Peer Coaching Intervention in Young Adults With Congenital Heart Disease

Not Applicable

Active, not recruiting

• Conditions: Congenital Heart Disease; Congenital Heart Defect
• Interventions: Behavioral: Peer Health Coaching

• Registration Number: NCT04271358
• Lead Sponsor: Duke University

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.

Study Timeline

• Study First Submitted: 2020-02-13
• Study First Submitted QC: 2020-02-13
• Study First Posted: 2020-02-17
• Study Start: 2020-10-08
• Primary Completion: 2023-01-18
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-20
• Study Completion: 2032-03-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Age 18-26
• Diagnosis of congenital heart disease
• Patient at a Duke pediatric cardiology clinic
• Access to a smart phone

Read More

Exclusion Criteria

• Cognitive delay
• Patient at an adult cardiology clinic

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peer Coaching	Peer Health Coaching	Participant receive a 6 month peer health coaching intervention.

Primary Outcome Measures

Name	Time	Method
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)
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

Secondary Outcome Measures

Name	Time	Method
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)
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 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)
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

Trial Locations

Locations (1)

Duke Health; 🇺🇸 Durham, North Carolina, United States