Peer Coaching Intervention in Young Adults With Congenital Heart Disease

NCT ID: NCT04271358

Last Updated: 2025-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-08

Study Completion Date

2032-03-02

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.

Conditions

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Congenital Heart Disease Congenital Heart Defect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Once enrolled, participants will be randomly assigned to the intervention or control group (1:1 ratio)
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Peer Coaching

Participant receive a 6 month peer health coaching intervention.

Group Type EXPERIMENTAL

Peer Health Coaching

Intervention Type BEHAVIORAL

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

Education only

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Peer Health Coaching

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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

26 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Adult Congenital Heart Association

UNKNOWN

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard A Krasuski, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Gary Maslow, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke Health

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00103600

Identifier Type: -

Identifier Source: org_study_id

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