Development and Evaluation of the DEA App

Study Overview
=================
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.

Official Title
-----------------
Development and Evaluation of an Application for Supporting Informal Caregivers of People With Dementia in Their Daily Life

Conditions
-----------------
Dementia

Intervention / Treatment
-----------------
* Other: DEA-App
* Other: Standard Information group


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DEA-App<br>The intervention (DEA) group will receive the newly developed app. | Other: DEA-App<br>* 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.<br>|
| Other: Standard Information group<br>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<br>* The control group will receive a leaflet on some general principles for promoting health and well-being in older adults with dementia.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 3 month after baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
informal caregivers, person with dementia, e-health solution