<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/NCT04405635</url>
  </required_header>
  <id_info>
    <org_study_id>614731</org_study_id>
    <nct_id>NCT04405635</nct_id>
  </id_info>
  <brief_title>Quantifying Digital Behavior on Smart Phones - Data From Stroke Survivors</brief_title>
  <acronym>QuantStroke</acronym>
  <official_title>Quantifying Digital Behavior on Smart Phones - Data From Stroke Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Leiden University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Carlsberg Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Aarhus</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>
      In this study, we want to continuously record the interaction of 50 stroke survivors with&#xD;
      their smartphones during the first 3 months after discharge. The linkage of smart phone use&#xD;
      to function and quality of life will be assessed with standardized outcome measures at&#xD;
      defined time points.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      People with stroke are among the most relevant target groups for unobtrusive monitoring.&#xD;
      Worldwide, stroke is the second most frequent cause for lasting disability and causes a&#xD;
      substantial burden for the individual, caregivers and society. Thanks to improved treatment,&#xD;
      many stroke survivors can be discharged to their homes. However, many have to live with&#xD;
      disabilities and are prone to declining function, cognitive impairment and depression. With&#xD;
      the acquired data, we want to create a database where digital behavior is analyzed with&#xD;
      advanced computational methods. In collaboration with the Department of Cognitive Psychology,&#xD;
      University of Leiden, Netherlands, these data will be used to discover specific features for&#xD;
      different health issues and to develop tools for the early detection of functional decline&#xD;
      for different populations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 30, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Different parameters of digital behavior</measure>
    <time_frame>Continuously throughout the 90 days of monitoring</time_frame>
    <description>Number of interactions with the smart phone, tapping speed, typing speed, social media use</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>EQ5D</measure>
    <time_frame>Once a week during 12 weeks</time_frame>
    <description>Health related quality of life, 5 point subscale, Index values of 0-1 (better), EQ5D VAS 0-100 (better)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mini MoCA</measure>
    <time_frame>3 times in three months, after 4, 8 and 12 weeks</time_frame>
    <description>Montreal Cognitive Assessment, cognitive function, scale 0-15 (better)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-36</measure>
    <time_frame>3 times in three months, after 4, 8 and 12 weeks</time_frame>
    <description>Health related quality of life, 0-100 (better)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke Specific Quality of Life Questionnaire - short version</measure>
    <time_frame>3 times in three months, after 4, 8 and 12 weeks</time_frame>
    <description>Stroke related quality of life, 12-60 (better)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Health today</measure>
    <time_frame>Every day throughout 90 days</time_frame>
    <description>One question about subjective health, VAS 0-100 (better)</description>
  </other_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Stroke</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention or exposure</intervention_name>
    <description>No intervention or exposure</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        We want to include a broad range of patients with stroke, incuding both ischemic and&#xD;
        hemorrhagic strokes and different impairments due to stroke. Patients are recruited at two&#xD;
        wards specialized in neurorehabilitation around 1 week before discharge to their home.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  New or recurrent stroke, admitted to rehabilitation, discharge to own home&#xD;
&#xD;
          -  Owns an Android smart phone&#xD;
&#xD;
          -  Smart phone is used by the patient only&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe cognitive impairments and / or psychiatric and behavioral conditions that&#xD;
             interfere with compliance.&#xD;
&#xD;
          -  Not able to provide informed consent&#xD;
&#xD;
          -  Discharge to nursing homes or other care facilities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Iris Brunner, PhD</last_name>
    <phone>+4560568195</phone>
    <email>Iris.Brunner@rm.dk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jørgen Feldbæk Nielsen, PhD</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hammel Neurorehabilitation Centre and University Research Clinic</name>
      <address>
        <city>Hammel</city>
        <state>Aarhus</state>
        <zip>8450</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Iris Brunner, PhD</last_name>
      <phone>+4560568195</phone>
      <email>Iris.Brunner@rm.dk</email>
    </contact>
    <contact_backup>
      <last_name>Helen Kragh</last_name>
      <phone>+4578443881</phone>
      <email>helen.kragh@rm.dk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>September 28, 2021</last_update_submitted>
  <last_update_submitted_qc>September 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stroke, digital behavior, health-related quality of life, cognitive function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Processed smartphone behavioral data and the associated processing codes will be made available upon publication and corresponding release in data repositories.</ipd_description>
  </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/NCT04405635
org study id: 614731
nct id: NCT04405635
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study, we want to continuously record the interaction of 50 stroke survivors with
      their smartphones during the first 3 months after discharge. The linkage of smart phone use
      to function and quality of life will be assessed with standardized outcome measures at
      defined time points.
People with stroke are among the most relevant target groups for unobtrusive monitoring.
      Worldwide, stroke is the second most frequent cause for lasting disability and causes a
      substantial burden for the individual, caregivers and society. Thanks to improved treatment,
      many stroke survivors can be discharged to their homes. However, many have to live with
      disabilities and are prone to declining function, cognitive impairment and depression. With
      the acquired data, we want to create a database where digital behavior is analyzed with
      advanced computational methods. In collaboration with the Department of Cognitive Psychology,
      University of Leiden, Netherlands, these data will be used to discover specific features for
      different health issues and to develop tools for the early detection of functional decline
      for different populations.
observational model: Cohort
time perspective: Prospective
measure: Different parameters of digital behavior
time frame: Continuously throughout the 90 days of monitoring
description: Number of interactions with the smart phone, tapping speed, typing speed, social media use
measure: EQ5D
time frame: Once a week during 12 weeks
description: Health related quality of life, 5 point subscale, Index values of 0-1 (better), EQ5D VAS 0-100 (better)
measure: Mini MoCA
time frame: 3 times in three months, after 4, 8 and 12 weeks
description: Montreal Cognitive Assessment, cognitive function, scale 0-15 (better)
measure: SF-36
time frame: 3 times in three months, after 4, 8 and 12 weeks
description: Health related quality of life, 0-100 (better)
measure: Stroke Specific Quality of Life Questionnaire - short version
time frame: 3 times in three months, after 4, 8 and 12 weeks
description: Stroke related quality of life, 12-60 (better)
measure: Health today
time frame: Every day throughout 90 days
description: One question about subjective health, VAS 0-100 (better)
intervention type: Other
intervention name: No intervention or exposure
description: No intervention or exposure
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Iris Brunner, PhD
phone: +4560568195
email: Iris.Brunner@rm.dk
last name: Jørgen Feldbæk Nielsen, PhD
facility: 
status: Recruiting
contact: 
contact backup: 
country: Denmark
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: Yes
ipd description: Processed smartphone behavioral data and the associated processing codes will be made available upon publication and corresponding release in data repositories.