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
  Purpose

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.


Condition Intervention
Congenital Heart Disease
Behavioral: Educational
Behavioral: Self management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The CHAPTER II Study - Congenital Heart Adolescents Participating in Transition Evaluation Research

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Excess time to first ACHD clinic appointment. [ Time Frame: 12 - 24 months post enrolment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: November 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Clinical based educational and self management intervention.
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.

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.

  Eligibility

Ages Eligible for Study:   16 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 16 and 17 year olds with moderate or complex CHD

Exclusion Criteria:

  • Significant developmental delay
  • Previous heart transplantation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01723332

Locations
Canada, Alberta
Stollery Children's Hospital
Edmonton, Alberta, Canada, T6G 2B7
Canada, Ontario
Hospital For Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
University of Alberta
Heart and Stroke Foundation of Canada
Investigators
Principal Investigator: Andrew S Mackie, MD, SM University of Alberta
  More Information

No publications provided

Responsible Party: Andrew Mackie, Associate Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT01723332     History of Changes
Other Study ID Numbers: CHAPTER II
Study First Received: November 5, 2012
Last Updated: June 18, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
Transition from pediatric to adult clinical care

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

ClinicalTrials.gov processed this record on July 24, 2014