Development and Evaluation of the DEA App (DEA)

June 16, 2023 updated by: Valentin Ritschl

Development and Evaluation of an Application for Supporting Informal Caregivers of People With Dementia in Their Daily Life

Background, current situation, and motivation

According to current estimates, 100,000 people in Austria suffer from various types of dementia. According to forecasts, this number of people will rise to approximately 230,000 by 2050 due to the demographic development and the increase of the prevalence rate. Data from the service statistics show that 85% of dementia patients still live in the community in their homes and informal caregivers, such as relatives, support them. In total, more than 300,000 people care for their relatives in Austria in addition to professional support. However, not only the person affected from dementia suffers from the disease, but also, and often at a higher rate, the informal caregivers. Vice versa, the quality of life of those suffering from dementia is significantly influenced by the caregivers' competences and their strategies for resilience.

Study aim and hypothesis

The aim of this study is to evaluate the usability, acceptance, and effect of an app consisting of three modules that provide multidimensional support for informal caregivers of a person with dementia.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Vienna, Austria, 1090
        • Medical University of Vienna
      • Vienna, Austria, 1100
        • University of Applied Sciences FH Campus Wien

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • informal caregivers of a person with dementia
  • 18 years or older
  • enough language skills to participate
  • give written and oral informed consent
  • have an Android smartphone or tablet (required to use the app).

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DEA-App
The intervention (DEA) group will receive the newly developed app.

The intervention (DEA) group will receive the newly developed app. DEA will consist of three simultaneous modules that provide multidimensional support for informal caregivers aiming to reduce the caregiver burden:

  1. Information module

    The information module consists of general information on the disease and the care of people suffering from dementia.

  2. Activity module

    The activity module suggests individualized activities and physical fitness exercises by a self-learning algorithm, which supports the caregiver to deliver more targeted and easier care.

  3. Communication module

If two or more persons are caring for one person with dementia, the communication module provides a networking possibility.

Other: Standard Information group
The control group will receive a leaflet on some general principles for promoting health and well-being in older adults with dementia.
The control group will receive a leaflet on some general principles for promoting health and well-being in older adults with dementia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Burden Scale for Family Caregivers
Time Frame: 3 month after baseline
The Burden Scale for Family Caregivers are rated on a scale from 0 (strongly disagree) to 3 (strongly agree). The score ranges from 0 to 84 points. Higher scores indicate greater caregiver burden
3 month after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
12-item Short-Form Health Survey
Time Frame: 3 month after baseline
The SF-12 is a shortened version of the 36-item Short Form Health Survey (SF-36). It is developed as an applicable instrument for measuring health-related quality of life.
3 month after baseline
Adult carers quality of life questionnaire
Time Frame: 3 month after baseline

The Adult Carer Quality of Life Questionnaire is a simple instrument for use with adult carers. It measures quality of life in eight domains:

  1. support for caring,
  2. caring choice,
  3. caring stress,
  4. money matters,
  5. personal growth,
  6. sense of value,
  7. ability to care, and
  8. carer satisfaction.
3 month after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Tanja A Stamm, PhD, Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

January 23, 2019

First Submitted That Met QC Criteria

January 24, 2019

First Posted (Actual)

January 29, 2019

Study Record Updates

Last Update Posted (Estimated)

June 19, 2023

Last Update Submitted That Met QC Criteria

June 16, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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