RT Journal Article T1 TV-based assistive integrated service to support European adults living with mild dementia or mild cognitive impairment (TV-AssistDem): study protocol for a multicentre randomized controlled trial A1 Goodman-Casanova, Jessica Marian A1 Guzmán-Parra, José A1 Guerrero, Gloria A1 Vera, Elisa A1 Barnestein-Fonseca, Pilar A1 Cortellessa, Gabriella A1 Fracasso, Francesca A1 Umbrico, Alessandro A1 Cesta, Amedeo A1 Toma, Diana A1 Boghiu, Flavia A1 Dewarrat, Rodolphe A1 Triantafyllidou, Valentina A1 Tamburini, Elena A1 Dionisio, Pietro A1 Mayoral, Fermín K1 Ambient assisted living K1 Assistive technology K1 Telemedicine K1 Remote consultations K1 Dementia K1 Person with dementia K1 Informal caregivers K1 Quality of life K1 Inteligencia ambiental K1 Dispositivos de autoayuda K1 Telemedicina K1 Telemonitorización K1 Demencia K1 Cuidadores K1 Calidad de vida AB 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. PB BioMed Central, Ltd. YR 2019 FD 2019-09-06 LK http://hdl.handle.net/10668/3200 UL http://hdl.handle.net/10668/3200 LA en NO Goodman-Casanova JM, Guzmán-Parra J, Guerrero G, Vera E, Barnestein-Fonseca P, Cortellessa G, et al. TV-based assistive integrated service to support European adults living with mild dementia or mild cognitive impairment (TV-AssistDem): study protocol for a multicentre randomized controlled trial. BMC Geriatr. 2019 Sep 6;19(1):247. DS RISalud RD Apr 7, 2025