<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/NCT04463446</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00097233</org_study_id>
    <nct_id>NCT04463446</nct_id>
  </id_info>
  <brief_title>The Impact of an Innovative eHealth Transition Intervention on Self-Management Skills Among Young Adults With Congenital Heart Disease</brief_title>
  <acronym>READYorNot CHD</acronym>
  <official_title>The Impact of an Innovative eHealth Transition Intervention on Self-Management Skills Among Young Adults With Congenital Heart Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>McGill University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Université de Montréal</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alberta</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Congenital heart disease (CHD) survivors constitute one of the fastest growing populations in&#xD;
      adult cardiology practices. This population is vulnerable to gaps in care, particularly as&#xD;
      they graduate from the pediatric to adult healthcare system. Their healthcare needs are&#xD;
      complex, and preparing this population for transfer to adult care is a resource-intense&#xD;
      process.&#xD;
&#xD;
      This trial will evaluate the use of the MyREADY Transition CHD app against a nurse-led&#xD;
      one-time intervention in clinic. Participants will be 16-17 year olds who attend a cardiology&#xD;
      outpatient clinic. The app will allow young adults to learn about their heart condition and&#xD;
      about self-management skills in the context of adult healthcare by using the app for 18&#xD;
      months. The nurse-led intervention will cover similar topics, but in a one-time in-person&#xD;
      session with a clinic nurse.&#xD;
&#xD;
      Outcomes: The primary outcome is change in Transition Readiness Assessment Questionnaire&#xD;
      (TRAQ) score over time. Secondary outcomes are change in the MyHeart Score and the General&#xD;
      Self-Efficacy (GSE) score. These questionnaires will be answered by all participants at&#xD;
      regular intervals (enrollment, 1 month, 6 months, 12 months, 18 months) throughout the trial.&#xD;
      The trial will also consider time to the first adult cardiology appointment, cost of the&#xD;
      interventions, and will conduct interviews with participants in the app group to learn about&#xD;
      their experiences using the app.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Congenital heart disease (CHD) survivors constitute one of the fastest growing populations in&#xD;
      adult cardiology practices. This population is vulnerable to gaps in care, particularly as&#xD;
      they graduate from the pediatric to adult healthcare system, yet their healthcare needs are&#xD;
      complex, costly, and chronic. With this submission, we focus on transitions in care (TiC)&#xD;
      from pediatric to adult healthcare with a research plan designed to optimize TiC outcomes.&#xD;
      Despite universal health insurance, clinical programs have insufficient resources to provide&#xD;
      transition preparation for adolescents with cardiac disease. This likely reflects a lack of&#xD;
      human and financial resources, geographic distance for patients and families living in rural&#xD;
      communities, and/or a &quot;process&quot; problem wherein no one is directly accountable for&#xD;
      transition. Nonetheless, Canadian policy mandates transfer to the adult healthcare system at&#xD;
      age 18 regardless of transition readiness.&#xD;
&#xD;
      2.1 Design. Cluster RCT with 2 arms conducted in accordance with CONSORT guidelines within a&#xD;
      mixed methods convergent design. The cluster design will minimize cross-contamination. The&#xD;
      qualitative and quantitative data will be collected concurrently, and the data merged to&#xD;
      ensure that intervention effectiveness is fully understood.&#xD;
&#xD;
      2.2 Planned trial interventions. This study will compare (i) access to the app vs. our team's&#xD;
      established 1-on-1 nurse-led TiC intervention.&#xD;
&#xD;
      The App: Content of the app will be developed during Phase 1 in conjunction with the PFAC. A&#xD;
      study registered nurse (RN) will orient participants to the app, provide them with a unique&#xD;
      username and password, and help them create an individualized MyHealth passport (note that&#xD;
      CHD transition guidelines recommend the use of health passports). The anticipated duration is&#xD;
      30 minutes. A research assistant (RA) will be available to participants throughout the study&#xD;
      period to answer questions about the app. System-generated automatic text messages will be&#xD;
      sent to participants every month to remind them about the app. The RA will check in with&#xD;
      participants every 3 months. Those who do not use the app over a 3-month period will be&#xD;
      flagged to identify psychological and environmental barriers to app use.&#xD;
&#xD;
      Nurse-led TiC intervention: There will be two cardiology RNs, each with adolescent&#xD;
      experience, at each site who are different from the RN working with participants in the app&#xD;
      group, to avoid cross contamination. The intervention will be provided during a single 60-75&#xD;
      minute session with the RN; this was the time required in the CHAPTER 1 and 2 Studies.&#xD;
      Sessions will occur on the same day as a clinic appointment. Sessions will be interactive and&#xD;
      engaging. Individual sessions, in contrast to a group, allow for the content to be&#xD;
      participant-specific and at a pace compatible with the participant and their cognitive and&#xD;
