Improving Parental Support in Hypospadias Care

NCT06832280 | Recruiting

• 2 other identifiers: 24-16121R01DK140178-01
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypospadias

Keywords

Hypospadias; Pediatric Urologists

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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.

Secondary Outcomes (4)

• 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.

• 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)

• 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)

• 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

Study Arms (2)

Enhanced Hypospadias Education

EXPERIMENTAL

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

Basic Hypospadias Education

SHAM COMPARATOR

Parents randomized into the control arm will receive access to a basic educational website about hypospadias.

Other: Basic Educational Website

Interventions

Basic Educational Website OTHER

This website is a basic education website about hypospadias.

Basic Hypospadias Education

Educational Website Developed by Study Team OTHER

This website was developed by the study team in previous research studies.

Enhanced Hypospadias Education

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• A parent must meet all of the following criteria to be included:
• Age ≥ 18 years old
• Fluent and literate in English or Spanish
• Parent or legal guardian
• Ability to consent
• One eligible parent per child
• Plan to attend urology consultation
• Has access to a smart phone, tablet, or computer with reliable internet access
• Has the ability and agrees to receive unencrypted communications by text or email
• A child must meet all of the following criteria to be included:
• years old at the time of urology consultation
• Have an upcoming urology consult with an enrolled pediatric urologist regarding hypospadias

You may not qualify if:

• If a parent meets any of the following criteria they will be excluded:
• Previous participant in hypospadias study
• Parent has another child with hypospadias or father of the child has a known history of hypospadias
• Parent is unaware of any penile abnormality with child
• A final hypospadias treatment decision has been made in discussion with a pediatric urologist
• Investigator discretion
• If a child meets any of the following criteria they will be excluded:
• Prior hypospadias surgery
• Upcoming hypospadias urology consult scheduled less than a week away from when the patient was identified

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Indiana University: collaborator

Study Sites (2)

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

MeSH Terms

Conditions

Hypospadias

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Samantha Schilling, MD, MSHP

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ariel Lunsford, BA

CONTACT

919-966-0690; improvinghypocare@unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Certain members of the research team will also be masked.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study team will use block randomization (i.e., four treatment assignments per block) to assign participants to the intervention or control group, stratifying by study site. The full description of the invention vs control arms will be registered after data collection is completed to preserve the scientific integrity of the study.

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 18, 2025
• Study Start: May 7, 2025
• Primary Completion (Estimated): July 25, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: December 17, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (2)