公开/Real time access

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):

2017-12-31

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

2017-12-31

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:

EXCEL

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

EXCEL

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-11-17
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