NCT06832280

Improving Parental Support in Hypospadias Care

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 324 (estimated)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The proposed study will approach and enroll parent-child dyads to receive one of two educational websites about hypospadias, a condition that their child has or may have. The parents will be approached and consented before their upcoming consultation with a pediatric urologist regarding hypospadias. The child may have one or more consultation visits with the pediatric urologist. Before the first consultation, the parents will be asked about their current hypospadias knowledge, questions about how they typically interact with doctors, comfort with information presented in a healthcare setting and demographics and then receive access to one of the educational websites. After reviewing the website, the parent will complete a pre-consultation survey asking about hypospadias knowledge and other items. The 1 or 2 urology clinic consultation visits then occur and are optionally audio recorded. After the consultation visit, if the child was found to have no evidence of hypospadias, the child may no longer meet eligibility criteria for the study and may be asked to complete one final telephone call. If the child was otherwise diagnosed with hypospadias, after the final urology consultation visit, the parent will complete the post consultation survey, which consists of questions regarding hypospadias knowledge, care management options, and the treatment chosen. Parents may also be asked to complete an additional phone call regarding any challenges experienced with the website and suggestions for improvement. The final follow up survey will be about 6 months after the treatment decision has been made and will again discuss the treatment option chosen, now that some time has passed. Pediatric urologists from the two study sites will be asked permission to record their clinic consultations, if the participant family agrees as well.\* \*To preserve scientific integrity certain details of the record are not included in the registration, and will be added to the record after the relevant data are gathered.

Conditions

• Hypospadias

Interventions

Type	Name	Description
OTHER	Educational Website Developed by Study Team	This website was developed by the study team in previous research studies.
OTHER	Basic Educational Website	This website is a basic education website about hypospadias.

Timeline

• Start date: 2025-05-07
• Primary completion: 2028-07-25
• Completion: 2029-12-01
• First posted: 2025-02-18
• Last updated: 2025-12-17

Locations

2 sites across 1 country: United States