Congenital Heart Adolescents: Program of Transition Evaluation Research

Congenital Heart Defects Clinical Trial

— CHAPTER  

Official title:

Evaluation of Novel Transition Interventions for Youth With Congenital Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01286480
• Other study ID #: AM-Chapter-01
• Status: Completed
• Phase: N/A
• First received: January 27, 2011
• Last updated: June 23, 2017
• Start date: January 2011
• Est. completion date: December 2013

Study information

• Verified date: June 2017
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Defects
• Heart Defects, Congenital

Intervention

Behavioral:
• Clinic-based Educational Intervention
This will involve a 60 minute interaction between the teen and an advanced practice nurse (APN) in the cardiology clinic. A MyHealth passport will be created covering the name of the teen's cardiac condition, previous cardiac interventions, and name and purpose of the teen's medications. Potential late cardiac complications and contact names and location of local adult CHD cardiologists will also be reviewed. Three scenarios regarding adolescent risk taking behaviors (written in the 3rd person) will be presented to the teen who will be asked what advice he/she would offer to the teen in each of those scenarios. The teen will be given a study email address and encouraged to contact the APN by email or text messaging with follow-up questions. If no contact is initiated after 1 week, the APN will email or text (based on preference) the youth, to discuss additional questions.

Locations

Country	Name	City	State
Canada	Stollery Children's Hospital	Edmonton	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
University of Alberta	Stollery Children's Hospital Foundation, Women and Children's Health Research Institute, Canada

Country where clinical trial is conducted

Canada, 

References & 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-201 — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transition Readiness Assessment Questionnaire (TRAQ) Score	The TRAQ is the most rigorously evaluated transition readiness questionnaire available and was developed in the USA. It has 29 items with two domains, self-management (16 items) and self-advocacy (13 ). The TRAQ is at a grade 5.7 reading level and uses a Likert scale. Each item is scored 1-5, with 1 being assigned for responses of "No, I do not know how" and a score of 5 assigned for responses of "Yes, I always do this when I need to." The TRAQ scores produced include an overall score and a subscale score. The overall score and the subscale scores are calculated simply by taking the average score across the items in the questionnaire (or subscale). The higher the score, the greater the perceived self-management or self-advocacy skills of the participant. The lower scores indicate the participant has a lower perceived level of self-management or self-advocacy.	Baseline, 1 month and 6 months
Secondary	MyHeart Score	Change in patient knowledge of his/her CHD (MyHeart score), comparing baseline to 1 month and 6 months follow-up. The MyHeart scale was developed for this study and has a grade 4.6 reading level. It consists of seven short answer or multiple-choice questions. Given the heterogeneity of prior medical and surgical interventions and need for medications in adolescents with heart disease, the denominator for some questions varied from one participant to the next. Accordingly, each participant was assigned a percentage correct score (numerator/denominator×100) at each time point. Higher percentage correct score reflects better patient knowledge of his/her CHD	Baseline, 1 month and 6 months