Congenital Heart Defect, Congenital Heart Disease
Conditions
Brief summary
The purpose of the study is to evaluate a peer coaching intervention in young adults with congenital heart disease.
Detailed description
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.
Interventions
BEHAVIORALPeer Health Coaching
The Peer Coaching group will receive 6 months of peer health coaching via a secure telephone and text messaging system.
Sponsors
Duke University
Adult Congenital Heart Association
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Once enrolled, participants will be randomly assigned to the intervention or control group (1:1 ratio)
Eligibility
Sex/Gender
ALL
Age
18 Years to 26 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate number of participants enrolled | Up to 2 months after recruitment closes | Evaluate the number of participants contacted about the study who actually enrolled |
| Evaluate completion of study | Up to 8 months after enrollment of each participant | Determine the number of participants who enrolled in the study who completed it |
| Measure impact on health | Up to 8 months after enrollment of each participant | Evaluate the number of participant who stated the intervention had a positive impact on their health |
| Determine change in patient activation | baseline, 3 months, 6 months | Determine change in patient activation as measured by changes over time on the Patient Activation Measure (PAM) |
| Determine change in self-management | baseline, 3 months, 6 months | Determine change in self-management as measured by changes over time in the Partners in health Scale (PIH) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine change in transition readiness | baseline, 3 months, 6 months | Determine the change in transition readiness over 6 months as measured by the Transition Readiness Assessment Questionaire (TRAQ) |
| Determine change in health related quality of life | baseline, 3 months, 6 months | Determine the change in health related quality of life over 6 months as measured by the Short-From 12 (SF-12) |
| Determine change in emotional health | baseline, 3 months, 6 months | Determine the change in emotional health over 6 months as measured by the Brief Symptom Inventory (BSI) |
| Evaluate successful transfer of participants from pediatric to adult cardiology care | up to 10 years | Evaluate number of participants that transfer from pediatric to adult cardiology care with at least consecutive visits 10 years post study |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRichard A Krasuski, MD
Duke University
PRINCIPAL_INVESTIGATORGary Maslow, MD, MPH
Duke University
Outcome results
None listed