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NCT Number: NCT06832280

Improving Parental Support in Hypospadias Care

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University, Indianapolis, Indiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 is less than five days away from when the patient was identified

Treatment and study plan

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.

Primary outcomes

  1. 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)

    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.

  2. Mean primary outcome measure 2 score among 50% of participants (to be disclosed after final subject completes T3 data collection)**

    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.

    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 outcomes

  1. Mean visit duration among 50% of participants

    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.

    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.

  2. Mean change in Low Literacy Decisional Conflict Scale (DCS-LL) scores (T1-T0, T3-T0, and T3-T1)

    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)

    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.

  3. Mean change in Hypospadias Knowledge Assessment scores (T1-T0, T3-T0, and T3-T1)

    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)

    Measures hypospadias knowledge.

    The total possible range of scores is from 0 to 6 with higher scores indicating more knowledge.

  4. Mean score on Decisional Regret Scale

    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

    Measures distress/remorse after a healthcare decision.

    The total possible range of scores is from 1 to 5 with higher scores indicating more regret.

Study contacts

Contact information is provided by the study sponsor or research team.

Ariel Lunsford, BA

CONTACT

[email protected]

919-966-0690

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Indiana University
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Feb 18, 2025
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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