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

University of Alberta

Status: Completed

Conditions: Congenital Heart Disease

Treatments: Behavioral: Self management; Behavioral: Educational

Study type: Interventional

Funder types: Other

Identifiers

NCT01723332

CHAPTER II

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 16 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 16 and 17 year olds with moderate or complex CHD

Exclusion criteria

• Significant developmental delay
• Previous heart transplantation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Intervention

Experimental group

Description:

Clinical based educational and self management intervention.

Treatment:

Behavioral: Educational

Behavioral: Self management

Usual Care

No Intervention group

Description:

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.