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Congenital Heart Adolescents: Program of Transition Evaluation Research (CHAPTER)

This study has been completed.
Women and Children's Health Research Institute, Canada
Stollery Children's Hospital Foundation
Information provided by (Responsible Party):
Andrew Mackie, University of Alberta Identifier:
First received: January 27, 2011
Last updated: October 24, 2016
Last verified: October 2016
The objective of this study is to evaluate the potential role of a cardiology clinic-based educational intervention for 15 to 17 year olds with congenital heart disease (CHD) and their parents, and to determine whether this intervention results in improved self-management skills (e.g., renewing medication prescriptions), teens having greater knowledge of their heart condition, and more teen and parent satisfaction with services. The results of this study will form the basis for a website that in turn may serve as an additional means of providing transition interventions. The results of this study may also be applicable to youth with other special health care needs.

Condition Intervention
Congenital Heart Defects
Behavioral: Clinic-based Educational Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Novel Transition Interventions for Youth With Congenital Heart Disease

Further study details as provided by Andrew Mackie, University of Alberta:

Primary Outcome Measures:
  • Change in the Transition Readiness Assessment Questionnaire (TRAQ) score of the patient between baseline and medium-term follow-up (6 months). [ Time Frame: 6 months. ]

Secondary Outcome Measures:
  • Change in the Patient Satisfaction Questionnaire (PSQ-18) score of the patient between baseline and 1 month and 6 months follow-up [ Time Frame: 1 month and 6 months ]
  • Change in the parent/guardian Patient Satisfaction Questionnaire (PSQ-18) score between baseline and 1 month and 6 months follow-up as it pertains to their satisfaction with their adolescent's care. [ Time Frame: 1 month and 6 months ]
  • Change in patient knowledge of his/her CHD (MyHeart score), comparing baseline to 1 month and 6 months follow-up. [ Time Frame: 1 month and 6 months ]

Enrollment: 58
Study Start Date: January 2011
Study Completion Date: December 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clinic-based Educational Intervention Behavioral: Clinic-based Educational Intervention
This will involve a 60 minute interaction between the teen and an advanced practice nurse (APN) in the cardiology clinic. A MyHealth passport will be created covering the name of the teen's cardiac condition, previous cardiac interventions, and name and purpose of the teen's medications. Potential late cardiac complications and contact names and location of local adult CHD cardiologists will also be reviewed. Three scenarios regarding adolescent risk taking behaviors (written in the 3rd person) will be presented to the teen who will be asked what advice he/she would offer to the teen in each of those scenarios. The teen will be given a study email address and encouraged to contact the APN by email or text messaging with follow-up questions. If no contact is initiated after 1 week, the APN will email or text (based on preference) the youth, to discuss additional questions.
No Intervention: Usual Care
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. Time-pressured clinic visits limit the opportunity to discuss many of the topics noted above.


Ages Eligible for Study:   15 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 15-17
  • Followed in the Stollery Pediatric Cardiology Clinic or the Northern Alberta Adult Congenital (NAACH) clinic
  • Moderate or Complex Congenital Heart Disease (as defined by the 2001 Bethesda guidelines) or Acquired Heart Disease (cardiomyopathy (dilated, hypertrophic, or restrictive forms), Marfan's syndrome or rheumatic heart disease with cardiac involvement)

Exclusion Criteria:

  • Developmental Delay, reading level below grade 6 based on patient or parent report
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01286480

Canada, Alberta
Stollery Children's Hospital
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
Women and Children's Health Research Institute, Canada
Stollery Children's Hospital Foundation
Principal Investigator: Andrew S Mackie, MD, SM University of Alberta