HypospadiasNCT06832280
Improving Parental Support in Hypospadias Care
A study testing Educational Website Developed by Study Team and Basic Educational Website in people with Hypospadias, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypospadias
- What is being tested?
- Educational Website Developed by Study Team and Basic Educational Website
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 324 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 May 2025to 1 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Ariel Lunsford, BA, 919-966-0690, improvinghypocare@unc.edu
Samantha Schilling, MD, MSHP
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
Stacy Keller, MSN, CPNP, 317-278-6127, stasulli@iu.edu
Martin Kaefer, MD
About this study
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.
Read the 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 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.
- Conditions
- Hypospadias
- Being tested
- Educational Website Developed by Study Team, Basic Educational Website
- Keywords
- Hypospadias, Pediatric Urologists
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Website Developed by Study TeamOther
This website was developed by the study team in previous research studies.
Basic Educational WebsiteOther
This website is a basic education website about hypospadias.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Hypospadias Education | Experimental | The parents randomized to this cohort will receive access to an educational website about hypospadias developed by the study team. Receives: 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. Receives: Other: Basic Educational Website |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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)
Measures hypospadias knowledge.
The total possible range of scores is from 0 to 6 with higher scores indicating more knowledge.
Measured: 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
Measures distress/remorse after a healthcare decision.
The total possible range of scores is from 1 to 5 with higher scores indicating more regret.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start7 May 2025
- Primary completion25 Jul 2028 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypospadiasStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Indiana University
- Responsible party
- Sponsor
- Investigators
- Samantha Schilling, MD, MSHP, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832280
- Sponsor's protocol ID
- 24-1612
- Other IDs
- 1R01DK140178-01
- Status last verified
- Jun 2026
- First submitted
- 7 Feb 2025
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data collected during the trial will be deposited in the UNC Dataverse, a trustworthy, generalist data repository managed by the Research Data Management Core at the University of North Carolina at Chapel Hill. UNC Dataverse provides persistent identifiers, robust standardized metadata, and is committed to long-term preservation and access of research data. Data are published under a CC0 license by default with customizable terms of use as needed. Additionally, UNC Dataverse is routinely backed up and preserved on multiple geographically distributed servers and is a member of Data-PASS, a community committed to the sustainability and access of research data.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Parental Support in Hypospadias Care
- ClinicalTrials.gov ID
- NCT06832280
- Acronym / sponsor ID
- 24-1612
- Conditions
- Hypospadias
- Keywords
- Hypospadias, Pediatric Urologists
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Indiana University
- Study start
- 7 May 2025 (actual)
- Primary completion
- 25 Jul 2028 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Enhanced Hypospadias Education | Experimental | Other: Educational Website Developed by Study TeamThe parents randomized to this cohort will receive access to an educational website about hypospadias developed by the study team. |
| Basic Hypospadias Education | Sham comparator | Other: Basic Educational WebsiteParents randomized into the control arm will receive access to a basic educational website about hypospadias. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years old
- Fluent and literate in English or Spanish
- Parent or legal guardian
- Ability to consent
- One eligible parent per child
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational Website Developed by Study TeamThis website was developed by the study team in previous research studies. | Other | Enhanced Hypospadias Education |
| Basic Educational WebsiteThis website is a basic education website about hypospadias. | Other | Basic Hypospadias Education |
Primary outcome
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.
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.
4 secondary outcomes
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.
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)
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)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data collected during the trial will be deposited in the UNC Dataverse, a trustworthy, generalist data repository managed by the Research Data Management Core at the University of North Carolina at Chapel Hill. UNC Dataverse provides persistent identifiers, robust standardized metadata, and is committed to long-term preservation and access of research data. Data are published under a CC0 license by default with customizable terms of use as needed. Additionally, UNC Dataverse is routinely backed up and preserved on multiple geographically distributed servers and is a member of Data-PASS, a community committed to the sustainability and access of research data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Samantha Schilling, MD, MSHP principal investigator
UNC Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Website Developed by Study Team and Basic Educational Website in people with Hypospadias, run by University of North Carolina, Chapel Hill at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ariel Lunsford, BA (919-966-0690, improvinghypocare@unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.