      social abilities. This intervention, already refined by our study team, will focus on&#xD;
      increasing knowledge about the adolescent's CHD and promotion of self-management and&#xD;
      self-efficacy skills.&#xD;
&#xD;
      Prior to the session, the RN will review the medical record to become familiar with the&#xD;
      participant's cardiac history. The intervention addresses both education about the&#xD;
      participant's CHD (steps i-v) and self-management skills (steps vi-viii). Specific elements&#xD;
      include: (i) introduction to transition and its importance, (ii) creation of a MyHealth&#xD;
      Passport, including name of CHD, prior cardiac interventions, and healthcare provider contact&#xD;
      information, (iii) diagram of participant's cardiac anatomy, (iv) discussion of three&#xD;
      potential future cardiac complications that are diagnosis-specific and individualized, (v)&#xD;
      introduction to the iHeartChange CHD transition website (iheartchange.org) developed by team&#xD;
      member Kovacs, (vi) discussion of the concept of self-management, (vii) viewing and&#xD;
      discussion of three professionally developed 1-minute videos that demonstrate interactions&#xD;
      between a healthcare provider and a young adult with poor communication skills (i.e., what&#xD;
      went wrong, how to handle this better) and three 1-minute videos demonstrating assertive&#xD;
      communication skills (i.e., strengths, successes), and (viii) adolescent practice of a&#xD;
      &quot;3-sentence summary&quot; about their CHD, with feedback from the RN.&#xD;
&#xD;
      Nurse-led intervention fidelity and quality assurance (Nurse-led intervention group only).&#xD;
      This will be performed in the same manner as the CHAPTER 2 study. Months 13-15 will be a&#xD;
      quality assurance (QA) phase. Role-modeling of an intervention with a standardized patient&#xD;
      will be led by team member Kovacs, who will provide in-person training to study RNs. Each RN&#xD;
      will then practice with a standardized patient with audio taping for review and feedback by&#xD;
      Kovacs and Dimitropoulos. Subsequently, 20 participants will be enrolled and receive the&#xD;
      intervention (2 patients per study RN x 2 RNs per site x 5 study sites). These sessions will&#xD;
      also be audio taped with participant permission. After each session the RN will complete a&#xD;
      fidelity checklist and nursing intervention log to record completion of each intervention&#xD;
      component as described above. Nurse-generated field notes will record RN's observations of&#xD;
      their interactions with adolescents, including the adolescent's confidence, engagement, and&#xD;
      emotional responses. Sessions will be digitally audio-recorded with participant permission;&#xD;
      1/5 will be randomly selected for evaluation of treatment fidelity. Evaluation of treatment&#xD;
      fidelity will be based on review of nursing intervention logs, fidelity checklists, field&#xD;
      notes and audiotapes monthly by Kovacs and Dimitropoulos. Participants enrolled from months&#xD;
      16-27 inclusive will contribute to study outcomes.&#xD;
&#xD;
      2.3 Group allocation. Participants will be randomized by clusters defined by week of&#xD;
      attendance in the pediatric cardiology clinic, as per CHAPTER 1 and 2 Studies. As week&#xD;
      (rather than individual participant) is the unit of randomization, this is a cluster&#xD;
      randomization design. This method of randomization prevents two adolescents in the same&#xD;
      waiting room being allocated to different groups, with adolescents in the app group&#xD;
      potentially preferring to be in the nurse intervention group (or vice-versa). Each&#xD;
      cardiologist has a weekly clinic and therefore a given cardiologist's patients will be&#xD;
      allocated to each study arm equally, preventing potential bias by cardiologist&#xD;
      co-intervention. We anticipate average enrolment of 1-2 participants per site per week, i.e.&#xD;
      cluster size will be ≤ 2. To determine &quot;app weeks&quot; vs. &quot;nurse intervention weeks&quot;, a&#xD;
      biostatistician will prepare the randomization sequence. Permuted-block randomization with&#xD;
      varying block sizes and equal allocation ratio will be used to ensure balanced allocation of&#xD;
      weeks (randomization unit) between the 2 treatment arms. Blocks of sizes 2 and 4 will be&#xD;
      randomly mixed to overcome the problem of predicting the allocation for the last few entries&#xD;
      in each block. Since five centers are participating in the trial, a randomization schedule&#xD;
      will be provided for each center.Randomization will be stratified by center to ensure a&#xD;
      similar number of participants are allocated to each group within each site; this will&#xD;
      mitigate the potential impact of center-specific confounders.&#xD;
&#xD;
      2.4 Protecting against sources of bias. Participants, their parents, and study RNs will be&#xD;
      aware of group allocation as blinding is not feasible. However, adolescents and parents in&#xD;
      both groups will be unaware of the primary outcome and therefore will not be able to&#xD;
      consciously influence this outcome. Intervention occurs on the same day as a clinic&#xD;
      appointment, but clinic RNs and pediatric cardiologists will not be informed of group&#xD;
      allocation, and this approach has been feasible in the CHAPTER 1 and CHAPTER 2 studies. Study&#xD;
      RNs will be instructed to not inform clinicians of app vs. nurse-intervention weeks.&#xD;
&#xD;
      2.5 Inclusion/exclusion criteria: described elsewhere&#xD;
&#xD;
