The Impact of an Innovative eHealth Transition Intervention on Self-Management Skills Among Young Adults With Congenital Heart Disease
NCT04463446 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 207
Last updated 2026-03-13
Summary
Congenital heart disease (CHD) survivors constitute one of the fastest growing populations in adult cardiology practices. This population is vulnerable to gaps in care, particularly as they graduate from the pediatric to adult healthcare system. Their healthcare needs are complex, and preparing this population for transfer to adult care is a resource-intense process.
This trial will evaluate the use of the MyREADY Transition CHD app against a nurse-led one-time intervention in clinic. Participants will be 16-17 year olds who attend a cardiology outpatient clinic. The app will allow young adults to learn about their heart condition and about self-management skills in the context of adult healthcare by using the app for 18 months. The nurse-led intervention will cover similar topics, but in a one-time in-person session with a clinic nurse.
Outcomes: The primary outcome is change in Transition Readiness Assessment Questionnaire (TRAQ) score over time. Secondary outcomes are change in the MyHeart Score and the General Self-Efficacy (GSE) score. These questionnaires will be answered by all participants at regular intervals (enrollment, 1 month, 6 months, 12 months, 18 months) throughout the trial. The trial will also consider time to the first adult cardiology appointment, cost of the interventions, and will conduct interviews with participants in the app group to learn about their experiences using the app.
Conditions
- Congenital Heart Disease
- Congenital Heart Disease in Adolescence
Interventions
- BEHAVIORAL
-
Use of the CHD app
Use of the CHD app
- BEHAVIORAL
-
Nurse-led intervention
Teaching session with clinic nurse
Sponsors & Collaborators
- collaborator OTHER
-
Oregon Health and Science University
collaborator OTHER -
University of British Columbia
collaborator OTHER -
University of Toronto
collaborator OTHER -
Université de Montréal
collaborator OTHER -
University of Alberta
lead OTHER
Principal Investigators
-
Andrew Mackie · University of Alberta
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 16 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-10
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
Countries
- Canada
Study Locations
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