GUARDIAN: The Social Robot Companion to Support Homecare Nurses

NCT ID: NCT05284292

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-16
• Study Completion Date: 2022-12-31

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).

Conditions

Aging Problems; Caregiver

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

experimental arm

The Guardian platform consists of the robot Misty II, the Senior App and the Caregiver App will be tested by the elderly subjects together with their caregivers

Group Type: EXPERIMENTAL

GUARDIAN platform

Intervention Type: DEVICE

The enrolled elderly subjects and their caregivers will use at home the GUARDIAN platform consists of the Senior App, the Caregiver App and the Misty II robot.

Interventions

GUARDIAN platform

The enrolled elderly subjects and their caregivers will use at home the GUARDIAN platform consists of the Senior App, the Caregiver App and the Misty II robot.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Commission

OTHER

Sponsor Role: collaborator

Istituto Nazionale di Ricovero e Cura per Anziani

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Irccs Inrca

Ancona, , Italy

Hospital St Jansdal

Harderwijk, , Netherlands

Hôpitaux Universitaires de Genève

Geneva, , Switzerland

Countries

Italy; Netherlands; Switzerland

References

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.

Reference Type: DERIVED

PMID: 36340699 (View on PubMed)

Other Identifiers

INRCA_001_2022

Identifier Type: -

Identifier Source: org_study_id