The CHAPTER II Study - Congenital Heart Adolescents Participating in Transition Evaluation Research
1 other identifier
interventional
120
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2012
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 5, 2012
CompletedFirst Posted
Study publicly available on registry
November 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedNovember 6, 2017
October 1, 2017
4.1 years
November 5, 2012
October 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Excess time to first ACHD clinic appointment.
12 - 24 months post enrolment
Secondary Outcomes (2)
Change in adolescent knowledge of their condition.
6 - 18 months post enrolment
Change in adolescent's self-management and self-advocacy skills/
6 - 18 months post enrolment
Study Arms (2)
Intervention
EXPERIMENTALClinical based educational and self management intervention.
Usual Care
NO INTERVENTIONYouth 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.
Interventions
The first interaction will happen at study enrolment and will be educational in nature. Following the session, the nurse will follow up with the participant to discuss any questions.
The second interaction will take place 2 months after enrollment and will focus on self management and communication skills. Following the session, the nurse will follow up with the participant to discuss any questions.
Eligibility Criteria
You may qualify if:
- and 17 year olds with moderate or complex CHD
You may not qualify if:
- Significant developmental delay
- Previous heart transplantation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Albertalead
- Heart and Stroke Foundation of Canadacollaborator
Study Sites (2)
Stollery Children's Hospital
Edmonton, Alberta, T6G 2B7, Canada
Hospital For Sick Children
Toronto, Ontario, M5G 1X8, Canada
Related Publications (2)
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.
PMID: 29673467DERIVEDMackie 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.
PMID: 27266868DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew S Mackie, MD, SM
University of Alberta
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 5, 2012
First Posted
November 7, 2012
Study Start
November 1, 2012
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
November 6, 2017
Record last verified: 2017-10