      2.6 Duration of intervention. As per section 2.2, participants in the app group will meet&#xD;
      with an RN for ~30 min and then have access to the app for ~ 18 months. Participants in the&#xD;
      nursing intervention will meet once with a study RN (60±15 min). All RN contact will be&#xD;
      coordinated with a clinic appointment.&#xD;
&#xD;
      2.7 Frequency and duration of follow-up. Participants in both groups will complete&#xD;
      questionnaires at enrollment (baseline), 1, 6, 12, and 18 months post enrollment (see below).&#xD;
      Eighteen months was chosen because our CHAPTER 1 and 2 studies yielded benefits at or before&#xD;
      this time.&#xD;
&#xD;
      2.9 Measurement of outcomes at follow-up. Participants will complete follow-up online&#xD;
      questionnaires at home, independently of their parents. For adolescents not having home&#xD;
      Internet access, we will arrange for access via their school or local library. Adolescents&#xD;
      not completing the follow-up questionnaires will be contacted by mail, email, or text&#xD;
      (depending on their preference) every 2 weeks for a total of 3 times, and then telephoned&#xD;
      once, to be reminded. A $25 gift card (iTunes, Tim Hortons or Amazon) will be provided to&#xD;
      participants at each time point to acknowledge their time and commitment to questionnaire&#xD;
      completion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 10, 2022</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2024</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Transition Readiness Assessment Questionnaire</measure>
    <time_frame>18 months</time_frame>
    <description>The Transition Readiness Assessment Questionnaire contains a series of questions in which the youth is asked to describe their ability level in various skill areas related to their health and health care, using the following scale:&#xD;
No, I do not know how No, but I want to learn No, but I am learning to do this Yes, I have started doing this Yes, I always do this when I need to&#xD;
This produces a minimum score 20, max score 100. A higher score indicates a better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MyHeart Score</measure>
    <time_frame>18 months</time_frame>
    <description>The MyHeart Scale assess CHD knowledge. Score is 0-100, a higher score indicates a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General Self-Efficacy Score</measure>
    <time_frame>18 months</time_frame>
    <description>The scale was created to assess a general sense of perceived self-efficacy with the aim in mind to predict coping with daily hassles as well as adaptation after experiencing all kinds of stressful life events. Score is between 10-40, a higher score insicates a better outcome.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Excess time to adult care</measure>
    <time_frame>18 months</time_frame>
    <description>The recommended time to first adult cardiology appointment will be compared to the actual time to first adult cardiology appointment. Participants who have not attended the adult clinic by the end of the study period (i.e., are &quot;censored&quot;) will still contribute to this outcome as survival analysis is designed to accommodate censored data. Delays in attending the adult clinic related to system factors (e.g. waiting list) will be documented.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">188</enrollment>
  <condition>Congenital Heart Disease</condition>
  <condition>Congenital Heart Disease in Adolescence</condition>
  <arm_group>
    <arm_group_label>The app arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of CHD app</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nurse-led intervention arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nurse-led intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Use of the CHD app</intervention_name>
    <description>Use of the CHD app</description>
    <arm_group_label>The app arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nurse-led intervention</intervention_name>
    <description>Teaching session with clinic nurse</description>
    <arm_group_label>Nurse-led intervention arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  moderate or complex CHD&#xD;
&#xD;
          -  seen at outpatient cardiology clinic at participating pediatric hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt; Grade 6 level of reading and comprehension&#xD;
&#xD;
          -  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 Mackie</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Andrew Mackie</last_name>
    <phone>780-407-8361</phone>
    <email>andrew.mackie@ahs.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Daniella San Martin-Feeney</last_name>
    <phone>780-407-3794</phone>
    <email>daniella.sanmartin-feeney@ahs.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Alberta</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2B7</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrew Mackie, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 7, 2023</last_update_submitted>
  <last_update_submitted_qc>July 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2023</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/NCT04463446
org study id: Pro00097233
nct id: NCT04463446
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Congenital heart disease (CHD) survivors constitute one of the fastest growing populations in
      adult cardiology practices. This population is vulnerable to gaps in care, particularly as
      they graduate from the pediatric to adult healthcare system. Their healthcare needs are
      complex, and preparing this population for transfer to adult care is a resource-intense
      process.

