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 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.

Telehealth Home Support During COVID-19 Confinement for Community-Dwelling Older Adults With Mild Cognitive Impairment or Mild Dementia: Survey Study

“…People with mild cognitive impairment or mild dementia and their caregivers provided written consent before taking part in the TV-AssistDem clinical trial as per protocol [18]. Taking into consideration the rights of the participants and to perform this study during this exceptional situation of confinement, we informed people with mild cognitive impairment or mild dementia and their caregivers at the beginning of the telephone interview that the reason for the call was additional follow-up within the framework of the project.…”

“…Exclusion criteria were a score >11 on the Geriatric Depression Scale, terminal illness, and specific conditions (cognitive, visual, motor, etc.) which could compromise the use of the system [18].…”

“…In addition to offering informational content, three of the established functionalities of TV-AssistDem guarantee physical and mental health and well-being, social connectedness, and cognitive stimulation. The Health Education functionality enables visualization of videos of physical activity at home; the Videocall functionality enables communication with loved ones and health professionals through videocalls; and the Memory Games functionality provides cognitive stimulation with Stimulus memory games [18].…”

Cognitive Outcomes During COVID-19 Confinement Among Older People and Their Caregivers Using Technologies for Dementia: Protocol for an Observational Cohort Study

“…Participants will be identified from the support, monitoring, and reminder technology for mild dementia (SMART4MD; trial# NCT03325699) [ 22 ] and television-based assistive integrated service to support European adults living with mild dementia or mild cognitive impairment (TV-AssistDem; trial# NCT03653234) [ 23 ] clinical trials, both of which aim to assess the effects of ICTs to support dementia by using a tablet-based health app and a television-based assistive integrated service, respectively. Participants will include people with self-perceived cognitive impairment or their caregiver’s perception of cognitive impairment that has been present for >6 months under primary and secondary care services, including those who are being followed-up at memory clinics, outpatient clinics, day hospitals, or other components of specialist mental health, geriatric medicine, and neurology services.…”

P.0034 Covid-19 strict home confinement decreased caregivers burden of people with cognitive impairment and mild dementia

“…Methods: This cohort study was conducted in the Spanish region of Andalucía (Málaga). In total 151 caregivers for people with mild cognitive impairment or mild dementia (PMCI/MD), from the SMART4MD (n=75) ( 2 ) and TV-AssistDem (n=76) ( 3 ) randomized clinical trials (RCTs), were interviewed by telephone between May 11 and June 26 2020. All participants had undergone between 1-3 assessments (in 6 month-intervals) on burden and quality of life prior to the COVID-19 breakout.…”