SHADOWING THE GOLDEN PATH ‐ A Systematic, Multi‐modal Program for Family Carers to Re‐ discover Positive Aspects of Caregiving

注册号:

Registration number:

ChiCTR2400089238 

最近更新日期:

Date of Last Refreshed on:

2024-09-04 11:03:04 

注册时间:

Date of Registration:

2024-09-04 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

SHADOWING THE GOLDEN PATH ‐ A Systematic, Multi‐modal Program for Family Carers to Re‐ discover Positive Aspects of Caregiving

Public title:

SHADOWING THE GOLDEN PATH ‐ A Systematic, Multi‐modal Program for Family Carers to Re‐ discover Positive Aspects of Caregiving

注册题目简写:

English Acronym:

研究课题的正式科学名称:

SHADOWING THE GOLDEN PATH ‐ A Systematic, Multi‐modal Program for Family Carers to Re‐ discover Positive Aspects of Caregiving

Scientific title:

SHADOWING THE GOLDEN PATH ‐ A Systematic, Multi‐modal Program for Family Carers to Re‐ discover Positive Aspects of Caregiving

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:

Harriet Tang 

研究负责人:

Professor Lam Chiu Wa 

Applicant:

Harriet Tang 

Study leader:

Professor Lam Chiu Wa 

申请注册联系人电话:

Applicant telephone:

+852 2831 4305

研究负责人电话:

Study leader's
telephone:

+852 2831 4305

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:

cwwpmex@cuhk.edu.hk

研究负责人电子邮件:

Study leader's E-mail:

cwlam@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:

Department of Psychiatry, G/F, Multi-centre, Tai Po Hospital, Tai Po, N.T., Hong Kong

研究负责人通讯地址:

Department of Psychiatry, G/F, Multi-centre, Tai Po Hospital, Tai Po, N.T., Hong Kong

Applicant address:

Department of Psychiatry, G/F, Multi-centre, Tai Po Hospital, Tai Po, N.T., Hong Kong

Study leader's address:

Department of Psychiatry, G/F, Multi-centre, Tai Po Hospital, Tai Po, N.T., Hong Kong

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:

The Chinese University of Hong Kong

研究负责人所在单位:

香港中文大學

Affiliation of the Leader:

The Chinese University of Hong Kong

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

SBRE-21-0859

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:

香港中文大學調查及行為研究操守委員會

Name of the ethic committee:

Survey and Conduct Research Conduct Committee of the University of Chinese Hong Kong

伦理委员会批准日期:

Date of approved by ethic committee:

2022-09-02 00:00:00

伦理委员会联系人:

Ms. Eva Yeung

Contact Name of the ethic committee:

Ms. Eva Yeung

伦理委员会联系地址:

香港新界沙田香港中文大學信和樓1樓111室 社會科學院院務處

Contact Address of the ethic committee:

Faculty Office of Social Science, Room 111, 1/F, Sino Building, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong

伦理委员会联系人电话:

Contact phone of the ethic committee:

+852 3943 9263

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

Primary sponsor:

The Chinese University of Hong Kong

研究实施负责(组长)单位地址:

The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong

Primary sponsor's address:

The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong

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):

香港中文大學

具体地址:

The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong

Institution
hospital:

The Chinese University of Hong Kong

Address:

The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong

经费或物资来源:

The D. H. Chen Foundation

Source(s) of funding:

The D. H. Chen Foundation

研究疾病:

mental health problems and neurocognitive disorders  

Target disease:

mental health problems and neurocognitive disorders

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:

单臂 

Study design:

Single arm 

研究目的:

The current study aims to achieve two major objectives 1) to evaluate the program effectiveness in alleviating mental distress and promoting mental well being of caregivers. 2) to identify the facilitators and barriers for program dissemination by frontline health professionals working at elderly centres  

Objectives of Study:

The current study aims to achieve two major objectives 1) to evaluate the program effectiveness in alleviating mental distress and promoting mental well being of caregivers. 2) to identify the facilitators and barriers for program dissemination by frontline health professionals working at elderly centres

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) Bedridden care recipients. 2) Caregiver is a domestic worker. 3) Caregiver is currently participating in other mental support programs.

Exclusion criteria:

1) Bedridden care recipients. 2) Caregiver is a domestic worker. 3) Caregiver is currently participating in other mental support programs.

研究实施时间:

Study execute time:

From 2022-08-17 00:00:00 To 2025-05-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2022-09-14 00:00:00 To 2025-05-31 00:00:00

干预措施:

Interventions:

组别:

Intervention

样本量:

180

Group:

Intervention

Sample size:

干预措施:

10-session weekly mindfulness and physical exercise practices

干预措施代码:

Intervention:

10-session weekly mindfulness and physical exercise practices

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 S.A.R

City:

单位(医院):

香港中文大學 

单位级别:

大學 

Institution
hospital:

The Chinese University of Hong Kong

Level of the institution:

University

测量指标:

Outcomes:

指标中文名:

常見精神健康徵狀

指标类型:

次要指标

Outcome:

Presence of symptoms of common mental disorders

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

Clinical Interview Schedule-revised (CIS-R)

指标中文名:

身心健康狀況

指标类型:

主要指标

Outcome:

Mental Well-being

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

The Warwick–Edinburgh Mental Well-being Scale (WEMWBS)

指标中文名:

靜觀覺察注意

指标类型:

主要指标

Outcome:

Mindfulness Attention Awareness

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

Mindfulness Attention Awareness Scale (MAAS)

指标中文名:

生活目標

指标类型:

主要指标

Outcome:

Purpose in Life

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

Purpose in Life Scale (Chinese, C-PIL, 4 questions)

指标中文名:

生活滿意度

指标类型:

主要指标

Outcome:

Satisfaction with Life

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

Satisfaction with Life Scale

指标中文名:

照顧者負擔

指标类型:

主要指标

Outcome:

Caregiver Burden

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

Zarit Caregiver Burden Interview 4-item (ZBI)

指标中文名:

計劃的促進因素及障礙因素

指标类型:

主要指标

Outcome:

acilitators and barriers for program

Type:

Primary indicator

测量时间点:

测量方法:

Semi-structured questionnaires

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

None

Tissue:

人体标本去向

其它  

说明

Fate of sample:

0thers  

Note:

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 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):

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

None

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:

Blinding:

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):

http://www.medresman.org.cn/login.aspx,在试验结束6个月内上传试验数据

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

http://www.medresman.org.cn/login.aspx,Data will be uploaded within 6 months of the end of the trial

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:

EDC

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

EDC

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2024-09-04 11:02:57