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

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01723332
• Other study ID #: CHAPTER II
• Status: Completed
• Phase: N/A
• First received: November 5, 2012
• Last updated: October 31, 2017
• Start date: November 2012
• Est. completion date: December 1, 2016

Study information

• Verified date: October 2017
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 1, 2016
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 17 Years

Eligibility

Inclusion Criteria:

• 16 and 17 year olds with moderate or complex CHD

Exclusion Criteria:

• Significant developmental delay

• Previous heart transplantation

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Diseases

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.
• 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.

Locations

Country	Name	City	State
Canada	Stollery Children's Hospital	Edmonton	Alberta
Canada	Hospital For Sick Children	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Heart and Stroke Foundation of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Excess time to first ACHD clinic appointment.		12 - 24 months post enrolment
Secondary	Change in adolescent knowledge of their condition.		6 - 18 months post enrolment
Secondary	Change in adolescent's self-management and self-advocacy skills/		6 - 18 months post enrolment