Clinical trial NCT01286480: Congenital Heart Adolescents: Program of Transition Evaluation Research
Official title: Evaluation of Novel Transition Interventions for Youth With Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Defects
Keywords: Health Care Transition
Adolescent
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Women and Children's Health Research Institute, Canada
name: Stollery Children's Hospital Foundation
First posted: 2011-01-31
Enrollment: 66
Sex: ALL
Minimum age (years): 15
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Transition Readiness Assessment Questionnaire (TRAQ) Score
timeFrame: Baseline, 1 month and 6 months
Secondary outcomes:
measure: MyHeart Score
timeFrame: Baseline, 1 month and 6 months
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Andrew S Mackie, MD, SM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sawicki GS, Lukens-Bull K, Yin X, Demars N, Huang IC, Livingood W, Reiss J, Wood D. Measuring the transition readiness of youth with special healthcare needs: validation of the TRAQ--Transition Readiness Assessment Questionnaire. J Pediatr Psychol. 2011 Mar;36(2):160-71. doi: 10.1093/jpepsy/jsp128. Epub 2009 Dec 29.
citation: Warnes CA, Liberthson R, Danielson GK, Dore A, Harris L, Hoffman JI, Somerville J, Williams RG, Webb GD. Task force 1: the changing profile of congenital heart disease in adult life. J Am Coll Cardiol. 2001 Apr;37(5):1170-5. doi: 10.1016/s0735-1097(01)01272-4. No abstract available.
citation: 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.