<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/NCT03833778</url>
  </required_header>
  <id_info>
    <org_study_id>18-007</org_study_id>
    <nct_id>NCT03833778</nct_id>
  </id_info>
  <brief_title>Kids + Adolescents Research Learning On Tablet Teaching Aachen</brief_title>
  <acronym>KARLOTTA</acronym>
  <official_title>Kids + Adolescents Research Learning On Tablet Teaching Aachen</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RWTH Aachen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RWTH Aachen University</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 aim of this study plan is to implement a tablet quiz in the German-speaking area, in&#xD;
      order to test the specific knowledge about chronic inflammatory intestinal diseases (CED)&#xD;
      concerning pediatric patients in the context of an age-appropriated and interesting digital&#xD;
      playing environment, and to process knowledge gaps at the subsequent doctor's contact. The&#xD;
      quiz should be combined with a game and can be performed by the patients, while they wait in&#xD;
      the ambulance for their doctor's appointment. The investigator's goals are to grasp playfully&#xD;
      gaps in the CED knowledge regarding the patients and to use these in the following consulting&#xD;
      hour for clarification and advice in line with a better understanding of the disease. With&#xD;
      this, the specific knowledge, the understanding of the disease, the therapeutic adherence,&#xD;
      and the self-efficacy should improve the self-responsible handling of the disease. In&#xD;
      particular, the willingness of the group of older teenagers to transit into the adult&#xD;
      medicine can be collected and processed. The investigators want to check the efficacy in a&#xD;
      randomized, controlled study with two groups of 15 pediatric CED patients. The hypothesis is&#xD;
      that the additional play of the tablet-CED-quiz and the individualized advice have a positive&#xD;
      impact on the CED knowledge, the disease activity, the CED-related life quality and the&#xD;
      willingness of teenagers for transition.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 5, 2019</start_date>
  <completion_date type="Actual">July 31, 2020</completion_date>
  <primary_completion_date type="Actual">July 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>knowledge test</measure>
    <time_frame>12 months</time_frame>
    <description>Comparing point values of the baseline tablet quiz and final test regarding the CED knowledge</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Chronic Inflammatory Intestinal Diseases (CED)</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Answering disease related questions during playing a tablet game</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>intervention group</intervention_name>
    <description>The CED patients play the tablet-CED-quiz, while they wait for their doctor's appointment, so that gaps in the CED knowledge can be clarified during the doctor's consultation.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female and male children and young adults between 8-21 years&#xD;
&#xD;
          -  Diagnosis Morbus Crohn, Colitis ulcerosa or Colitis indeterminate&#xD;
&#xD;
          -  Clarification and signed Informed Consent Form&#xD;
&#xD;
          -  Patients must know how to write and read in German&#xD;
&#xD;
          -  Patients must be able to play independently on the tablet&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 8 years or &gt; 21 years&#xD;
&#xD;
          -  Illiteracy&#xD;
&#xD;
          -  Mental or psychomotor disability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Angeliki Pappa, Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinic for Pediatrics and Youth Medicine, University Hospital of RWTH Aachen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinic for Pediatrics and Youth Medicine, University Hospital of RWTH Aachen University</name>
      <address>
        <city>Aachen</city>
        <state>NRW</state>
        <zip>52074</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>October 25, 2022</last_update_submitted>
  <last_update_submitted_qc>October 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 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>Intestinal Diseases</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/NCT03833778
org study id: 18-007
nct id: NCT03833778
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study plan is to implement a tablet quiz in the German-speaking area, in
      order to test the specific knowledge about chronic inflammatory intestinal diseases (CED)
      concerning pediatric patients in the context of an age-appropriated and interesting digital
      playing environment, and to process knowledge gaps at the subsequent doctor's contact. The
      quiz should be combined with a game and can be performed by the patients, while they wait in
      the ambulance for their doctor's appointment. The investigator's goals are to grasp playfully
      gaps in the CED knowledge regarding the patients and to use these in the following consulting
      hour for clarification and advice in line with a better understanding of the disease. With
      this, the specific knowledge, the understanding of the disease, the therapeutic adherence,
      and the self-efficacy should improve the self-responsible handling of the disease. In
      particular, the willingness of the group of older teenagers to transit into the adult
      medicine can be collected and processed. The investigators want to check the efficacy in a
      randomized, controlled study with two groups of 15 pediatric CED patients. The hypothesis is
      that the additional play of the tablet-CED-quiz and the individualized advice have a positive
      impact on the CED knowledge, the disease activity, the CED-related life quality and the
      willingness of teenagers for transition.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: knowledge test
time frame: 12 months
description: Comparing point values of the baseline tablet quiz and final test regarding the CED knowledge
arm group label: Intervention group
arm group type: Other
description: Answering disease related questions during playing a tablet game
arm group label: control group
arm group type: No Intervention
intervention type: Other
intervention name: intervention group
description: The CED patients play the tablet-CED-quiz, while they wait for their doctor's appointment, so that gaps in the CED knowledge can be clarified during the doctor's consultation.
arm group label: Intervention group
criteria: 
gender: All
minimum age: 8 Years
maximum age: 21 Years
healthy volunteers: No
last name: Angeliki Pappa, Dr. med.
role: Principal Investigator
affiliation: Clinic for Pediatrics and Youth Medicine, University Hospital of RWTH Aachen University
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Intestinal Diseases
sharing ipd: No