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

Study Overview
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Brief Summary
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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.

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

Conditions
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Congenital Heart Disease

Intervention / Treatment
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* Behavioral: Educational
* Behavioral: Self management


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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Clinical based educational and self management intervention. | Behavioral: Educational<br>* 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.<br>Behavioral: Self management<br>* 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.<br>|
| No Intervention: Usual Care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Excess time to first ACHD clinic appointment. |  | 12 - 24 months post enrolment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transition from pediatric to adult clinical care