<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/NCT01699035</url>
  </required_header>
  <id_info>
    <org_study_id>H133B080031</org_study_id>
    <nct_id>NCT01699035</nct_id>
  </id_info>
  <brief_title>Survey on Return to Work After Stroke</brief_title>
  <official_title>Survivor Perspective on Critical Factors to Return to Work After Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shirley Ryan AbilityLab</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>U.S. Department of Education</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Shirley Ryan AbilityLab</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Survey of survivor perspective on critical elements that either facilitate or inhibit return&#xD;
      to work after a stroke. Critical elements are queried in areas of finances, stroke&#xD;
      impairments, interpersonal support, therapeutic support, organization influences, work or job&#xD;
      specific issues and psychological issues.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this project is to more accurately describe the stroke survivor's&#xD;
      perspective on return to work. The survey development included qualitative analysis of a set&#xD;
      of interviews with stroke survivors to arrive at the critical elements described above,&#xD;
      followed by item development with an expert panel and preliminary testing of the wording and&#xD;
      format for legibility. The survey is being administered both on-line and by paper through the&#xD;
      mail to a wide range of survivors with the objective of obtaining a large, diverse sample.&#xD;
      The ultimate goal of the project is to arrive at a refined set of recommendations to inform&#xD;
      stroke survivors, health care professionals and employers to increase their sensitivity to&#xD;
      the needs and desires of individual attempting to return to work after stroke.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>critical factors that facilitate or inhibit return to work after stroke</measure>
    <time_frame>after collection of data on all surveys</time_frame>
    <description>38 multiple choice items that assess psychological factors important to return to work, financial incentives and disincentives, the role of stroke impairments, interpersonal supports that facilitate and inhibit return, the role of therapeutic support especially vocational rehabilitation, organizational influences, and work specific issues that impact on return. Demographic information is also queried including work type and current work status. Data will be analyzed descriptively by these critical factors and also by other demographic factors such as age, work status, and race.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">715</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>stroke survivors</arm_group_label>
    <description>stroke survivors who have either returned to work, have thought about returning to work, or have tried to return to work</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        stroke survivors&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  have returned to work, have thought about returning to work, or have tried to return&#xD;
             to work&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non-stroke disability&#xD;
&#xD;
          -  retired or no plan to return to work&#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>Robert J Hartke, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shirley Ryan AbilityLab</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rehabilitation Institute of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Hartke RJ, Trierweiler R, Bode R. Critical factors related to return to work after stroke: a qualitative study. Top Stroke Rehabil. 2011 Jul-Aug;18(4):341-51. doi: 10.1310/tsr1804-341.</citation>
    <PMID>21914598</PMID>
  </reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>September 10, 2014</last_update_submitted>
  <last_update_submitted_qc>September 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shirley Ryan AbilityLab</investigator_affiliation>
    <investigator_full_name>Robert Hartke</investigator_full_name>
    <investigator_title>Lead Psychologist</investigator_title>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>work</keyword>
  <keyword>vocational rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT01699035
org study id: H133B080031
nct id: NCT01699035
lead sponsor: 
collaborator: 
has dmc: No
Survey of survivor perspective on critical elements that either facilitate or inhibit return
      to work after a stroke. Critical elements are queried in areas of finances, stroke
      impairments, interpersonal support, therapeutic support, organization influences, work or job
      specific issues and psychological issues.
The objective of this project is to more accurately describe the stroke survivor's
      perspective on return to work. The survey development included qualitative analysis of a set
      of interviews with stroke survivors to arrive at the critical elements described above,
      followed by item development with an expert panel and preliminary testing of the wording and
      format for legibility. The survey is being administered both on-line and by paper through the
      mail to a wide range of survivors with the objective of obtaining a large, diverse sample.
      The ultimate goal of the project is to arrive at a refined set of recommendations to inform
      stroke survivors, health care professionals and employers to increase their sensitivity to
      the needs and desires of individual attempting to return to work after stroke.
time perspective: Cross-Sectional
measure: critical factors that facilitate or inhibit return to work after stroke
time frame: after collection of data on all surveys
description: 38 multiple choice items that assess psychological factors important to return to work, financial incentives and disincentives, the role of stroke impairments, interpersonal supports that facilitate and inhibit return, the role of therapeutic support especially vocational rehabilitation, organizational influences, and work specific issues that impact on return. Demographic information is also queried including work type and current work status. Data will be analyzed descriptively by these critical factors and also by other demographic factors such as age, work status, and race.
arm group label: stroke survivors
description: stroke survivors who have either returned to work, have thought about returning to work, or have tried to return to work
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robert J Hartke, Ph.D.
role: Principal Investigator
affiliation: Shirley Ryan AbilityLab
facility: 
country: United States
citation: Hartke RJ, Trierweiler R, Bode R. Critical factors related to return to work after stroke: a qualitative study. Top Stroke Rehabil. 2011 Jul-Aug;18(4):341-51. doi: 10.1310/tsr1804-341.
PMID: 21914598
responsible party type: Principal Investigator
investigator affiliation: Shirley Ryan AbilityLab
investigator full name: Robert Hartke
investigator title: Lead Psychologist
mesh term: Stroke