      This trial will evaluate the use of the MyREADY Transition CHD app against a nurse-led
      one-time intervention in clinic. Participants will be 16-17 year olds who attend a cardiology
      outpatient clinic. The app will allow young adults to learn about their heart condition and
      about self-management skills in the context of adult healthcare by using the app for 18
      months. The nurse-led intervention will cover similar topics, but in a one-time in-person
      session with a clinic nurse.

      Outcomes: The primary outcome is change in Transition Readiness Assessment Questionnaire
      (TRAQ) score over time. Secondary outcomes are change in the MyHeart Score and the General
      Self-Efficacy (GSE) score. These questionnaires will be answered by all participants at
      regular intervals (enrollment, 1 month, 6 months, 12 months, 18 months) throughout the trial.
      The trial will also consider time to the first adult cardiology appointment, cost of the
      interventions, and will conduct interviews with participants in the app group to learn about
      their experiences using the app.
Congenital heart disease (CHD) survivors constitute one of the fastest growing populations in
      adult cardiology practices. This population is vulnerable to gaps in care, particularly as
      they graduate from the pediatric to adult healthcare system, yet their healthcare needs are
      complex, costly, and chronic. With this submission, we focus on transitions in care (TiC)
      from pediatric to adult healthcare with a research plan designed to optimize TiC outcomes.
      Despite universal health insurance, clinical programs have insufficient resources to provide
      transition preparation for adolescents with cardiac disease. This likely reflects a lack of
      human and financial resources, geographic distance for patients and families living in rural
      communities, and/or a "process" problem wherein no one is directly accountable for
      transition. Nonetheless, Canadian policy mandates transfer to the adult healthcare system at
      age 18 regardless of transition readiness.

