DementiaDEANCT03819816
Development and Evaluation of the DEA App
A study testing DEA-App and Standard Information group in people with Dementia, run by Valentin Ritschl at 2 sites in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- DEA-App and Standard Information group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesAustria
- Study dates
- 1 Feb 2019to 1 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
Medical University of Vienna
Vienna, 1090
University of Applied Sciences FH Campus Wien
Vienna, 1100
About this study
Official title: 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.
Read more
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.
- Conditions
- Dementia
- Being tested
- DEA-App, Standard Information group
- Keywords
- informal caregivers, person with dementia, e-health solution
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEA-AppOther
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.
Standard Information groupOther
The control group will receive a leaflet on some general principles for promoting health and well-being in older adults with dementia.
| Study group | Role | What they receive |
|---|---|---|
| DEA-App | Experimental | The intervention (DEA) group will receive the newly developed app. Receives: Other: DEA-App |
| Standard Information group | Other | The control group will receive a leaflet on some general principles for promoting health and well-being in older adults with dementia. Receives: Other: Standard Information group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 month after baseline
Secondary outcomes (2)
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.
Measured: 3 month after baseline
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.
Measured: 3 month after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start1 Feb 2019
- Primary completion1 Aug 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valentin Ritschl
- Sponsor type
- University, hospital or other
- Collaborators
- Hochschule Campus Wien (University of Applied Sciences Campus Vienna)
- Responsible party
- Sponsor-investigator, Valentin Ritschl, Medical University of Vienna
- Investigators
- Tanja A Stamm, PhD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819816
- Sponsor's protocol ID
- DEA_APP_2019
- Acronym
- DEA
- Status last verified
- Jun 2023
- First submitted
- 23 Jan 2019
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of an Application for Supporting Informal Caregivers of People With Dementia in Their Daily Life
- ClinicalTrials.gov ID
- NCT03819816
- Acronym / sponsor ID
- DEA / DEA_APP_2019
- Conditions
- Dementia
- Keywords
- informal caregivers, person with dementia, e-health solution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Valentin RitschlUniversity, hospital or other
- Collaborators
- Hochschule Campus Wien (University of Applied Sciences Campus Vienna)
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 29 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEA-App | Experimental | Other: DEA-AppThe intervention (DEA) group will receive the newly developed app. |
| Standard Information group | Other | Other: Standard Information groupThe control group will receive a leaflet on some general principles for promoting health and well-being in older adults with dementia. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEA-AppThe 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 | DEA-App |
| Standard Information groupThe control group will receive a leaflet on some general principles for promoting health and well-being in older adults with dementia. | Other | Standard Information group |
Primary outcome
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
2 secondary outcomes
12-item Short-Form Health Survey
Time frame: 3 month after baseline
Adult carers quality of life questionnaire
Time frame: 3 month after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Dementia
Recruiting
Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models
Alzheimer's Disease (AD), Frontotemporal Dementia (FTD)
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
Active, not recruiting
Primary Care Detection of Cognitive Impairment Leveraging Health & Consumer Technologies in Underserved Communities: The MyCog Trial
Dementia, Cognitive Impairment
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
OCT-Angiography and Adaptive Optics in Patients With Memory Impairment
Amnesia, Alzheimer Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanja A Stamm, PhD principal investigator
Medical University of Vienna
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DEA-App and Standard Information group in people with Dementia, run by Valentin Ritschl at 2 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Burden Scale for Family Caregivers (time frame: 3 month after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.