A cluster randomized trial of a transition intervention for adolescents with congenital heart disease: rationale and design of the CHAPTER 2 study.
The population of adolescents and young adults with congenital heart disease (CHD) is growing exponentially. These survivors are at risk of late cardiac complications and require lifelong cardiology care. However, there is a paucity of data on how to prepare adolescents to assume responsibility for their health and function within the adult health care system. Evidence-based transition strategies are required.



The Congenital Heart Adolescents Participating in Transition Evaluation Research (CHAPTER 2) Study is a two-site cluster randomized clinical trial designed to evaluate the efficacy of a nurse-led transition intervention for 16-17 year olds with moderate or complex CHD. The primary endpoint is excess time to adult CHD care, defined as the time interval between the final pediatric cardiology appointment and the first adult CHD appointment, minus the recommended time interval between these appointments. Secondary endpoints include the MyHeart score (CHD knowledge), Transition Readiness Assessment Questionnaire score, and need for catheter or surgical re-intervention. Participants are enrolled in clusters based on week of attendance in the pediatric cardiology clinic. The intervention consists of two one-hour individualized sessions between a cardiology nurse and study participant. Session One focuses on knowledge of the participant's CHD, review of their cardiac anatomy and prior interventions, and potential late cardiac complications. Session Two focuses on self-management and communication skills through review and discussion of videos and role-play. The study will recruit 120 participants.



Many adolescents and young adults experience a gap in care predisposing them to late cardiac complications. The CHAPTER 2 Study will investigate the impact of a nurse-led transition intervention among adolescents with CHD. Fidelity of the intervention is a major focus and priority. This study will build on our experience by (i) enrolling at two tertiary care programs, (ii) including a self-management intervention component, and (iii) evaluating the impact of the intervention on time to ACHD care, a clinically relevant outcome. The results of this study will inform pediatric cardiology programs, patients and policy makers in judging whether a structured intervention program provides clinically meaningful outcomes for adolescents and young adults living with CHD.



ClinicalTrials.gov ID NCT01723332.
Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada. andrew.mackie@ualberta.ca.|Division of Cardiology, Stollery Children's Hospital, 4C2 Walter C. Mackenzie Center, 8440-112th St. NW, Edmonton, Alberta, T6G 2B7, Canada. andrew.mackie@ualberta.ca.
Andrew S
AS
Mackie
Athabasca University, Athabasca, Alberta, Canada.
Gwen R
GR
Rempel
University Health Network, Peter Munk Cardiac Centre, Toronto Congenital Cardiac Centre for Adults, and University of Toronto, Toronto, Ontario, Canada.
Adrienne H
AH
Kovacs
The Hospital for Sick Children, Toronto, Ontario, Canada.|Department of Pediatrics, University of Toronto, Toronto, Ontario, Canada.
Miriam
M
Kaufman
Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada.
Kathryn N
KN
Rankin
The Hospital for Sick Children, Toronto, Ontario, Canada.
Ahlexxi
A
Jelen
The Hospital for Sick Children, Toronto, Ontario, Canada.
Cedric
C
Manlhiot
The Hospital for Sick Children, Toronto, Ontario, Canada.
Samantha J
SJ
Anthony
Faculty of Rehabilitation Medicine, University of Alberta, Edmonton, Alberta, Canada.
Joyce
J
Magill-Evans
Faculty of Social Work, University of Calgary, Calgary, Alberta, Canada.
David
D
Nicholas
The Hospital for Sick Children, Toronto, Ontario, Canada.
Renee
R
Sananes
University Health Network, Peter Munk Cardiac Centre, Toronto Congenital Cardiac Centre for Adults, and University of Toronto, Toronto, Ontario, Canada.
Erwin
E
Oechslin
The Hospital for Sick Children, Toronto, Ontario, Canada.
Dimi
D
Dragieva
The Hospital for Sick Children, Toronto, Ontario, Canada.
Sonila
S
Mustafa
Division of Cardiology, Stollery Children's Hospital, 4C2 Walter C. Mackenzie Center, 8440-112th St. NW, Edmonton, Alberta, T6G 2B7, Canada.
Elina
E
Williams
Division of Cardiology, Stollery Children's Hospital, 4C2 Walter C. Mackenzie Center, 8440-112th St. NW, Edmonton, Alberta, T6G 2B7, Canada.
Michelle
M
Schuh
The Hospital for Sick Children, Toronto, Ontario, Canada.|Department of Pediatrics, University of Toronto, Toronto, Ontario, Canada.
Brian W
BW
McCrindle
D000293:Adolescent; D000328:Adult; D019468:Disease Management; D005260:Female; D006330:Heart Defects, Congenital / Q000451:nursing / Q000628:therapy*; D006801:Humans; D008297:Male; D011795:Surveys and Questionnaires; D060305:Transition to Adult Care; D055815:Young Adult
Adolescents; Clinical trial; Congenital heart disease; Continuity of care; Education; Transition