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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a web-based education tool for young people with congenital heart disease. The goal is to determine if this online resource can better prepare them for managing their condition and using health services. Participants will either receive access to this educational tool alongside their usual care or continue with their standard care. Suitable candidates have been diagnosed with congenital heart disease and regularly visit a cardiologist for check-ups. As an unphased trial, this study offers a unique opportunity to contribute to valuable research that could enhance educational resources for managing congenital heart disease.

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 prior data suggests that this web-based educational intervention is safe?

Research has shown that online educational programs are generally safe. These programs use websites or apps to provide information and support. Studies have found no physical risks, as they primarily deliver information online.

Previous studies on similar digital tools, such as health education apps, have not reported major problems. Participants can use these resources at their own pace, making them easy to manage.

Overall, considering a trial with an online educational component is a low-risk choice. Participants are unlikely to experience harmful side effects from this type of study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the web-based educational intervention for congenital heart disease because it offers a unique approach to patient education and self-management. Unlike the standard of care, which primarily involves in-person consultations and printed materials, this intervention uses an online platform to provide continuous, accessible, and personalized education. This method empowers patients by allowing them to learn at their own pace and revisit information as needed, potentially improving their understanding and management of their condition. The digital format is particularly appealing as it leverages technology to engage younger patients, who are often more comfortable with digital learning tools.

What evidence suggests that this web-based educational intervention is effective for congenital heart disease transition?

Research has shown that online educational programs can help young people with congenital heart disease improve their quality of life and increase their understanding of their condition. In this trial, participants in the Web-based Educational Intervention arm will receive access to a web-based educational resource alongside the standard of care. For instance, the TRANSITION-CHD program helped teenagers and young adults better understand their heart condition and feel more prepared for changes in their healthcare. Another study found that educational apps can enhance skills for managing their own health. These findings suggest that online education might be a useful tool for young people to better manage their congenital heart disease. ^{3 6 7 8 9}

Who Is on the Research Team?

Karen Uzark, PhD, CPNP

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03303248

Evaluation of Web-based Transition Education to Enhance ... A method used to assign participants to an arm of a clinical study. The types of allocation are randomized allocation and nonrandomized. ... A group or subgroup ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7814637/

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

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772812925000764

A Cluster Randomized Trial of an mHealth Intervention for ... Indeed, there is a lack of high-quality transition outcome data for pediatric-onset chronic health conditions. Our team previously designed and ...

4. jahonline.org jahonline.org/article/S1054-139X(24)00231-3/fulltext

The TRANSITION-CHD Randomized Controlled Trial The TRANSITION-CHD program improved HRQoL and disease knowledge in adolescents and young adults with CHD, supporting the generalization and ...

5. trialx.com trialx.com/clinical-trials/listings/218330/the-impact-of-an-innovative-ehealth-transition-intervention-on-self-management-skills-among-young-adults-with-congenital-heart-disease/

The Impact of an Innovative eHealth Transition Intervention ... 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- ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03303248

Evaluation of Web-based Transition Education to Enhance ... 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6298756/

Mobile App Development Using Formative Research - PMC The goal of our study was to describe the formative research used to develop a prototype mobile app to facilitate transition to adult care for adolescents with ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2772812925000466

Virtual Peer Mentoring for Adolescents With Congenital ... iPeer2Peer is an evidence-based virtual peer mentorship program that has improved outcomes for youth in several chronic illness populations.

9. ahajournals.org ahajournals.org/doi/10.1161/JAHA.125.043809?doi=10.1161/JAHA.125.043809

Are Patients Game? Investigating the Role of ... People living with congenital heart disease (CHD) require lifelong care, but up to 60% discontinue care or are lost during the transition ...