Peer Coaching Intervention in Young Adults With Congenital Heart Disease

Congenital Heart Disease Clinical Trial

— CHASM in ACHD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04271358
• Other study ID #: Pro00103600
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 8, 2020
• Est. completion date: March 2, 2032

Study information

• Verified date: March 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 33
• Est. completion date: March 2, 2032
• Est. primary completion date: January 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 26 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Defect
• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

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.

Locations

Country	Name	City	State
United States	Duke Health	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Adult Congenital Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate number of participants enrolled	Evaluate the number of participants contacted about the study who actually enrolled	Up to 2 months after recruitment closes
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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