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Improving Parental Support in Hypospadias Care

NCT ID: NCT06832280

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-07

Study Completion Date

2029-12-01

Brief Summary

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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

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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

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Hypospadias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Certain members of the research team will also be masked.

Study Groups

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Enhanced Hypospadias Education

The parents randomized to this cohort will receive access to an educational website about hypospadias developed by the study team.

Group Type EXPERIMENTAL

Educational Website Developed by Study Team

Intervention Type OTHER

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

Basic Hypospadias Education

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

Group Type SHAM_COMPARATOR

Basic Educational Website

Intervention Type OTHER

This website is a basic education website about hypospadias.

Interventions

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Educational Website Developed by Study Team

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

Intervention Type OTHER

Basic Educational Website

This website is a basic education website about hypospadias.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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:

* 0-5 years old at the time of urology consultation
* Have an upcoming urology consult with an enrolled pediatric urologist regarding hypospadias

Exclusion Criteria

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samantha Schilling, MD, MSHP

Role: PRINCIPAL_INVESTIGATOR

UNC Chapel Hill

Locations

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Indiana University

Indianapolis, Indiana, United States

Site Status RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ariel Lunsford, BA

Role: CONTACT

[email protected]
919-966-0690

Facility Contacts

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Stacy Keller, MSN, CPNP

Role: primary

[email protected]
317-278-6127

Ariel Lunsford, BA

Role: primary

[email protected]
919-966-0690

Other Identifiers

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1R01DK140178-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-1612

Identifier Type: -

Identifier Source: org_study_id