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

Recruiting in Palo Alto (17 mi)

Overseen byAndrew Mackie, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Alberta

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

Seen at outpatient cardiology clinic at participating pediatric hospital

I have moderate or complex congenital heart disease.

Exclusion Criteria

I have had a heart transplant.

Below Grade 6 level of reading and comprehension

Participant Groups

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.

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