The CHAPTER III Study of Young Adolescents
Condition: Heart Defects, Congenital
MeSH terms: Heart Defects, Congenital; Congenital Abnormalities
Study type: Interventional

Summary: 
      The CHAPTER III Study (Congenital Heart Adolescents Participating in Transition Evaluation
      Research) is a cluster randomized controlled trial evaluating the impact of a nurse-led
      transition intervention in combination with usual care, versus usual care alone, on preparing
      adolescents with congenital heart disease (CHD) to successfully transition from pediatric to
      adult cardiology care. The Canadian Pediatric Society and American Academy of Pediatrics have
      recommended that transition interventions begin in early adolescence. Therefore, the
      investigators propose to conduct a nurse-led intervention that addresses the educational
      needs of 13-14 year olds.
    

Detailed description: 
      BACKGROUND:

      The numbers of youth and young adults with congenital heart disease (CHD) is rapidly
      increasing, yet youth, parents, and health care providers (HCPs) are unprepared to manage the
      health care transition from pediatric to adult cardiology care. Both youth and parents report
      significant anxiety regarding the transition process. When transition is not managed well,
      youth may not engage with adult HCPs,which may lead to late detection of new problems,excess
      morbidity, and diminished quality of life.This speaks to the urgency of addressing clinical
      and health services research gaps, which leave affected youth, families, HCPs, and policy
      makers with insufficient evidence for transition program delivery.

      OBJECTIVE:

      The primary aim is to determine the impact of a nurse-led transition intervention in
      combination with usual care, compared to usual care alone, on self-management and
      self-advocacy skills among 13-14 year olds with moderate or complex CHD using a validated
      instrument. [Hypothesis: the transition intervention will result in superior self-management
      and self-advocacy skills compared to usual care alone]. The secondary aim is to determine
      knowledge of their CHD lesion [Hypothesis: the transition intervention will result in
      superior knowledge of the CHD lesion compared to usual care alone].

      METHODS:

      Study Participants

      Inclusion criteria: 13-14 year olds with moderate or complex CHD (as previously defined)who
      are followed at the Stollery Children's Hospital (Edmonton).

      Exclusion criteria: (i) less than a Grade 6 level of reading and comprehension, based on
      parent report; (ii) heart transplantation, as this results in distinct health challenges.

      STUDY DESIGN:

      Subjects will be randomized by clusters defined by week of attendance in the pediatric
      cardiology clinic. Because week is the unit of randomization and not the study subject, this
      is a cluster randomization design. We anticipate 1-2 subjects per week will be enrolled per
      site, i.e. the cluster size will be ≤ 2.

      INTERVENTIONS:

      This intervention will be conducted by a cardiology nurse who is experienced working with
      teens and will a one-on-one sessions approximately 60 minutes in length. Sessions will be
      youth-oriented, interactive, and engaging. This session will be held in conjunction with a
      scheduled pediatric cardiology clinic visit. This timing minimizes the study burden and is
      consistent with Canadian Pediatric Society recommendations that transition interventions be
      delivered in clinical settings. Individual sessions, in contrast to group sessions, allow the
      intervention content to be patient-specific. Immediately prior to the session, the RN will
      review the cardiology chart to familiarize them self with the cardiac history including
      cardiac diagnoses, names and dates of cardiac surgical procedures and cardiac
      catheterizations, and current cardiac medications and doses.

      The one-on-one session will combine Education and an introduction of Self-Management. It will
      involve an introduction to transition and its importance, a discussion of confidentiality to
      promote trust with the RN, the creation of a MyHealth passport, review of diagram
      illustrating the teen's cardiac anatomy, the introduction to websites of the Sick Kids
      Good2Go program, and the youth-oriented YoungAndHealthy, the introduce youth-friendly written
      materials about risk-taking behaviours, a review of videos of good and bad interactions with
      a health care provider and encouragement to contact the RN at a study email address or by
      text messaging with follow-up questions..

      STUDY PROCEDURE:

      Potential study participants will be approached in the Stollery Children's Hospital
      Cardiology clinic. A trained project coordinator will approach subjects on both
      "intervention" days and "usual care" days. The nature and purpose of the study will be
      explained and informed consent sought from the teen's parent(s)/guardian(s).

      MEASURES:

        1. The TRANSITION-Q score is a Canadian created, generic self-management skills scale for
           use with adolescents diagnosed with a chronic health condition who are aged 12 to 18
           years. The content of the scale was designed to include a range of skills that vary from
           those that even young adolescents should be able to do (e.g. answer a doctor's or
           nurse's questions) to skills that may require instruction or training (e.g. book an
           appointment).consists of a knowledge scale and behavior index that reports on the youths
           health and self-care related knowledge and behavior.

        2. Knowledge of the cardiac condition will be measured with the MyHeart Scale.

        3. Chart review: Descriptive data collected from the cardiology chart will be: date of
           birth, CHD diagnosis, names and dates of cardiac surgical procedures and cardiac
           catheterizations, current use of cardiac medications (Y/N), history of missed
           appointments (Y/N), and cardiologist's name.

      Youth will complete the MyHeart Scale and the TRANSITION-Q Questionnaire in the clinic area
      at enrollment for the "usual care" group, and prior to intervention for the "intervention"
      group. Both groups will repeat the questionnaires 1 month and 6 months post enrollment.
    

Intervention name(s): CHAPTER III Study Intervention
Intervention type(s): Behavioral
Intervention description(s): This will involve a 60 minute interaction between the adolescent and a cardiology nurse. A MyHealth passport will be created covering the name of the adolescents' cardiac condition, previous cardiac interventions, and name and purpose of the teen's medications. Potential late cardiac complications will be discussed. The adolescent and nurse will watch videos on talking to various health professionals. The adolescent will be given a study email address and encouraged to contact the nurse by email or text messaging with follow-up
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Intervention; Congenital Heart Disease; Adolescent; Education; Self-management