Background Mild cognitive impairment and mild dementia progressively compromise the ability of people to live independently and can have a negative impact on their quality of life. Within the current European Active and Assisted Living programme (AAL), project TV-AssistDem has been developed to deliver a TV-based platform service to support patients with mild cognitive impairment or mild dementia and provide relief to their caregivers. The application is intended to be used daily at home, mainly by the participants themselves, with the help of their informal caregivers. The aim of this study is to evaluate the effectiveness of TV-AssistDem to improve quality of life in people with mild cognitive impairment or mild dementia. Methods This is a 12-month European multicentre randomized controlled trial which will be performed in two countries: Spain and Romania. Two hundred and forty older adults will be recruited using identical inclusion/exclusion criteria. The primary outcome will be the change from baseline of TV-AssistDem on patient quality of life at 12 months. The secondary outcomes will be the changes from baseline of: 1) informal caregiver quality of life, 2) informal caregiver burden, 3) patient treatment adherence, 4) patient treatment compliance, 5) patient functional status, and 6) healthcare cost-effectiveness at 12 months. Patients in the intervention group will have access to an interactive platform which offers remote assistive services through a device connected to the television. The core services of the platform are: 1) Calendar and reminders, 2) Health monitoring and data transmission to a health server and 3) Videoconference; service-oriented applications are: 4) Cognitive stimulation; 5) Reminiscences; and 6) Patient and caregiver healthcare education. The analysis will be made following an intention-to-treat procedure. Linear and Generalized Mixed Model analysis will be performed. Discussion We hypothesize that the regular use of TV-AssistDem will result in an improvement in patient quality of life. The uniqueness of this home TV-based intervention lies on its widespread accessibility and its integrative approach to quality of life in people with mild cognitive impairment or mild dementia and their informal caregivers. However, several anticipated challenges will need to be faced: poor engagement and connectivity problems. Trial registration ClinicalTrials.gov Identifier NCT03653234 , Date of registration: 31 August 2018.

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BACKGROUND Considering the changing demographic trends in Europe, the rising prevalence of dementia, and the increasing demand, limited accessibility and finite resources for long-term healthcare and support services, developing active and assisted living technological solutions becomes necessary for the independent living of community-dwelling adults. The TV-AssistDem project aims to develop a TV-based assistive integrated service for people with mild cognitive impairment by conducting a feasibility study for prototype development and refinement. OBJECTIVE To identify (1) usability barriers and facilitators to implementation, (2) usage and clinical change from baseline and (3) user and caregiver satisfaction. METHODS A two-phased study was carried out between August 2018 and April 2019. PHASE I consisted of a one-time introduction to the TV-AssistDem functionalities at the users´ home environment for usability testing and clinical evaluation at baseline. PHASE II analyzed the usage of the service during a one-month intervention period. Completion of the System Usability Scale, clinical evaluation and assessment of satisfaction was carried out to conclude PHASE II. Participants: Two European countries: Biomedical Research Institute of Malaga (IBIMA) and the Romanian NGO Home Care Association (Îngrijiri La Domiciliu). Twelve dyads (N=24) formed by people with mild cognitive impairment and mild dementia and their informal caregivers, healthcare professionals (nurse and social worker) and technological developers. RESULTS Usability testing reported 72 issues, identifying implementation barriers and corresponding solutions, categorized into human (7) and technological axis (7); and implementation facilitators (4). The likelihood to recommend TV-AssistDem is “passive” and the prototype may be considered as “marginally acceptable”. For almost all services the usage analysis identified 3 very intensive users (more than twice the expected average), 5 normal users and 4 with almost no use of the system. The limited sample size did not provide statistically significant clinical data but the overall increase in clinical average values and delta values is a promising finding that will be validated during the randomized clinical trial which will cover a larger population (N=240) over a longer period of time (12 months). Dyads satisfaction reported TV-AssistDem to be user-friendly, innovative and interactive overall. CONCLUSIONS This user and caregiver centered study with healthcare professional participation tested the TV-AssistDem prototype as an important starting point in prototype refinement, intervention planning, adaptation and successful implementation demonstrating the technological viability for full trial commitment. CLINICALTRIAL NCT03653234 May 13, 2020 INTERNATIONAL REGISTERED REPORT RR2-10.1186/s12877-019-1267-z