COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu
Trial record 1 of 1 for:    NCT01723332
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01723332
Recruitment Status : Completed
First Posted : November 7, 2012
Last Update Posted : November 6, 2017
Heart and Stroke Foundation of Canada
Information provided by (Responsible Party):
Andrew Mackie, University of Alberta

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.

Condition or disease Intervention/treatment Phase
Congenital Heart Disease Behavioral: Educational Behavioral: Self management Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The CHAPTER II Study - Congenital Heart Adolescents Participating in Transition Evaluation Research
Study Start Date : November 2012
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : December 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Excess time to first ACHD clinic appointment. [ Time Frame: 12 - 24 months post enrolment ]

Secondary Outcome Measures :
  1. Change in adolescent knowledge of their condition. [ Time Frame: 6 - 18 months post enrolment ]
  2. Change in adolescent's self-management and self-advocacy skills/ [ Time Frame: 6 - 18 months post enrolment ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   16 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 16 and 17 year olds with moderate or complex CHD

Exclusion Criteria:

  • Significant developmental delay
  • Previous heart transplantation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01723332

Layout table for location information
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
Layout table for investigator information
Principal Investigator: Andrew S Mackie, MD, SM University of Alberta
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Andrew Mackie, Associate Professor, University of Alberta Identifier: NCT01723332    
Other Study ID Numbers: CHAPTER II
First Posted: November 7, 2012    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017
Keywords provided by Andrew Mackie, University of Alberta:
Transition from pediatric to adult clinical care
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Cardiovascular Diseases