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护理院痴呆症患者家属教育支持干预措施的可行性和有效性:一项序列嵌入式混合研究
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注册号:

Registration number:

ChiCTR1900024582 

最近更新日期:

Date of Last Refreshed on:

2019-07-18 

注册时间:

Date of Registration:

2019-07-18 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

护理院痴呆症患者家属教育支持干预措施的可行性和有效性:一项序列嵌入式混合研究 

Public title:

Feasibility and effectiveness of an education and support intervention for family members of nursing home residents with dementia: a sequential embedded mixed methods study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

护理院痴呆症患者家属教育支持干预措施的可行性和有效性:一项序列嵌入式混合研究 

Scientific title:

Feasibility and effectiveness of an education and support intervention for family members of nursing home residents with dementia: a sequential embedded mixed methods study 

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:

惠沼沼 

研究负责人:

惠沼沼 

Applicant:

HUI Zhaozhao 

Study leader:

HUI Zhaozhao 

申请注册联系人电话:

Applicant telephone:

+86 15809243551 

研究负责人电话:

Study leader's telephone:

+86 15809243551 

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:

huizhaozhao93@link.cuhk.edu.hk 

研究负责人电子邮件:

Study leader's E-mail:

huizhaozhao93@link.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:

中国香港特别行政区香港中文大学利黄瑶璧楼6楼 

研究负责人通讯地址:

中国香港特别行政区香港中文大学利黄瑶璧楼6楼 

Applicant address:

6/F, Esther Lee Building,The Chinese University of Hong Kong, N.T., Hong Kong SAR, China 

Study leader's address:

6/F, Esther Lee Building,The Chinese University of Hong Kong, N.T., Hong Kong SAR, 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:

香港中文大学 

Applicant's institution:

The 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 

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:

香港中文大学那打素护理学院 

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:

香港特别行政区香港中文大学利黄瑶璧楼6楼 

Primary sponsor's address:

6/F, Esther Lee Building, The Chinese University of Hong Kong, N.T., Hong Kong SAR, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

香港

市(区县):

Country:

China

Province:

Hong Kong Special Administrative Region

City:

单位(医院):

香港中文大学那打素护理学院

具体地址:

香港特别行政区香港中文大学利黄瑶璧楼6楼

Institution
hospital:

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

Address:

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

经费或物资来源:

研究生奖学金 

Source(s) of funding:

Postgraduate studentships 

研究疾病:

痴呆 

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 

研究目的:

本研究的目的:为中国护理院痴呆症家属(转至护理院一年内)开发一项教育支持干预,并进一步评估其在痴呆症患者家属和患者中的应用效果。 研究目标:(1)基于护理院痴呆症家属的体验和认知,制定文化适宜的的干预措施;(2)评估其减轻家属压力水平、增强家属应对策略、减轻家属照顾负担,以及改善患者精神行为症状的效果。 

Objectives of Study:

The aims of this study are to develop an education and support intervention for Chinese family members within the first year of placing a relative with dementia into a nursing home, and further to evaluate the intervention effects for both the family members and their relatives. The objectives are to (1) develop a culturally feasible and acceptable intervention for Chinese family members of nursing home residents with dementia on the basis of their own experience and perception of care involvement after nursing home placement, and (2) evaluate the intervention effects in terms of reducing family members stress level, increasing their ability to use coping strategies, reducing their caregiving burden, as well as reducing their relatives psychological and behavioural symptoms. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1)护理院痴呆症患者的家属; (2)在一年内将痴呆症患者安置到护理院; (3)年满18周岁; (4)患者在护理院中的主要责任人; (5)自愿参加; (6)能够阅读、书写和理解中文。 

Inclusion criteria

(1) be a family member of a nursing home resident with dementia; (2) have placed their relative with dementia in the nursing home within the first year; (3) be aged 18 years or older; (4) take the chief responsibility for their relative's care at the nursing home; (5) be willing to participate in this study; (6) be able to read, write and understand Chinese. 

排除标准:

(1)患有精神障碍(例如精神分裂症、抑郁症、焦虑症); (2)认知能力受损; (3)有偿照顾者; (4)在本研究期间接受心理/精神治疗; (5)在本研究期间参与其他支持干预措施或项目。 

Exclusion criteria:

(1) have mental disorders (e.g. schizophrenia, depression, anxiety); (2) have impaired cognitive ability; (3) be paid caregivers; (4) be receiving psychotherapies at the time of this study; (5) be participating in other support interventions or programmes at the time of this study. 

研究实施时间:

Study execute time:

From2019-08-01To 2020-06-30 

征募观察对象时间:

Recruiting time:

From2020-01-01To 2020-04-30 

干预措施:

Interventions:

组别:

干预组

样本量:

60

Group:

Experimental group

Sample size:

干预措施:

教育支持

干预措施代码:

Intervention:

Education & support

Intervention code:

组别:

对照组

样本量:

60

Group:

Control group

Sample size:

干预措施:

常规护理

干预措施代码:

Intervention:

Usual care

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

陕西省 

市(区县):

西安市 

Country:

China 

Province:

Shaanxi 

City:

Xi'an 

单位(医院):

西安市碑林区第三爱心护理院 

单位级别:

 

Institution
hospital:

The Third Nursing Home in Beilin District, Xi’an  

Level of the institution:

 

测量指标:

Outcomes:

指标中文名:

压力

指标类型:

主要指标 

Outcome:

Perceived stress

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

应对策略

指标类型:

主要指标 

Outcome:

Use of coping stategies

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

照护负担

指标类型:

次要指标 

Outcome:

Caregiving burden

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

痴呆症精神行为症状

指标类型:

次要指标 

Outcome:

Psychological and behavioural symptoms of dementia

Type:

Secondary 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:

不需要

组织:

Sample Name:

Not required

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

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 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):

随机化将采用计算机生成的随机数列(http://www.randomization.com)进行。 一名研究助理将负责生成随机数列,并将其打印放入顺序编号的不透明密封信封中。

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

Randomisation will be carried out using computer-generated random numbers (http://www.randomization.com). One research assistant will be responsible to generate the random numbers and put them into sequentially numbered opaque sealed envelopes.

盲法:

Open label

Blinding:

Open label

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):

可发送邮件至研究者索取原始数据(huizhaozhao93@link.cuhk.edu.hk)。

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

The individual participant date will be shared via email (huizhaozhao93@link.cuhk.edu.hk).

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:

本研究的质性数据将逐字转录,然后导入NVivo 12软件; 数据分析将使用主题分析法进行;量性数据将输入EpiData 3.1,借助Excel 2016管理,并使用SPSS 24.0进行分析。

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

The qualitative data of this study will be transcribed verbatim and then be imported into NVivo 12 software; data analyses will be conducted using thematic analysis method; the quantitative data will be input into EpiData 3.1, managed by Excel, and analysed using SPSS 24.0.

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:

 2019-07-18
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