The usability and feasibility validation of the social robot MINI in people with dementia and mild cognitive impairment; a study protocol

Background: Social robots have demonstrated promising outcomes in terms of increasing the social health and well-being of people with dementia and mild cognitive impairment. According to the World Health Organization's Monitoring and assessing digital health interventions framework, usability and feasibility studies are crucial before implementing prototype social robots and proving their efficacy and effectiveness. This protocol paper aims to detail the plan for conducting the usability and feasibility study of the MINI robot based on evidence-based recommended methodology. Methods: In this study, an experimental design and a mixed method of data collection will be applied. Twenty participants aged 65 and over with dementia or mild cognitive impairment will be recruited. Eight sessions of interaction with the robot, as well as qualitative and quantitative assessments, will be accomplished. The research will take place in a laboratory. Ethical approvals have been acquired. This research will be valuable in the development of the MINI robot and its practical deployment in the actual world, as well as the methodological evidence base in the sector of social robots. Discussion: By the winter of 2022-23, the findings of this study will be accessible for dissemination. This study will aid to improve the evidence-based methodology used to study the feasibility and usability of social robots in people with dementia and mild cognitive impairment as well as what can be learned to advance such study designs in the future.This project is part of the Marie Skłodowska Curie Actions Innovative Training Network H 2020 MSCA ITN, under grant agreement number 813196. Any potential costs for conducting the research, materials, human resources, and dissemination will be covered. The Robotics Lab of Universidad Carlos III de Madrid received funding from the projects: Robots Sociales para Estimulación Física, Cognitiva y Afectiva de Mayores (ROSES), RTI2018–096338-B-I00, funded by the Ministerio de Ciencia, Innovación y Universidades, Spanish Government; Robots Sociales para mitigar la soledad y el aislamiento en mayores (SOROLI), PID2021-123941OA-I00, funded by Agencia Estatal de Investigación (AEI), Ministerio de Ciencia e Innovación, Spanish Goverment. The funders/sponsor have no role in study design or analysis