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

Not Applicable

Completed

• Conditions: Congenital Heart Disease
• Interventions: Behavioral: Educational; Behavioral: Self management

• Registration Number: NCT01723332
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-05
• Study First Submitted QC: 2012-11-06
• Study First Posted: 2012-11-07
• Primary Completion: 2016-12-01
• Study Completion: 2016-12-01
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-31
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 16 and 17 year olds with moderate or complex CHD

Exclusion Criteria

• Significant developmental delay
• Previous heart transplantation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Educational	Clinical based educational and self management intervention.
Intervention	Self management	Clinical based educational and self management intervention.

Primary Outcome Measures

Name	Time	Method
Excess time to first ACHD clinic appointment.	12 - 24 months post enrolment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Stollery Children's Hospital; 🇨🇦 Edmonton, Alberta, Canada

Hospital For Sick Children; 🇨🇦 Toronto, Ontario, Canada