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临床试验/NCT05284292
NCT05284292已完成不适用

GUARDIAN: The Social Robot Companion to Support Homecare Nurses

Istituto Nazionale di Ricovero e Cura per Anziani5 个研究点 分布在 3 个国家目标入组 30 人开始时间: 2022年3月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
5
主要终点
Change in the acceptability of the GUARDIAN platform

研究概览

简要总结

The primary objective of this study is to verify the acceptability of the GUARDIAN system by the elderly, detected through the scale Unified Theory of Acceptance and Use of Technology (UTAUT). The GUARDIAN platform consists of two connected apps: one dedicated to the caregiver and one dedicated to the older people, plus a robot (Misty II). Misty II will live with the elderly, it will have the task of detecting his presence inside the house, reminding him of appointments, assisting him in his daily activities and diminishing the sense of loneliness. The application dedicated to the caregiver receives the data and self reports of the elderly from the robot, in order to constantly offer an updated picture of the condition of the elderly and to keep them informed about their condition and well-being.

详细描述

The primary objective of this study is to verify the acceptability of the GUARDIAN platform by the elderly, detected through the scale Unified Theory of Acceptance and Use of Technology (UTAUT). The aim of this project is to enable the older adult to live as long as possible at home, involving the informal caregiver, using the available technologies. The GUARDIAN platform consists of the Senior App, the Caregiver App and the Misty II robot. The Senior App is an easy-to-use application that will ask the elderly for health status, whether they have carried out their daily activities, if they have taken pre-establishable drugs and if they have eaten properly. The application will generate self-reports that will be transmitted to the app caregiver. The elderly can answer the questions via a tablet on the robot or by voice. The Caregiver App is the application intended for the caregiver, in which you can set up reminders for the elderly about meals or drugs, send communications and ask for reports on his health. This application will be used by both the informal caregiver and the formal caregiver (health care professional). It is the social robot that will complete the platform. Reminders will be sent via the robot and questions will be asked to the patient. The trial will consist of two phases involving, in each of the three participant countries (Italy, Nederlands and Switzerland), 4 seniors with their informal caregivers in the Alpha phase and 10 seniors with their informal caregivers in the following GUARDIAN trial. In both phases the presence of a formal caregiver is expected. In the Alpha phase 4 users and their caregivers will use a first version of the GUARDIAN platform, for three months. The results and feedback from the Alpha phase will give indications to improve and refine the platform.

The GUARDIAN trial involves the enrollment of 10 elderly people in each of the three participant countries (different from those recruited in the Alpha phase) and their respective informal caregivers. The evaluations will be carried out at baseline (T0) and then every month, for three months (T1, T2, T3).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cognitive integrity (Mini Mental State Examination >=24)
  • Have an informal caregiver
  • Healthy sight and hearing

排除标准

  • Mini Mental State Examination < 24
  • Lack of informal caregivers
  • Sight and hearing not intact
  • Lack of informed consent

结局指标

主要结局

Change in the acceptability of the GUARDIAN platform

时间窗: change from baseline to 1, 2 and 3 months after intervention commencement

Acceptability will be assessed using a 32-item questionnaire based on the unified theory of acceptance and use of technology (UTAUT) model. It's a standardized instrument for measuring the likelihood of success for new technology introductions and helps to understand the drivers of its acceptance. The questionnaire has 32 questions distributed in 4 key constructs: 1) performance expectancy, 2) effort expectancy, 3) social influence, and 4) facilitating conditions. Each question are based on a Likert-type 5-point scale ranging from 1 = strongly disagree to 5 = strongly agree. Increments are integers between 1 to 5.

次要结局

  • Quality of life of the elderly(change from baseline to 1,2 and 3 months after intervention commencement)
  • Care load of the informal caregiver(change from baseline to 1, 2 and 3 months after intervention commencement)
  • Elderly person's perception of their health(change from baseline to 1, 2 and 3 months after intervention commencement)
  • Caregiver's Stress and Anxiety(change from baseline to 1, 2 and 3 months after intervention commencement)

研究者

发起方
Istituto Nazionale di Ricovero e Cura per Anziani
申办方类型
Other
责任方
Sponsor

研究点 (5)

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