ChiCTR-IIC-17011097 版本V1.0 版本创建时间2018/09/22 22:21:44 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：

ChiCTR-IIC-17011097 

最近更新日期：

Date of Last Refreshed on：

2017-04-09 15:49:04 

注册时间：

Date of Registration：

2017-04-06 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

探討腦退化症患者的家庭照顧者接受健康教育計劃後在改善心理健康上的成效之研究

Public title：

The effects of a strengths–based intervention based on salutogenic model on sense of coherence, coping, psychological status and health-related quality of life of family caregivers of persons with dementia

注册题目简写：

English Acronym：

研究课题的正式科学名称：

探討腦退化症患者的家庭照顧者接受健康教育計劃後在改善心理健康上的成效之研究

Scientific title：

The effects of a strengths–based intervention based on salutogenic model on sense of coherence, coping, psychological status and health-related quality of life of family caregivers of persons with dementia

研究课题代号(代码)：

Study subject ID：

 CRE2016.063-T

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_CCRB00551

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/382

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/382

申请注册联系人通讯地址：

7/F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

研究负责人通讯地址：

7/F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

Applicant address：

7/F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

Study leader's address：

7/F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, 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：

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/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

CRE2016.063-T

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：

2016-03-08 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：

Faculty of Medicine, The Chinese University of Hong Kong

Primary sponsor：

Faculty of Medicine, The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

Faculty of Medicine, The Chinese University of Hong Kong

Primary sponsor's address：

Faculty of Medicine, 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：

NA

Source(s) of funding：

NA

Target disease：

Dementia

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：

探討腦退化症患者的家庭照顧者接受健康教育計劃後在改善心理健康上的成效  

Objectives of Study：

The effects of a strengths–based intervention based on salutogenic model on sense of coherence, coping, psychological status and health-related quality of life of family caregivers of persons with dementia

药物成份或治疗方案详述：

The strengths-based intervention will adopt an eclectic approach to integrate skills in narrative therapy and empowerment strategies. Narrative skills including externalisation and re-authoring conversations will be used to enhance the caregivers’ awareness of the generalised resistance resources (GRR) in their internal and external environment, whereas the empowerment strategies (i.e., goal setting and attainment process) will be used to empower the caregivers to mobilise the GRR in day-to-day caregiving. To ensure the strengths-based intervention thoroughly covers the complex dementia caregiving experience, six core areas have been identified to provide focus for the intervention, including: a) handling the functional loss of patients with dementia (PWDs), b) handling challenging behaviours of PWDs, c) communication and interaction with PWDs, d) gauging PWDs’ capabilities, e) dyadic relational strain, and f) self-care for caregivers. Each core area will be addressed in two consecutive sessions. A total of 12 sessions will be required to cover the six core areas. Together with a team building session at the commencement and a round-up session in closing, the strengths-based intervention include a total of 14 weekly sessions (90 minutes/ session) conducted in a group of six caregivers. Upon the completion of these 14 sessions, a bi-weekly telephone calls will be given to monitor the goal attainment of the caregivers. Basic education on dementia caregiving serves as the control intervention. It includes seven bi-weekly group-based (6 caregivers/ group) information seminars (45minutes/ session) delivered by a another research assistant (RA) according to a PowerPoint developed. Topics relating to dementia caregiving including: a) handling functional loss, b) handling challenging behaviors, c) home safety, d) brain health initiatives, e) communication with PWD, f) stress management, and g) community resource will be covered. The RA will answer the questions from the caregivers upon asked. The discussed content will be documented to allow evaluating the nature of control intervention. Upon the completion of all sessions, the RA will give two bi-weekly telephone calls to each caregiver for general greetings. Questions raised by the caregivers will be answered according to the educative content. Any extra information given will be documented. 

