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【ChiCTR2400085952】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

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基本信息

登记号

ChiCTR2400085952

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2024-06-21

临床申请受理号

靶点

适应症

Loneliness

试验通俗题目

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

试验专业题目

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

申办单位信息

申请人联系人

申请人名称

联系人邮箱

联系人邮编

联系人通讯地址

临床试验信息

试验目的

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.

试验分类

试验类型

随机平行对照

试验分期

探索性研究/预试验

随机化

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

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.

试验项目经费来源

Health and Medical Research Fund (HMRF)

试验范围

目标入组人数

实际入组人数

第一例入组时间

2024-04-01

试验终止时间

2026-07-31

是否属于一致性

入选标准

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.；

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).；

研究者信息

研究负责人姓名

试验机构

the Hong Kong Polytechnic University

研究负责人电话

研究负责人邮箱

研究负责人邮编

联系人通讯地址

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