engAGE: Managing cognitivE decliNe throuGh Theatre Therapy, Artificial Intelligence and Social Robots drivEn Interventions

NCT ID: NCT06302686

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-09
• Study Completion Date: 2024-06-24

Brief Summary

The objectives of the engAGE project are to counteract and slow down cognitive decline progression, to enhance the intrinsic capacity of the users, and to support the wellbeing of older persons with mild cognitive impairment (MCI) by providing an ecosystem of services based on an innovative system that integrates social robots.

Detailed Description

The study is focused on older people with mild cognitive impairment, aiming to improve their quality of life and well-being, allowing them to preserve their identity, to reduce stress, memory loss, or communication challenges by the use of the technological engAGE system that includes the social robot Pepper. The social robot can be a great tool in engaging older adults in this kind of activities. It is always available and able to provide verbal clues or suggestions according to older adult's wishes, needs and memories. Moreover, the social robots may coach the older adults to perform daily activities with greater independence (i.e. coaching stepwise prompting to complete activities in-home) and support to caregivers as well.

Since caring for people with mild cognitive impairment puts a significant burden on informal caregivers, having the support of a technological platform can reduce anxiety, worries, and stress. The caregivers can personalize the content of interventions to the wishes and preferences of the older adults. Together with the older adults, they can be involved with the robot in joyful and fun activities like drama playing, storytelling, etc.

The formal caregivers who need to keep track of older adult progress which is a difficult and time-consuming process due to the lack of objective monitoring of cognitive decline and wellbeing may get valuable support from the cognitive assessment procedure implemented by the machine learning algorithm. Also, the social robot and tablet may facilitate the follow-up of older adults through reminders and cognitive interventions.

Conditions

Mild Cognitive Impairment; Older Adults

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

engAGE group

The experimental group will use the technological engAGE system for 6 months.

Group Type: EXPERIMENTAL

engAGE system

Intervention Type: DEVICE

The experimental group use the engAGE system at both healthcare organization and home. At the healthcare organization, the subject interacts with Pepper robot. The interaction is supervised by the formal caregivers and includes the following activities: dialoguing with the robot, storytelling, drama play, cognitive and physical games. This interaction is planned to last about 1 hour twice a week for 6 months. At home, the older user interacts with the tablet supervised by the informal caregiver. The user plays cognitive and physical games installed on MEMAS app. This activity is performed for 0.5 hour, every day for 6 months. Throughout the whole period of experimentation, the older user wears the smartwatch that measures his/her physiological parameters and the steps. Any activity performed by the seniors is assigned by formal caregiver and can be personalized taking into account the user's abilities, lifestyle, and social interactions.

control group

To the control group will be given a booklet containing information and activities on well-being to do at home.

Group Type: OTHER

Group practicing with only the support of a booklet

Intervention Type: OTHER

To the control group will be given a booklet containing information and activities on well-being to do at home.

Interventions

engAGE system

The experimental group use the engAGE system at both healthcare organization and home. At the healthcare organization, the subject interacts with Pepper robot. The interaction is supervised by the formal caregivers and includes the following activities: dialoguing with the robot, storytelling, drama play, cognitive and physical games. This interaction is planned to last about 1 hour twice a week for 6 months. At home, the older user interacts with the tablet supervised by the informal caregiver. The user plays cognitive and physical games installed on MEMAS app. This activity is performed for 0.5 hour, every day for 6 months. Throughout the whole period of experimentation, the older user wears the smartwatch that measures his/her physiological parameters and the steps. Any activity performed by the seniors is assigned by formal caregiver and can be personalized taking into account the user's abilities, lifestyle, and social interactions.

Intervention Type: DEVICE

Group practicing with only the support of a booklet

To the control group will be given a booklet containing information and activities on well-being to do at home.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• mild cognitive impairment (MCI);
• Montreal Cognitive Assessment (MoCA) score 21 - 25;
• Memory Assessment Clinics - Questionnaire (MAC-Q) ≥ 25;
• Reisberg scale 2 - 4;
• Clinical Frailty Scale score 1 - 3;
• 4-items GDS score ≤ 1;
• have an informal caregiver to support in carrying out the main daily activities.

Exclusion Criteria

• lack of informal caregivers;
• significant visual or hearing impairment.

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

Sponsors

European Union

OTHER

Sponsor Role: collaborator

Istituto Nazionale di Ricovero e Cura per Anziani

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS INRCA Hospital

Ancona, , Italy

Site Status: RECRUITING

Karde A/S

Oslo, , Norway

Site Status: RECRUITING

HUG

Geneva, , Switzerland

Site Status: RECRUITING

Countries

Italy; Norway; Switzerland

Central Contacts

Anna Rita Bonfigli

Role: CONTACT

a.bonfigli@inrca.it

0718003719

Facility Contacts

Elvira Maranesi

Role: primary

Terje Grimstad

Role: primary

Christian Lovis

Role: primary

References

Amabili G, Maranesi E, Margaritini A, Bonfigli AR, Felici E, Barbarossa F, Benadduci M, Gosetto L, Guebey J, Grimstad T, Hellman R, Marin AI, Boye LT, Anghel IM, Cioara T, Bevilacqua R. Managing Cognitive Decline Through a Social Robot-Based Intervention: Protocol for the engAGE Proof of Concept and Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 2;14:e67601. doi: 10.2196/67601.

Reference Type: DERIVED

PMID: 40896828 (View on PubMed)

Other Identifiers

INRCA_004_2023

Identifier Type: -

Identifier Source: org_study_id