<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/NCT04475003</url>
  </required_header>
  <id_info>
    <org_study_id>MMS2020.017</org_study_id>
    <nct_id>NCT04475003</nct_id>
  </id_info>
  <brief_title>Health Literacy Among Caregivers of Children With IgE-mediated Allergy With Risk of Anaphylaxis</brief_title>
  <official_title>Health Literacy Among Caregivers of Children With IgE-mediated Allergy With Risk of Anaphylaxis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Algemeen Ziekenhuis Maria Middelares</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Algemeen Ziekenhuis Maria Middelares</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Research on health literacy among caregivers of children with IgE-mediated allergy at risk of&#xD;
      anaphylaxis (life-threatening allergic reaction). Health literacy is a person's ability to&#xD;
      understand health information so that they can maintain or improve their health and quality&#xD;
      of life (of themself and children).&#xD;
&#xD;
      The aim of the study is to test the general knowledge of anaphylaxis. Furthermore we test the&#xD;
      extent to which caregivers consider themselves able to recognize and to treat anaphylaxis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 30, 2020</start_date>
  <completion_date type="Anticipated">April 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>General knowledge of anaphylaxis.</measure>
    <time_frame>1.5 year</time_frame>
    <description>Knowledge Quiz</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The extent to which caregivers consider themselves able to recognize and to treat anaphylaxis.</measure>
    <time_frame>1.5 year</time_frame>
    <description>Numeric scoring scale (0= cannot do at all, 5= highly certain can do)</description>
  </secondary_outcome>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Health Literacy</condition>
  <condition>Anaphylaxis</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Teaching</intervention_name>
    <description>Teaching session about anaphylaxis</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        For each child that is known with IgE-mediated allergy with risk of anaphylaxis parents can&#xD;
        invitate 4 Caregivers of children with IgE-mediated allergy with risk of anaphylaxis&#xD;
        (adults, grandparents, school caregivers etc.).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  caregivers of children with IgE-mediated allergy with risk of anaphylaxis (adults,&#xD;
             grandparents, school caregivers etc.).&#xD;
&#xD;
          -  minimum 18 years old.&#xD;
&#xD;
          -  signed informed consent&#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>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jasmine S Leus</last_name>
    <role>Principal Investigator</role>
    <affiliation>Algemeen Ziekenhuis Maria Middelares</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jasmine S Leus</last_name>
    <phone>+329 246 8200</phone>
    <email>jasmine.leus@azmmsj.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Josefien L Vandekerckhove</last_name>
    <phone>+329 246 8200</phone>
    <email>josefien.vandekerckhove@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Algemeen Ziekenhuis Maria Middelares</name>
      <address>
        <city>Gent</city>
        <state>Oost-Vlaanderen</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <contact>
      <last_name>Jasmine S Leus</last_name>
      <phone>+329 246 8200</phone>
      <email>jasmine.leus@azmmsj.be</email>
    </contact>
    <contact_backup>
      <last_name>Josefien L Vandekerckhove</last_name>
      <phone>+329 246 8200</phone>
      <email>josefien.vandekerckhove@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>July 16, 2020</last_update_submitted>
  <last_update_submitted_qc>July 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Algemeen Ziekenhuis Maria Middelares</investigator_affiliation>
    <investigator_full_name>dr. Jasmine Leus</investigator_full_name>
    <investigator_title>Kinderarts</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anaphylaxis</mesh_term>
    <mesh_term>Shock</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04475003
org study id: MMS2020.017
nct id: NCT04475003
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Research on health literacy among caregivers of children with IgE-mediated allergy at risk of
      anaphylaxis (life-threatening allergic reaction). Health literacy is a person's ability to
      understand health information so that they can maintain or improve their health and quality
      of life (of themself and children).

      The aim of the study is to test the general knowledge of anaphylaxis. Furthermore we test the
      extent to which caregivers consider themselves able to recognize and to treat anaphylaxis.
observational model: Case-Crossover
time perspective: Prospective
measure: General knowledge of anaphylaxis.
time frame: 1.5 year
description: Knowledge Quiz
measure: The extent to which caregivers consider themselves able to recognize and to treat anaphylaxis.
time frame: 1.5 year
description: Numeric scoring scale (0= cannot do at all, 5= highly certain can do)
intervention type: Other
intervention name: Teaching
description: Teaching session about anaphylaxis
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jasmine S Leus
role: Principal Investigator
affiliation: Algemeen Ziekenhuis Maria Middelares
last name: Jasmine S Leus
phone: +329 246 8200
email: jasmine.leus@azmmsj.be
last name: Josefien L Vandekerckhove
phone: +329 246 8200
email: josefien.vandekerckhove@gmail.com
facility: 
contact: 
contact backup: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Algemeen Ziekenhuis Maria Middelares
investigator full name: dr. Jasmine Leus
investigator title: Kinderarts
mesh term: Anaphylaxis
mesh term: Shock
sharing ipd: No