Support Monitoring and Reminder Technology

Summary

This multicentre randomized control trial aims to evaluate the effects of an intervention consisting of an health application developed to improve the quality of life (QoL) in older people with mild dementia and their informal caregivers. The study is a collaboration between five European countries where the clinical trials will be conducted in four of these countries (Sweden, Belgium, Spain and Czech Republic).

In total 1200 dyads (consisting of a person with mild dementia (PWD) and their informal caregiver (carer) will be recruited for this study. Participant dyads will be randomized in a 1:1 ratio in two parallel groups: PWD to receive either usual care from primary or specialized providers (control group) or to receive usual care plus access to a tablet with the SMART4MD health application (intervention group).

Participants in the trial will be assessed for a period of 18 months. After the baseline visit, all participants will have follow-up visits every 6 months together with a checkup of the PWDs capacity to remain in the study. In the follow up visits, investigators will assess the PWD's quality of life, their cognitive and functional status, adherence to prescribed medication and attendance at healthcare appointments and admissions to healthcare services institutions. Investigators will also assess the burden of the informal caregivers.

Conditions

• Mild Dementia
• Cognitive Impairment, Mild

Interventions

DEVICE

SMART4MD Health Application

SMART4MD is a general health application which has been adapted specifically for people with 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 carers. The application is optimized for tablet devices running on Android operating system (OS). Participants will be provided with a tablet with the SMART4MD health application. The core functionalities of the application are based on reminders (medication, appointments with healthcare providers), brain supporting activities (clock, calendar, brain games, photos) and optional status and health information sharing with family and informal carers (including daily feeling status, specific health problems, and quality of life). An important feature of SMART4MD is its personalization facility: main users (PWD and informal carers) will be able to switch off/on various features and information sharing possibilities.

Sponsors & Collaborators

• HealthBit

  collaborator UNKNOWN

• Andaluz Health Service

  collaborator OTHER_GOV

• Blekinge Institute of Technology

  collaborator OTHER

• Consorci Sanitari de Terrassa

  collaborator OTHER

• DEX Innovation Centre

  collaborator UNKNOWN

• Anglia Ruskin University

  collaborator OTHER

• University College Leuven - Limburg

  collaborator UNKNOWN

• Universidad Politecnica de Madrid

  collaborator OTHER

• Athena ICT

  collaborator UNKNOWN

• Johan Sanmartin Berglund

  lead OTHER

Principal Investigators

• Tomer Regev, PhD · Anglia Ruskin University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

55 Years

Max Age

120 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-12-03

Primary Completion

2019-10-01

Completion

2019-10-01

Countries

• Belgium
• Czechia
• Spain
• Sweden

Study Locations