<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/NCT01711151</url>
  </required_header>
  <id_info>
    <org_study_id>2012RESP05</org_study_id>
    <secondary_id>UEAILDQUEST</secondary_id>
    <nct_id>NCT01711151</nct_id>
  </id_info>
  <brief_title>Interstitial Lung Disease Questionnaire</brief_title>
  <official_title>Questionnaire Study for Patients With Interstitial Lung Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of East Anglia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of East Anglia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. To evaluate the health status of patients with Interstitial Lung Disease (ILD), and how&#xD;
           this varies between subgroups of ILD.&#xD;
&#xD;
        2. To investigate the prevalence of symptoms, anxiety, depression, and sleep-disordered&#xD;
           breathing within ILD patient population.&#xD;
&#xD;
        3. To assess the economic impact of ILD.&#xD;
&#xD;
        4. To understand how self-aware ILD patients are regarding their treatment/management.&#xD;
&#xD;
        5. To compare the demographic details, including smoking status and occupational history,&#xD;
           of patients with interstitial lung disease&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary endpoint&#xD;
&#xD;
      • Health status in the target populations, as determined by the K-BILD questionnaire.&#xD;
&#xD;
      Secondary endpoints -&#xD;
&#xD;
        -  Severity of dyspnoea suffered by patients&#xD;
&#xD;
        -  Prevalence of anxiety and depression&#xD;
&#xD;
        -  Prevalence of sleep-disordered breathing symptoms&#xD;
&#xD;
        -  Degree of self-awareness displayed by patients&#xD;
&#xD;
        -  The costs associated with ILD from a patient and healthcare perspective.&#xD;
&#xD;
        -  Demographic details&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">November 2013</completion_date>
  <primary_completion_date type="Anticipated">November 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in the Mean K-BILD score between the 4 groups</measure>
    <time_frame>Baseline</time_frame>
    <description>HRQL</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Severity of dyspnoea suffered by patients</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of anxiety and depression</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of sleep-disordered breathing symptoms</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of self-awareness displayed by patients</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The costs associated with ILD from a patient and healthcare perspective</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Demographic details</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">304</enrollment>
  <condition>Interstitial Lung Disease</condition>
  <arm_group>
    <arm_group_label>Idiopathic Pulmonary Fibrosis</arm_group_label>
    <description>Questionnaire evaluation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non Idiopathic Pulmonary Fibrosis</arm_group_label>
    <description>Questionnaire evaluation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sarciodosis</arm_group_label>
    <description>Questionnaire evaluation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Controls</arm_group_label>
    <description>Questionnaire evaluation</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Secondary Care&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  Age greater than 18 years of age&#xD;
&#xD;
          -  Any smoking status&#xD;
&#xD;
          -  Diagnosis of Interstitial Lung Disease as defined below&#xD;
&#xD;
          -  Full pulmonary lung function tests and routine immunological tests undertaken within 6&#xD;
             months of entry into study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Unable to give consent to take part&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew M Wilson</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of East Anglia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Andrew M Wilson, MRCP, MD</last_name>
    <phone>00441603591257</phone>
    <email>a.m.wilson@uea.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Christopher Atkins, MBBS, MRCP</last_name>
    <phone>00441603286286</phone>
    <email>christopher.atkins@nnuh.nhs.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Norfolk and Norwich Univeristy Hospital NHS foundation Trust</name>
      <address>
        <city>Norwich</city>
        <state>Norfolk</state>
        <zip>NR47UY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <investigator>
      <last_name>Christopher Atkins</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <last_update_submitted>October 17, 2012</last_update_submitted>
  <last_update_submitted_qc>October 17, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 22, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ILD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Interstitial</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/NCT01711151
org study id: 2012RESP05
secondary id: UEAILDQUEST
nct id: NCT01711151
lead sponsor: 
has dmc: No
1. To evaluate the health status of patients with Interstitial Lung Disease (ILD), and how
           this varies between subgroups of ILD.

        2. To investigate the prevalence of symptoms, anxiety, depression, and sleep-disordered
           breathing within ILD patient population.

        3. To assess the economic impact of ILD.

        4. To understand how self-aware ILD patients are regarding their treatment/management.

        5. To compare the demographic details, including smoking status and occupational history,
           of patients with interstitial lung disease
Primary endpoint

      • Health status in the target populations, as determined by the K-BILD questionnaire.

      Secondary endpoints -

        -  Severity of dyspnoea suffered by patients

        -  Prevalence of anxiety and depression

        -  Prevalence of sleep-disordered breathing symptoms

        -  Degree of self-awareness displayed by patients

        -  The costs associated with ILD from a patient and healthcare perspective.

        -  Demographic details
observational model: Case-Control
time perspective: Prospective
measure: Difference in the Mean K-BILD score between the 4 groups
time frame: Baseline
description: HRQL
measure: Severity of dyspnoea suffered by patients
time frame: Baseline
measure: Prevalence of anxiety and depression
time frame: Baseline
measure: Prevalence of sleep-disordered breathing symptoms
time frame: Baseline
measure: Degree of self-awareness displayed by patients
time frame: Baseline
measure: The costs associated with ILD from a patient and healthcare perspective
time frame: Baseline
measure: Demographic details
time frame: Baseline
arm group label: Idiopathic Pulmonary Fibrosis
description: Questionnaire evaluation
arm group label: Non Idiopathic Pulmonary Fibrosis
description: Questionnaire evaluation
arm group label: Sarciodosis
description: Questionnaire evaluation
arm group label: Healthy Controls
description: Questionnaire evaluation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Andrew M Wilson
role: Principal Investigator
affiliation: University of East Anglia
last name: Andrew M Wilson, MRCP, MD
phone: 00441603591257
email: a.m.wilson@uea.ac.uk
last name: Christopher Atkins, MBBS, MRCP
phone: 00441603286286
email: christopher.atkins@nnuh.nhs.uk
facility: 
investigator: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Interstitial