Improving Parental Support in Hypospadias Care

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT06832280
Status
Recruiting
Apply to this trial

Conditions

  • Hypospadias

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 7, 2025
Status verified
May 2025
Primary completion
Jul 25, 2028
Completion
Dec 1, 2029

Study Design

Enrollment
324 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Enhanced Hypospadias Education
    The parents randomized to this cohort will receive access to an educational website about hypospadias developed by the study team.
  • Sham Comparator: Basic Hypospadias Education
    Parents randomized into the control arm will receive access to a basic educational website about hypospadias.

Primary Outcome Measure

Mean primary outcome measure 1 score (to be disclosed after final subject completes T3 data collection)* [ Time Frame: Post-clinic visit, 1-30 days after the final clinic visit (T3) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Indiana UniversityIndianapolisIndiana46202
Stacy Keller, MSN, CPNP
[email protected]
317-278-6127
Martin Kaefer, MD (SUB_INVESTIGATOR)
University of North Carolina at Chapel HillChapel HillNorth Carolina27599
Ariel Lunsford, BA
[email protected]
919-966-0690
Samantha Schilling, MD, MSHP (PRINCIPAL_INVESTIGATOR)

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By research site
Indiana University· Indianapolis, INUniversity of North Carolina at Chapel Hill· Chapel Hill, NC

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