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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Heart and Stroke Foundation of Canada
Information provided by (Responsible Party):
Andrew Mackie, University of Alberta
ClinicalTrials.gov Identifier:
NCT01723332
First received: November 5, 2012
Last updated: June 18, 2014
Last verified: June 2014

November 5, 2012
June 18, 2014
November 2012
November 2014   (final data collection date for primary outcome measure)
Excess time to first ACHD clinic appointment. [ Time Frame: 12 - 24 months post enrolment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01723332 on ClinicalTrials.gov Archive Site
  • Change in adolescent knowledge of their condition. [ Time Frame: 6 - 18 months post enrolment ] [ Designated as safety issue: No ]
  • Change in adolescent's self-management and self-advocacy skills/ [ Time Frame: 6 - 18 months post enrolment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The CHAPTER II Study - Congenital Heart Adolescents Participating in Transition Evaluation Research
The CHAPTER II Study - Congenital Heart Adolescents Participating in Transition Evaluation Research

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Congenital Heart Disease
  • Behavioral: Educational

    The first interaction will happen at study enrolment and will be educational in nature.

    Following the session, the nurse will follow up with the participant to discuss any questions.

  • Behavioral: Self management

    The second interaction will take place 2 months after enrollment and will focus on self management and communication skills.

    Following the session, the nurse will follow up with the participant to discuss any questions.

  • Experimental: Intervention
    Clinical based educational and self management intervention.
    Interventions:
    • Behavioral: Educational
    • Behavioral: Self management
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
April 2016
November 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 16 and 17 year olds with moderate or complex CHD

Exclusion Criteria:

  • Significant developmental delay
  • Previous heart transplantation
Both
16 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01723332
CHAPTER II
No
Andrew Mackie, University of Alberta
University of Alberta
Heart and Stroke Foundation of Canada
Principal Investigator: Andrew S Mackie, MD, SM University of Alberta
University of Alberta
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP