Arianna Margaritini

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.

BACKGROUND Loneliness and social isolation are some of the several risk factors that contribute to dementia. Technology‑based interventions using socially assistive robots (SARs) and mobile apps may help not only to maintain cognitive functioning but also to support social connectedness and psychosocial wellbeing in older adults with mild cognitive impairment (MCI); however, evidence from multicountry trials remains limited. OBJECTIVE The proof‑of‑concept (PoC) evaluated the benefits of the engAGE platform, a hybrid intervention combining a social robot, mobile app, and wearable activity tracker, designed to support both social connectedness and cognitive functioning in older people with MCI across three European countries. METHODS Older adults with MCI were recruited in Italy, Switzerland, and Norway. The 6‑month intervention combined weekly robot‑guided group sessions with daily tablet use and continuous activity tracker wear at home. Outcomes were assessed at baseline and post-test and included subjective memory complaints as primary outcome (MAC‑Q), and global cognition (MoCA), loneliness (UCLA), quality of life (QoL‑AD and EQ‑5D‑5L VAS), and mental wellbeing (WEMWBS) as secondary outcomes. Also, usability and acceptance were assessed through SUS and UTAUT after 3 and 6 months of intervention. Intra-group and inter‑group differences in change were explored for any dimension to determine the effects of the intervention. RESULTS Of 50 enrolled participants, 44 (36 assigned to the experimental group - EG; and 8 to the control group - CG) completed the final assessment and were included in the analyses. The subjective memory complaints reduced significantly from 26.41 (±2.23) to 25.22 (±3.19) in the EG, whereas remained unchanged in the CG (26.75 ±0.71). MoCA scores remained stable overall (EG: 23.51 ±2.16 to 23.44 ±3.21), with no significant differences between groups. Psychosocial outcomes showed a mixed pattern: in the Italian EG, loneliness decreased significantly (UCLA: 45.18 ± 9.61 to 37.94 ± 6.56), whereas in Switzerland significantly worsened (p=.021). Also, the self‑rated health (EQ‑5D‑5L-VAS) improved significantly in the EG (p=.013), but no significant differences were detected between groups. Overall QoL‑AD and WEMWBS scores remained broadly stable. SUS scores in the EG improved significantly (p=.020) from 58.81 (±18.17) to 68.54 (±18.54), reaching the commonly accepted usability threshold. CONCLUSIONS The engAGE hybrid intervention, combining robot‑guided group activities with home‑based tablet use and activity monitoring, was delivered across three different socio‑healthcare contexts and showed preliminary benefits in subjective memory, selected psychosocial measures, and usability. CLINICALTRIAL ClinicalTrials.gov NCT06302686; https://clinicaltrials.gov/study/NCT06302686 INTERNATIONAL REGISTERED REPORT RR2-10.2196/67601

(1) Background: Parkinson’s disease (PD) is a neurodegenerative disorder characterized by gait and postural impairments. Recently, physical activity has emerged as a key strategy in PD management. This study aimed to evaluate the effectiveness of an innovative technology-assisted rehabilitation program in improving gait and reducing fall risk in older adults with PD. (2) Methods: Fifty-eight patients were randomly assigned to three groups: conventional rehabilitation (CG), or conventional therapy combined with technology-assisted rehabilitation using Tymo (TG) or Walker View (WG). The intervention consisted of 10 sessions over 5 weeks. Assessments were conducted at baseline (T0), post-intervention (T1), and at 6-month follow-up (FW). Outcomes included gait and balance performance, fear of falling, quality of life, activities of daily living, and physical function. (3) Results: The CG showed no significant improvements, with a decline in Barthel Index from T1 to FW. The WG demonstrated significant improvement in POMA Gait scores, while the TG improved both POMA Total and Balance scores at T1. Post-treatment, TG and WG outperformed CG in POMA outcomes; however, these differences were lost at follow-up. (4) Conclusions: Technology-assisted rehabilitation can improve gait and balance in older adults with PD, although sustained or repeated interventions may be necessary to maintain long-term benefits.

Background: Humanoid robots are being used more frequently in health care: in geriatrics and pediatrics, robots such as “Pepper” and “Nao” have been shown to enhance communication, emotional well-being, and patient engagement. During the pandemic, their role expanded, for example, to include remote monitoring and reducing the risk of infection. Given these applications, our study examines the integration of 2 advanced humanoid robots, Pepper and Nao, within the reception area of a geriatric hospital. Objective: The study aims to develop a reception service directed to enhance the quality of the IRCCS Istituto Nazionale di Riposo e Cura per Anziani (INRCA), Ancona, Italy. The primary end point of the study is the assessment of the perceived quality of an innovative reception service. Second, the study aims at evaluating the usability, human-robot interaction, user experience, and technical performance of the solution. Methods: The HOSPER (analysis of the quality of reception services using robotic platforms, Nao and Pepper) study is a feasibility pilot project coordinated by IRCCS INRCA. During the trial, 200 older adults using services at IRCCS INRCA in Ancona will be enrolled. Two humanoid robots, Nao and Pepper, which are already available at the hospital, will be used to support reception and orientation services. Data collection will include general demographics, cognitive and functional status, usability measures, perceived service quality, and human-robot interaction indicators. Results: The recruitment and data collection started in January 2025 and will be concluded by December 2025. Results regarding the feasibility of a robotic-based reception service in a geriatric hospital will be published in 2027. Conclusions: The HOSPER study aims to assess the feasibility of an innovative robot-mediated reception service in a geriatric hospital, with specific focus on recruitment feasibility, completion rates, user acceptability, and perceived service quality. In fact, the usability and user experience evaluation will demonstrate the feasibility of the approach and provide indications for future developments and improvements.

Background: Type 2 diabetes is a prevalent chronic condition, particularly among older adults, and is associated with significant morbidity, mortality, and health care costs. Effective disease self-management is crucial for achieving glycemic control and preventing complications. Objective: This pilot study aims to evaluate the effectiveness of a structured, 5-week training program in improving eHealth literacy among older adults with type 2 diabetes and to assess its impact on health literacy, self-efficacy, psychological well-being, and clinical outcomes. Methods: In total, 200 community-dwelling adults aged ≥60 years with type 2 diabetes, a Mini-Mental State Examination score ≥24, a Geriatric Depression Scale score 1c and lipid profiles. Finally, participants’ experiences, satisfaction, and perceived benefits will be explored to inform the future scalability and refinement of the program. A prestudy will be conducted, involving stakeholders, older adults, and caregivers, to refine the training content using co-design techniques. Descriptive statistics will be used to summarize sample characteristics. Preintervention and postintervention changes will be evaluated using 2-tailed paired t tests or their nonparametric equivalents, with repeated-measures models applied to follow-up data. A P value <.05 will indicate statistical significance. Results: The prestudy phase began in April 2025. Improvements in both health literacy and eHealth literacy are expected to be observed among participants, as assessed through validated instruments administered before and after the intervention. Conclusions: The Joint Action on Cardiovascular Diseases and Diabetes (JACARDI) study provides a structured and participatory approach to addressing the digital divide in chronic disease management among older adults. By focusing on personalized, evidence-based training, the study offers a promising model for empowering patients and improving health outcomes through enhanced digital and self-management competencies.

