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

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Enrolling

Conditions: Mild Cognitive Impairment; Older Adults

Treatments: Other: Group practicing with only the support of a booklet; Device: engAGE system

Study type: Interventional

Funder types: Other

Identifiers

NCT06302686

INRCA_004_2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

engAGE group

Experimental group

Description:

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

Treatment:

Device: engAGE system

control group

Other group

Description:

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

Treatment:

Other: Group practicing with only the support of a booklet