<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03819816</url>
  </required_header>
  <id_info>
    <org_study_id>DEA_APP_2019</org_study_id>
    <nct_id>NCT03819816</nct_id>
  </id_info>
  <brief_title>Development and Evaluation of the DEA App</brief_title>
  <acronym>DEA</acronym>
  <official_title>Development and Evaluation of an Application for Supporting Informal Caregivers of People With Dementia in Their Daily Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Valentin Ritschl</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>FH Campus Wien, University of Applied Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of Vienna</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background, current situation, and motivation&#xD;
&#xD;
      According to current estimates, 100,000 people in Austria suffer from various types of&#xD;
      dementia. According to forecasts, this number of people will rise to approximately 230,000 by&#xD;
      2050 due to the demographic development and the increase of the prevalence rate. Data from&#xD;
      the service statistics show that 85% of dementia patients still live in the community in&#xD;
      their homes and informal caregivers, such as relatives, support them. In total, more than&#xD;
      300,000 people care for their relatives in Austria in addition to professional support.&#xD;
      However, not only the person affected from dementia suffers from the disease, but also, and&#xD;
      often at a higher rate, the informal caregivers. Vice versa, the quality of life of those&#xD;
      suffering from dementia is significantly influenced by the caregivers' competences and their&#xD;
      strategies for resilience.&#xD;
&#xD;
      Study aim and hypothesis&#xD;
&#xD;
      The aim of this study is to evaluate the usability, acceptance, and effect of an app&#xD;
      consisting of three modules that provide multidimensional support for informal caregivers of&#xD;
      a person with dementia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">November 1, 2019</completion_date>
  <primary_completion_date type="Actual">August 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Burden Scale for Family Caregivers</measure>
    <time_frame>3 month after baseline</time_frame>
    <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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>12-item Short-Form Health Survey</measure>
    <time_frame>3 month after baseline</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adult carers quality of life questionnaire</measure>
    <time_frame>3 month after baseline</time_frame>
    <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:&#xD;
support for caring,&#xD;
caring choice,&#xD;
caring stress,&#xD;
money matters,&#xD;
personal growth,&#xD;
sense of value,&#xD;
ability to care, and&#xD;
carer satisfaction.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Dementia</condition>
  <arm_group>
    <arm_group_label>DEA-App</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention (DEA) group will receive the newly developed app.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Information group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The control group will receive a leaflet on some general principles for promoting health and well-being in older adults with dementia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>DEA-App</intervention_name>
    <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:&#xD;
Information module&#xD;
The information module consists of general information on the disease and the care of people suffering from dementia.&#xD;
Activity module&#xD;
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.&#xD;
Communication module&#xD;
If two or more persons are caring for one person with dementia, the communication module provides a networking possibility.</description>
    <arm_group_label>DEA-App</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Information group</intervention_name>
    <description>The control group will receive a leaflet on some general principles for promoting health and well-being in older adults with dementia.</description>
    <arm_group_label>Standard Information group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  informal caregivers of a person with dementia&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  enough language skills to participate&#xD;
&#xD;
          -  give written and oral informed consent&#xD;
&#xD;
          -  have an Android smartphone or tablet (required to use the app).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tanja A Stamm, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Vienna</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Applied Sciences FH Campus Wien</name>
      <address>
        <city>Vienna</city>
        <zip>1100</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>June 16, 2023</last_update_submitted>
  <last_update_submitted_qc>June 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Valentin Ritschl</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>informal caregivers</keyword>
  <keyword>person with dementia</keyword>
  <keyword>e-health solution</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03819816
org study id: DEA_APP_2019
nct id: NCT03819816
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Burden Scale for Family Caregivers
time frame: 3 month after baseline
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
measure: 12-item Short-Form Health Survey
time frame: 3 month after baseline
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.
measure: Adult carers quality of life questionnaire
time frame: 3 month after baseline
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.
arm group label: DEA-App
arm group type: Experimental
description: The intervention (DEA) group will receive the newly developed app.
arm group label: Standard Information group
arm group type: Other
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: DEA-App
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.
arm group label: DEA-App
intervention type: Other
intervention name: Standard Information group
description: The control group will receive a leaflet on some general principles for promoting health and well-being in older adults with dementia.
arm group label: Standard Information group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Tanja A Stamm, PhD
role: Principal Investigator
affiliation: Medical University of Vienna
facility: 
facility: 
country: Austria
responsible party type: Sponsor-Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Valentin Ritschl
investigator title: Principal Investigator
mesh term: Dementia
sharing ipd: Undecided