GUARDIAN: The Social Robot Companion to Support Homecare Nurses

NCT05284292 | Completed

• 1 other identifier: INRCA_001_2022
• Study Type: interventional
• Target: 30
• Locations: 3 countries
• Sites: 3

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.

Conditions

Aging Problems; Caregiver

Keywords

Health informatics; Attitude to computers; Technology; Technological Innovations

Outcome Measures

Primary Outcomes (1)

• Change in the acceptability of the GUARDIAN platform

  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.

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

Secondary Outcomes (4)

• Care load of the informal caregiver

  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

• Quality of life of the elderly

  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

Study Arms (1)

experimental arm

EXPERIMENTAL

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

Device: GUARDIAN platform

Interventions

GUARDIAN platform 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.

experimental arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Nazionale di Ricovero e Cura per Anziani: lead
• European Commission: collaborator

Study Sites (3)

Irccs Inrca

Ancona, 60127, Italy

Location

Hospital St Jansdal

Harderwijk, Netherlands

Location

Hôpitaux Universitaires de Genève

Geneva, CH-1211, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 36340699 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 17, 2022
• Study Start: March 16, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

CH (1); IT (1); NL (1)