      2.1 Design. Cluster RCT with 2 arms conducted in accordance with CONSORT guidelines within a
      mixed methods convergent design. The cluster design will minimize cross-contamination. The
      qualitative and quantitative data will be collected concurrently, and the data merged to
      ensure that intervention effectiveness is fully understood.

      2.2 Planned trial interventions. This study will compare (i) access to the app vs. our team's
      established 1-on-1 nurse-led TiC intervention.

      The App: Content of the app will be developed during Phase 1 in conjunction with the PFAC. A
      study registered nurse (RN) will orient participants to the app, provide them with a unique
      username and password, and help them create an individualized MyHealth passport (note that
      CHD transition guidelines recommend the use of health passports). The anticipated duration is
      30 minutes. A research assistant (RA) will be available to participants throughout the study
      period to answer questions about the app. System-generated automatic text messages will be
      sent to participants every month to remind them about the app. The RA will check in with
      participants every 3 months. Those who do not use the app over a 3-month period will be
      flagged to identify psychological and environmental barriers to app use.

      Nurse-led TiC intervention: There will be two cardiology RNs, each with adolescent
      experience, at each site who are different from the RN working with participants in the app
      group, to avoid cross contamination. The intervention will be provided during a single 60-75
      minute session with the RN; this was the time required in the CHAPTER 1 and 2 Studies.
      Sessions will occur on the same day as a clinic appointment. Sessions will be interactive and
      engaging. Individual sessions, in contrast to a group, allow for the content to be
      participant-specific and at a pace compatible with the participant and their cognitive and
      social abilities. This intervention, already refined by our study team, will focus on
      increasing knowledge about the adolescent's CHD and promotion of self-management and
      self-efficacy skills.

      Prior to the session, the RN will review the medical record to become familiar with the
      participant's cardiac history. The intervention addresses both education about the
      participant's CHD (steps i-v) and self-management skills (steps vi-viii). Specific elements
      include: (i) introduction to transition and its importance, (ii) creation of a MyHealth
      Passport, including name of CHD, prior cardiac interventions, and healthcare provider contact
      information, (iii) diagram of participant's cardiac anatomy, (iv) discussion of three
      potential future cardiac complications that are diagnosis-specific and individualized, (v)
      introduction to the iHeartChange CHD transition website (iheartchange.org) developed by team
      member Kovacs, (vi) discussion of the concept of self-management, (vii) viewing and
      discussion of three professionally developed 1-minute videos that demonstrate interactions
      between a healthcare provider and a young adult with poor communication skills (i.e., what
      went wrong, how to handle this better) and three 1-minute videos demonstrating assertive
      communication skills (i.e., strengths, successes), and (viii) adolescent practice of a
      "3-sentence summary" about their CHD, with feedback from the RN.

      Nurse-led intervention fidelity and quality assurance (Nurse-led intervention group only).
      This will be performed in the same manner as the CHAPTER 2 study. Months 13-15 will be a
      quality assurance (QA) phase. Role-modeling of an intervention with a standardized patient
      will be led by team member Kovacs, who will provide in-person training to study RNs. Each RN
      will then practice with a standardized patient with audio taping for review and feedback by
      Kovacs and Dimitropoulos. Subsequently, 20 participants will be enrolled and receive the
      intervention (2 patients per study RN x 2 RNs per site x 5 study sites). These sessions will
      also be audio taped with participant permission. After each session the RN will complete a
      fidelity checklist and nursing intervention log to record completion of each intervention
      component as described above. Nurse-generated field notes will record RN's observations of
      their interactions with adolescents, including the adolescent's confidence, engagement, and
      emotional responses. Sessions will be digitally audio-recorded with participant permission;
      1/5 will be randomly selected for evaluation of treatment fidelity. Evaluation of treatment
      fidelity will be based on review of nursing intervention logs, fidelity checklists, field
      notes and audiotapes monthly by Kovacs and Dimitropoulos. Participants enrolled from months
      16-27 inclusive will contribute to study outcomes.

      2.3 Group allocation. Participants will be randomized by clusters defined by week of
      attendance in the pediatric cardiology clinic, as per CHAPTER 1 and 2 Studies. As week
      (rather than individual participant) is the unit of randomization, this is a cluster
      randomization design. This method of randomization prevents two adolescents in the same
      waiting room being allocated to different groups, with adolescents in the app group
      potentially preferring to be in the nurse intervention group (or vice-versa). Each
      cardiologist has a weekly clinic and therefore a given cardiologist's patients will be
      allocated to each study arm equally, preventing potential bias by cardiologist
      co-intervention. We anticipate average enrolment of 1-2 participants per site per week, i.e.
      cluster size will be ≤ 2. To determine "app weeks" vs. "nurse intervention weeks", a
      biostatistician will prepare the randomization sequence. Permuted-block randomization with
      varying block sizes and equal allocation ratio will be used to ensure balanced allocation of
      weeks (randomization unit) between the 2 treatment arms. Blocks of sizes 2 and 4 will be
      randomly mixed to overcome the problem of predicting the allocation for the last few entries
      in each block. Since five centers are participating in the trial, a randomization schedule
      will be provided for each center.Randomization will be stratified by center to ensure a
      similar number of participants are allocated to each group within each site; this will
      mitigate the potential impact of center-specific confounders.

