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

Primary Purpose

Congenital Heart Disease, Congenital Heart Defect

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer Health Coaching
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Congenital Heart Disease

Eligibility Criteria

18 Years - 26 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Peer Coaching

Education only

Arm Description

Participant receive a 6 month peer health coaching intervention.

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

Outcomes

Primary Outcome Measures

Evaluate number of participants enrolled
Evaluate the number of participants contacted about the study who actually enrolled
Evaluate completion of study
Determine the number of participants who enrolled in the study who completed it
Measure impact on health
Evaluate the number of participant who stated the intervention had a positive impact on their health
Determine change in patient activation
Determine change in patient activation as measured by changes over time on the Patient Activation Measure (PAM)
Determine change in self-management
Determine change in self-management as measured by changes over time in the Partners in health Scale (PIH)

Secondary Outcome Measures

Determine change in transition readiness
Determine the change in transition readiness over 6 months as measured by the Transition Readiness Assessment Questionaire (TRAQ)
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)
Determine change in emotional health
Determine the change in emotional health over 6 months as measured by the Brief Symptom Inventory (BSI)
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

Full Information

First Posted
February 13, 2020
Last Updated
March 14, 2023
Sponsor
Duke University
Collaborators
Adult Congenital Heart Association
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1. Study Identification

Unique Protocol Identification Number
NCT04271358
Brief Title
Peer Coaching Intervention in Young Adults With Congenital Heart Disease
Acronym
CHASM in ACHD
Official Title
Peer Coaching Adaptive Self-Management Interventions for Young Adults With Congenital Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 8, 2020 (Actual)
Primary Completion Date
January 18, 2023 (Actual)
Study Completion Date
March 2, 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Adult Congenital Heart Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease, Congenital Heart Defect

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Once enrolled, participants will be randomly assigned to the intervention or control group (1:1 ratio)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peer Coaching
Arm Type
Experimental
Arm Description
Participant receive a 6 month peer health coaching intervention.
Arm Title
Education only
Arm Type
No Intervention
Arm Description
Participants receive education-only material (newsletter) biweekly for 6 months
Intervention Type
Behavioral
Intervention Name(s)
Peer Health Coaching
Intervention Description
The Peer Coaching group will receive 6 months of peer health coaching via a secure telephone and text messaging system.
Primary Outcome Measure Information:
Title
Evaluate number of participants enrolled
Description
Evaluate the number of participants contacted about the study who actually enrolled
Time Frame
Up to 2 months after recruitment closes
Title
Evaluate completion of study
Description
Determine the number of participants who enrolled in the study who completed it
Time Frame
Up to 8 months after enrollment of each participant
Title
Measure impact on health
Description
Evaluate the number of participant who stated the intervention had a positive impact on their health
Time Frame
Up to 8 months after enrollment of each participant
Title
Determine change in patient activation
Description
Determine change in patient activation as measured by changes over time on the Patient Activation Measure (PAM)
Time Frame
baseline, 3 months, 6 months
Title
Determine change in self-management
Description
Determine change in self-management as measured by changes over time in the Partners in health Scale (PIH)
Time Frame
baseline, 3 months, 6 months
Secondary Outcome Measure Information:
Title
Determine change in transition readiness
Description
Determine the change in transition readiness over 6 months as measured by the Transition Readiness Assessment Questionaire (TRAQ)
Time Frame
baseline, 3 months, 6 months
Title
Determine change in health related quality of life
Description
Determine the change in health related quality of life over 6 months as measured by the Short-From 12 (SF-12)
Time Frame
baseline, 3 months, 6 months
Title
Determine change in emotional health
Description
Determine the change in emotional health over 6 months as measured by the Brief Symptom Inventory (BSI)
Time Frame
baseline, 3 months, 6 months
Title
Evaluate successful transfer of participants from pediatric to adult cardiology care
Description
Evaluate number of participants that transfer from pediatric to adult cardiology care with at least consecutive visits 10 years post study
Time Frame
up to 10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard A Krasuski, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gary Maslow, MD, MPH
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Health
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Peer Coaching Intervention in Young Adults With Congenital Heart Disease

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