Preprint · Jul 7, 2025
Technology-Assisted Cognitive Support for Older Adults with Mild Cognitive Impairment: Study Protocol for the DHEAL-COM Randomized Pilot Trial (Preprint)
By Bevilacqua R, Maranesi E, Felici E et al.
BACKGROUND Mild Cognitive Impairment (MCI) represents a transitional phase between normal aging and dementia. While no pharmacological treatments have proven effective, non-pharmacological interventions, such as cognitive stimulation and psychosocial support, have shown promise. Integrating digital tools and social assistive robotics may improve engagement, personalization, and access to care, contributing to the preservation of cognitive function and overall well-being in older adults. OBJECTIVE The DHEAL-COM pilot study aims to evaluate the feasibility, acceptability, and preliminary efficacy of a socio-technological intervention that combines digital cognitive stimulation, social robot interaction, and group training in digital and health literacy to counteract cognitive decline and promote autonomy among older adults with MCI. METHODS This is a single-blind, randomized controlled feasibility trial involving 60 older adults with MCI, recruited from the Neurology and Alzheimer Units of IRCCS INRCA. Participants are randomized into two groups: the experimental group receives home-based cognitive training via the Brainer app, a month-long interaction with the NAO social robot, and weekly group sessions on eHealth and digital literacy; the control group receives a well-being booklet with optional activities. Assessments are conducted at baseline (T0), post-intervention after 12 weeks (T1), and follow-up after 3 months (T2), using validated instruments such as MoCA, EQ-5D-5L, IT-eHEALS, SUS, UTAUT, and PWB. RESULTS Patient recruitment began in March 2025 and will continue through September 2025. The trial started in May 2025 and will run throughout the year. Results will focus on changes in cognitive performance, psychological well-being, quality of life, eHealth literacy, and user acceptability and usability of the technologies. Findings will be analyzed quantitatively and qualitatively and are expected to be published by 2026. CONCLUSIONS The DHEAL-COM study proposes an innovative, integrated intervention for older adults with MCI, using digital platforms and social robotics to support cognitive health and autonomy. This pilot study represents a promising step toward a more integrated and technology-supported model of care for older adults with MCI. CLINICALTRIAL The study protocol was recorded in ClinicalTrials.gov on the number NCT06984367.