<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/NCT03303248</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00130432</org_study_id>
    <nct_id>NCT03303248</nct_id>
  </id_info>
  <brief_title>Evaluation of Web-based Transition Education to Enhance Transition Readiness</brief_title>
  <official_title>Evaluation of Web-based Transition Education to Enhance Transition Readiness and Health Service Utilization in Adolescents/Young Adults With Congenital Heart Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan</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 study looks to learn more about the helpfulness of web-based transition education and its&#xD;
      effect on transition readiness and health service utilization in the adolescent and young&#xD;
      adult congenital heart disease population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 27, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2023</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>Change in transition readiness score, as measured by transition readiness survey</measure>
    <time_frame>baseline, 12 months</time_frame>
    <description>The transition readiness survey is used to measure a participant's self-reported knowledge about their health and readiness to take charge of their healthcare. Each item is scored from 1 to 5, where 1 means &quot;No, I do not know how&quot; and 5 means &quot;Yes, I always do this when I need to.&quot; The overall score is determined by calculating the sum of all questions on a 100 point scale. A higher score indicates greater readiness for transition.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Congenital Heart Disease</condition>
  <condition>Transition</condition>
  <condition>Pediatric Congenital Heart Disease</condition>
  <arm_group>
    <arm_group_label>Web-based Educational Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group of participants will be given access to a web-based educational resource in addition to the standard of care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group will be given only the standard of care during their clinic visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Web-based Educational Intervention</intervention_name>
    <description>A web-based educational tool, created for patients with congenital heart disease, will be given to patients using an ipad. This additional educational tool will be used with the standard of care visit with provider.</description>
    <arm_group_label>Web-based Educational Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with congenital heart disease&#xD;
&#xD;
          -  Ages 13-25&#xD;
&#xD;
          -  Routine outpatient cardiology follow-up visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  New patients to cardiology clinic&#xD;
&#xD;
          -  Patients being evaluated for an acute medical problem&#xD;
&#xD;
          -  Patients who do not speak English&#xD;
&#xD;
          -  Severe neurocognitive impairment that precludes ability to complete the questionnaire&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karen Uzark, PhD, CPNP</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Katherine Afton, BS</last_name>
    <phone>734-232-3945</phone>
    <email>kafton@umich.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Cynthia Smith, RN</last_name>
    <phone>734-615-0590</phone>
    <email>csmithw@umich.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>C.S. Mott Children's Hospital</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Research Coordinator</last_name>
      <email>kafton@med.umich.edu</email>
    </contact>
    <contact_backup>
      <last_name>Principal Investigator</last_name>
      <email>karenu@med.umich.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Uzark K, Smith C, Donohue J, Yu S, Afton K, Norris M, Cotts T. Assessment of Transition Readiness in Adolescents and Young Adults with Heart Disease. J Pediatr. 2015 Dec;167(6):1233-8. doi: 10.1016/j.jpeds.2015.07.043. Epub 2015 Aug 19.</citation>
    <PMID>26298627</PMID>
  </reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>June 21, 2023</last_update_submitted>
  <last_update_submitted_qc>June 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Karen Uzark</investigator_full_name>
    <investigator_title>Clinical Professor of Cardiac Surgery and Pediatric Cardiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Heart Defects, Congenital</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/NCT03303248
org study id: HUM00130432
nct id: NCT03303248
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study looks to learn more about the helpfulness of web-based transition education and its
      effect on transition readiness and health service utilization in the adolescent and young
      adult congenital heart disease population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in transition readiness score, as measured by transition readiness survey
time frame: baseline, 12 months
description: The transition readiness survey is used to measure a participant's self-reported knowledge about their health and readiness to take charge of their healthcare. Each item is scored from 1 to 5, where 1 means "No, I do not know how" and 5 means "Yes, I always do this when I need to." The overall score is determined by calculating the sum of all questions on a 100 point scale. A higher score indicates greater readiness for transition.
arm group label: Web-based Educational Intervention
arm group type: Experimental
description: This group of participants will be given access to a web-based educational resource in addition to the standard of care.
arm group label: Standard of Care
arm group type: No Intervention
description: This group will be given only the standard of care during their clinic visit.
intervention type: Behavioral
intervention name: Web-based Educational Intervention
description: A web-based educational tool, created for patients with congenital heart disease, will be given to patients using an ipad. This additional educational tool will be used with the standard of care visit with provider.
arm group label: Web-based Educational Intervention
criteria: 
gender: All
minimum age: 13 Years
maximum age: 25 Years
healthy volunteers: No
last name: Karen Uzark, PhD, CPNP
role: Principal Investigator
affiliation: University of Michigan
last name: Katherine Afton, BS
phone: 734-232-3945
email: kafton@umich.edu
last name: Cynthia Smith, RN
phone: 734-615-0590
email: csmithw@umich.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
citation: Uzark K, Smith C, Donohue J, Yu S, Afton K, Norris M, Cotts T. Assessment of Transition Readiness in Adolescents and Young Adults with Heart Disease. J Pediatr. 2015 Dec;167(6):1233-8. doi: 10.1016/j.jpeds.2015.07.043. Epub 2015 Aug 19.
PMID: 26298627
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Karen Uzark
investigator title: Clinical Professor of Cardiac Surgery and Pediatric Cardiology
mesh term: Heart Diseases
mesh term: Heart Defects, Congenital
sharing ipd: No