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

Abstract 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 develope...

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Main Authors: Jessica Marian Goodman-Casanova, José Guzmán-Parra, Gloria Guerrero, Elisa Vera, Pilar Barnestein-Fonseca, Gabriella Cortellessa, Francesca Fracasso, Alessandro Umbrico, Amedeo Cesta, Diana Toma, Flavia Boghiu, Rodolphe Dewarrat, Valentina Triantafyllidou, Elena Tamburini, Pietro Dionisio, Fermín Mayoral
Format: Article
Language:English
Published: BMC 2019-09-01
Series:BMC Geriatrics
Subjects:
Online Access:http://link.springer.com/article/10.1186/s12877-019-1267-z
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author Jessica Marian Goodman-Casanova
José Guzmán-Parra
Gloria Guerrero
Elisa Vera
Pilar Barnestein-Fonseca
Gabriella Cortellessa
Francesca Fracasso
Alessandro Umbrico
Amedeo Cesta
Diana Toma
Flavia Boghiu
Rodolphe Dewarrat
Valentina Triantafyllidou
Elena Tamburini
Pietro Dionisio
Fermín Mayoral
author_facet Jessica Marian Goodman-Casanova
José Guzmán-Parra
Gloria Guerrero
Elisa Vera
Pilar Barnestein-Fonseca
Gabriella Cortellessa
Francesca Fracasso
Alessandro Umbrico
Amedeo Cesta
Diana Toma
Flavia Boghiu
Rodolphe Dewarrat
Valentina Triantafyllidou
Elena Tamburini
Pietro Dionisio
Fermín Mayoral
author_sort Jessica Marian Goodman-Casanova
collection DOAJ
description Abstract 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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spelling doaj.art-b4adcef204ca4d019208baa062678beb2022-12-21T20:15:39ZengBMCBMC Geriatrics1471-23182019-09-0119111210.1186/s12877-019-1267-zTV-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 trialJessica Marian Goodman-Casanova0José Guzmán-Parra1Gloria Guerrero2Elisa Vera3Pilar Barnestein-Fonseca4Gabriella Cortellessa5Francesca Fracasso6Alessandro Umbrico7Amedeo Cesta8Diana Toma9Flavia Boghiu10Rodolphe Dewarrat11Valentina Triantafyllidou12Elena Tamburini13Pietro Dionisio14Fermín Mayoral15Instituto de Investigación Biomédica de Málaga – Fundación Pública Andaluza para la Investigación de Málaga de Biomedicina y Salud (IBIMA-FIMABIS)Instituto de Investigación Biomédica de Málaga – Fundación Pública Andaluza para la Investigación de Málaga de Biomedicina y Salud (IBIMA-FIMABIS)Instituto de Investigación Biomédica de Málaga – Fundación Pública Andaluza para la Investigación de Málaga de Biomedicina y Salud (IBIMA-FIMABIS)Instituto de Investigación Biomédica de Málaga – Fundación Pública Andaluza para la Investigación de Málaga de Biomedicina y Salud (IBIMA-FIMABIS)Instituto de Investigación Biomédica de Málaga – Fundación Pública Andaluza para la Investigación de Málaga de Biomedicina y Salud (IBIMA-FIMABIS)CNR–Italian National Research Council, ISTCCNR–Italian National Research Council, ISTCCNR–Italian National Research Council, ISTCCNR–Italian National Research Council, ISTCS.C. INGRIJIRI LA DOMICILIU S.R.L.S.C. INGRIJIRI LA DOMICILIU S.R.L.Institut multidisciplinaire de science de donnees (IMSD)Institut multidisciplinaire de science de donnees (IMSD)MEDEAMEDEAInstituto de Investigación Biomédica de Málaga – Fundación Pública Andaluza para la Investigación de Málaga de Biomedicina y Salud (IBIMA-FIMABIS)Abstract 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.http://link.springer.com/article/10.1186/s12877-019-1267-zAmbient assisted livingAssistive technologyTelemedicineRemote consultationsDementiaPerson with dementia
spellingShingle Jessica Marian Goodman-Casanova
José Guzmán-Parra
Gloria Guerrero
Elisa Vera
Pilar Barnestein-Fonseca
Gabriella Cortellessa
Francesca Fracasso
Alessandro Umbrico
Amedeo Cesta
Diana Toma
Flavia Boghiu
Rodolphe Dewarrat
Valentina Triantafyllidou
Elena Tamburini
Pietro Dionisio
Fermín Mayoral
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 Geriatrics
Ambient assisted living
Assistive technology
Telemedicine
Remote consultations
Dementia
Person with dementia
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Ambient assisted living
Assistive technology
Telemedicine
Remote consultations
Dementia
Person with dementia
url http://link.springer.com/article/10.1186/s12877-019-1267-z
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