Development and Evaluation of the DEA App

• Sponsor: Valentin Ritschl (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03819816
• Collaborator: FH Campus Wien, University of Applied Sciences (Other)
• Enrollment: 104
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 9
• Patients Per Site: 52
• Patients Per Site Per Month: 5.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dementia	Other: DEA-App; Other: Standard Information group	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 104 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Development and Evaluation of an Application for Supporting Informal Caregivers of People With Dementia in Their Daily Life
• Actual Study Start Date: Feb 1, 2019
• Actual Primary Completion Date: Aug 1, 2019
• Anticipated Study Completion Date: Nov 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Burden Scale for Family Caregivers [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

Secondary Outcome Measures

1. 12-item Short-Form Health Survey [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.

2. Adult carers quality of life questionnaire [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: support for caring, caring choice, caring stress, money matters, personal growth, sense of value, ability to care, and carer satisfaction.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna	Vienna		Austria	1090
2	University of Applied Sciences FH Campus Wien	Vienna		Austria	1100

Sponsors and Collaborators

• Valentin Ritschl
• FH Campus Wien, University of Applied Sciences

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Valentin Ritschl, Principal Investigator, Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT03819816
• Other Study ID Numbers: DEA_APP_2019
• First Posted: Jan 29, 2019
• Last Update Posted: Oct 7, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Valentin Ritschl, Principal Investigator, Medical University of Vienna: informal caregivers; person with dementia; e-health solution
• Additional relevant MeSH terms: Dementia

Study Results

No Results Posted as of Oct 7, 2019