An interventional study of Educational Website Developed by Study Team and Basic Educational Website in Hypospadias, sponsored by University of North Carolina, Chapel Hill. Recruiting at 2 sites in United States. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Health services research
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.
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 urology consultation visit, the parent will complete a 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.
123 studies on the registry are indexed under Hypospadias; 34 are open to participants now.
This study's planned enrollment of 324 is above the median of 70 across 97 interventional studies indexed under Hypospadias.
Browse Hypospadias studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A parent must meet all of the following criteria to be included:
A child must meet all of the following criteria to be included:
Exclusion Criteria
If a parent meets any of the following criteria they will be excluded:
If a child meets any of the following criteria they will be excluded:
The parents randomized to this cohort will receive access to an educational website about hypospadias developed by the study team.
Other: Educational Website Developed by Study Team
Parents randomized into the control arm will receive access to a basic educational website about hypospadias.
Other: Basic Educational Website
This website was developed by the study team in previous research studies.
This website is a basic education website about hypospadias.
Mean primary outcome measure 1 score (to be disclosed after final subject completes T3 data collection)*
Measures primary outcome 1 construct. The total possible range of scores is from 1 to 6, where higher scores indicate more of the primary outcome 1 construct. \*To preserve scientific integrity certain details of the record are not included in the registration and will be added to the record after all primary outcome data have been gathered.
Time frame: Post-clinic visit, 1-30 days after the final clinic visit (T3)
Mean primary outcome measure 2 score among 50% of participants (to be disclosed after final subject completes T3 data collection)**
Clinic visits will be audio recorded and coded using primary outcome measure 2 to measure primary outcome 2 construct. The total possible range of scores is from 0 to 4, where higher scores indicate more of the primary outcome 2 construct. \*\*To preserve scientific integrity certain details of the record are not included in the registration and will be added to the record after all primary outcome data have been gathered.
Time frame: Clinic visit(s), 3-60 days after enrollment (T2a) and up to 12 months after the first clinic visit (T2b). Note some patients will only have T2a.
Mean visit duration among 50% of participants
Time stamps from audio recorded clinic visits will be used to calculate visit duration in minutes. The total possible range of duration is estimated to be 10 to 40 minutes. Higher numbers indicate longer duration.
Time frame: Clinic visit(s), 3-60 days after enrollment (T2a) and up to 12 months after the first clinic visit (T2b). Note some patients will only have T2a.
Mean change in Low Literacy Decisional Conflict Scale (DCS-LL) scores (T1-T0, T3-T0, and T3-T1)
The DCS-LL measures the degree of decisional conflict. The total possible range of scores is from 0 to 100 with higher scores indicating more conflict.
Time frame: Baseline, 3-60 days before the first clinic visit (T0) Pre-clinic visit, 1-7 days before the first clinic visit (T1) Post-clinic visit, 1-30 days after the final clinic visit (T3)
Mean change in Hypospadias Knowledge Assessment scores (T1-T0, T3-T0, and T3-T1)
Measures hypospadias knowledge. The total possible range of scores is from 0 to 6 with higher scores indicating more knowledge.
Time frame: Baseline, 3-60 days before the first clinic visit (T0) Pre-clinic visit, 1-7 days before the first clinic visit (T1) Post-clinic visit, 1-30 days after the final clinic visit (T3)
Mean score on Decisional Regret Scale
Measures distress/remorse after a healthcare decision. The total possible range of scores is from 1 to 5 with higher scores indicating more regret.
Time frame: Follow-up (T4): 150-210 days post-final clinic visit in non-surgery patients;150-210 days postoperatively in surgery patients. Because surgery may occur up to 18 months after the last clinic visit, not all participants will complete T4 before study end
Plan to share: Yes — Deidentified individual participant data collected during the trial will be deposited in the UNC Dataverse, a trustworthy, generalist data repository managed by the Research Data Management Core at the University of North Carolina at Chapel Hill. UNC Dataverse provides persistent identifiers, robust standardized metadata, and is committed to long-term preservation and access of research data. Data are published under a CC0 license by default with customizable terms of use as needed. Additionally, UNC Dataverse is routinely backed up and preserved on multiple geographically distributed servers and is a member of Data-PASS, a community committed to the sustainability and access of research data.
Supporting information: Study protocol
Time frame: Beginning 36 months (3 years) following article (primary aim) publication and ending 60 months (5 years) following article publication.
Access criteria: Data will be shared with researchers who (1) provide a methodologically sound proposal that focuses on meta-analysis, (2) have obtained IRB approval for the proposal, and (3) execute a data use agreement. Proposals should be directed to Samantha_Schilling@med.unc.edu and improvinghypocare@unc.edu.
Data sharing details ↗ · researchdata.unc.edu
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