<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/NCT03286894</url>
  </required_header>
  <id_info>
    <org_study_id>7/2017_D</org_study_id>
    <nct_id>NCT03286894</nct_id>
  </id_info>
  <brief_title>AQUAPed: Validation Study of AQUA© Questionnaire Modified for Childhood</brief_title>
  <acronym>AQUAPed</acronym>
  <official_title>AQUAPed: Validation Study of AQUA© Questionnaire Modified for Childhood</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto per la Ricerca e l'Innovazione Biomedica</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istituto per la Ricerca e l'Innovazione Biomedica</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>
      The AQUA© questionnaire developed in 2008 is a validated tools for the screening of allergic&#xD;
      diseases in adult athletes. The objective of the present study is to develop and validate a&#xD;
      modified version of the AQUA© questionnaire to be used in childhood. In this phase, the&#xD;
      validation is intended to assess the reliability of the information collected through the&#xD;
      AQUA© modified version: question difficulty and response patterns with respect to children&#xD;
      characteristics (in particular age, sex and physical activity). In particular, the focus will&#xD;
      be on the &quot;core questions&quot;, i.e. the indicators of allergic disorders. This is a&#xD;
      cross-sectional study on 1264 healthy schoolchildren aged 8 to 14 years.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Question difficulty</measure>
    <time_frame>Study end (4 months)</time_frame>
    <description>Comprehensibility (or difficulty) of the questions, especially the &quot;core questions&quot;, will be assessed by the percentages of non-response possibly stratified by children characteristics (in particular age, sex and physical activity).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patterns of missing response</measure>
    <time_frame>Study end (4 months)</time_frame>
    <description>Possible tendency to skip consecutive questions will be assessed by studying the association between the presence of missing (0 = answer missing, 1 = answer given) in sequence (tetrachoric correlation).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patterns of non-missing responses</measure>
    <time_frame>Study end (4 months)</time_frame>
    <description>Analysis of the distribution of non-missing responses, possibly stratified by children characteristics (in particular age, sex and physical activity).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1264</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>1264 healthy schoolchildren</arm_group_label>
    <description>There is only one study group consisting of 1264 children recruited at school.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study population consists of 1264 healthy schoolchildren, both males and females, aged&#xD;
        8 to 14 years, recruited in 7 primary and secondary schools of the city of Palermo.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aforementioned sex and age criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Respiratory infections in the previous 3 weeks;&#xD;
&#xD;
          -  Immunological or metabolic systemic disease;&#xD;
&#xD;
          -  Major malformations of the upper airways;&#xD;
&#xD;
          -  Active smoker.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council</name>
      <address>
        <city>Palermo</city>
        <state>Sicily</state>
        <zip>90146</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>October 23, 2018</last_update_submitted>
  <last_update_submitted_qc>October 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istituto per la Ricerca e l'Innovazione Biomedica</investigator_affiliation>
    <investigator_full_name>Stefania La Grutta, MD</investigator_full_name>
    <investigator_title>MD. Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.</investigator_title>
  </responsible_party>
  <!-- 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/NCT03286894
org study id: 7/2017_D
nct id: NCT03286894
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The AQUA© questionnaire developed in 2008 is a validated tools for the screening of allergic
      diseases in adult athletes. The objective of the present study is to develop and validate a
      modified version of the AQUA© questionnaire to be used in childhood. In this phase, the
      validation is intended to assess the reliability of the information collected through the
      AQUA© modified version: question difficulty and response patterns with respect to children
      characteristics (in particular age, sex and physical activity). In particular, the focus will
      be on the "core questions", i.e. the indicators of allergic disorders. This is a
      cross-sectional study on 1264 healthy schoolchildren aged 8 to 14 years.
observational model: Other
time perspective: Cross-Sectional
measure: Question difficulty
time frame: Study end (4 months)
description: Comprehensibility (or difficulty) of the questions, especially the "core questions", will be assessed by the percentages of non-response possibly stratified by children characteristics (in particular age, sex and physical activity).
measure: Patterns of missing response
time frame: Study end (4 months)
description: Possible tendency to skip consecutive questions will be assessed by studying the association between the presence of missing (0 = answer missing, 1 = answer given) in sequence (tetrachoric correlation).
measure: Patterns of non-missing responses
time frame: Study end (4 months)
description: Analysis of the distribution of non-missing responses, possibly stratified by children characteristics (in particular age, sex and physical activity).
arm group label: 1264 healthy schoolchildren
description: There is only one study group consisting of 1264 children recruited at school.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 8 Years
maximum age: 14 Years
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Istituto per la Ricerca e l'Innovazione Biomedica
investigator full name: Stefania La Grutta, MD
investigator title: MD. Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.