<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/NCT03005626</url>
  </required_header>
  <id_info>
    <org_study_id>9752</org_study_id>
    <nct_id>NCT03005626</nct_id>
  </id_info>
  <brief_title>Transition From Adolescents to Adulthood for Patients With Congenital Heart Diseases</brief_title>
  <official_title>Transition From Adolescents to Adulthood for Patients With Congenital Patients With Congenital Heart Diseases: Impact of a Therapeutic Education Program on Quality of Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Investigators aim to measure the impact of a transition program in congenital cardiology&#xD;
      in terms of health-related quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The number of adults with congenital heart diseases (CHD) is increasing. However, many young&#xD;
      adults are lost to follow-up even in experienced tertiary care centers. American and European&#xD;
      guidelines recommend to improve the management of young adults with CHD. Structured&#xD;
      therapeutic education programs are therefore needed to optimize the transfer to adult&#xD;
      healthcare. Our tertiary care CHD center recently implemented a transition program and&#xD;
      simultaneously investigators decided to measure its impact. Indeed investigators need data&#xD;
      from randomized trials in this filed. After previous controlled quality of life studies among&#xD;
      children and adults with CHD, investigators chose to use the health-related quality of life&#xD;
      (HR-QoL) as primary endpoint in this randomized study to focus on patient related outcomes.&#xD;
&#xD;
      The investigators assume that patients who participate in this program will improve their&#xD;
      quality of life compared to controls. If investigators demonstrate the benefit of this&#xD;
      program, it will have important consequences for patients with CHD and eventually for&#xD;
      patients with other chronic medical conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">November 16, 2020</completion_date>
  <primary_completion_date type="Actual">November 16, 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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PedsQL 4.0 score</measure>
    <time_frame>Follow up of patients over 12 months</time_frame>
    <description>Evolution of the quality of life assessed by PedsQL 4.0 self-reported scores from month 0 to month 12.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physiological parameters</measure>
    <time_frame>Follow up of patients over 12 months</time_frame>
    <description>Evolution of the physiological parameters during a cardiopulmonary exercise test performed on a treadmill according to a modified Bruce protocole. Evolution of the physiological parameters from month 0 to month 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ricci and Gagnon score</measure>
    <time_frame>Follow up of patients over 12 months</time_frame>
    <description>Evolution of the physical activity assessed by Ricci and Gagnon scores from month 0 to month 12. Ricci and Ganon score is a physical activity self-questionnaire with a total score out of 40 (&lt;16 points: not very active, between 16 and 32 points: fairly active, &gt; 32 points: very active).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leuven Knowledge score</measure>
    <time_frame>Follow up of patients over 12 months</time_frame>
    <description>Evolution of the knowledge of the disease assessed by Leuven Knowledge scores from month 0 to month 12. The level of knowledge was assessed by the &quot;transition readdiness assessment&quot; instrument : 10-item questionnaire reflecting the basic knowledge of the diseases and its management.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease severity</measure>
    <time_frame>Follow up of patients over 12 months</time_frame>
    <description>The evolution of the severity of the disease from month 0 to month 12 was assessed by the degree of heart failure (NYHA functionnal class I to IV) and the number of hospitalizations (in stays and days) for complications related to the congenital heart disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and depression</measure>
    <time_frame>Follow up of patients over 12 months</time_frame>
    <description>The evolution of the levels of depression and/or anxiety from month 0 to month 12 was assessed respectively by :&#xD;
the BDI (Beck Depression Inventory) for young adults&#xD;
the CDI (Child Depression Inventory) for adolescents&#xD;
the STAI (State and Trait Anxiety Inventory) for adults and STAI-C (Children) for adolescents.&#xD;
A higher score is associated with a higher risk of depression/anxiety.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Congenital Heart Diseases</condition>
  <arm_group>
    <arm_group_label>Therapeutic education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Structured therapeutic education programs</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>standard outpatient follow-up</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Therapeutic education</intervention_name>
    <arm_group_label>Therapeutic education</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard follow-up</intervention_name>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient from 13 years to 25 years inclusive.&#xD;
&#xD;
          -  Carrying of Congenital Heart Disease as defined in the International Classification.&#xD;
&#xD;
          -  Possible follow-up for one year on one of the three hospital center.&#xD;
&#xD;
          -  Informed consent of the patient for adults and, parents or legal guardians for minors.&#xD;
&#xD;
          -  Affiliation to a social security system.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-francophone,&#xD;
&#xD;
          -  Severe intellectual impairment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>December 26, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>December 13, 2022</last_update_submitted>
  <last_update_submitted_qc>December 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 16, 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>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/NCT03005626
org study id: 9752
nct id: NCT03005626
lead sponsor: 
has dmc: No
The Investigators aim to measure the impact of a transition program in congenital cardiology
      in terms of health-related quality of life.
