<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/NCT03013725</url>
  </required_header>
  <id_info>
    <org_study_id>HUSK9799</org_study_id>
    <nct_id>NCT03013725</nct_id>
  </id_info>
  <brief_title>The Hordaland Health Study</brief_title>
  <acronym>HUSK</acronym>
  <official_title>The Hordaland Health Studies (HHS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Bergen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Part of CONOR, and participates in the Norwegian Epidemiologic Osteoporosis Studies</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Bergen</source>
  <brief_summary>
    <textblock>
      The Hordaland Health Studies (HHS) were conducted in 1992-93 (The Homocysteine study) and in&#xD;
      1997-99 (HUSK). Both surveys were conducted as a joint project between the University of&#xD;
      Bergen, the Norwegian Health Screening Service (SHUS) (now part of the National Institute of&#xD;
      Public Health) and the Municipal Health Service in Hordaland.&#xD;
&#xD;
      The main focus of the studies is on chronic diseases including cardiovascular disease,&#xD;
      cancer, osteoporosis, anxiety and depression. Some projects focus on psychosocial factors,&#xD;
      occupational research, musculoskeletal diseases, urinary incontinence and mapping of drug&#xD;
      use. The main purpose of the surveys is to gather information so that disease ultimately can&#xD;
      be prevented.&#xD;
&#xD;
      Approximately 36,000 residents of Hordaland county participated in the studies, ca. 18,000 in&#xD;
      1992-93 and ca. 26,000 in 1997-99. About 7,000 of those who participated in the 1992-93&#xD;
      survey also participated in 1997-99.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 1992</start_date>
  <completion_date type="Actual">June 1999</completion_date>
  <primary_completion_date type="Actual">June 1999</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>Total mortality.</measure>
    <time_frame>Participants are followed from baseline (1992-93 or 1997-99) until death or December 31st, 2015.</time_frame>
    <description>The unique 11-digit personal identification number assigned to all Norwegian residents facilitates linkage between HHS and the Norwegian Population Register, which contains information on vital status (alive, emigrated, or dead). The follow-up period varies from 16 - 23 years, depending on whether first or second measurement is used as baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality or morbidity from chronic diseases (for example cardiovascular disease, cancer). Also, award of disability pension are used as an outcome.</measure>
    <time_frame>Participants are followed from baseline (1992-93 or 1997-99) until time of diagnosis/death from disease or the last day of follow-up.</time_frame>
    <description>The Cause of Death Registry, Cancer Registry of Norway, CVDNOR and FD-trygd (a national database of Health and social benefits) will be used to get information on outcomes. The last day of follow-up for cardiovascular disease is December 31st, 2014. The last day of follow-up for cancer is December 31st, 2014.&#xD;
The last day of follow-up for Cause of Death is December 31st, 2014. The follow-up period for cardiovascular disease varies from 15 - 22 years, depending on whether first or second measurement is used as baseline.&#xD;
The follow-up period for cancer varies from 15 - 22 years, depending on whether first or second measurement is used as baseline.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">36000</enrollment>
  <condition>Chronic Disease</condition>
  <arm_group>
    <arm_group_label>The Homocysteine Study</arm_group_label>
    <description>Conducted in 1992-93, ca. 18000 participated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The Hordaland Health Study (HUSK)</arm_group_label>
    <description>Conducted in 1997-99, ca. 26000 participated.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>No intervention</description>
    <arm_group_label>The Homocysteine Study</arm_group_label>
    <arm_group_label>The Hordaland Health Study (HUSK)</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples are stored at two biobanks located in Bergen and Levanger. The blood was&#xD;
      divided in full blood, plasma and serum.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Approximately 36,000 residents of Hordaland county participated in the studies (both men&#xD;
        and women), ca. 18,000 in 1992-93 and ca. 26,000 in 1997-99. About 7,000 of those who&#xD;
        participated in the 1992-93 survey also participated in 1997-99.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Born in a specific time-period&#xD;
