ChiCTR2400085952 版本V1.0 版本创建时间2024/06/21 14:34:17 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：

ChiCTR2400085952 

最近更新日期：

Date of Last Refreshed on：

2024-06-21 14:34:14 

注册时间：

Date of Registration：

2024-06-21 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Supporting Current Home Care Services with a Robot-mediated Interactive Intervention (RMII) to Reduce Loneliness in Older Adults: A Feasibility and Pilot Randomized Controlled Trial

Public title：

Supporting Current Home Care Services with a Robot-mediated Interactive Intervention (RMII) to Reduce Loneliness in Older Adults: A Feasibility and Pilot Randomized Controlled Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Supporting Current Home Care Services with a Robot-mediated Interactive Intervention (RMII) to Reduce Loneliness in Older Adults: A Feasibility and Pilot Randomized Controlled Trial

Scientific title：

Supporting Current Home Care Services with a Robot-mediated Interactive Intervention (RMII) to Reduce Loneliness in Older Adults: A Feasibility and Pilot Randomized Controlled Trial

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：

Yan Zhao 

研究负责人：

Yan Zhao 

Applicant：

Yan Zhao 

Study leader：

Yan Zhao 

申请注册联系人电话：

Applicant telephone：

+852 2766 4550

研究负责人电话：

Study leader's telephone：

+852 2766 4550

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：

yan-ivy.zhao@polyu.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

yan-ivy.zhao@polyu.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：

11 Yucai Road, Hung Hom, Kowloon, Hong Kong

研究负责人通讯地址：

11 Yucai Road, Hung Hom, Kowloon, Hong Kong

Applicant address：

11 Yucai Road, Hung Hom, Kowloon, Hong Kong

Study leader's address：

11 Yucai Road, Hung Hom, Kowloon, 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 Hong Kong Polytechnic University

Applicant's institution：

the Hong Kong Polytechnic University

研究负责人所在单位：

the Hong Kong Polytechnic University

Affiliation of the Leader：

the Hong Kong Polytechnic University

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：

HSEARS20230314003

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：

the PolyU Institutional Review Board

Name of the ethic committee：

the PolyU Institutional Review Board

伦理委员会批准日期：

Date of approved by ethic committee：

2023-05-23 00:00:00

伦理委员会联系人：

Tracy Tang

Contact Name of the ethic committee：

Tracy Tang

伦理委员会联系地址：

11 Yucai Road, Hung Hom, Kowloon, Hong Kong

Contact Address of the ethic committee：

11 Yucai Road, Hung Hom, Kowloon, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

+852 3400 8541

伦理委员会联系人邮箱：

Contact email of the ethic committee：

institutional.review.board@polyu.edu.hk

研究实施负责（组长）单位：

the Hong Kong Polytechnic University

Primary sponsor：

the Hong Kong Polytechnic University

研究实施负责（组长）单位地址：

11 Yucai Road, Hung Hom, Kowloon, Hong Kong

Primary sponsor's address：

11 Yucai Road, Hung Hom, Kowloon, 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)：

Research Fund Secretariat, Research and Data Analytics Office, Health Bureau

具体地址：

9/F, Rumsey Street Multi-storey Carpark Building, 2 Rumsey Street, Sheung Wan, Hong Kong

Institution
hospital：

Research Fund Secretariat, Research and Data Analytics Office, Health Bureau

Address：

9/F, Rumsey Street Multi-storey Carpark Building, 2 Rumsey Street, Sheung Wan, Hong Kong

经费或物资来源：

Health and Medical Research Fund (HMRF)

Source(s) of funding：

Health and Medical Research Fund (HMRF)

Target disease：

Loneliness

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

The study aims to assess the feasibility and acceptability of supplementing a robot-mediated interactive intervention (RMII) to current home care services in HK for older adults who live alone or with an older spouse at home, and to examine the preliminary efficacy of RMII on reducing loneliness. The objectives of the study are: 1. To assess the feasibility (recruitment rate, retention rate, intervention adherence, implementation fidelity, and safety) of RMII; 2. To assess the acceptability (participant satisfaction and usability of the features, cultural acceptance, electricity cost, etc.) of RMII; 3. To examine the preliminary efficacy of the RMII on loneliness, visuo-motor function, psychological distress, and quality of life among older adults.  

Objectives of Study：

The study aims to assess the feasibility and acceptability of supplementing a robot-mediated interactive intervention (RMII) to current home care services in HK for older adults who live alone or with an older spouse at home, and to examine the preliminary efficacy of RMII on reducing loneliness. The objectives of the study are: 1. To assess the feasibility (recruitment rate, retention rate, intervention adherence, implementation fidelity, and safety) of RMII; 2. To assess the acceptability (participant satisfaction and usability of the features, cultural acceptance, electricity cost, etc.) of RMII; 3. To examine the preliminary efficacy of the RMII on loneliness, visuo-motor function, psychological distress, and quality of life among older adults.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1) ethnic Chinese aged 60 years or above; 2) living alone or with an older spouse at home and receiving home care services); 3) with moderate or severe loneliness [score of 3-6 on the Chinese De Jong Gierveld loneliness scale]; 4) cognitively intact [score of ≦2 on the 5-item Abbreviated Memory Inventory for the Chinese (AMIC]; 5) able to command a robot by voice and use a hand to operate it on a surface pro.

