<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/NCT03034590</url>
  </required_header>
  <id_info>
    <org_study_id>ID 3-3013-583/1/</org_study_id>
    <nct_id>NCT03034590</nct_id>
  </id_info>
  <brief_title>How to Identify Fatigue in Stroke Patients</brief_title>
  <official_title>How to Identify Fatigue in Stroke Patients: Validity of the Post-stroke Fatigue Case Definition</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Herlev Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Herlev Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will translate an English case definition of poststroke fatigue and validate it&#xD;
      against the Multidimensional Fatigue Questionnaire-20 and the Fatigue Severity Scale&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>Mean MFI-20 score for case positive patients</measure>
    <time_frame>at inclusion in the trial</time_frame>
    <description>Describes validity of the case definition with regards to the MFI-20 questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean FSS-7 score for case positive patients</measure>
    <time_frame>At inclusion in the trial</time_frame>
    <description>Describes validity of the case definition with regards to the FSS-7 questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>inter rater variability of the case definition</measure>
    <time_frame>within a week</time_frame>
    <description>Reinterview by a second interviewer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optimal cut off score for case positiveness on MFI-20 and FSS</measure>
    <time_frame>at inclusion in the trial (which is the time the values used are measured)</time_frame>
    <description>decide the optimal cut-off score on the two questionnaires to define case positiveness</description>
  </secondary_outcome>
  <enrollment type="Actual">70</enrollment>
  <condition>Post Stroke Fatigue</condition>
  <condition>Stroke</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionnaire</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        stroke patients with a new stroke within 120 days&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients with a clinical stroke within the last 6 months as judged by a senior doctor or by&#xD;
        the research assistant.&#xD;
&#xD;
        Patients that have given written informed consent&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients with aphasia, dementia or cognitive deficits so severe that they are unable to&#xD;
        understand the purpose of the interview and the questionnaire. -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karsten Overgaard, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Neurology, Herlev Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Neurology, Herlev Hospital</name>
      <address>
        <city>Herlev</city>
        <zip>2730</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>October 12, 2016</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>January 25, 2017</last_update_submitted>
  <last_update_submitted_qc>January 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Herlev Hospital</investigator_affiliation>
    <investigator_full_name>Karsten Overgaard</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03034590
org study id: ID 3-3013-583/1/
nct id: NCT03034590
lead sponsor: 
has dmc: Yes
This study will translate an English case definition of poststroke fatigue and validate it
      against the Multidimensional Fatigue Questionnaire-20 and the Fatigue Severity Scale
observational model: Cohort
time perspective: Prospective
measure: Mean MFI-20 score for case positive patients
time frame: at inclusion in the trial
description: Describes validity of the case definition with regards to the MFI-20 questionnaire
measure: Mean FSS-7 score for case positive patients
time frame: At inclusion in the trial
description: Describes validity of the case definition with regards to the FSS-7 questionnaire
measure: inter rater variability of the case definition
time frame: within a week
description: Reinterview by a second interviewer
measure: Optimal cut off score for case positiveness on MFI-20 and FSS
time frame: at inclusion in the trial (which is the time the values used are measured)
description: decide the optimal cut-off score on the two questionnaires to define case positiveness
intervention type: Other
intervention name: questionnaire
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Karsten Overgaard, MD
role: Principal Investigator
affiliation: Department of Neurology, Herlev Hospital
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Herlev Hospital
investigator full name: Karsten Overgaard
investigator title: MD
mesh term: Stroke
mesh term: Fatigue
sharing ipd: No