- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03819816
Development and Evaluation of the DEA App (DEA)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Vienna, Austria, 1090
- Medical University of Vienna
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Vienna, Austria, 1100
- University of Applied Sciences FH Campus Wien
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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.
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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:
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.
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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
|
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Adult carers quality of life questionnaire
Time Frame: 3 month after baseline
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The Adult Carer Quality of Life Questionnaire is a simple instrument for use with adult carers. It measures quality of life in eight domains:
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3 month after baseline
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Tanja A Stamm, PhD, Medical University of Vienna
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DEA_APP_2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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