Educational Website for Hypospadias

Recruiting at 1 trial location

Overseen By Ariel Lunsford, BA

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Previous study participant, Prior surgery, others

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

Compensation: Varies

Number of Visits: 2

Duration: Up to 12 months

324 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance understanding and care for children with hypospadias, a condition where the urethra's opening is not at the tip of the penis. Parents and their children will be divided into groups to access either a detailed educational website or a basic one about hypospadias. The goal is to determine which approach better improves parents' knowledge and management of their child's condition. Suitable participants include parents or guardians planning a urology consultation for a child aged 0-5 years, who has been referred for a potential new diagnosis of hypospadias. As an unphased trial, this study offers parents a unique opportunity to contribute to valuable research that could enhance educational resources and support for families facing hypospadias.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this educational website is safe for parent-child pairs?

Research has shown that educational websites about hypospadias can be helpful and safe for parents and children. One study found that parents who used a specific educational website about hypospadias gained more knowledge and felt more confident in making decisions for their child's care. No negative effects were reported from using these websites. As these websites provide information, they are generally easy to use and safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how educational websites can better support parents of children with hypospadias, a condition affecting the urethra in males. Unlike standard care, which typically involves direct consultations with healthcare providers, this trial compares an enhanced educational website, "Hypospadias Hub," with basic information available on the CDC website. The enhanced website offers a comprehensive, tailored educational experience, potentially empowering parents with more detailed, accessible, and engaging information. This approach could lead to better-informed decisions and improved comfort and understanding for families navigating hypospadias treatment options.

What evidence suggests that this educational website is effective for improving hypospadias care?

Research has shown that educational websites can help parents of boys with hypospadias, a condition affecting the urinary tract, make better decisions. In this trial, parents assigned to the "Enhanced Hypospadias Education" group will access a website called the Hypospadias Hub, designed to assist in making informed choices about their child's care. A pilot study found that the Hypospadias Hub successfully engaged both parents and pediatric providers, indicating it could improve understanding and management of the condition. Developers created the tool with input from both parents and healthcare professionals to ensure it met users' needs. Overall, early findings suggest that such educational tools can enhance support and care for children with hypospadias. ^{1 2 4 6 7}

Who Is on the Research Team?

Samantha Schilling, MD, MSHP

Principal Investigator

UNC Chapel Hill

Are You a Good Fit for This Trial?

This trial is for parent-child pairs where the child has hypospadias, a condition affecting the urethra. Participants will be involved in the study for at least 6 months over a period of 36 months.

Inclusion Criteria

My child is under 6 years old and may have hypospadias.

I am over 18, speak English or Spanish, can consent, will attend a urology visit, have internet and a smart device, and agree to get texts or emails.

Exclusion Criteria

Parent is a previous participant in hypospadias study, has another child with hypospadias or father of the child has a known history of hypospadias, is unaware of any penile abnormality with child, or at investigator discretion

My child had hypospadias surgery or is scheduled for a urology consult soon.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3-60 days

1 visit (in-person)

Treatment

Parents receive access to an educational website about hypospadias and participate in consultation visits

Up to 12 months

1-2 visits (in-person), additional phone calls

Follow-up

Participants are monitored for knowledge and decision-making outcomes after treatment

6 months

Final follow-up phone call

Long-term follow-up

Participants are monitored for decisional regret and other outcomes

150-210 days post-final clinic visit

What Are the Treatments Tested in This Trial?

Interventions

• Educational Website
• Educational Website Developed by Study Team

Trial Overview The study is testing an educational website developed by the research team to see if it improves support and care for children with hypospadias. Parent-child pairs are randomly placed into different groups to compare outcomes.

How Is the Trial Designed?

Group I: Enhanced Hypospadias Education: Hypospadias Hub Experimental Treatment 1 Intervention

The parents randomized to this cohort will receive access to an educational website about hypospadias.

Group II: Basic Hypospadias Education: CDC website Placebo Group 1 Intervention

Parents randomized into the control arm will receive access to a basic educational website about hypospadias.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Indiana University

Collaborator

Trials

1,063

Recruited

1,182,000+

Citations

1. withpower.com withpower.com/trial/educational-website-for-hypospadias-ba7f6

Educational Website for Hypospadias Trial Overview The study is testing an educational website developed by the research team to see if it improves support and care for children with hypospadias.

2. sidra.org sidra.org/research/translational-research-programs/hypospadias-education-research-and-outcomes-hub/

Hypospadias Education, Research, and Outcomes Hub The HERO Hub at Sidra Medicine is committed to enhancing hypospadias' understanding, treatment, and management by uniting researchers, healthcare professionals ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1477513123000281

A multi-site pilot study of a parent-centered tool to promote ... We conducted a two-site pilot study to evaluate a decision aid (DA) website, the Hypospadias Hub, for parents of hypospadias patients.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7686073/

User-centered development of a hypospadias decision aid ... The objective of this study was to engage parents of hypospadias patients and pediatric providers in the co-design of a decision aid (DA) prototype.

5. cureus.com cureus.com/articles/145763-outcomes-assessment-of-hypospadias-repair

Outcomes Assessment of Hypospadias Repair This study aims to provide descriptive data on cosmetic, functional, and surgical outcomes of hypospadias repair at a single medical institute ...

6. spuonline.org spuonline.org/Hypospadias/

SPU Hypospadias Task Force To serve as a resource for pediatric urologists for hypospadias education and research. Objectives. Promote standardized reporting in hypospadias through the ...

7. chop.edu chop.edu/news/hypospadias-research-update

Hypospadias Research Update Our study analyzed distal hypospadias patients undergoing primary hypospadias repair with urethroplasty and compared outcomes of those who did ...