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

Trial Summary

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 data supports the effectiveness of the treatment Educational Website for Hypospadias?

The research highlights the importance of patient-reported outcomes and the need for well-developed tools to measure these outcomes in hypospadias patients. While it doesn't directly assess the effectiveness of an educational website, it suggests that patient education and understanding are crucial for improving care and satisfaction, which an educational website could potentially enhance. ^{1 2 3 4 5}

How does the Educational Website treatment for hypospadias differ from other treatments?

The Educational Website treatment for hypospadias is unique because it focuses on providing information and education to patients and their families, rather than a direct medical or surgical intervention. This approach aims to empower patients with knowledge about the condition and its management, which is different from traditional treatments that involve surgical correction. ^{6 7 8 9 10}

What is the purpose of this trial?

The proposed study will enroll parent-child pairs and is designed to obtain new knowledge and improve hypospadias care. Parent-child pairs will be randomized into different groups over 36 months and participate for at least 6 months.

Research Team

Samantha Schilling, MD, MSHP

Principal Investigator

UNC Chapel Hill

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

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

Patient Reported Outcomes in Preoperative and Postoperative Patients with Hypospadias. [2022]

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

Assessing quality of life of patients with hypospadias: A systematic review of validated patient-reported outcome instruments. [2019]

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

Long-term follow-up of children who underwent severe hypospadias repair using an online survey with validated questionnaires. [2015]

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

Assessing the Readability of Online Patient Education Resources Related to Neophallus Reconstruction. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

A Systematic Review of Core Outcomes for Hypospadias Surgery. [2020]

6. Italy pubmed.ncbi.nlm.nih.gov

Hypospadias surgery on YouTube: is it valid? [2021]

7. England pubmed.ncbi.nlm.nih.gov

Recent advances in understanding/management of hypospadias. [2020]

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

Consulting "Dr. YouTube": an objective evaluation of hypospadias videos on a popular video-sharing website. [2021]

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

Separating the Wheat From the Chaff: An Evaluation of Readability, Quality, and Accuracy of Online Health Information for Treatment of Peyronie Disease. [2018]

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

Assessment of the Educational Value of Distal Hypospadias Repair Videos on YouTube. [2022]