Clinical trial NCT05284292: GUARDIAN: The Social Robot Companion to Support Homecare Nurses
Official title: GUARDIAN: The Social Robot Companion to Support Homecare Nurses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging Problems
Caregiver
Keywords: Health informatics
Attitude to computers
Technology
Technological Innovations
Lead sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Sponsor class: OTHER
Collaborators: name: European Commission
First posted: 2022-03-17
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in the acceptability of the GUARDIAN platform
timeFrame: change from baseline to 1, 2 and 3 months after intervention commencement
Secondary outcomes:
measure: Care load of the informal caregiver
timeFrame: change from baseline to 1, 2 and 3 months after intervention commencement
measure: Caregiver's Stress and Anxiety
timeFrame: change from baseline to 1, 2 and 3 months after intervention commencement
measure: Quality of life of the elderly
timeFrame: change from baseline to 1,2 and 3 months after intervention commencement
measure: Elderly person's perception of their health
timeFrame: change from baseline to 1, 2 and 3 months after intervention commencement
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Irccs Inrca
city: Harderwijk
country: Netherlands
facility: Hospital St Jansdal
city: Geneve
country: Switzerland
facility: Hôpitaux Universitaires de Genève
Study officials:
References:
citation: Margaritini A, Benadduci M, Amabili G, Bonfigli AR, Luzi R, Wac K, Nap HH, Maranesi E, Bevilacqua R. The social robot companion to support homecare nurses: The guardian study protocol. Contemp Clin Trials Commun. 2022 Oct 30;30:101024. doi: 10.1016/j.conctc.2022.101024. eCollection 2022 Dec.