<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/NCT01727219</url>
  </required_header>
  <id_info>
    <org_study_id>2011-I010</org_study_id>
    <nct_id>NCT01727219</nct_id>
  </id_info>
  <brief_title>COPD Assessment Test Can Predict Depression</brief_title>
  <official_title>COPD Assessment Test Can Predict Depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hallym University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hallym University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The frequency of depression in COPD patients are substantial and early detection and&#xD;
      prevention of depression is critical.&#xD;
&#xD;
      Recently, COPD assessment test (CAT) was developed and validated to assess the impact of COPD&#xD;
      on patients' quality of life.&#xD;
&#xD;
      In this prospective study, we will investigate the predictive utility of CAT for predicting&#xD;
      depression in COPD patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is aimed to investigate the association between the COPD Assessment Test (CAT) and&#xD;
      depression in stable COPD patients. Stable COPD patients will be enrolled from the tertiary&#xD;
      hospitals. All patients will undergo lung function tests. The Korean versions of the CAT&#xD;
      (COPD assessment test) and Patient Health Questionnaire-9 (PHQ-9) will be used to assess COPD&#xD;
      symptoms and depressive disorder, respectively.&#xD;
&#xD;
      We will compare the depresssion frequency among GOLD classifications of airway limitation and&#xD;
      among the four CAT groups. And. we will also investigate which items of the CAT are the&#xD;
      strongest indicators of depression.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2012</start_date>
  <completion_date type="Anticipated">May 2013</completion_date>
  <primary_completion_date type="Anticipated">February 2013</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The predictive utility of the COPD assessment test (CAT) scores for predicting depression in COPD patients</measure>
    <time_frame>1 year</time_frame>
    <description>The association of CAT with depression score</description>
  </primary_outcome>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Depression,</condition>
  <condition>COPD</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Stable COPD patients who visit outpatient departments.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COPD patients who aged &gt; or = 40 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute exacerbation within 3 months&#xD;
&#xD;
          -  bronchial asthma or an increase in FEV1 of more than 12% of the predicted value with&#xD;
             the use of 400 µg of albuterol.&#xD;
&#xD;
          -  other lung diseases such as bronchiectasis, interstitial lung disease, and&#xD;
             tuberculosis-destroyed lungs.&#xD;
&#xD;
          -  who denied to consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>KI-Suck Jung, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hallym University Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sunghoon Park, Dr.</last_name>
    <phone>82-31-380-3803</phone>
    <email>f2000tj@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hallym University Sacred Heart Hospital, Department of Pulmonary, Critical Care Medicine</name>
      <address>
        <city>Anyang-</city>
        <state>Gyeonggi-do</state>
        <zip>431-070</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <contact>
      <last_name>Sunghoon Park, MD</last_name>
      <phone>82-31-380-3803</phone>
      <email>f2000tj@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Sun Hyang Kim</last_name>
      <phone>82-31-380-1975</phone>
      <email>tjsgid625@naver.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2011</verification_date>
  <study_first_submitted>November 12, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <last_update_submitted>November 18, 2012</last_update_submitted>
  <last_update_submitted_qc>November 18, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 20, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</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/NCT01727219
org study id: 2011-I010
nct id: NCT01727219
lead sponsor: 
has dmc: No
The frequency of depression in COPD patients are substantial and early detection and
      prevention of depression is critical.

      Recently, COPD assessment test (CAT) was developed and validated to assess the impact of COPD
      on patients' quality of life.

      In this prospective study, we will investigate the predictive utility of CAT for predicting
      depression in COPD patients.
This study is aimed to investigate the association between the COPD Assessment Test (CAT) and
      depression in stable COPD patients. Stable COPD patients will be enrolled from the tertiary
      hospitals. All patients will undergo lung function tests. The Korean versions of the CAT
      (COPD assessment test) and Patient Health Questionnaire-9 (PHQ-9) will be used to assess COPD
      symptoms and depressive disorder, respectively.

      We will compare the depresssion frequency among GOLD classifications of airway limitation and
      among the four CAT groups. And. we will also investigate which items of the CAT are the
      strongest indicators of depression.
observational model: Cohort
time perspective: Cross-Sectional
measure: The predictive utility of the COPD assessment test (CAT) scores for predicting depression in COPD patients
time frame: 1 year
description: The association of CAT with depression score
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: KI-Suck Jung, Dr.
role: Principal Investigator
affiliation: Hallym University Medical Center
last name: Sunghoon Park, Dr.
phone: 82-31-380-3803
email: f2000tj@gmail.com
facility: 
contact: 
contact backup: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder