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

NCT06302686 | Unknown

• 1 other identifier: INRCA_004_2023
• Study Type: interventional
• Target: 78
• Locations: 3 countries
• Sites: 3

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.

Conditions

Mild Cognitive Impairment; Older Adults

Keywords

ageing; older adults; mild cognitive impairment; caregiver; technological platform

Outcome Measures

Primary Outcomes (1)

• Change in perceived stability of cognitive status by the older adults

  The Memory Assessment Clinics - Questionnaire (MAC-Q) is a 6-item scale that uses a 5-item Likert scale from "much better now"=1 to "much worse now"=5, and the last question scores double. The questionnaire asks the person to compare his or her memory with a previous period to measure age-related memory decline. Five items address specific situations frequently reported as problematic by those who experience memory loss with age. One item is a global item assessing general memory decline. A cutoff of 25 points or more indicates that the individual has a memory disorder.

  baseline and 6 months later

Secondary Outcomes (9)

• Change in cognitive impairment in older adults

  baseline and 6 months later

• Change in depression in older adults

  baseline and 6 months later

• Change in frailty status in older adults

  baseline and 6 months later

• Change in mental well being in older adults

  baseline and 6 months later

• Change in quality of life in older adults

  baseline and 6 months later

Study Arms (2)

engAGE group

EXPERIMENTAL

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

Device: engAGE system

control group

OTHER

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

Other: Group practicing with only the support of a booklet

Interventions

engAGE system 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.

engAGE group

Group practicing with only the support of a booklet OTHER

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

control group

Eligibility Criteria

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

You may qualify if:

• 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;
• items GDS score ≤ 1;
• have an informal caregiver to support in carrying out the main daily activities.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (3)

IRCCS INRCA Hospital

Ancona, 60127, Italy

RECRUITING

Karde A/S

Oslo, Norway

RECRUITING

HUG

Geneva, Switzerland

RECRUITING

Related Publications (1)

• 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.

  PMID: 40896828 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Anna Rita Bonfigli

CONTACT

0718003719; a.bonfigli@inrca.it

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: March 4, 2024
• First Posted: March 12, 2024
• Study Start: October 9, 2023
• Primary Completion: June 24, 2024
• Study Completion: June 24, 2024
• Last Updated: March 12, 2024

Record last verified: 2023-04

Locations

NO (1); IT (1); CH (1)