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

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

READYorNot CHD Trial 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.Check my eligibility

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.See study design

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.

READYorNot CHD Trial 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.

READYorNot CHD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Transition Readiness Assessment Questionnaire

Secondary outcome measures

General Self-Efficacy Score

MyHeart Score

Other outcome measures

Excess time to adult care

READYorNot CHD 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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Université de MontréalOTHER

214 Previous Clinical Trials

102,583 Total Patients Enrolled

University of AlbertaLead Sponsor

889 Previous Clinical Trials

384,946 Total Patients Enrolled

McGill UniversityOTHER

395 Previous Clinical Trials

999,189 Total Patients Enrolled

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do the parameters of this clinical trial include elderly participants?

"Eligibility for this trial is limited to those aged 16 through 17."

Answered by AI

What is the aggregate number of subjects involved in this research?

"Affirmative. Clinicaltrials.gov data confirms that this medical study is currently open for recruitment, having been initially posted on 10th of January 2022 and last updated on 7th July 2022. The trial aims to recruit 188 individuals from a single location."

Answered by AI

Would this trial accept new participants at this time?

"Clinicaltrials.gov informs us that this medical experiment, which was initially published on January 10th 2022, is actively searching for participants. The trial's information has been updated most recently on July 7th of the same year."

Answered by AI

Is my profile compatible with the stipulations of this research program?

"The qualifications for this clinical trial necessitate a diagnosis of congenital heart defects and an age between 16 to 17 years old. The research aims to enroll 188 participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Impact of an Innovative eHealth Transition Intervention on Self-Management Skills Among Young Adults With Congenital Heart Disease

2022. "The Impact of an Innovative eHealth Transition Intervention on Self-Management Skills Among Young Adults With Congenital Heart Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04463446.

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