Congenital Heart Adolescents: Program of Transition Evaluation Research (CHAPTER)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Novel Transition Interventions for Youth With Congenital Heart Disease|
- Change in the Transition Readiness Assessment Questionnaire (TRAQ) score of the patient between baseline and medium-term follow-up (6 months). [ Time Frame: 6 months. ] [ Designated as safety issue: No ]
- Change in the Patient Satisfaction Questionnaire (PSQ-18) score of the patient between baseline and 1 month and 6 months follow-up [ Time Frame: 1 month and 6 months ] [ Designated as safety issue: No ]
- Change in the parent/guardian Patient Satisfaction Questionnaire (PSQ-18) score between baseline and 1 month and 6 months follow-up as it pertains to their satisfaction with their adolescent's care. [ Time Frame: 1 month and 6 months ] [ Designated as safety issue: No ]
- Change in patient knowledge of his/her CHD (MyHeart score), comparing baseline to 1 month and 6 months follow-up. [ Time Frame: 1 month and 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||December 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
|Experimental: Clinic-based Educational 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.
No Intervention: Usual Care
Youth 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. Time-pressured clinic visits limit the opportunity to discuss many of the topics noted above.
|Stollery Children's Hospital|
|Edmonton, Alberta, Canada, T6G 2B7|
|Principal Investigator:||Andrew S Mackie, MD, SM||University of Alberta|