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Clinical Trials/NCT01723332
NCT01723332
Completed
Not Applicable

The CHAPTER II Study - Congenital Heart Adolescents Participating in Transition Evaluation Research

University of Alberta2 sites in 1 country120 target enrollmentNovember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Heart Disease
Sponsor
University of Alberta
Enrollment
120
Locations
2
Primary Endpoint
Excess time to first ACHD clinic appointment.
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

Transition is the planned movement of teens with chronic conditions from child-centered to adult-oriented healthcare. National bodies have published detailed guidelines about the importance of helping teens move to adult healthcare. However, there is no research regarding how to best organize and deliver Congenital Heart Disease (CHD) transition programs. Data is urgently needed. Therefore, the aim of this program is to develop research evidence that will better prepare health care providers to improve how they can help adolescents with transition.

This project will determine whether a nurse-led transition intervention program is better at preparing teens with CHD to independently manage their medical care, compared to the care that is currently provided. The most important finding of this study will be whether or not these teens subsequently attend the adult cardiology clinic that specializes in CHD problems, and the timing of when they attend.

Hypothesis: A transition intervention in combination with usual care, improved time to first Adult Congenital Heart Disease (ACHD) clinic attendance compared to usual care alone.

Registry
clinicaltrials.gov
Start Date
November 2012
End Date
December 1, 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Andrew Mackie

Associate Professor

University of Alberta

Eligibility Criteria

Inclusion Criteria

  • 16 and 17 year olds with moderate or complex CHD

Exclusion Criteria

  • Significant developmental delay
  • Previous heart transplantation

Outcomes

Primary Outcomes

Excess time to first ACHD clinic appointment.

Time Frame: 12 - 24 months post enrolment

Secondary Outcomes

  • Change in adolescent knowledge of their condition.(6 - 18 months post enrolment)
  • Change in adolescent's self-management and self-advocacy skills/(6 - 18 months post enrolment)

Study Sites (2)

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