ChiCTR1800016097 版本V1.1 版本创建时间2018/09/13 17:03:07 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR1800016097 

最近更新日期：

Date of Last Refreshed on：

 2018-09-13 16:58:42 

注册时间：

Date of Registration：

 2018-05-02 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

探討中度認知障礙及中度腦退化症患者及其照顧者參與優勢取向計劃後 在改善與健康相關之生活質素的成效之研究

Public title：

The effects of strengths-based dyadic program on health-related quality of life (HRQL) of people with mild cognitive impairment and mild dementia in the community

注册题目简写：

English Acronym：

研究课题的正式科学名称：

探討中度認知障礙及中度腦退化症患者及其照顧者參與優勢取向計劃後 在改善與健康相關之生活質素的成效之研究

Scientific title：

The effects of strengths-based dyadic program on health-related quality of life (HRQL) of people with mild cognitive impairment and mild dementia in the community

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：

CUHK_CCRB00604

申请注册联系人：

Doris, Sau-fung Yu 

研究负责人：

Doris, Sau-fung Yu 

Applicant：

Doris, Sau-fung Yu 

Study leader：

Doris, Sau-fung Yu 

申请注册联系人电话：

Applicant telephone：

 +852 39434289

研究负责人电话：

Study leader's
telephone：

+852 39434289

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：

 dyu@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 dyu@cuhk.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 https://www2.ccrb.cuhk.edu.hk/registry/public/550

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 https://www2.ccrb.cuhk.edu.hk/registry/public/550

申请注册联系人通讯地址：

Rm 729, 7/F, Esther Lee Building, The Nethersole School of Nursing, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong, China

研究负责人通讯地址：

Rm 729, 7/F, Esther Lee Building, The Nethersole School of Nursing, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong, China

Applicant address：

Rm 729, 7/F, Esther Lee Building, The Nethersole School of Nursing, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong, China

Study leader's address：

Rm 729, 7/F, Esther Lee Building, The Nethersole School of Nursing, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong, 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：

The Nethersole School of Nurisng, Faculty of Medicine, The Chinese University of Hong Kong

Applicant's institution：

The Nethersole School of Nurisng, Faculty of Medicine, The Chinese University of Hong Kong

研究负责人所在单位：

The Nethersole School of Nurisng, Faculty of Medicine, The Chinese University of Hong Kong

Affiliation of the Leader：

The Nethersole School of Nurisng, Faculty of Medicine, The Chinese University of Hong Kong

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：

 2017.380

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：

Joint CUHK-NTEC Clinical Research Ethics Committee

Name of the ethic committee：

Joint CUHK-NTEC Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2017-08-17 00:00:00

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：

香港中文大學那打素護理學院

Primary sponsor：

The Nethersole School of Nursing, The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

The Nethersole School of Nursing, The Chinese University of Hong Kong

Primary sponsor's address：

The Nethersole School of Nursing, The Chinese University of Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Tung Wah Group of Hospitals

Source(s) of funding：

Tung Wah Group of Hospitals

研究疾病：

認知障礙及中度腦退化症  

Target disease：

people with mild cognitive impairment and mild dementia

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：

 I期临床试验 

Study phase：

1

研究设计：

横断面 

Study design：

Cross-sectional 

研究目的：

探討中度認知障礙及中度腦退化症患者及其照顧者參與優勢取向計劃後 在改善與健康相關之生活質素的成效  

Objectives of Study：

To explore the effects of strengths-based dyadic program on health-related quality of life (HRQL) of people with mild cognitive impairment and mild dementia in the community

药物成份或治疗方案详述：

Strengths-based dyadic program. The educative-counseling program will contain five interactive educative-counseling sessions, with four sessions focus on the following the core topics for the dyads, followed by one wrap up session. The four core topics include: a) effective dyadic communication, b) managing memory loss and the associated problems, c) ways to stay active even with cognitive impairment or caregiving responsibilities; d) recognizing and managing maladaptive emotions and behaviors in coping with the disease or caregiving. The control intervention will include the usual care as provided by the Neighborhood Elderly Centre (NEC) or District Elderly Community Centre (DECC) under the operation of the Tung Wah Hospital. 

Description for medicine or protocol of treatment in detail：

Strengths-based dyadic program. The educative-counseling program will contain five interactive educative-counseling sessions, with four sessions focus on the following the core topics for the dyads, followed by one wrap up session. The four core topics include: a) effective dyadic communication, b) managing memory loss and the associated problems, c) ways to stay active even with cognitive impairment or caregiving responsibilities; d) recognizing and managing maladaptive emotions and behaviors in coping with the disease or caregiving. The control intervention will include the usual care as provided by the Neighborhood Elderly Centre (NEC) or District Elderly Community Centre (DECC) under the operation of the Tung Wah Hospital. 

