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

Sponsor
Duke University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04271358
Collaborator
Adult Congenital Heart Association (Other)
80
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Peer Health Coaching
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Once enrolled, participants will be randomly assigned to the intervention or control group (1:1 ratio)Once enrolled, participants will be randomly assigned to the intervention or control group (1:1 ratio)
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Peer Coaching Adaptive Self-Management Interventions for Young Adults With Congenital Heart Disease
Actual Study Start Date :
Oct 8, 2020
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Jul 31, 2032

Arms and Interventions

Arm Intervention/Treatment
Experimental: Peer Coaching

Participant receive a 6 month peer health coaching 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.

No Intervention: Education only

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

Outcome Measures

Primary Outcome Measures

  1. Evaluate number of participants enrolled [Up to 2 months after recruitment closes]

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

  2. Evaluate completion of study [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 [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 [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 [baseline, 3 months, 6 months]

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

Secondary Outcome Measures

  1. Determine change in transition readiness [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 [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 26 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke Health Durham North Carolina United States 27710

Sponsors and Collaborators

  • Duke University
  • Adult Congenital Heart Association

Investigators

  • Principal Investigator: Richard A Krasuski, MD, Duke University
  • Principal Investigator: Gary Maslow, MD, MPH, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT04271358
Other Study ID Numbers:
  • Pro00103600
First Posted:
Feb 17, 2020
Last Update Posted:
Nov 2, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 2, 2021