<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/NCT02191722</url>
  </required_header>
  <id_info>
    <org_study_id>0213-14-RMC</org_study_id>
    <nct_id>NCT02191722</nct_id>
  </id_info>
  <brief_title>&quot;Medikidz Explain JIA Comic Book- Hebrew&quot;</brief_title>
  <official_title>Evaluating the Efficacy of a Comic Book as an Educating Tool for Children With Juvenile Idiopathic Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rabin Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rabin Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We believe, that the results of this study will show that children learn from the comic book&#xD;
      about their disease, and are now more aware and less frightened about it, and increase their&#xD;
      compliance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We believe, that the results of this study will show that children learn from the comic book&#xD;
      about their disease, and are now more aware and less frightened about it, and increase their&#xD;
      compliance. If so, it may promote the use of comic books or other fun educational tool in&#xD;
      teaching children various other diseases.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>30% or more improvement in a knowledge questionnaire (before and after reading the comics booklet)</measure>
    <time_frame>2 Years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>10% or higher score in CHQ questionnaire (after reading the comics booklet)</measure>
    <time_frame>2 Years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>better compliance ( &gt;1 score improvement in 1-5 scale score, as evaluated by the physician after reading the comics booklet).</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Juvenile Idiopathic Arthritis</condition>
  <arm_group>
    <arm_group_label>JIA patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will be evaluated before and after reading the comics booklet</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>reading comics booklet</intervention_name>
    <arm_group_label>JIA patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Children with JIA aged 10-18 after parents signed ICF&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Parents that do not wanf their children to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gil Amarilyo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Schneider Children Medical Center of Israel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SCMCI</name>
      <address>
        <city>Petah-Tikva, 14 Kaplan s.</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <reference>
    <citation>Hampton T. Media lab uses videos, comics, and more to help people understand health issues. JAMA. 2012 Apr 25;307(16):1679-80. doi: 10.1001/jama.2012.507. No abstract available.</citation>
    <PMID>22535844</PMID>
  </reference>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>May 9, 2016</last_update_submitted>
  <last_update_submitted_qc>May 9, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 10, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rabin Medical Center</investigator_affiliation>
    <investigator_full_name>GIL AMARILYO</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Juvenile</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/NCT02191722
org study id: 0213-14-RMC
nct id: NCT02191722
lead sponsor: 
has dmc: No
We believe, that the results of this study will show that children learn from the comic book
      about their disease, and are now more aware and less frightened about it, and increase their
      compliance.
We believe, that the results of this study will show that children learn from the comic book
      about their disease, and are now more aware and less frightened about it, and increase their
      compliance. If so, it may promote the use of comic books or other fun educational tool in
      teaching children various other diseases.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: 30% or more improvement in a knowledge questionnaire (before and after reading the comics booklet)
time frame: 2 Years
measure: 10% or higher score in CHQ questionnaire (after reading the comics booklet)
time frame: 2 Years
measure: better compliance ( >1 score improvement in 1-5 scale score, as evaluated by the physician after reading the comics booklet).
time frame: 2 years
arm group label: JIA patients
arm group type: Experimental
description: All participants will be evaluated before and after reading the comics booklet
intervention type: Behavioral
intervention name: reading comics booklet
arm group label: JIA patients
criteria: 
gender: All
minimum age: 10 Years
maximum age: 18 Years
healthy volunteers: No
last name: Gil Amarilyo, MD
role: Principal Investigator
affiliation: Schneider Children Medical Center of Israel
facility: 
country: Israel
citation: Hampton T. Media lab uses videos, comics, and more to help people understand health issues. JAMA. 2012 Apr 25;307(16):1679-80. doi: 10.1001/jama.2012.507. No abstract available.
PMID: 22535844
responsible party type: Principal Investigator
investigator affiliation: Rabin Medical Center
investigator full name: GIL AMARILYO
investigator title: MD
mesh term: Arthritis
mesh term: Arthritis, Juvenile