Description for medicine or protocol of treatment in detail：

The strengths-based intervention will adopt an eclectic approach to integrate skills in narrative therapy and empowerment strategies. Narrative skills including externalisation and re-authoring conversations will be used to enhance the caregivers awareness of the generalised resistance resources (GRR) in their internal and external environment, whereas the empowerment strategies (i.e., goal setting and attainment process) will be used to empower the caregivers to mobilise the GRR in day-to-day caregiving. To ensure the strengths-based intervention thoroughly covers the complex dementia caregiving experience, six core areas have been identified to provide focus for the intervention, including: a) handling the functional loss of patients with dementia (PWDs), b) handling challenging behaviours of PWDs, c) communication and interaction with PWDs, d) gauging PWDs capabilities, e) dyadic relational strain, and f) self-care for caregivers. Each core area will be addressed in two consecutive sessions. A total of 12 sessions will be required to cover the six core areas. Together with a team building session at the commencement and a round-up session in closing, the strengths-based intervention include a total of 14 weekly sessions (90 minutes/ session) conducted in a group of six caregivers. Upon the completion of these 14 sessions, a bi-weekly telephone calls will be given to monitor the goal attainment of the caregivers. Basic education on dementia caregiving serves as the control intervention. It includes seven bi-weekly group-based (6 caregivers/ group) information seminars (45minutes/ session) delivered by a another research assistant (RA) according to a PowerPoint developed. Topics relating to dementia caregiving including: a) handling functional loss, b) handling challenging behaviors, c) home safety, d) brain health initiatives, e) communication with PWD, f) stress management, and g) community resource will be covered. The RA will answer the questions from the caregivers upon asked. The discussed content will be documented to allow evaluating the nature of control intervention. Upon the completion of all sessions, the RA will give two bi-weekly telephone calls to each caregiver for general greetings. Questions raised by the caregivers will be answered according to the educative content. Any extra information given will be documented. 

纳入标准：

i) Chinese family caregivers of PWDs diagnosed for more than 1 year
ii) live in the same household with the PWDs
iii) provide daily caregiving for more than 4 hours per day
iv) consent to participate

Inclusion criteria

i) Chinese family caregivers of PWDs diagnosed for more than 1 year
ii) live in the same household with the PWDs
iii) provide daily caregiving for more than 4 hours per day
iv) consent to participate

排除标准：

Family caregivers with psychotic disorders

Exclusion criteria：

Family caregivers with psychotic disorders

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 2017-05-01 00:00:00 至 To 1990-01-01 00:00:00  

干预措施：

Interventions：

组别：

Two groups

样本量：

186

Group：

Two groups

Sample size：

干预措施：

strengths-based intervention will adopt an eclectic approach to integrate skills in narrative therapy and empowerment strategies versus Basic education on dementia caregiving serves

干预措施代码：

Intervention：

strengths-based intervention will adopt an eclectic approach to integrate skills in narrative therapy and empowerment strategies versus Basic education on dementia caregiving serves

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)：

Faculty of Medicine, The Chinese University of Hong Kong 

单位级别：

Faculty of Medicine, The Chinese University of Hong Kong 

Institution
hospital：

Faculty of Medicine, The Chinese University of Hong Kong

Level of the institution：

Faculty of Medicine, The Chinese University of Hong Kong

测量指标：

Outcomes：

指标中文名：

Sense of Coherence (SOC)

指标类型：

主要指标

Outcome：

Sense of Coherence (SOC)

Type：

Primary indicator

测量时间点：

Baseline, week 14 and week 22

测量方法：

Sense of Coherence Scale

Measure time point of outcome：

Baseline, week 14 and week 22

Measure method：

Sense of Coherence Scale

指标中文名：

Coping Style

指标类型：

次要指标

Outcome：

Coping Style

Type：

Secondary indicator

测量时间点：

Baseline, week 14 and week 22

测量方法：

Simplified Coping Style Questionnaire

Measure time point of outcome：

Baseline, week 14 and week 22

Measure method：

Simplified Coping Style Questionnaire

指标中文名：

Perceived Burden

指标类型：

次要指标

Outcome：

Perceived Burden

Type：

Secondary indicator

测量时间点：

Baseline, week 14 and week 22

测量方法：

Zarit Burden Interview

Measure time point of outcome：

Baseline, week 14 and week 22

Measure method：

Zarit Burden Interview

指标中文名：

Depression

指标类型：

次要指标

Outcome：

Depression

Type：

Secondary indicator

测量时间点：

Baseline, week 14 and week 22.

测量方法：

Center for Epidemiologic Studies Depression Scale

Measure time point of outcome：

Baseline, week 14 and week 22.

Measure method：

Center for Epidemiologic Studies Depression Scale

指标中文名：

Health-related Quality of Life

指标类型：

次要指标

Outcome：

Health-related Quality of Life

Type：

Secondary indicator

测量时间点：

Baseline, week 14 and week 22

测量方法：

Medical Outcomes Study 36-item Short Form Health Survey

Measure time point of outcome：

Baseline, week 14 and week 22

Measure method：

Medical Outcomes Study 36-item Short Form Health Survey

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 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）：

Block randomization with a block size of 12 will be used.

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

Block randomization with a block size of 12 will be used.

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：

Double-blind

Blinding：

Double-blind

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

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：

注册人：

Name of Registration：

  2017-04-09 15:49:04