Goodman-Casanova, Jessica MarianGuzmán-Parra, JoséGuerrero, GloriaVera, ElisaBarnestein-Fonseca, PilarCortellessa, GabriellaFracasso, FrancescaUmbrico, AlessandroCesta, AmedeoToma, DianaBoghiu, FlaviaDewarrat, RodolpheTriantafyllidou, ValentinaTamburini, ElenaDionisio, PietroMayoral, Fermín2020-10-292020-10-292019-09-06Goodman-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.http://hdl.handle.net/10668/3200Background: 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.enAmbient assisted livingAssistive technologyTelemedicineRemote consultationsDementiaPerson with dementiaInformal caregiversQuality of lifeInteligencia ambientalDispositivos de autoayudaTelemedicinaTelemonitorizaciónDemenciaCuidadoresCalidad de vidaMedical Subject Headings::Psychiatry and Psychology::Behavioral Disciplines and Activities::Psychotherapy::Behavior Therapy::Cognitive TherapyMedical Subject Headings::Psychiatry and Psychology::Mental Disorders::Delirium, Dementia, Amnestic, Cognitive Disorders::Cognition Disorders::Mild Cognitive ImpairmentMedical Subject Headings::Health Care::Health Services Administration::Patient Care Management::Delivery of Health Care::Delivery of Health Care, IntegratedMedical Subject Headings::Persons::Persons::Age Groups::Adult::AgedMedical Subject Headings::Persons::Persons::Age Groups::Adult::Aged::Aged, 80 and overMedical Subject Headings::Persons::Persons::CaregiversMedical Subject Headings::Psychiatry and Psychology::Mental Disorders::Delirium, Dementia, Amnestic, Cognitive Disorders::DementiaMedical Subject Headings::Geographical Locations::Geographic Locations::EuropeMedical Subject Headings::Check Tags::FemaleMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Cohort Studies::Longitudinal Studies::Follow-Up StudiesMedical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::HumansMedical Subject Headings::Check Tags::MaleMedical Subject Headings::Anthropology, Education, Sociology and Social Phenomena::Social Sciences::Quality of LifeMedical Subject Headings::Health Care::Health Services Administration::Patient Care Management::Delivery of Health Care::TelemedicineMedical Subject Headings::Information Science::Information Science::Communications Media::Telecommunications::Televisionresearch article31492113open access10.1186/s12877-019-1267-z1471-2318PMC6731559