<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/NCT04459793</url>
  </required_header>
  <id_info>
    <org_study_id>DST7055</org_study_id>
    <nct_id>NCT04459793</nct_id>
  </id_info>
  <brief_title>The Danish Occupational Medicine Cohort - Long-term Prognosis for Patients With Work-related Disorders</brief_title>
  <acronym>PRORISK</acronym>
  <official_title>The Danish Occupational Medicine Cohort - Long-term Prognosis for Patients With Work-related Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Regional Hospital West Jutland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aarhus University Hospital Skejby</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aalborg University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Regional Hospital West Jutland</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>
      Each year about 10.000 patients are referred due to suspected work-related disorders to the&#xD;
      Danish departments of occupational medicine. In Denmark and internationally there is a lack&#xD;
      of follow-up studies investigating the long-term prognosis of employees with work-related&#xD;
      disorders. To facilitate long-term prognostic studies for work-related conditions a Danish&#xD;
      Occupational Medicine Cohort has been established through the Danish population registers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Danish departments of occupational medicine examine around 10,000 patients each year referred&#xD;
      due to suspected work-related disorders. In Denmark and internationally there is a lack of&#xD;
      follow-up studies investigating the long-term prognosis of employees with work-related&#xD;
      disorders. The purpose of this cohort is to facilitate long-term prognostic studies for&#xD;
      conditions such as mental or musculoskeletal disorders.&#xD;
&#xD;
      The Danish Occupational Medicine cohort has been created through The Danish National Patient&#xD;
      Register and comprises all patients seen in Danish Departments of Occupational Medicine from&#xD;
      2000-2018 (N=145.521). Numerous register data are included in the database from five years&#xD;
      prior to time of inclusion until 2018. Examples of register data are; information on work,&#xD;
      sickness absence and disability as well as number and type of contacts to health services,&#xD;
      use of medication, income, education, type of occupation, social status, death and cause of&#xD;
      death. Job Exposure Matrices (JEMs) on physical and psychosocial work exposure, life styles&#xD;
      and other matrices are also available. The cohort will be updated with new patients and&#xD;
      register data regularly.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 1, 2000</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2025</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>Annual work participation score</measure>
    <time_frame>5 years</time_frame>
    <description>Work participation score is defined as number of weeks of employment relative to the total sum of number of weeks of employment plus number of weeks on temporary or permanent health related public compensation as registered by the Danish National Register on Public Transfer Payments register (DREAM).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Annual health care utilization</measure>
    <time_frame>5 years</time_frame>
    <description>Primary and secondary Health care contacts - includes all face to face contacts from the Danish National Health Service Register and Danish National Patient Register</description>
  </primary_outcome>
  <enrollment type="Actual">145521</enrollment>
  <condition>Work-Related Condition</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The cohort was created through The Danish National Patient Register and comprises all&#xD;
        patients seen in Danish Departments of Occupational Medicine from 2000-2018 (N= 145.521).&#xD;
        Numerous register data are included in the database from five years prior to time of&#xD;
        inclusion until 2018. The cohort will be updated with new patients and register data&#xD;
        regularly.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A record of contact at Danish departments of occupational medicine with a relevant&#xD;
             primary or secondary diagnosis according to the International Classification of&#xD;
             Diseases, 10th revision.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No record of contact or only a record of referral without subsequent records of&#xD;
             relevant primary or secondary diagnosis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David H Christiansen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Occupational Medicine, Regional Hospital Herning</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>David H Christiansen</name>
      <address>
        <city>Herning</city>
        <state>Central Denmark Region</state>
        <zip>7400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>September 14, 2021</last_update_submitted>
  <last_update_submitted_qc>September 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Regional Hospital West Jutland</investigator_affiliation>
    <investigator_full_name>David H Christiansen</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Prognosis</keyword>
  <keyword>Work-related disorders</keyword>
  <keyword>Occupational medicine</keyword>
  <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/NCT04459793
org study id: DST7055
nct id: NCT04459793
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Each year about 10.000 patients are referred due to suspected work-related disorders to the
      Danish departments of occupational medicine. In Denmark and internationally there is a lack
      of follow-up studies investigating the long-term prognosis of employees with work-related
      disorders. To facilitate long-term prognostic studies for work-related conditions a Danish
      Occupational Medicine Cohort has been established through the Danish population registers.
Danish departments of occupational medicine examine around 10,000 patients each year referred
      due to suspected work-related disorders. In Denmark and internationally there is a lack of
      follow-up studies investigating the long-term prognosis of employees with work-related
      disorders. The purpose of this cohort is to facilitate long-term prognostic studies for
      conditions such as mental or musculoskeletal disorders.

      The Danish Occupational Medicine cohort has been created through The Danish National Patient
      Register and comprises all patients seen in Danish Departments of Occupational Medicine from
      2000-2018 (N=145.521). Numerous register data are included in the database from five years
      prior to time of inclusion until 2018. Examples of register data are; information on work,
      sickness absence and disability as well as number and type of contacts to health services,
      use of medication, income, education, type of occupation, social status, death and cause of
      death. Job Exposure Matrices (JEMs) on physical and psychosocial work exposure, life styles
      and other matrices are also available. The cohort will be updated with new patients and
      register data regularly.
observational model: Cohort
time perspective: Prospective
measure: Annual work participation score
time frame: 5 years
description: Work participation score is defined as number of weeks of employment relative to the total sum of number of weeks of employment plus number of weeks on temporary or permanent health related public compensation as registered by the Danish National Register on Public Transfer Payments register (DREAM).
measure: Annual health care utilization
time frame: 5 years
description: Primary and secondary Health care contacts - includes all face to face contacts from the Danish National Health Service Register and Danish National Patient Register
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: David H Christiansen
role: Principal Investigator
affiliation: Occupational Medicine, Regional Hospital Herning
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Regional Hospital West Jutland
investigator full name: David H Christiansen
investigator title: Associate Professor
sharing ipd: No