&#xD;
          -  From Hordaland County&#xD;
&#xD;
          -  Community-dwelling people who were able to come to the study site on their own, and&#xD;
             able to fill out questionnaires.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not born within the specific time-period&#xD;
&#xD;
          -  Not from Hordaland County&#xD;
&#xD;
          -  Institutionalized People&#xD;
&#xD;
          -  People who were not able to fill out questionnaires&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://husk-en.b.uib.no/</url>
    <description>homepage</description>
  </link>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 5, 2017</last_update_submitted>
  <last_update_submitted_qc>January 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Bergen</investigator_affiliation>
    <investigator_full_name>Grethe Seppola Tell</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Disease</mesh_term>
  </condition_browse>
  <study_docs>
    <study_doc>
      <doc_type>Study Protocol</doc_type>
      <doc_url>http://husk.b.uib.no/prototest/</doc_url>
      <doc_comment>Protocol</doc_comment>
    </study_doc>
  </study_docs>
  <!-- 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/NCT03013725
org study id: HUSK9799
nct id: NCT03013725
lead sponsor: 
collaborator: 
The Hordaland Health Studies (HHS) were conducted in 1992-93 (The Homocysteine study) and in
      1997-99 (HUSK). Both surveys were conducted as a joint project between the University of
      Bergen, the Norwegian Health Screening Service (SHUS) (now part of the National Institute of
      Public Health) and the Municipal Health Service in Hordaland.

      The main focus of the studies is on chronic diseases including cardiovascular disease,
      cancer, osteoporosis, anxiety and depression. Some projects focus on psychosocial factors,
      occupational research, musculoskeletal diseases, urinary incontinence and mapping of drug
      use. The main purpose of the surveys is to gather information so that disease ultimately can
      be prevented.

      Approximately 36,000 residents of Hordaland county participated in the studies, ca. 18,000 in
      1992-93 and ca. 26,000 in 1997-99. About 7,000 of those who participated in the 1992-93
      survey also participated in 1997-99.
observational model: Cohort
time perspective: Prospective
measure: Total mortality.
time frame: Participants are followed from baseline (1992-93 or 1997-99) until death or December 31st, 2015.
description: The unique 11-digit personal identification number assigned to all Norwegian residents facilitates linkage between HHS and the Norwegian Population Register, which contains information on vital status (alive, emigrated, or dead). The follow-up period varies from 16 - 23 years, depending on whether first or second measurement is used as baseline.
measure: Mortality or morbidity from chronic diseases (for example cardiovascular disease, cancer). Also, award of disability pension are used as an outcome.
time frame: Participants are followed from baseline (1992-93 or 1997-99) until time of diagnosis/death from disease or the last day of follow-up.
description: The Cause of Death Registry, Cancer Registry of Norway, CVDNOR and FD-trygd (a national database of Health and social benefits) will be used to get information on outcomes. The last day of follow-up for cardiovascular disease is December 31st, 2014. The last day of follow-up for cancer is December 31st, 2014.
The last day of follow-up for Cause of Death is December 31st, 2014. The follow-up period for cardiovascular disease varies from 15 - 22 years, depending on whether first or second measurement is used as baseline.
The follow-up period for cancer varies from 15 - 22 years, depending on whether first or second measurement is used as baseline.
arm group label: The Homocysteine Study
description: Conducted in 1992-93, ca. 18000 participated.
arm group label: The Hordaland Health Study (HUSK)
description: Conducted in 1997-99, ca. 26000 participated.
intervention type: Other
intervention name: No intervention
description: No intervention
arm group label: The Homocysteine Study
arm group label: The Hordaland Health Study (HUSK)
Blood samples are stored at two biobanks located in Bergen and Levanger. The blood was
      divided in full blood, plasma and serum.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 74 Years
healthy volunteers: No
url: http://husk-en.b.uib.no/
description: homepage
responsible party type: Principal Investigator
investigator affiliation: University of Bergen
investigator full name: Grethe Seppola Tell
investigator title: Professor
mesh term: Chronic Disease
study doc: 