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Strengthening professional collaboration in dementia caregiver education and research via the provision and evaluation of the iSupport program in Hong Kong
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注册号：

Registration number：

 ChiCTR2100049125 

最近更新日期：

Date of Last Refreshed on：

 2021-07-21 03:52:20 

注册时间：

Date of Registration：

 2021-07-21 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Strengthening professional collaboration in dementia caregiver education and research via the provision and evaluation of the iSupport program in Hong Kong

Public title：

Strengthening professional collaboration in dementia caregiver education and research via the provision and evaluation of the iSupport program in Hong Kong

注册题目简写：

English Acronym：

Evaluation of iSupport Program in Hong Kong

研究课题的正式科学名称：

Strengthening professional collaboration in dementia caregiver education and research via the provision and evaluation of the iSupport program in Hong Kong

Scientific title：

Strengthening professional collaboration in dementia caregiver education and research via the provision and evaluation of the iSupport program in Hong Kong

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：

Bel Wong 

研究负责人：

Prof Timothy Kwok 

Applicant：

Bel Wong 

Study leader：

Prof Timothy Kwok 

申请注册联系人电话：

Applicant telephone：

 +852 26366323

研究负责人电话：

Study leader's
telephone：

+86 3505 3145

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：

 bel.wong@jccpa.org.hk

研究负责人电子邮件：

Study leader's E-mail：

 tkwok@cuhk.edu.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：

27 A Kung Kok Street, Shatin, Hong Kong, China

研究负责人通讯地址：

9/F., Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong, China

Applicant address：

27 A Kung Kok Street, Shatin, Hong Kong, China

Study leader's address：

9/F., Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, 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：

香港中文大學

Applicant's institution：

JCCPA

研究负责人所在单位：

香港中文大學

Affiliation of the Leader：

Chinese University of Hong Kong

是否获伦理委员会批准：

否

Approved by ethic committee：

No

伦理委员会批件文号：

Approved No. of ethic committee：

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：

Name of the ethic committee：

伦理委员会批准日期：

Date of approved by ethic committee：

 2013-08-26 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：

2020 Australian Government National Foundation for Overseas research grant Australia-China Relations

Primary sponsor：

2020 Australian Government National Foundation for Overseas research grant Australia-China Relations

研究实施负责（组长）单位地址：

Suite 4502, Australia Square, 264 George Street, Sydney NSW 2000

Primary sponsor's address：

Suite 4502, Australia Square, 264 George Street, Sydney NSW 2000

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Research grant

Source(s) of funding：

Research grant

研究疾病：

disease  

Target disease：

disease

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational 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：

To conduct a multicentre trial with 34 careers in a 9 month period (1) to evaluate the effectiveness and cost-effectiveness of the iSupport program; (2) to understand caregivers experiences in the program.  

Objectives of Study：

To conduct a multicentre trial with 34 carers in a 9 month period (1) to evaluate the effectiveness and cost-effectiveness of the iSupport program; (2) to understand caregivers experiences in the program.

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：

1. Careers have severe mental health conditions or terminal illness;
2. Careers involved in phase 1 study or other studies;
3. Careers who cannot read Chinese without assistance.

Exclusion criteria：

1. Careers have severe mental health conditions or terminal illness;
2. Careers involved in phase 1 study or other studies;
3. Careers who cannot read Chinese without assistance.

研究实施时间：

Study execute time：

从 From 2021-09-01 00:00:00至 To 2022-12-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-08-16 00:00:00 至 To 2022-06-30 00:00:00

干预措施：

Interventions：

组别：

样本量：

 34

Group：

2

Sample size：

干预措施：

干预措施代码：

Intervention：

Online self-learning site

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)：

 JCCPA 

单位级别：

  

Institution
hospital：

JCCPA

Level of the institution：

测量指标：

Outcomes：

指标中文名：

12-Item Short-Form Health Survey

指标类型：

主要指标

Outcome：

12-Item Short-Form Health Survey

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：

标本中文名：

NA

组织：

NA

Sample Name：

NA

Tissue：

NA

人体标本去向

 使用后销毁  

说明

NA

Fate of sample：

Destruction after use  

Note：

NA

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 18 岁 years
最大 Max age 99 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）：

After baseline data collection, careers will be randomly assigned to either an iSupport group or a usual care group on a 1:1 ratio with a block size of four. Random numbers will be generated using SPSS by a researcher not involved in the subject recruitment and baseline assessment.

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

After baseline data collection, careers will be randomly assigned to either an iSupport group or a usual care group on a 1:1 ratio with a block size of four. Random numbers will be generated using SPSS by a researcher not involved in the subject recruitment and baseline assessment.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

N/A

Blinding：

N/A

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）：

N/A

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

NA

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：

The data of online assessment will be downloaded and migrated into the SPSS data template once a week to prevent data loss. Data cleaning will be done periodically. Audio-recorded monthly meetings will be transcribed verbatim for qualitative analysis. All personal data will be kept confidential according to the Personal Data (Privacy) Ordinance and the general ethical guideline of human research of CUHK. We would not record the name and other information such as HKID no. which would potentially identify the identity of the control subjects; only patient codes will be recorded. Dataset containing personal data will be kept separate from the questionnaires and only involved researchers can get access to it. In any form of publications, no personal information of any subject will be disclosed on an individual basis. De-identified data will be stored at JCCPA server as well as Flinders University OneDrive for five years upon findings publication, after that the data will be destroyed.

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

The data of online assessment will be downloaded and migrated into the SPSS data template once a week to prevent data loss. Data cleaning will be done periodically. Audio-recorded monthly meetings will be transcribed verbatim for qualitative analysis. All personal data will be kept confidential according to the Personal Data (Privacy) Ordinance and the general ethical guideline of human research of CUHK. We would not record the name and other information such as HKID no. which would potentially identify the identity of the control subjects; only patient codes will be recorded. Dataset containing personal data will be kept separate from the questionnaires and only involved researchers can get access to it. In any form of publications, no personal information of any subject will be disclosed on an individual basis. De-identified data will be stored at JCCPA server as well as Flinders University OneDrive for five years upon findings publication, after that the data will be destroyed.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-07-21 03:52:21
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