Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 16, 2024
Date Accepted: Jun 3, 2025
Managing Cognitive Decline through Social Robot-Based Intervention: Protocol for the engAGE Proof-of-Concept and Randomized Controlled Trial
ABSTRACT
Background:
Every year in Europe the number of diagnoses of dementia increases significantly. Dementia is challenging the society in terms of quality of life, costs of healthcare systems and caregivers’ burden. Dementia is often preceded by a status of mild cognitive impairment (MCI), during which healthy lifestyle and cognitive therapy seem to be effective in counteracting the decline.
Objective:
The engAGE project aims to build a technological platform to counteract cognitive decline in people with MCI through both cognitive therapy and lifestyle management. The platform is built around the social robot Pepper, which provides cognitive therapy weekly at healthcare or daycare facilities. In addition to the social robot, a mobile app and an activity tracker are integrated within the platform to help older people with MCI to monitor their sleep and physical activity, other than offer cognitive games at home.
Methods:
The proof of concept of the engAGE platform is a 6-months long randomized controlled trial (RCT) aimed to test the solution in three European countries: Italy, Switzerland, and Norway. The primary interest of the study is to assess the impact of the engAGE platform on cognitive capacity through MoCA and MAC-Q. In addition, changes in social engagement and quality of life are measured through UCLA and WEMWBS. Then, the proof of concept also focuses on the acceptability and usability of the platform, evaluated through the SUS scale and the UTAUT questionnaire.
Results:
Data collection commenced in November 2023 and finished in July 2024, with the enrollment of 49 older people with MCI conducted from October 2023 to April 2024. The results will be ready for publication by January 2025.
Conclusions:
The proof of concept, is an innovative study focused on the impact of a technological-based intervention designed for older people with MCI, that aims to tackle directly the cognitive decline through cognitive training, and indirectly through the improvement in terms of quality of life, social engagement, physical activity and sleep quality of primary end users. Clinical Trial: The study was recorded in ClinicalTrials.gov on the number NCT06302686. The study was approved by the Ethic Committee of the IRCCS INRCA in Italy (protocol number: 6293/2023) and by Canton Commission of Etihics and Research (Commission cantonale d’éthique de la recherche – CCER) in Switzerland (project ID: 2023-00774).
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