Overview

This trial is active, not recruiting.

Condition congenital heart disease
Treatments educational, self management
Sponsor University of Alberta
Collaborator Heart and Stroke Foundation of Canada
Start date November 2012
End date April 2017
Trial size 120 participants
Trial identifier NCT01723332, CHAPTER II

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Clinical based educational and self management intervention.
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.
(No Intervention)
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 Outcomes

Measure
Excess time to first ACHD clinic appointment.
time frame: 12 - 24 months post enrolment

Secondary Outcomes

Measure
Change in adolescent knowledge of their condition.
time frame: 6 - 18 months post enrolment
Change in adolescent's self-management and self-advocacy skills/
time frame: 6 - 18 months post enrolment

Eligibility Criteria

Male or female participants from 16 years up to 17 years old.

Inclusion Criteria: - 16 and 17 year olds with moderate or complex CHD Exclusion Criteria: - Significant developmental delay - Previous heart transplantation

Additional Information

Official title The CHAPTER II Study - Congenital Heart Adolescents Participating in Transition Evaluation Research
Principal investigator Andrew S Mackie, MD, SM
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of Alberta.