Web-based Education for Congenital Heart Disease Transition

Overseen By Cynthia Smith, RN

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: New patients, Acute medical problem, Non-English, Neurocognitive impairment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

180 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Web-based Educational Intervention for congenital heart disease transition?

Research shows that online, evidence-based information portals can effectively provide patient education for congenital heart disease, as seen in a study on a similar portal for congenital aortic and pulmonary valve disease. Additionally, transition clinics have been shown to improve patient education and self-care skills, which are important for successful transition to adult care. ^{1 2 3 4 5}

How does the Web-based Education for Congenital Heart Disease Transition treatment differ from other treatments for this condition?

This treatment is unique because it uses an online platform to provide education specifically for transitioning adolescents and young adults with congenital heart disease, helping them understand their condition and manage their care as they move from pediatric to adult healthcare services. Unlike traditional treatments, this approach focuses on improving health literacy and autonomy through digital education tools. ^{1 2 6 7 8}

What is the purpose of this trial?

The study looks to learn more about the helpfulness of web-based transition education and its effect on transition readiness and health service utilization in the adolescent and young adult congenital heart disease population.

Research Team

Karen Uzark, PhD, CPNP

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for young people aged 13-25 with congenital heart disease who are already seeing a cardiologist regularly. It's not suitable for new patients, those currently dealing with an urgent health issue, non-English speakers, or individuals with severe brain function issues that make it hard to fill out a survey.

Inclusion Criteria

I am between 13 and 25 years old.

I was born with a heart condition.

I regularly see a cardiologist for check-ups.

Exclusion Criteria

Patients being evaluated for an acute medical problem

I cannot complete a questionnaire due to severe memory or thinking problems.

New patients to cardiology clinic

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Web-based Educational Intervention

Participants receive access to a web-based educational resource in addition to the standard of care

12 months

Standard of care visits

Follow-up

Participants are monitored for changes in transition readiness and health service utilization

4 weeks

Treatment Details

Interventions

• Web-based Educational Intervention

Trial Overview The study is testing if learning about transitioning from pediatric to adult healthcare through a web-based program can help teens and young adults manage their heart condition better and use health services more effectively.

Participant Groups

Group I: Web-based Educational Intervention Experimental Treatment 1 Intervention

This group of participants will be given access to a web-based educational resource in addition to the standard of care.

Group II: Standard of Care Active Control 1 Intervention

This group will be given only the standard of care during their clinic visit.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

University of Nebraska

Collaborator

Trials

563

Recruited

1,147,000+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Development of an Online, Evidence-Based Patient Information Portal for Congenital Heart Disease: A Pilot Study. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Patient information portal for congenital aortic and pulmonary valve disease: a stepped-wedge cluster randomised trial. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Transition to adult care of young people with congenital heart disease: impact of a service on knowledge and self-care skills and correlates of a successful transition. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of eHealth physical activity encouragement in adolescents with complex congenital heart disease: The PReVaiL randomized clinical trial. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Multistakeholder Recommendations for Supporting Patients and Families Transitioning From Paediatric to Adult Congenital Heart Disease Care. [2023]

6. Ireland pubmed.ncbi.nlm.nih.gov

Factors influencing the participation of adolescents and young adults with a congenital heart disease in a transition education program: A prospective multicentre controlled study. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

The Use of Virtual Reality Learning on Transition Education in Adolescents with Congenital Heart Disease. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Impact of a transition education program on health-related quality of life in pediatric patients with congenital heart disease: study design for a randomised controlled trial. [2021]