Peer Coaching Intervention in Young Adults With Congenital Heart Disease (CHASM in ACHD)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Congenital Heart Disease; Congenital Heart Defect
• Intervention / Treatment: Behavioral: Peer Health Coaching

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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 26 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Adult Congenital Heart Association
• Investigators: Principal Investigator: Richard A Krasuski, MD, Duke University; Principal Investigator: Gary Maslow, MD, MPH, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2020
• Primary Completion (Actual): January 18, 2023
• Study Completion (Estimated): March 2, 2032

Study Registration Dates

• First Submitted: February 13, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Defects, Congenital
• Other Study ID Numbers: Pro00103600

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No