N/A N=66 Randomized Single-blind Treatment

Congenital Heart Adolescents: Program of Transition Evaluation Research

Congenital Heart Defects

Bottom Line

View on ClinicalTrials.gov: NCT01286480 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2017

Primary outcome: Primary: Transition Readiness Assessment Questionnaire (TRAQ) Score — 2.77; 2.95; 3.80; 3.92 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Clinic-based Educational Intervention (Behavioral)
Age: Pediatric · 15+ yrs
Sex: All
Sponsor: University of Alberta
Primary completion: Nov 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Transition Readiness Assessment Questionnaire (TRAQ) Score	2.77; 2.95; 3.80; 3.92; 3.12; 3.08	—
SECONDARY MyHeart Score	57; 58; 74; 61; 75; 61	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01286480). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.