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Congenital Heart Adolescents: Program of Transition Evaluation Research (CHAPTER)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Women and Children's Health Research Institute, Canada
Stollery Children's Hospital Foundation
Information provided by (Responsible Party):
Andrew Mackie, University of Alberta
ClinicalTrials.gov Identifier:
NCT01286480
First received: January 27, 2011
Last updated: August 23, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention
Congenital Heart Defects
 Behavioral: Clinic-based Educational Intervention

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: January 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   15 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01286480

Locations
Canada, Alberta
Stollery Children's Hospital
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
Women and Children's Health Research Institute, Canada
Stollery Children's Hospital Foundation
Investigators
Principal Investigator: Andrew S Mackie, MD, SM University of Alberta
  More Information

Publications:

Responsible Party: Andrew Mackie, Principal Investigator, University of Alberta
ClinicalTrials.gov Identifier: NCT01286480     History of Changes
Other Study ID Numbers: AM-Chapter-01
Study First Received: January 27, 2011
Last Updated: August 23, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
Health Care Transition
Adolescent

Additional relevant MeSH terms:
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on May 16, 2013