Background: Dementia is challenging society in terms of the quality of life, the costs of health care systems, and caregivers’ burden. Dementia is often preceded by a status of mild cognitive impairment (MCI), during which a healthy lifestyle and cognitive therapy seem to be effective in counteracting the decline. Objective: The engAGE (Managing Cognitive Decline Through Theatre Therapy, Artificial Intelligence, and Social Robot–Driven Interventions) project aimed to build a technological platform to counteract cognitive decline in older adults with MCI through both cognitive therapy and lifestyle management. Methods: The engAGE platform was built around the social robot Pepper, which provides cognitive therapy. An activity tracker and a mobile app were also integrated within the platform to help older adults with MCI monitor their sleep and physical activity, in addition to offering cognitive games at home. The proof of concept (PoC) of engAGE was designed as a 6-month long randomized controlled trial (RCT) aimed to test the solution in three European countries: Italy, Switzerland, and Norway. During this period, under the supervision of a psychologist or a therapist, Pepper provided cognitive therapy on a weekly basis at health care or daycare facilities. In parallel, the use of the mobile app and the activity tracker was recommended on a daily basis. Participants were recruited through health care institutions and care organizations and evaluated through face-to-face interviews. The primary interest of the study was to assess the impact of engAGE on cognitive capacity through the Montreal Cognitive Assessment (MoCA) and the Memory Assessment Clinic Questionnaire (MAC-Q). In addition, changes in social engagement and quality of life were measured through the University of California, Los Angeles (UCLA) Loneliness Scale and the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS). The PoC also focused on the acceptability and usability of engAGE, evaluated through the System Usability Scale (SUS) and the Unified Theory of Acceptance and Use of Technology (UTAUT) questionnaire. In addition, data were collected regarding the frequency of weekly sessions and access to the mobile app, as well as activity tracker measurements. Results: Data collection commenced in November 2023 and finished in July 2024, with the enrollment of 49 older adults with MCI (n=40, 81.6%, assigned to the experimental group [EG] and n=9, 18.4%, to the control group [CG]) conducted from October 2023 to April 2024. Data analysis was concluded in November 2024, and results will be published by 2026. Conclusions: The engAGE PoC represents an innovative study focused on the impact of a technology-based multidomain intervention designed for older adults with MCI that aimed to counteract cognitive decline through cognitive training, as well as improvement in terms of the quality of life, social engagement, physical activity, and sleep quality of primary end users. Trial Registration: ClinicalTrials.gov NCT06302686; https://clinicaltrials.gov/study/NCT06302686 International Registered Report Identifier (IRRID): RR1-10.2196/67601

Background: Dementia is a syndrome characterized by a wide spectrum of symptoms and needs. There is no cure for this syndrome, which represents a major challenge to society in terms of quality of life for those affected and in terms of workload and stress burden for those who take care of them. Objective: The Healthy Ageing Ecosystem for People With Dementia (HAAL) aimed to improve the quality of life of both people with dementia and their formal caregivers (FCs) and informal caregivers (ICs) by providing a personalized set of devices to the person with dementia, along with a dashboard designed for caregivers to monitor and manage the older person. Methods: The HAAL platform comprises a dashboard that integrates, aggregates, and analyzes heterogeneous data gathered from an ecosystem of devices designed for and tested with people with dementia. The study was designed as a technical feasibility pilot to test the HAAL ecosystem in 3 countries: Italy, Taiwan, and the Netherlands, where older people with initial, moderate, and severe dementia were enrolled, respectively. The study was run in 2 stages: the alpha and beta pilot studies aimed to test the second and third prototypes of the platform, respectively. Results: The alpha test was conducted from March to May 2023, involving 41 end users, of which 13 were people with dementia, 13 were ICs, and 15 were FCs. The beta test was conducted from September 2023 to February 2024, involving 83 end users, of which 26 were people with dementia, 20 were ICs, and 37 were FCs. The results have been elaborated and are supposed to be published by 2026. Conclusions: The HAAL pilot study was an innovative feasibility study whose primary objectives were to assess reduction in care load for FCs, stress relief for FCs and ICs, and improvement in the perceived quality of life for ICs and people with dementia. The study also evaluated the usability and the acceptance of the platform. Preliminary analyses of the results showed that the HAAL platform partially relieved caregivers’ stress and that the quality of life of people with dementia did not worsen over the test period. International Registered Report Identifier (IRRID): RR1-10.2196/59860