      2.4 Protecting against sources of bias. Participants, their parents, and study RNs will be
      aware of group allocation as blinding is not feasible. However, adolescents and parents in
      both groups will be unaware of the primary outcome and therefore will not be able to
      consciously influence this outcome. Intervention occurs on the same day as a clinic
      appointment, but clinic RNs and pediatric cardiologists will not be informed of group
      allocation, and this approach has been feasible in the CHAPTER 1 and CHAPTER 2 studies. Study
      RNs will be instructed to not inform clinicians of app vs. nurse-intervention weeks.

      2.5 Inclusion/exclusion criteria: described elsewhere

      2.6 Duration of intervention. As per section 2.2, participants in the app group will meet
      with an RN for ~30 min and then have access to the app for ~ 18 months. Participants in the
      nursing intervention will meet once with a study RN (60±15 min). All RN contact will be
      coordinated with a clinic appointment.

      2.7 Frequency and duration of follow-up. Participants in both groups will complete
      questionnaires at enrollment (baseline), 1, 6, 12, and 18 months post enrollment (see below).
      Eighteen months was chosen because our CHAPTER 1 and 2 studies yielded benefits at or before
      this time.

      2.9 Measurement of outcomes at follow-up. Participants will complete follow-up online
      questionnaires at home, independently of their parents. For adolescents not having home
      Internet access, we will arrange for access via their school or local library. Adolescents
      not completing the follow-up questionnaires will be contacted by mail, email, or text
      (depending on their preference) every 2 weeks for a total of 3 times, and then telephoned
      once, to be reminded. A $25 gift card (iTunes, Tim Hortons or Amazon) will be provided to
      participants at each time point to acknowledge their time and commitment to questionnaire
      completion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Transition Readiness Assessment Questionnaire
time frame: 18 months
description: The Transition Readiness Assessment Questionnaire contains a series of questions in which the youth is asked to describe their ability level in various skill areas related to their health and health care, using the following scale:
No, I do not know how No, but I want to learn No, but I am learning to do this Yes, I have started doing this Yes, I always do this when I need to
This produces a minimum score 20, max score 100. A higher score indicates a better outcome.
measure: MyHeart Score
time frame: 18 months
description: The MyHeart Scale assess CHD knowledge. Score is 0-100, a higher score indicates a better outcome.
measure: General Self-Efficacy Score
time frame: 18 months
description: The scale was created to assess a general sense of perceived self-efficacy with the aim in mind to predict coping with daily hassles as well as adaptation after experiencing all kinds of stressful life events. Score is between 10-40, a higher score insicates a better outcome.
measure: Excess time to adult care
time frame: 18 months
description: The recommended time to first adult cardiology appointment will be compared to the actual time to first adult cardiology appointment. Participants who have not attended the adult clinic by the end of the study period (i.e., are "censored") will still contribute to this outcome as survival analysis is designed to accommodate censored data. Delays in attending the adult clinic related to system factors (e.g. waiting list) will be documented.
arm group label: The app arm
arm group type: Experimental
description: Use of CHD app
arm group label: Nurse-led intervention arm
arm group type: Active Comparator
description: Nurse-led intervention
intervention type: Behavioral
intervention name: Use of the CHD app
description: Use of the CHD app
arm group label: The app arm
intervention type: Behavioral
intervention name: Nurse-led intervention
description: Teaching session with clinic nurse
arm group label: Nurse-led intervention arm
criteria: 
gender: All
minimum age: 16 Years
maximum age: 17 Years
healthy volunteers: No
last name: Andrew Mackie
role: Principal Investigator
affiliation: University of Alberta
last name: Andrew Mackie
phone: 780-407-8361
email: andrew.mackie@ahs.ca
last name: Daniella San Martin-Feeney
phone: 780-407-3794
email: daniella.sanmartin-feeney@ahs.ca
facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Heart Defects, Congenital