Clinical trial NCT06302686: engAGE: Managing cognitivE decliNe throuGh Theatre Therapy, Artificial Intelligence and Social Robots drivEn Interventions
Official title: engAGE: Managing cognitivE decliNe throuGh Theatre Therapy, Artificial Intelligence and Social Robots drivEn Interventions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Older Adults
Keywords: ageing
older adults
mild cognitive impairment
caregiver
technological platform
Lead sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Sponsor class: OTHER
Collaborators: name: European Union
First posted: 2024-03-12
Enrollment: 78
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Change in perceived stability of cognitive status by the older adults
timeFrame: baseline and 6 months later
Secondary outcomes:
measure: Change in cognitive impairment in older adults
timeFrame: baseline and 6 months later
measure: Change in depression in older adults
timeFrame: baseline and 6 months later
measure: Change in frailty status in older adults
timeFrame: baseline and 6 months later
measure: Change in mental well being in older adults
timeFrame: baseline and 6 months later
measure: Change in quality of life in older adults
timeFrame: baseline and 6 months later
measure: Change in acceptability of the engAGE system in older adults
timeFrame: baseline and 6 months later
measure: Change in quality of life in informal caregivers
timeFrame: baseline and 6 months later
measure: Change in mental well being in informal caregivers
timeFrame: baseline and 6 months later
measure: Change in caregiver burden
timeFrame: baseline and 6 months later
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: IRCCS INRCA Hospital
city: Oslo
country: Norway
facility: Karde A/S
city: Geneva
country: Switzerland
facility: HUG
Study officials:
References: