e-VITA: European-Japanese Virtual Coach for Smart Ageing (WAVE II)

NCT05835856 | Unknown

• 1 other identifier: INRCA_005_2023
• Study Type: interventional
• Target: 240
• Locations: 4 countries
• Sites: 4

Brief Summary

The study is a multicentre Proof-of-Concept. The general objective of the e-VITA project is to develop a personalized virtual coach capable of interacting with its elderly interlocutor. The experimentation will be carried out in 4 sites: Italy, France, Germany and Japan.

Conditions

Older Adults; Quality of Life

Keywords

virtual coach; older adults; technological system; quality of life; usability; well-being

Outcome Measures

Primary Outcomes (1)

• Change in the Quality of Life

  The EQ-5D-5L scale consists of five dimensions: mobility, independence, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, mild problems, moderate problems, severe problems and extreme problems. The participant is asked to indicate his/her health status by ticking the box corresponding to the most appropriate statement in each of the five dimensions. The numbers from the five dimensions can be combined into a 5-digit number that describes the health status of the participant.

  baseline and 6 months later

Secondary Outcomes (8)

• Change in usability

  At 3 and 6 months from baseline

• Change in frailty status

  baseline and 6 months later

• Change in nutritional capacity

  baseline and 6 months later

• Change in affinity with technology

  baseline and 6 months later

• Change in cognitive status

  baseline and 6 months later

Study Arms (5)

NAO robot group

EXPERIMENTAL

Device: Virtual coach with NAO robot

Google Nest Hub (2e generation) group

EXPERIMENTAL

Device: Virtual coach with Google Nest Hub (2e generation) group

Gatebox group

EXPERIMENTAL

Device: Virtual coach with Gatebox device

CelesTE robot group

EXPERIMENTAL

Device: virtual coach with CelesTE robot

Control group

OTHER

Other: booklet

Interventions

Virtual coach with NAO robot DEVICE

The coaching device used is the softbank NAO 5 and NAO 6 humanoid interactive mobile robot. These robot platform allows multimodal natural language interaction and robot autonomous movement.

NAO robot group

Virtual coach with Google Nest Hub (2e generation) group DEVICE

The coaching device used is Google Nest Hub (2e generation). This is a connected speaker enriched with a 7-chip touch screen. It has a loudspeaker and 3 microphones, making interaction possible.

Google Nest Hub (2e generation) group

Virtual coach with Gatebox device DEVICE

The coaching device used is the Gatebox, a hologram like device which the user can interact. There are internal sensors such as a camera and a microphone allow the user to converse with the projected character. It connects to the Internet via a wireless LAN. With infrared rays and Bluetooth, it can also be connected to household appliances and other devices.

Gatebox group

virtual coach with CelesTE robot DEVICE

The coaching device used is the CelesTE robot, a prayer companion designed for Christian Catholic users.The intended main function of CelesTE is to be a "guardian angel", especially thought for elderly people. It can be a prayer companion, and contains a vast number of teachings, including the whole Bible. Its AI is capable of keeping a short conversation, in which the user may ask and receive an answer about a sensitive topic (such as happiness, death, faith, etc.). It can also printout a selection of contents. The coaching device CelesTE will be substituted by DarumaTO for the Japanese centers.

CelesTE robot group

booklet OTHER

Participant in the control group will receive a booklet containing information and activities on well-being

Control group

Eligibility Criteria

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

You may qualify if:

• Able to stand and walk unaided;
• No acute or untreated medical problems;
• Montreal Cognitive Assessement test (MOCA) ≥ 22;
• Geriatric Depression Scale (GDS) \< 9;
• Short performance physical battery (SPPB) ≥ 7
• Clinical Frailty Scale score between 2 and 4.

You may not qualify if:

• Use of active implant or not-implant medical devices;
• Allergy to nichel;
• A myocardial infarction or stroke within 6 months;
• Painful arthritis, spinal stenosis, amputation, painful foot lesions or neuropathy limiting balance and mobility;
• Uncontrolled hypertension;
• Pacemaker or implantable cardioverter defibrillator;

Sponsors & Collaborators

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

Study Sites (4)

Broca Hospital

Paris, France

Location

Diocesan Caritas Association for the Archdiocese of Cologne

Cologne, Germany

Location

IRCCS INRCA Hospital

Ancona, 60127, Italy

Location

Tohoku University -Smart Ageing Research Center

Miyagi, Japan

Location

Study Officials

• Roberta Bevilacqua

  IRCCS INRCA, Ancona, Italy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: April 28, 2023
• Study Start: July 24, 2023
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: October 27, 2023

Record last verified: 2023-10

Locations

DE (1); FR (1); JP (1); IT (1)