<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/NCT03275714</url>
  </required_header>
  <id_info>
    <org_study_id>bipolarAPP</org_study_id>
    <nct_id>NCT03275714</nct_id>
  </id_info>
  <brief_title>Evaluation of an App for Smartphones for People With a Bipolar Affective Disorder</brief_title>
  <official_title>Evaluation of an App for Smartphones for People With a Bipolar Affective Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Graz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Graz</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>
      The primary objective of the clinical trial is to evaluate the data of an app for smartphones&#xD;
      (BiP-App) with regard to sleep, movement, mood and communication behavior.&#xD;
&#xD;
      The data will be compared between two groups: people with a bipolar affective disorder and&#xD;
      individuals without a psychiatric disorder.&#xD;
&#xD;
      Secondary objective of the trial is to investigate if it is possible to detect early warning&#xD;
      symptoms of depressive / (hypo) manic episodes via the measured behavior patterns.&#xD;
&#xD;
      Furthermore it will be evaluated whether the BiP-app can find applicability in the examined&#xD;
      patient group.&#xD;
&#xD;
      Study design: Clinical evaluation of a medical device without CE mark; Parallel study design&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">November 20, 2019</completion_date>
  <primary_completion_date type="Actual">November 20, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sleep duration</measure>
    <time_frame>6 months</time_frame>
    <description>in minutes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Movement behaviour</measure>
    <time_frame>6 months</time_frame>
    <description>evaluated through motion sensors and localization services</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mood</measure>
    <time_frame>6 months</time_frame>
    <description>evaluated by mood surveys</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Communication behaviour</measure>
    <time_frame>6 months</time_frame>
    <description>Frequency of usage of communication services</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient acceptance</measure>
    <time_frame>6 months</time_frame>
    <description>evaluated by a questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Bipolar Affective Disorder</condition>
  <arm_group>
    <arm_group_label>People With a Bipolar Affective Disorder</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control subjects without a psychiatric disorder</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Smartphone APP</intervention_name>
    <description>Participants use the BiP-App for 6 months. The app continuously records data on light and motion sensors, as well as Global Positioning System (GPS) and mood surveys.</description>
    <arm_group_label>Control subjects without a psychiatric disorder</arm_group_label>
    <arm_group_label>People With a Bipolar Affective Disorder</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written consent of the participant after clarification&#xD;
&#xD;
          -  Patients with a bipolar affective disorder (group of patients) Or control persons&#xD;
             without a mental illness (control group)&#xD;
&#xD;
          -  Age between 18 and 70 years&#xD;
&#xD;
          -  Knowledge about using a smartphone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Rejection of participation&#xD;
&#xD;
          -  Lack of knowledge about how to deal with a smartphone&#xD;
&#xD;
          -  Congenital / early-childhood intelligence reduction&#xD;
&#xD;
          -  Moderate / severe dementia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Universitätsklinik für Psychiatrie und Psychotherapeutische Medizin</name>
      <address>
        <city>Graz</city>
        <zip>8010</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>December 13, 2019</last_update_submitted>
  <last_update_submitted_qc>December 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Genetic Diseases, X-Linked</mesh_term>
    <mesh_term>Mood Disorders</mesh_term>
    <mesh_term>Bipolar Disorder</mesh_term>
  </condition_browse>
  <!-- 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/NCT03275714
org study id: bipolarAPP
nct id: NCT03275714
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective of the clinical trial is to evaluate the data of an app for smartphones
      (BiP-App) with regard to sleep, movement, mood and communication behavior.

      The data will be compared between two groups: people with a bipolar affective disorder and
      individuals without a psychiatric disorder.

      Secondary objective of the trial is to investigate if it is possible to detect early warning
      symptoms of depressive / (hypo) manic episodes via the measured behavior patterns.

      Furthermore it will be evaluated whether the BiP-app can find applicability in the examined
      patient group.

      Study design: Clinical evaluation of a medical device without CE mark; Parallel study design
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Sleep duration
time frame: 6 months
description: in minutes
measure: Movement behaviour
time frame: 6 months
description: evaluated through motion sensors and localization services
measure: Mood
time frame: 6 months
description: evaluated by mood surveys
measure: Communication behaviour
time frame: 6 months
description: Frequency of usage of communication services
measure: Patient acceptance
time frame: 6 months
description: evaluated by a questionnaire
arm group label: People With a Bipolar Affective Disorder
arm group type: Active Comparator
arm group label: Control subjects without a psychiatric disorder
arm group type: Active Comparator
intervention type: Device
intervention name: Smartphone APP
description: Participants use the BiP-App for 6 months. The app continuously records data on light and motion sensors, as well as Global Positioning System (GPS) and mood surveys.
arm group label: Control subjects without a psychiatric disorder
arm group label: People With a Bipolar Affective Disorder
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Austria
responsible party type: Sponsor
mesh term: Genetic Diseases, X-Linked
mesh term: Mood Disorders
mesh term: Bipolar Disorder