纳入标准：

1. People with a confirmed diagnosis of MCI as indicated by a Clinical Dementia Rating Score of 0.5 or mild dementia and their primary co-residing family caregivers;
2. Able to communicate with the intervention specialist and research assistants;
3. No pre-existing acute psychotic disease;
4. Consent to participate.

Inclusion criteria

1. People with a confirmed diagnosis of MCI as indicated by a Clinical Dementia Rating Score of 0.5 or mild dementia and their primary co-residing family caregivers;
2. Able to communicate with the intervention specialist and research assistants;
3. No pre-existing acute psychotic disease;
4. Consent to participate.

排除标准：

Subjects with psychotic disorders, unable to communicate and unable to give consent will be excluded.

Exclusion criteria：

Subjects with psychotic disorders, unable to communicate and unable to give consent will be excluded.

研究实施时间：

Study execute time：

从 From 1990-01-01 00:00:00至 To 1990-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2018-05-02 00:00:00 至 To 1990-01-01 00:00:00

干预措施：

Interventions：

组别：

Two groups

样本量：

 142

Group：

Two groups

Sample size：

干预措施：

Strengths-based dyadic program 1 hour per session, 1 session per week, for 9 weeks versus usual care

干预措施代码：

Intervention：

Strengths-based dyadic program 1 hour per session, 1 session per week, for 9 weeks versus usual care

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 The Nethersole School of Nursing, The Chinese University of Hong Kong 

单位级别：

 The Nethersole School of Nursing, The Chinese University of Hong Kong 

Institution
hospital：

The Nethersole School of Nursing, The Chinese University of Hong Kong

Level of the institution：

The Nethersole School of Nursing, The Chinese University of Hong Kong

测量指标：

Outcomes：

指标中文名：

Cognitive Function

指标类型：

主要指标

Outcome：

Cognitive Function

Type：

Primary indicator

测量时间点：

测量方法：

30-item Mini-Mental State Examination Questionnaire

Measure time point of outcome：

Measure method：

30-item Mini-Mental State Examination Questionnaire

指标中文名：

Subjective Memory

指标类型：

主要指标

Outcome：

Subjective Memory

Type：

Primary indicator

测量时间点：

测量方法：

24-item Memory Inventory for Chinese (MIC) Questionnaire

Measure time point of outcome：

Measure method：

24-item Memory Inventory for Chinese (MIC) Questionnaire

指标中文名：

Behavioral and psychological symptoms of dementia

指标类型：

主要指标

Outcome：

Behavioral and psychological symptoms of dementia

Type：

Primary indicator

测量时间点：

测量方法：

The 24-item Revised Memory and Behavioural Problem Checklist

Measure time point of outcome：

Measure method：

The 24-item Revised Memory and Behavioural Problem Checklist

指标中文名：

Depressive symptoms of caregiver

指标类型：

主要指标

Outcome：

Depressive symptoms of caregiver

Type：

Primary indicator

测量时间点：

测量方法：

Center for Epidemiologic Studies Depression Scale (CESD-10, Chinese version)

Measure time point of outcome：

Measure method：

Center for Epidemiologic Studies Depression Scale (CESD-10, Chinese version)

指标中文名：

Caregiver self-efficacy

指标类型：

主要指标

Outcome：

Caregiver self-efficacy

Type：

Primary indicator

测量时间点：

测量方法：

15-item Caregiving Self-Efficacy Scale

Measure time point of outcome：

Measure method：

15-item Caregiving Self-Efficacy Scale

指标中文名：

Dyadic relationship strain

指标类型：

主要指标

Outcome：

Dyadic relationship strain

Type：

Primary indicator

测量时间点：

测量方法：

Dyadic Relationship Scale

Measure time point of outcome：

Measure method：

Dyadic Relationship Scale

指标中文名：

Health-related quality of life

指标类型：

主要指标

Outcome：

Health-related quality of life

Type：

Primary indicator

测量时间点：

测量方法：

12-item version of the Short Form Health Survey (version 2)

Measure time point of outcome：

Measure method：

12-item version of the Short Form Health Survey (version 2)

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 60 岁 years
最大 Max age 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）：

Randomized

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

Randomized

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：

Single-blind for Investigator/research team

Blinding：

Single-blind for Investigator/research team

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

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）：

Not stated

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

Not stated

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：

Not stated

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

Not stated

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2018-05-11 13:15:31