Peer Coaching Intervention in Young Adults With Congenital Heart Disease

Study Overview
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Brief Summary
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The purpose of the study is to evaluate a peer coaching intervention in young adults with congenital heart disease.

Detailed Description
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Our research team has developed a peer coaching intervention that has been deployed to promote activated self-management for AYAs with several conditions, and this has been modified adolescents and young adults (AYA) with with congenital heart disease (CHD). This study will be conducted over two years and pair AYA with CHD with a peer coach who also has CHD has successfully navigated the transition to adult medical care and over six months will work to promote the motivation for self-care as well as the development of self-management skills. This pilot study will test feasibility and acceptability, as well as preliminary efficacy and long-term effects on successful transfer to adult cardiology.

Official Title
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Peer Coaching Adaptive Self-Management Interventions for Young Adults With Congenital Heart Disease

Conditions
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Congenital Heart Disease, Congenital Heart Defect

Intervention / Treatment
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* Behavioral: Peer Health Coaching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-26 Diagnosis of congenital heart disease Patient at a Duke pediatric cardiology clinic Access to a smart phone Exclusion Criteria: Cognitive delay Patient at an adult cardiology clinic

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 26 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Once enrolled, participants will be randomly assigned to the intervention or control group (1:1 ratio)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peer Coaching<br>Participant receive a 6 month peer health coaching intervention. | Behavioral: Peer Health Coaching<br>* The Peer Coaching group will receive 6 months of peer health coaching via a secure telephone and text messaging system.<br>|
| No Intervention: Education only<br>Participants receive education-only material (newsletter) biweekly for 6 months | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate number of participants enrolled | Evaluate the number of participants contacted about the study who actually enrolled | Up to 2 months after recruitment closes | 
| Evaluate completion of study | Determine the number of participants who enrolled in the study who completed it | Up to 8 months after enrollment of each participant | 
| Measure impact on health | Evaluate the number of participant who stated the intervention had a positive impact on their health | Up to 8 months after enrollment of each participant | 
| Determine change in patient activation | Determine change in patient activation as measured by changes over time on the Patient Activation Measure (PAM) | baseline, 3 months, 6 months | 
| Determine change in self-management | Determine change in self-management as measured by changes over time in the Partners in health Scale (PIH) | baseline, 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine change in transition readiness | Determine the change in transition readiness over 6 months as measured by the Transition Readiness Assessment Questionaire (TRAQ) | baseline, 3 months, 6 months | 
| Determine change in health related quality of life | Determine the change in health related quality of life over 6 months as measured by the Short-From 12 (SF-12) | baseline, 3 months, 6 months | 
| Determine change in emotional health | Determine the change in emotional health over 6 months as measured by the Brief Symptom Inventory (BSI) | baseline, 3 months, 6 months | 
| Evaluate successful transfer of participants from pediatric to adult cardiology care | Evaluate number of participants that transfer from pediatric to adult cardiology care with at least consecutive visits 10 years post study | up to 10 years |