Clinical trial NCT01723332: The CHAPTER II Study - Congenital Heart Adolescents Participating in Transition Evaluation Research
Official title: The CHAPTER II Study - Congenital Heart Adolescents Participating in Transition Evaluation Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Keywords: Transition from pediatric to adult clinical care
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Canada
First posted: 2012-11-07
Enrollment: 120
Sex: ALL
Minimum age (years): 16
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Transition is the planned movement of teens with chronic conditions from child-centered to adult-oriented healthcare. National bodies have published detailed guidelines about the importance of helping teens move to adult healthcare. However, there is no research regarding how to best organize and deliver Congenital Heart Disease (CHD) transition programs. Data is urgently needed. Therefore, the aim of this program is to develop research evidence that will better prepare health care providers to improve how they can help adolescents with transition.

This project will determine whether a nurse-led transition intervention program is better at preparing teens with CHD to independently manage their medical care, compared to the care that is currently provided. The most important finding of this study will be whether or not these teens subsequently attend the adult cardiology clinic that specializes in CHD problems, and the timing of when they attend.

Hypothesis: A transition intervention in combination with usual care, improved time to first Adult Congenital Heart Disease (ACHD) clinic attendance compared to usual care alone.


Eligibility criteria: Inclusion Criteria:

* 16 and 17 year olds with moderate or complex CHD

Exclusion Criteria:

* Significant developmental delay
* Previous heart transplantation

Primary outcomes:
measure: Excess time to first ACHD clinic appointment.
timeFrame: 12 - 24 months post enrolment
Secondary outcomes:
measure: Change in adolescent knowledge of their condition.
timeFrame: 6 - 18 months post enrolment
measure: Change in adolescent's self-management and self-advocacy skills/
timeFrame: 6 - 18 months post enrolment
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
city: Toronto
country: Canada
facility: Hospital For Sick Children
state: Ontario
Study officials:
affiliation: University of Alberta
name: Andrew S Mackie, MD, SM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mackie AS, Rempel GR, Kovacs AH, Kaufman M, Rankin KN, Jelen A, Yaskina M, Sananes R, Oechslin E, Dragieva D, Mustafa S, Williams E, Schuh M, Manlhiot C, Anthony SJ, Magill-Evans J, Nicholas D, McCrindle BW. Transition Intervention for Adolescents With Congenital Heart Disease. J Am Coll Cardiol. 2018 Apr 24;71(16):1768-1777. doi: 10.1016/j.jacc.2018.02.043.
citation: Mackie AS, Rempel GR, Kovacs AH, Kaufman M, Rankin KN, Jelen A, Manlhiot C, Anthony SJ, Magill-Evans J, Nicholas D, Sananes R, Oechslin E, Dragieva D, Mustafa S, Williams E, Schuh M, McCrindle BW. A cluster randomized trial of a transition intervention for adolescents with congenital heart disease: rationale and design of the CHAPTER 2 study. BMC Cardiovasc Disord. 2016 Jun 6;16:127. doi: 10.1186/s12872-016-0307-2.