The CHAPTER III Study of Young Adolescents
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2015
Longer than P75 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
February 23, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedFirst Posted
Study publicly available on registry
March 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedApril 25, 2019
April 1, 2019
3.8 years
February 23, 2015
April 24, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
TRANSITION-Q Questionnaires
Change in TRANSITION-Q Questionnaire score between baseline, 1 month, and 6-months post enrollment.
6 Months
Secondary Outcomes (1)
MyHeart Scale
6 Months
Study Arms (2)
Intervention
EXPERIMENTALAdolescents will attend a single one-on-one session with a nurse. Sessions will be youth-oriented, interactive, and engaging. They will make a health passport, go over their cardiac anatomy, watch videos among other things. The adolescent will be given a study email address and encouraged to contact the nurse by email or text messaging with follow-up.
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
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
Eligibility Criteria
You may qualify if:
- (i) moderate or complex CHD (as defined by the 2001 Bethesda Guidelines) (ii) followed at the Stollery Children's Hospital
You may not qualify if:
- (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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stollery Children's Hospital
Edmonton, Alberta, T6G 2B7, Canada
Related Publications (3)
Mackie AS, Islam S, Magill-Evans J, Rankin KN, Robert C, Schuh M, Nicholas D, Vonder Muhll I, McCrindle BW, Yasui Y, Rempel GR. Healthcare transition for youth with heart disease: a clinical trial. Heart. 2014 Jul;100(14):1113-8. doi: 10.1136/heartjnl-2014-305748. Epub 2014 May 19.
PMID: 24842870BACKGROUNDKlassen AF, Grant C, Barr R, Brill H, Kraus de Camargo O, Ronen GM, Samaan MC, Mondal T, Cano SJ, Schlatman A, Tsangaris E, Athale U, Wickert N, Gorter JW. Development and validation of a generic scale for use in transition programmes to measure self-management skills in adolescents with chronic health conditions: the TRANSITION-Q. Child Care Health Dev. 2015 Jul;41(4):547-58. doi: 10.1111/cch.12207. Epub 2014 Oct 28.
PMID: 25351414BACKGROUNDMackie AS, Rankin KN, Yaskina M, Gingrich J, Williams E, Schuh M, Kovacs AH, McCrindle BW, Nicholas D, Rempel GR. Transition Preparation for Young Adolescents with Congenital Heart Disease: A Clinical Trial. J Pediatr. 2022 Feb;241:36-41.e2. doi: 10.1016/j.jpeds.2021.09.053. Epub 2021 Oct 4.
PMID: 34619115DERIVED
MeSH Terms
Conditions
Condition 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
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2015
First Posted
March 2, 2015
Study Start
March 1, 2015
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
April 25, 2019
Record last verified: 2019-04