Development and Evaluation of the DEA App (DEA)
Primary Purpose
Dementia
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
DEA-App
Standard Information group
Sponsored by
About this trial
This is an interventional treatment trial for Dementia focused on measuring informal caregivers, person with dementia, e-health solution
Eligibility Criteria
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
Sites / Locations
- Medical University of Vienna
- University of Applied Sciences FH Campus Wien
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
DEA-App
Standard Information group
Arm Description
The intervention (DEA) group will receive the newly developed app.
The control group will receive a leaflet on some general principles for promoting health and well-being in older adults with dementia.
Outcomes
Primary Outcome Measures
Burden Scale for Family Caregivers
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
Secondary Outcome Measures
12-item Short-Form Health Survey
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.
Adult carers quality of life questionnaire
The Adult Carer Quality of Life Questionnaire is a simple instrument for use with adult carers. It measures quality of life in eight domains:
support for caring,
caring choice,
caring stress,
money matters,
personal growth,
sense of value,
ability to care, and
carer satisfaction.
Full Information
NCT ID
NCT03819816
First Posted
January 23, 2019
Last Updated
June 16, 2023
Sponsor
Valentin Ritschl
Collaborators
FH Campus Wien, University of Applied Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03819816
Brief Title
Development and Evaluation of the DEA App
Acronym
DEA
Official Title
Development and Evaluation of an Application for Supporting Informal Caregivers of People With Dementia in Their Daily Life
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
November 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Valentin Ritschl
Collaborators
FH Campus Wien, University of Applied Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
informal caregivers, person with dementia, e-health solution
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DEA-App
Arm Type
Experimental
Arm Description
The intervention (DEA) group will receive the newly developed app.
Arm Title
Standard Information group
Arm Type
Other
Arm Description
The control group will receive a leaflet on some general principles for promoting health and well-being in older adults with dementia.
Intervention Type
Other
Intervention Name(s)
DEA-App
Intervention Description
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:
Information module
The information module consists of general information on the disease and the care of people suffering from dementia.
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.
Communication module
If two or more persons are caring for one person with dementia, the communication module provides a networking possibility.
Intervention Type
Other
Intervention Name(s)
Standard Information group
Intervention Description
The control group will receive a leaflet on some general principles for promoting health and well-being in older adults with dementia.
Primary Outcome Measure Information:
Title
Burden Scale for Family Caregivers
Description
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
Time Frame
3 month after baseline
Secondary Outcome Measure Information:
Title
12-item Short-Form Health Survey
Description
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.
Time Frame
3 month after baseline
Title
Adult carers quality of life questionnaire
Description
The Adult Carer Quality of Life Questionnaire is a simple instrument for use with adult carers. It measures quality of life in eight domains:
support for caring,
caring choice,
caring stress,
money matters,
personal growth,
sense of value,
ability to care, and
carer satisfaction.
Time Frame
3 month after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanja A Stamm, PhD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
University of Applied Sciences FH Campus Wien
City
Vienna
ZIP/Postal Code
1100
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Development and Evaluation of the DEA App
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