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The Evaluation of Interactive Cognitive Function Training Program (ICFTP) on Elders's abilities
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注册号:

Registration number:

ChiCTR-IOR-14005490 

最近更新日期:

Date of Last Refreshed on:

2014-11-16 

注册时间:

Date of Registration:

2014-11-16 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

互動式認知功能訓練模式於社區老人之成效探討 

Public title:

The Evaluation of Interactive Cognitive Function Training Program (ICFTP) on Elders's abilities 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

評值互動式認知功能訓練模式(Interactive Cognitive Function Training Program, ICFTP)於社區老人之整體認知功能、執行功能及手眼協調功能成效之探討:一臨床試驗研究 

Scientific title:

The Evaluation of Interactive Cognitive Function Training Program (ICFTP) on Elders' General Cognitive Functions, Executive Functions, and Visuo-Motor Abilities: A Randomized Controlled Study 

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:

邱惠鈴 

研究负责人:

周桂如 

Applicant:

Huei-ling, Chiu 

Study leader:

Kuei-ru,Chou 

申请注册联系人电话:

Applicant telephone:

+886-921324342 

研究负责人电话:

Study leader's telephone:

+886-227361661 

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:

getreiko@gmail.com 

研究负责人电子邮件:

Study leader's E-mail:

kueiru@tmu.edu.tw 

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:

台北市南港區重陽路491號2樓之一 

研究负责人通讯地址:

台北市信義區吳興街250號 

Applicant address:

2F.-1, No.491, Chongyang Rd., Nangang Dist., Taipei City 115, Taiwan 

Study leader's address:

No.2501, Wuxing St., Xinyi Dist., Taipei City 110, Taiwan 

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:

台北醫學大學護理學研究所 

Applicant's institution:

Taipei medical 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:

201312037 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

台北醫學大學暨附屬醫院聯合人體研究倫理委員會 

Name of the ethic committee:

TMU--joint institutional review bosrd 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-02-12 

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:

台北醫學大學 

Primary sponsor:

Taipei medical university 

研究实施负责(组长)单位地址:

台北市信義區吳興街250號 

Primary sponsor's address:

No.2501, Wuxing St., Xinyi Dist., Taipei City 110, Taiwan 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

台灣

市(区县):

台北

Country:

China

Province:

Taiwan

City:

Taipei

单位(医院):

健康服務中心

具体地址:

台北市信義區吳興街250號

Institution
hospital:

Health Centers in Taipei City

Address:

No.2501, Wuxing St., Xinyi Dist., Taipei City 110, Taiwan

经费或物资来源:

none 

Source(s) of funding:

none 

研究疾病:

健康促進,屬預防性介入 

Target disease:

health promotion 

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:

其它 

Study phase:

N/A 

研究目的:

探討互動式認知功能訓練模式(ICFTP)介入對社區老人之『整體認知功能』(General cognitive functions)之影響。 

Objectives of Study:

To evaluate the effecness of interactive cognitive training in elderly 

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:

Inclusion criteria for community-dwelling elderly will be: (1) age 65 and older; (2) ability to understand the meaning of a consent form; (3) not currently enrolled in another research study were invited to participate. 

Inclusion criteria

Inclusion criteria for community-dwelling elderly will be: (1) age 65 and older; (2) ability to understand the meaning of a consent form; (3) not currently enrolled in another research study were invited to participate. 

排除标准:

Exclusion criteria will be: (1) the subject is diagnosed with dementia using the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) or the National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA); (2) medical conditions indicative of rapid functional or cognitive decline (e.g., previous head trauma, loss of consciousness, or stroke history); (3) diagnosis of severe psychiatric disorders or behavioral problems that preclude cooperation with the training procedure; or (4) severe visual, auditory or communication disorders (e.g., difficulty in reading a newspaper or visual examination scores lower than 20/70) 

Exclusion criteria:

Exclusion criteria will be: (1) the subject is diagnosed with dementia using the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) or the National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA); (2) medical conditions indicative of rapid functional or cognitive decline (e.g., previous head trauma, loss of consciousness, or stroke history); (3) diagnosis of severe psychiatric disorders or behavioral problems that preclude cooperation with the training procedure; or (4) severe visual, auditory or communication disorders (e.g., difficulty in reading a newspaper or visual examination scores lower than 20/70) 

研究实施时间:

Study execute time:

From2014-12-01To  

干预措施:

Interventions:

组别:

Two groups

样本量:

70

Group:

Two groups

Sample size:

干预措施:

cognitive training

干预措施代码:

Intervention:

cognitive training

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

台灣 

市(区县):

台北 

Country:

China 

Province:

Taiwan 

City:

Taipei 

单位(医院):

健康服務中心 

单位级别:

二级 

Institution
hospital:

Health Centers in Taipei City  

Level of the institution:

Secondary 

测量指标:

Outcomes:

指标中文名:

認知功能

指标类型:

主要指标 

Outcome:

cognitive function

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 99 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):

電腦隨機號碼分配

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

computer-generate the random number

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

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

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:

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

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2014-11-16
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