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Nurse-Led Transition Support for Congenital Heart Defects Transition (TRAAC Trial)

N/A

Recruiting

Led By Andrew Mackie, MD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

16-25 year olds with moderate or complex congenital heart disease (CHD), as previously defined

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 month, 6 months

Awards & highlights

TRAAC Trial Summary

This trial will help us to understand if providing a nurse-led teaching session to adolescents with CHD using Telehealth is an effective way of helping them to take charge of their health as they transition from pediatric to adult care.

Who is the study for?

This trial is for young people aged 16-25 with moderate or complex congenital heart disease who are patients at certain clinics affiliated with Stollery Children's Hospital. It's not suitable for those with a reading and comprehension level below Grade 6, or individuals who have had a heart transplant.Check my eligibility

What is being tested?

The study tests if nurse-led teaching sessions via Telehealth can help teens in rural areas manage their health as they transition from pediatric to adult care. Participants will also use the iHeartChange website, designed for young people with CHD.See study design

What are the potential side effects?

Since this intervention involves educational sessions and website usage, there are no direct medical side effects. However, participants may experience stress or anxiety related to learning about their condition.

TRAAC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am aged 16-25 and have a moderate or complex type of congenital heart disease.

TRAAC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 month, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 month, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month, 6 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

adolescents' knowledge of their heart

Secondary outcome measures

Nurse-adolescent Interactions

Self-Efficacy

Transition Readiness

+1 more

TRAAC Trial Design

1Treatment groups

Experimental Treatment

Group I: InterventionExperimental Treatment1 Intervention

Nurse-led transition intervention and access to the iHeartChange website

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

889 Previous Clinical Trials

385,102 Total Patients Enrolled

Andrew Mackie, MDPrincipal InvestigatorStollery Children's Hospital

1 Previous Clinical Trials

337 Total Patients Enrolled

Media Library

Nurse-led transition intervention Clinical Trial Eligibility Overview. Trial Name: NCT04090827 — N/A

Congenital Heart Defects Research Study Groups: Intervention

Congenital Heart Defects Clinical Trial 2023: Nurse-led transition intervention Highlights & Side Effects. Trial Name: NCT04090827 — N/A

Nurse-led transition intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04090827 — N/A

Frequently Asked Questions

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

Might I be eligible to partake in this experiment?

"To be considered for participation in this trial, potential participants must have undergone a transition and fall between the ages of 16 to 25. The team is currently recruiting roughly 36 people."

Answered by AI

Is the recruitment process ongoing for this investigation?

"Affirmative. According to clinicaltrials.gov, this research is actively seeking participants that were initially registered on September 1st 2019 and updated most recently in May 16th 2022. There are 36 spaces available at a single trial site."

Answered by AI

Is the age criteria for this experiment limited to those below twenty-five?

"All participants in this research must be between 16 and 25 years old, inclusive."

Answered by AI

Has there been an established limit to the number of participants in this clinical trial?

"Affirmative. Clinicaltrials.gov documents demonstrate that this medical trial is currently recruiting, having been first posted on September 1st 2019 and last updated on May 16th 2022. The study requires 36 patients to be enrolled from a single research centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Transitioning Rural Adolescents to Adult Care Study

Andrew Mackie 2019. "The Transitioning Rural Adolescents to Adult Care Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04090827.