Peer Coaching Intervention in Young Adults With Congenital Heart Disease

NCT04271358 | Active Not Recruiting

• 1 other identifier: Pro00103600
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Congenital Heart Disease; Congenital Heart Defect

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Determine change in transition readiness

  baseline, 3 months, 6 months

• Determine change in health related quality of life

  baseline, 3 months, 6 months

• Determine change in emotional health

  baseline, 3 months, 6 months

• Evaluate successful transfer of participants from pediatric to adult cardiology care

  up to 10 years

Study Arms (2)

Peer Coaching

EXPERIMENTAL

Participant receive a 6 month peer health coaching intervention.

Behavioral: Peer Health Coaching

Education only

NO INTERVENTION

Participants receive education-only material (newsletter) biweekly for 6 months

Interventions

Peer Health Coaching BEHAVIORAL

The Peer Coaching group will receive 6 months of peer health coaching via a secure telephone and text messaging system.

Peer Coaching

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Cognitive delay
• Patient at an adult cardiology clinic

Sponsors & Collaborators

• Duke University: lead
• Adult Congenital Heart Association: collaborator

Study Sites (1)

Duke Health

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Richard A Krasuski, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Gary Maslow, MD, MPH

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Once enrolled, participants will be randomly assigned to the intervention or control group (1:1 ratio)

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 17, 2020
• Study Start: October 8, 2020
• Primary Completion: January 18, 2023
• Study Completion (Estimated): March 2, 2032
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)