TV-based Service to Support People Living With Mild Dementia or Mild Cognitive Impariment

Summary

This multicentre randomized controlled trial aims to evaluate the effects of an intervention consisting of a TV-based Assistive Integrated Service developed to improve the quality of life in older people with mild cognitive impairment or mild dementia (PMCI/MD) and their informal caregivers. This study is a collaboration between four European countries (Spain, Romania, Italy and Switzerland) and the clinical trials will be conducted in two of these countries (Spain and Romania) In total 240 dyads, consisting of a person with mild cognitive impairment or mild dementia and their informal caregiver will be recruited for this study. Participant dyads will be randomized in a 1:1 ratio in two parallel groups: to receive either usual care from primary or specialized providers (control group) or to receive usual care plus access to a device with the Tv-AssistDem platform (intervention group).

Participants in the trial will be assessed for a period of 12 months. After the baseline visit, all participants will have follow-up visits every 6 months together with a checkup of the PMCI/MD capacity to remain in the study. In the follow up visits, investigators will assess the PMCI/MD quality of life, caregiver's quality of life and burden, patient treatment adherence, patient functional status and service utilization. A user-behaviour analysis and usability evaluation will also be performed.

Conditions

• Mild Cognitive Impairment
• Mild Dementia

Interventions

DEVICE

TV-based Assistive Integrated Service

TV-AssistDem is an interactive platform which has been adapted specifically for people with MCI and mild dementia through a structured process. The application is intended to be used daily at home, mainly by the participants themselves, with the help of their informal caregivers. The device consists of an Android software and hardware TV (a Digital TV STB with Android technology). The core services of the platform are: 1) Calendar and reminders, 2) Health tracking and data transmission and 3) Videoconference; service-oriented applications are: 4) Cognitive stimulation (Stimulus© software); 5) Reminiscences; and 6) Patient and caregiver advice.

Sponsors & Collaborators

• Îngrijiri la domiciliu, Romania

  collaborator UNKNOWN

• Consiglio Nazionale delle Ricerche, Italy

  collaborator UNKNOWN

• Institut multidisciplinaire de science de données, Italy

  collaborator UNKNOWN

• Asociación de Familiares de Personas con Alzheimer y otras Demencias de Málaga, Spain

  collaborator UNKNOWN

• Smart Health TV Solution, Spain

  collaborator UNKNOWN

• Istituto di Scienze e Tecnologie della Cognizione, Switzerland

  collaborator UNKNOWN

• MEDEA, Italy

  collaborator UNKNOWN

• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

  lead OTHER

Principal Investigators

• Fermín Mayoral Cleries · Instituto de Investigación Biomédica de Malaga (IBIMA)-Fundacion FIMABIS

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-04-01

Primary Completion

2020-08-31

Completion

2020-12-31

Countries

• Romania
• Spain

Study Locations