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A Randomized Controlled Trial of an Online Benefit-Finding Intervention for Dementia Family
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注册号：

Registration number：

 ChiCTR2500097859 

最近更新日期：

Date of Last Refreshed on：

 2025-03-10 16:11:08 

注册时间：

Date of Registration：

 2025-02-26 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

A Randomized Controlled Trial of an Online Benefit-Finding Intervention for Dementia Family

Public title：

A Randomized Controlled Trial of an Online Benefit-Finding Intervention for Dementia Family

注册题目简写：

English Acronym：

研究课题的正式科学名称：

A Randomized Controlled Trial of an Online Benefit-Finding Intervention for Dementia Family

Scientific title：

A Randomized Controlled Trial of an Online Benefit-Finding Intervention for Dementia Family

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：

Sheung-Tak Cheng 

研究负责人：

Sheung-Tak Cheng 

Applicant：

Sheung-Tak Cheng 

Study leader：

Sheung-Tak Cheng 

申请注册联系人电话：

Applicant telephone：

 +852 2948 6563

研究负责人电话：

Study leader's
telephone：

+852 2948 6563

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：

 takcheng@eduhk.hk

研究负责人电子邮件：

Study leader's E-mail：

 takcheng@eduhk.hk

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：

Room D4-2F-22, The Education University of Hong Kong, 10 Lo Ping Road, Tai Po, Hong Kong, China

研究负责人通讯地址：

Room D4-2F-22, The Education University of Hong Kong, 10 Lo Ping Road, Tai Po, Hong Kong, China

Applicant address：

Room D4-2F-22, The Education University of Hong Kong, 10 Lo Ping Road, Tai Po, Hong Kong, China

Study leader's address：

Room D4-2F-22, The Education University of Hong Kong, 10 Lo Ping Road, Tai Po, 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 Education University of Hong Kong, China

Applicant's institution：

The Education University of Hong Kong, China

研究负责人所在单位：

The Education University of Hong Kong, China

Affiliation of the Leader：

The Education University of Hong Kong, China

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：

 2021-2022-0077

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：

Human Research Ethics Committee, The Education University of Hong Kong

Name of the ethic committee：

Human Research Ethics Committee, The Education University of Hong Kong

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-01-28 00:00:00

伦理委员会联系人：

Jacqueline Hui

Contact Name of the ethic committee：

Jacqueline Hui

伦理委员会联系地址：

Research and Development Office, Room D4-1F-21, The Education University of Hong Kong, 10 Lo Ping Road, Tai Po, Hong Kong, China

Contact Address of the ethic committee：

Research and Development Office, Room D4-1F-21, The Education University of Hong Kong, 10 Lo Ping Road, Tai Po, Hong Kong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 2948 8058

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 hrec@eduhk.hk

研究实施负责（组长）单位：

The Education University of Hong Kong

Primary sponsor：

The Education University of Hong Kong

研究实施负责（组长）单位地址：

Room D4-2F-22, The Education University of Hong Kong, 10 Lo Ping Road, Tai Po, Hong Kong, China

Primary sponsor's address：

Room D4-2F-22, The Education University of Hong Kong, 10 Lo Ping Road, Tai Po, Hong Kong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

Committee for Research and Development

具体地址：

Research and Development Office, The Education University of Hong Kong, 10 Lo Ping Road, Tai Po, Hong Kong, China

Institution
hospital：

The Education University of Hong Kong

Address：

Research and Development Office, The Education University of Hong Kong, 10 Lo Ping Road, Tai Po, Hong Kong, China

经费或物资来源：

Research Grants Council of Hong Kong

Source(s) of funding：

Research Grants Council of Hong Kong

研究疾病：

Dementia  

Target disease：

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：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

This study explores whether a chatbot designed for dementia caregivers can be extended to non-caregiving family members and its acceptability and impacts. It aims to explore how such a chatbot would be received by these individuals and whether the chatbot is likely beneficial to them. It is also exploratory in the sense that it is the first study to test whether non-caregivers can be recruited directly and independently (i.e., not together with caregivers or patients) for an intervention study.  

Objectives of Study：

This study explores whether a chatbot designed for dementia caregivers can be extended to non-caregiving family members and its acceptability and impacts. It aims to explore how such a chatbot would be received by these individuals and whether the chatbot is likely beneficial to them. It is also exploratory in the sense that it is the first study to test whether non-caregivers can be recruited directly and independently (i.e., not together with caregivers or patients) for an intervention study.

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：

Those involved in providing care (either as primary or secondary caregivers) and those below 18 years of age would be excluded.

Exclusion criteria：

Those involved in providing care (either as primary or secondary caregivers) and those below 18 years of age would be excluded.

研究实施时间：

Study execute time：

从 From 2025-02-27 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-02-27 00:00:00 至 To 2025-11-30 00:00:00

干预措施：

Interventions：

组别：

Waitlist control group

样本量：

 20

Group：

Waitlist control group

Sample size：

干预措施：

None

干预措施代码：

Intervention：

None

Intervention code：

组别：

Intervention group

样本量：

 40

Group：

Intervention group

Sample size：

干预措施：

Chatbot use

干预措施代码：

Intervention：

Chatbot use

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong Special Administrative Region 

市(区县)：

  

Country：

China

Province：

Hong Kong Special Administrative Region

City：

单位(医院)：

 The Education University of Hong Kong 

单位级别：

 University 

Institution
hospital：

The Education University of Hong Kong

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

Caregiving preparedness

指标类型：

主要指标

Outcome：

Caregiving preparedness

Type：

Primary indicator

测量时间点：

Baseline and 1 month later

测量方法：

Self-report

Measure time point of outcome：

Baseline and 1 month later

Measure method：

Self-report

指标中文名：

Filial anxiety (anxiety related to filial responsibility)

指标类型：

次要指标

Outcome：

Filial anxiety (anxiety related to filial responsibility)

Type：

Secondary indicator

测量时间点：

Baseline and 1 month later

测量方法：

Self-report

Measure time point of outcome：

Baseline and 1 month later

Measure method：

Self-report

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

Questionnaire

组织：

NA

Sample Name：

Questionnaire

Tissue：

N/A

人体标本去向

 使用后销毁  

说明

N/A

Fate of sample：

Destruction after use  

Note：

N/A

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 18 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）：

The PI performs randomization using a true random number generator.

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

The PI performs randomization using a true random number generator.

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：

None

Blinding：

None

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

是Yes

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）：

Openclinica.com (data will be uploaded within six months of study completion)

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

Openclinica.com (data will be uploaded within six months of study completion)

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 is via self-administered questionnaire. Questionnaires will be destroyed after anonymized data are input into an electronic data file. The data file will be encrypted and accessible by the PI only.

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

Data collection is via self-administered questionnaire. Questionnaires will be destroyed after anonymized data are input into an electronic data file. The data file will be encrypted and accessible by the PI only.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-02-26 15:12:03
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