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eHealth App vs Nurse-Led Intervention for Congenital Heart Disease (READYorNot CHD Trial)

N/A
Waitlist Available
Led By Andrew Mackie
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Moderate or complex CHD
Be younger than 18 years old
Must not have
Heart transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the MyREADY Transition CHD app to a nurse-led one-time intervention in clinic to see which is more effective in preparing young adults with CHD for transfer to adult care.

Who is the study for?
This trial is for young adults aged 16-17 with moderate or complex congenital heart disease (CHD) who are patients at a participating pediatric cardiology outpatient clinic. It's not suitable for those with a reading and comprehension level below Grade 6 or who have had a heart transplant.
What is being tested?
The study compares two methods to help CHD patients transition from pediatric to adult healthcare: an innovative MyREADY Transition CHD app, which they'll use over 18 months, versus a one-time nurse-led session covering self-management skills.
What are the potential side effects?
Since this trial involves educational interventions rather than medications, traditional side effects are not expected. However, participants may experience varying levels of engagement or stress related to using the app or attending the session.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have moderate or complex congenital heart disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a heart transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Transition Readiness Assessment Questionnaire
Secondary study objectives
General Self-Efficacy Score
MyHeart Score
Other study objectives
Excess time to adult care

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: The app armExperimental Treatment1 Intervention
Use of CHD app
Group II: Nurse-led intervention armActive Control1 Intervention
Nurse-led intervention

Find a Location

Who is running the clinical trial?

Université de MontréalOTHER
221 Previous Clinical Trials
104,085 Total Patients Enrolled
University of AlbertaLead Sponsor
942 Previous Clinical Trials
434,188 Total Patients Enrolled
McGill UniversityOTHER
412 Previous Clinical Trials
1,018,329 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
1,006 Previous Clinical Trials
7,413,905 Total Patients Enrolled
University of TorontoOTHER
721 Previous Clinical Trials
1,115,052 Total Patients Enrolled
University of British ColumbiaOTHER
1,472 Previous Clinical Trials
2,489,413 Total Patients Enrolled
Andrew MackiePrincipal InvestigatorUniversity of Alberta

Media Library

MyREADY Transition CHD app Clinical Trial Eligibility Overview. Trial Name: NCT04463446 — N/A
Congenital Heart Disease Research Study Groups: The app arm, Nurse-led intervention arm
Congenital Heart Disease Clinical Trial 2023: MyREADY Transition CHD app Highlights & Side Effects. Trial Name: NCT04463446 — N/A
MyREADY Transition CHD app 2023 Treatment Timeline for Medical Study. Trial Name: NCT04463446 — N/A
~42 spots leftby Sep 2025
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