<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/NCT01723332</url>
  </required_header>
  <id_info>
    <org_study_id>CHAPTER II</org_study_id>
    <nct_id>NCT01723332</nct_id>
  </id_info>
  <brief_title>The CHAPTER II Study - Congenital Heart Adolescents Participating in Transition Evaluation Research</brief_title>
  <official_title>The CHAPTER II Study - Congenital Heart Adolescents Participating in Transition Evaluation Research</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Heart and Stroke Foundation of Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alberta</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Transition is the planned movement of teens with chronic conditions from child-centered to&#xD;
      adult-oriented healthcare. National bodies have published detailed guidelines about the&#xD;
      importance of helping teens move to adult healthcare. However, there is no research regarding&#xD;
      how to best organize and deliver Congenital Heart Disease (CHD) transition programs. Data is&#xD;
      urgently needed. Therefore, the aim of this program is to develop research evidence that will&#xD;
      better prepare health care providers to improve how they can help adolescents with&#xD;
      transition.&#xD;
&#xD;
      This project will determine whether a nurse-led transition intervention program is better at&#xD;
      preparing teens with CHD to independently manage their medical care, compared to the care&#xD;
      that is currently provided. The most important finding of this study will be whether or not&#xD;
      these teens subsequently attend the adult cardiology clinic that specializes in CHD problems,&#xD;
      and the timing of when they attend.&#xD;
&#xD;
      Hypothesis: A transition intervention in combination with usual care, improved time to first&#xD;
      Adult Congenital Heart Disease (ACHD) clinic attendance compared to usual care alone.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 1, 2016</completion_date>
  <primary_completion_date type="Actual">December 1, 2016</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Excess time to first ACHD clinic appointment.</measure>
    <time_frame>12 - 24 months post enrolment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in adolescent knowledge of their condition.</measure>
    <time_frame>6 - 18 months post enrolment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in adolescent's self-management and self-advocacy skills/</measure>
    <time_frame>6 - 18 months post enrolment</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Congenital Heart Disease</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Clinical based educational and self management intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Youth seen in the Cardiology clinic see a nurse only to measure weight, height, and blood pressure. They rely on their cardiologist for information about their heart condition. The approach and amount of time taken by each cardiologist with a youth varies.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Educational</intervention_name>
    <description>The first interaction will happen at study enrolment and will be educational in nature.&#xD;
Following the session, the nurse will follow up with the participant to discuss any questions.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Self management</intervention_name>
    <description>The second interaction will take place 2 months after enrollment and will focus on self management and communication skills.&#xD;
Following the session, the nurse will follow up with the participant to discuss any questions.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  16 and 17 year olds with moderate or complex CHD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant developmental delay&#xD;
&#xD;
          -  Previous heart transplantation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew S Mackie, MD, SM</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stollery Children's Hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2B7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital For Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <last_update_submitted>October 31, 2017</last_update_submitted>
  <last_update_submitted_qc>October 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alberta</investigator_affiliation>
    <investigator_full_name>Andrew Mackie</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Transition from pediatric to adult clinical care</keyword>
  <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>
  <!-- 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/NCT01723332
org study id: CHAPTER II
nct id: NCT01723332
lead sponsor: 
collaborator: 
has dmc: No
Transition is the planned movement of teens with chronic conditions from child-centered to
      adult-oriented healthcare. National bodies have published detailed guidelines about the
      importance of helping teens move to adult healthcare. However, there is no research regarding
      how to best organize and deliver Congenital Heart Disease (CHD) transition programs. Data is
      urgently needed. Therefore, the aim of this program is to develop research evidence that will
      better prepare health care providers to improve how they can help adolescents with
      transition.

      This project will determine whether a nurse-led transition intervention program is better at
      preparing teens with CHD to independently manage their medical care, compared to the care
      that is currently provided. The most important finding of this study will be whether or not
      these teens subsequently attend the adult cardiology clinic that specializes in CHD problems,
      and the timing of when they attend.

      Hypothesis: A transition intervention in combination with usual care, improved time to first
      Adult Congenital Heart Disease (ACHD) clinic attendance compared to usual care alone.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Excess time to first ACHD clinic appointment.
time frame: 12 - 24 months post enrolment
measure: Change in adolescent knowledge of their condition.
time frame: 6 - 18 months post enrolment
measure: Change in adolescent's self-management and self-advocacy skills/
time frame: 6 - 18 months post enrolment
arm group label: Intervention
arm group type: Experimental
description: Clinical based educational and self management intervention.
arm group label: Usual Care
arm group type: No Intervention
description: Youth seen in the Cardiology clinic see a nurse only to measure weight, height, and blood pressure. They rely on their cardiologist for information about their heart condition. The approach and amount of time taken by each cardiologist with a youth varies.
intervention type: Behavioral
intervention name: Educational
description: The first interaction will happen at study enrolment and will be educational in nature.
Following the session, the nurse will follow up with the participant to discuss any questions.
arm group label: Intervention
intervention type: Behavioral
intervention name: Self management
description: The second interaction will take place 2 months after enrollment and will focus on self management and communication skills.
Following the session, the nurse will follow up with the participant to discuss any questions.
arm group label: Intervention
criteria: 
gender: All
minimum age: 16 Years
maximum age: 17 Years
healthy volunteers: No
last name: Andrew S Mackie, MD, SM
role: Principal Investigator
affiliation: University of Alberta
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Alberta
investigator full name: Andrew Mackie
investigator title: Associate Professor
mesh term: Heart Diseases
mesh term: Heart Defects, Congenital