The number of adults with congenital heart diseases (CHD) is increasing. However, many young
      adults are lost to follow-up even in experienced tertiary care centers. American and European
      guidelines recommend to improve the management of young adults with CHD. Structured
      therapeutic education programs are therefore needed to optimize the transfer to adult
      healthcare. Our tertiary care CHD center recently implemented a transition program and
      simultaneously investigators decided to measure its impact. Indeed investigators need data
      from randomized trials in this filed. After previous controlled quality of life studies among
      children and adults with CHD, investigators chose to use the health-related quality of life
      (HR-QoL) as primary endpoint in this randomized study to focus on patient related outcomes.

      The investigators assume that patients who participate in this program will improve their
      quality of life compared to controls. If investigators demonstrate the benefit of this
      program, it will have important consequences for patients with CHD and eventually for
      patients with other chronic medical conditions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: PedsQL 4.0 score
time frame: Follow up of patients over 12 months
description: Evolution of the quality of life assessed by PedsQL 4.0 self-reported scores from month 0 to month 12.
measure: Physiological parameters
time frame: Follow up of patients over 12 months
description: Evolution of the physiological parameters during a cardiopulmonary exercise test performed on a treadmill according to a modified Bruce protocole. Evolution of the physiological parameters from month 0 to month 12
measure: Ricci and Gagnon score
time frame: Follow up of patients over 12 months
description: Evolution of the physical activity assessed by Ricci and Gagnon scores from month 0 to month 12. Ricci and Ganon score is a physical activity self-questionnaire with a total score out of 40 (<16 points: not very active, between 16 and 32 points: fairly active, > 32 points: very active).
measure: Leuven Knowledge score
time frame: Follow up of patients over 12 months
description: Evolution of the knowledge of the disease assessed by Leuven Knowledge scores from month 0 to month 12. The level of knowledge was assessed by the "transition readdiness assessment" instrument : 10-item questionnaire reflecting the basic knowledge of the diseases and its management.
measure: Disease severity
time frame: Follow up of patients over 12 months
description: The evolution of the severity of the disease from month 0 to month 12 was assessed by the degree of heart failure (NYHA functionnal class I to IV) and the number of hospitalizations (in stays and days) for complications related to the congenital heart disease
measure: Anxiety and depression
time frame: Follow up of patients over 12 months
description: The evolution of the levels of depression and/or anxiety from month 0 to month 12 was assessed respectively by :
the BDI (Beck Depression Inventory) for young adults
the CDI (Child Depression Inventory) for adolescents
the STAI (State and Trait Anxiety Inventory) for adults and STAI-C (Children) for adolescents.
A higher score is associated with a higher risk of depression/anxiety.
arm group label: Therapeutic education
arm group type: Experimental
description: Structured therapeutic education programs
arm group label: Control group
arm group type: Active Comparator
description: standard outpatient follow-up
intervention type: Other
intervention name: Therapeutic education
arm group label: Therapeutic education
intervention type: Other
intervention name: Standard follow-up
arm group label: Control group
criteria: 
gender: All
minimum age: 13 Years
maximum age: 25 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Heart Defects, Congenital