养老机构护理员失智老人照护核心胜任力培训方案的构建与应用

注册号:

Registration number:

ChiCTR2500100278 

最近更新日期:

Date of Last Refreshed on:

2025-04-07 14:47:39 

注册时间:

Date of Registration:

2025-04-07 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

养老机构护理员失智老人照护核心胜任力培训方案的构建与应用

Public title:

Construction and Application of the Core Competency Training Program for Pension Caregivers in Dementia Care at Nursing Home

注册题目简写:

English Acronym:

研究课题的正式科学名称:

养老机构护理员失智老人照护核心胜任力培训方案的构建与应用

Scientific title:

Construction and Application of the Core Competency Training Program for Pension Caregivers in Dementia Care at Nursing Home

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:

许清女 

研究负责人:

肖春秀 

Applicant:

Qingnv Xu 

Study leader:

Chunxiu Xiao 

申请注册联系人电话:

Applicant telephone:

+86 181 5077 2167

研究负责人电话:

Study leader's
telephone:

+86 133 6591 2276

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:

513143674@qq.com

研究负责人电子邮件:

Study leader's E-mail:

1435335080@qq.com

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:

福建省福州市台江区交通路88号

研究负责人通讯地址:

福建省福州市闽侯县荆溪关口366号

Applicant address:

No. 88, Jiaotong Road, Taijiang District, Fuzhou City, Fujian Province, China

Study leader's address:

No. 366, Jingxi Guankou, Minhou County, Fuzhou City, Fujian Province, China Fujian Medical University

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:

福建医科大学

Applicant's institution:

Fujian Medical University

研究负责人所在单位:

福建医科大学

Affiliation of the Leader:

Fujian Medical University

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:

福医伦理审字[2025]第129号

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:

福建医科大学生物医学研究伦理审查委员会

Name of the ethic committee:

Biomedical Research Ethics Review Committee of Fujian Medical University

伦理委员会批准日期:

Date of approved by ethic committee:

2025-03-01 00:00:00

伦理委员会联系人:

张俊

Contact Name of the ethic committee:

Jun Zhang

伦理委员会联系地址:

福建省福州市大学新区学府北路1号

Contact Address of the ethic committee:

No. 1, Xuefu North Road, University Town, Fuzhou City, Fujian Province, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 591 2286 2443

伦理委员会联系人邮箱:

Contact email of the ethic committee:

fmuptk@fjmu.edu.cn

研究实施负责(组长)单位:

福建医科大学

Primary sponsor:

Fujian Medical University

研究实施负责(组长)单位地址:

福建省福州市台江区交通路88号

Primary sponsor's address:

No. 88, Jiaotong Road, Taijiang District, Fuzhou City, Fujian Province, 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):

福建

市(区县):

Country:

China

Province:

Fujian

City:

单位(医院):

福建医科大学

具体地址:

福建省福州市台江区交通路88号

Institution
hospital:

Fujian Medical University

Address:

No. 88, Jiaotong Road, Taijiang District, Fuzhou City, Fujian Province, China

经费或物资来源:

福建医科大学

Source(s) of funding:

Fujian Medical University

研究疾病:

失智症  

Target disease:

Cognitive 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:

非随机对照试验 

Study design:

Non randomized control 

研究目的:

1.构建养老机构护理员失智老人照护核心胜任力培训方案。 2.应用养老机构护理员失智老人照护核心胜任力培训方案,评价干预效果。  

Objectives of Study:

1.To develop a core competency training program for caregivers in dementia care for the elderly in nursing homes. 2.To implement the core competency training program for caregivers in dementia care for the elderly in nursing homes and evaluate its intervention effectiveness.

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.研究期间因各种原因不在岗者。 2.中途退出及不能在规定时间内完成问卷调查者。

Exclusion criteria:

1. Participants who are absent from their duties for various reasons during the study period. 2. Participants who withdraw from the study midway or fail to complete the questionnaire within the designated time frame.

研究实施时间:

Study execute time:

From 2025-04-15 00:00:00 To 2026-01-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2025-04-15 00:00:00 To 2026-01-31 00:00:00

干预措施:

Interventions:

组别:

对照组

样本量:

26

Group:

control group

Sample size:

干预措施:

对照组养老护理员常规进行机构的一般知识宣教与培训,如失智症相关宣传海报、科普知识手册和展板、日常技能培训等。研究将于结束后给予对照组护理员补偿性的失智老人照护核心胜任力培训讲座。

干预措施代码:

Intervention:

The elderly caregivers in the control group routinely conduct general knowledge education and training in the institution, such as dementia-related posters, science brochures and display boards, and daily skills training. Compensatory core competency training seminars on dementia elderly care will be given to the control group caregivers at the end of the study.

Intervention code:

组别:

干预组

样本量:

26

Group:

intervention group

Sample size:

干预措施:

培训组在对照组的基础上实施养老机构护理员失智老人照护核心胜任力培训方案

干预措施代码:

Intervention:

The intervention group will receive the core competency training program for caregivers in dementia care for the elderly in nursing homes, in addition to the standard care provided to the control group.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

福建 

市(区县):

 

Country:

China

Province:

Fujian

City:

单位(医院):

福建省长青养老服务有限公司 

单位级别:

无 

Institution
hospital:

Fujian Changqing Elderly Care Service Group Co.

Level of the institution:

N/A

国家:

中国

省(直辖市):

福建 

市(区县):

 

Country:

China

Province:

Fujian

City:

单位(医院):

福州高新区子路老年之家 

单位级别:

无 

Institution
hospital:

Zilu Elderly Home, Fuzhou High-Tech Zone

Level of the institution:

N/A

测量指标:

Outcomes:

指标中文名:

痴呆患者照顾者护理能力

指标类型:

主要指标

Outcome:

Nursing Ability for Dementia Caregivers

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

护理员认知障碍症照护胜任感

指标类型:

主要指标

Outcome:

Sense of Competence in Dementia Care Staff

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

老年痴呆患者生活质量

指标类型:

次要指标

Outcome:

Quality of Life-Alzheimer’s Disease

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:

组织:

Sample Name:

N/A

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:

尚未开始

Not yet 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):

N/A

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):

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

N/A

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

N/A

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:

 2025-04-07 14:47:16