Technology-Assisted Cognitive Support for Older Adults With Mild Cognitive Impairment: Study Protocol for the DHEAL-COM COGNITIVE Quasi-Experimental Pilot Study.

Background: Mild cognitive impairment (MCI) represents a transitional phase between normal aging and dementia. While no pharmacological treatments have proven effective, nonpharmacological interventions, such as cognitive stimulation and psychosocial support, have shown promise. Integrating digital tools and socially 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 COGNITIVE pilot study aims to evaluate the feasibility, acceptability, and preliminary efficacy of a sociotechnological intervention that combines digital cognitive stimulation, social robot interaction, and group training in digital and health literacy to counteract cognitive decline. Methods: This is a single-blind, quasi-experimental feasibility trial involving 60 older adults with MCI, recruited from the Neurology and Alzheimer Units of IRCCS INRCA (INRCA - IRCCS Istituto Nazionale di Ricovero e Cura per Anziani). Participants were allocated into 2 groups: the experimental group received home-based cognitive training via the Brainer app, a month-long interaction with the NAO social robot, and weekly group sessions on eHealth literacy and cognitive stimulation; the control group received a well-being booklet with optional activities. Assessments were conducted at baseline, postintervention after 12 weeks, and follow-up after 3 months, using validated instruments, such as the Montreal Cognitive Assessment, the EQ-5D-5L, the Italian version of the eHealth Literacy Scale, the System Usability Scale, the unified theory of acceptance and use of technology, and the Psychological Well-Being Scale. Descriptive statistics will be used to summarize feasibility, usability, and acceptability outcomes, while preliminary differences over time will be explored using appropriate inferential analyses, acknowledging that the study is not powered to detect effectiveness. Results: Patient recruitment began in March 2025 and continued through September 2025. As of April 2026, 36 patients have been recruited, with 18 participants per group. The trial started in May 2025 and ran 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 the end of 2026. Conclusions: The DHEAL-COM COGNITIVE 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.