Improving Parental Support in Hypospadias Care

Not Applicable

Recruiting

• Conditions: Hypospadias

• Registration Number: NCT06832280
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief 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 may have. The parents will be approached and consented before their initial consultation with a pediatric urologist regarding hypospadias. The child may have one or two 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, a study team member will perform the post consultation phone call, 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 phone call 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.

Study Timeline

• Study First Submitted: 2025-02-07
• Study First Submitted QC: 2025-02-12
• Study First Posted: 2025-02-18
• Status Verified: 2025-05
• Study Start: 2025-05-07
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-16
• Primary Completion: 2028-07-25
• Study Completion: 2029-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 324

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean primary outcome measure 1 score (to be disclosed after final subject completes T3 data collection)*	Post-clinic visit, 1-30 days after the final clinic visit (T3)	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.
Mean primary outcome measure 2 score among 50% of participants (to be disclosed after final subject completes T3 data collection)**	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.	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.

Secondary Outcome Measures

Name	Time	Method
Mean visit duration among 50% of participants	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.	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.
Mean change in Hypospadias Knowledge Assessment scores (T1-T0, T3-T0, and T3-T1)	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)	Measures hypospadias knowledge.; The total possible range of scores is from 0 to 6 with higher scores indicating more knowledge.
Mean score on Decisional Regret Scale	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	Measures distress/remorse after a healthcare decision.; The total possible range of scores is from 1 to 5 with higher scores indicating more regret.
Mean change in Low Literacy Decisional Conflict Scale (DCS-LL) scores (T1-T0, T3-T0, and T3-T1)	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)	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.

Trial Locations

Locations (2)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States