Inclusion criteria

1) ethnic Chinese aged 60 years or above; 2) living alone or with an older spouse at home and receiving home care services); 3) with moderate or severe loneliness [score of 3-6 on the Chinese De Jong Gierveld loneliness scale]; 4) cognitively intact [score of ≦2 on the 5-item Abbreviated Memory Inventory for the Chinese (AMIC]; 5) able to command a robot by voice and use a hand to operate it on a surface pro.

排除标准：

1) those with diagnosis of a major neurocognitive disorder; 2) a history of symptomatic stroke or other disease of the central nervous system; 3) a serious medical or psychiatric illness (e.g., severe depression, schizophrenia, bi-polar disorder) or unremitting visual or hearing impairment that would interfere with using a robot; 4) have limited access to electricity and/or no Wi-Fi at home (as these are not favourable conditions for the use of technology).

Exclusion criteria：

1) those with diagnosis of a major neurocognitive disorder; 2) a history of symptomatic stroke or other disease of the central nervous system; 3) a serious medical or psychiatric illness (e.g., severe depression, schizophrenia, bi-polar disorder) or unremitting visual or hearing impairment that would interfere with using a robot; 4) have limited access to electricity and/or no Wi-Fi at home (as these are not favourable conditions for the use of technology).

研究实施时间：

Study execute time：

从 From 2024-04-01 00:00:00至 To 2026-07-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-07-01 00:00:00 至 To 2025-07-31 00:00:00  

干预措施：

Interventions：

组别：

Intervention group

样本量：

30

Group：

Intervention group

Sample size：

干预措施：

In addition to the home care services, each participant will be given a social robot KaKa to be placed in their home for 8 weeks (to be operated 24 hours a day and 7days/week).

干预措施代码：

Intervention：

In addition to the home care services, each participant will be given a social robot KaKa to be placed in their home for 8 weeks (to be operated 24 hours a day and 7days/week).

Intervention code：

组别：

Control group

样本量：

30

Group：

Control group

Sample size：

干预措施：

Will maintain the home care services

干预措施代码：

Intervention：

Will maintain the home care services

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China 

Province：

Hong Kong 

City：

 

单位(医院)：

Hong Kong Young Women’s Christian Association 

单位级别：

social service organisation  

Institution
hospital：

Hong Kong Young Women’s Christian Association

Level of the institution：

social service organisation

测量指标：

Outcomes：

指标中文名：

Loneliness

指标类型：

主要指标

Outcome：

Loneliness

Type：

Primary indicator

测量时间点：

Baseline, Week 2, 4, 6, 8 and 3 months after the intervention

测量方法：

the 6-item De Jong Gierveld loneliness scale (Chinese version) for 60 participants

Measure time point of outcome：

Baseline, Week 2, 4, 6, 8 and 3 months after the intervention

Measure method：

the 6-item De Jong Gierveld loneliness scale (Chinese version) for 60 participants

指标中文名：

Visuo-motor function

指标类型：

次要指标

Outcome：

Visuo-motor function

Type：

Secondary indicator

测量时间点：

Baseline, Week 8 and 3 months after the intervention

测量方法：

The Trail Making Test for 60 participants

Measure time point of outcome：

Baseline, Week 8 and 3 months after the intervention

Measure method：

The Trail Making Test for 60 participants

指标中文名：

Psychological distress

指标类型：

次要指标

Outcome：

Psychological distress

Type：

Secondary indicator

测量时间点：

Baseline, Week 8 and 3 months after the intervention

测量方法：

a 21-item short-Chinese version questionnaire of the Depression-Anxiety-Stress Scale (DASS-21) for 60 participants

Measure time point of outcome：

Baseline, Week 8 and 3 months after the intervention

Measure method：

a 21-item short-Chinese version questionnaire of the Depression-Anxiety-Stress Scale (DASS-21) for 60 participants

指标中文名：

Quality of life

指标类型：

次要指标

Outcome：

Quality of life

Type：

Secondary indicator

测量时间点：

Baseline, Week 8 and 3 months after the intervention

测量方法：

Quality of life short questionnaire for 60 participants

Measure time point of outcome：

Baseline, Week 8 and 3 months after the intervention

Measure method：

Quality of life short questionnaire for 60 participants

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

None

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 60 岁 years
最大 Max age 100 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）：

Participants will be randomly assigned to the IG or CG in a 1:1 ratio by an independent statistician using a computer program.

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

Participants will be randomly assigned to the IG or CG in a 1:1 ratio by an independent statistician using a computer program.

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：

After receiving consent from the participant, a research assistant, who will be blinded to the group allocations, will collect demographic information and administer the baseline outcome measures (T0). This research assistant will again administer the outcome measures at week 2,4, 6, 8 and 3 months after the intervention through phone.

Blinding：

After receiving consent from the participant, a research assistant, who will be blinded to the group allocations, will collect demographic information and administer the baseline outcome measures (T0). This research assistant will again administer the outcome measures at week 2,4, 6, 8 and 3 months after the intervention through phone.

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

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）：

We will publish results in peer reviewed international journals. The dataset can be access per request and approve by the study team.

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

We will publish results in peer reviewed international journals. The dataset can be access per request and approve by the study team.

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 statistical software package IBM SPSS version 26.0 will be used.

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

The statistical software package IBM SPSS version 26.0 will be used.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2024-06-21 14:34:14