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Active, Not Recruiting

NCT Number: NCT04271358

Peer Coaching Intervention in 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital Heart Defect Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

18 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Health

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peer health coaching

Behavioral

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

Primary outcomes

  1. Evaluate number of participants enrolled

    Time frame: Up to 2 months after recruitment closes

    Evaluate the number of participants contacted about the study who actually enrolled

  2. Evaluate completion of study

    Time frame: Up to 8 months after enrollment of each participant

    Determine the number of participants who enrolled in the study who completed it

  3. Measure impact on health

    Time frame: 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

  4. Determine change in patient activation

    Time frame: baseline, 3 months, 6 months

    Determine change in patient activation as measured by changes over time on the Patient Activation Measure (PAM)

  5. Determine change in self-management

    Time frame: baseline, 3 months, 6 months

    Determine change in self-management as measured by changes over time in the Partners in health Scale (PIH)

Secondary outcomes

  1. Determine change in transition readiness

    Time frame: baseline, 3 months, 6 months

    Determine the change in transition readiness over 6 months as measured by the Transition Readiness Assessment Questionaire (TRAQ)

  2. Determine change in health related quality of life

    Time frame: 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)

  3. Determine change in emotional health

    Time frame: baseline, 3 months, 6 months

    Determine the change in emotional health over 6 months as measured by the Brief Symptom Inventory (BSI)

  4. Evaluate successful transfer of participants from pediatric to adult cardiology care

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Adult Congenital Heart Association

Registry information

Official study title

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

Acronym: CHASM in ACHD

Important dates

Study start
2020
Primary completion
2023
Study completion
2032
First posted
Feb 17, 2020
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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