<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/NCT02226718</url>
  </required_header>
  <id_info>
    <org_study_id>HRQOL-COM1</org_study_id>
    <nct_id>NCT02226718</nct_id>
  </id_info>
  <brief_title>Validation of a Questionnaire for Measuring Quality of Life in Patients With Chronic Inflammation of the Middle Ear</brief_title>
  <official_title>Validation of a Questionnaire for Measuring Health-related Quality of Life in Patients With Chronic Otitis Media</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      For measuring quality of life in patients with chronic inflammation of the middle ear, only&#xD;
      two questionnaires currently exist. However, these questionnaires are designed only to&#xD;
      measure either disease-specific health or hearing-related quality of life. The aim of this&#xD;
      project is the validation of a pre-existing comprehensive questionnaire, which is routinely&#xD;
      administered in the investigators clinic but has never been validated. Following a&#xD;
      retrospective item reduction based on existing data, this questionnaire will be prospectively&#xD;
      validated. Applying the resulting questionnaire in future studies on chronic middle ear&#xD;
      inflammation, not only objective outcome parameters (e.g. audiograms) but also quality of&#xD;
      life will be assessed. Therefore, the investigators questionnaire will add substantial&#xD;
      information to these outcome studies by providing a subjective outcome parameter.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">December 2018</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>Validity</measure>
    <time_frame>day 1 (day of consultation)</time_frame>
    <description>Several aspects of Validity will be determined by different methods:&#xD;
content validity is made certain by construction procedure of the questionnaire (e.g. involving of specialists and patients)&#xD;
construct validity by factor analysis&#xD;
criterion validity by correlating a global question with the overall questionnaire score</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Chronic Otitis Media</condition>
  <arm_group>
    <arm_group_label>questionnaire</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Administration of questionnaire</intervention_name>
    <arm_group_label>questionnaire</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients suffering from chronic otitis media, visiting a tertiary referral centre&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  clinical diagnosis of chronic otitis media&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        none&#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>Alexander Huber, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitätsspital Zürich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitätsspital Zürich</name>
      <address>
        <city>Zürich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>November 7, 2022</last_update_submitted>
  <last_update_submitted_qc>November 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2022</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>Otitis</mesh_term>
    <mesh_term>Otitis Media</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/NCT02226718
org study id: HRQOL-COM1
nct id: NCT02226718
lead sponsor: 
has dmc: No
For measuring quality of life in patients with chronic inflammation of the middle ear, only
      two questionnaires currently exist. However, these questionnaires are designed only to
      measure either disease-specific health or hearing-related quality of life. The aim of this
      project is the validation of a pre-existing comprehensive questionnaire, which is routinely
      administered in the investigators clinic but has never been validated. Following a
      retrospective item reduction based on existing data, this questionnaire will be prospectively
      validated. Applying the resulting questionnaire in future studies on chronic middle ear
      inflammation, not only objective outcome parameters (e.g. audiograms) but also quality of
      life will be assessed. Therefore, the investigators questionnaire will add substantial
      information to these outcome studies by providing a subjective outcome parameter.
observational model: Cohort
time perspective: Prospective
measure: Validity
time frame: day 1 (day of consultation)
description: Several aspects of Validity will be determined by different methods:
content validity is made certain by construction procedure of the questionnaire (e.g. involving of specialists and patients)
construct validity by factor analysis
criterion validity by correlating a global question with the overall questionnaire score
arm group label: questionnaire
intervention type: Other
intervention name: Administration of questionnaire
arm group label: questionnaire
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alexander Huber, M.D.
role: Principal Investigator
affiliation: Universitätsspital Zürich
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Otitis
mesh term: Otitis Media