NCT03819816

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 29, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

6 months

First QC Date

January 23, 2019

Last Update Submit

June 16, 2023

Conditions

Dementia

Keywords

informal caregiversperson with dementiae-health solution

Outcome Measures

Primary Outcomes (1)

  • 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

    3 month after baseline

Secondary Outcomes (2)

  • 12-item Short-Form Health Survey

    3 month after baseline

  • Adult carers quality of life questionnaire

    3 month after baseline

Study Arms (2)

DEA-App

EXPERIMENTAL

The intervention (DEA) group will receive the newly developed app.

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.

Other: Standard Information group

Interventions

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: 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.

DEA-App
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.

Standard Information group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • informal caregivers of a person with dementia
  • 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).

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical University of Vienna

Vienna, 1090, Austria

Location

University of Applied Sciences FH Campus Wien

Vienna, 1100, Austria

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Tanja A Stamm, PhD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 23, 2019

First Posted

January 29, 2019

Study Start

February 1, 2019

Primary Completion

August 1, 2019

Study Completion

November 1, 2019

Last Updated

June 18, 2023

Record last verified: 2023-06

Locations

AU(2)