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NCT05056311 · ClinicalTrials.gov registry record · NA
Engaging Families to Improve the Care of Patients With Hypospadias
A NA study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 65
- Enrollment target
NCT05056311 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 65 participants.
The verdict
NCT05056311, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 65 participants
- Enrollment target
Study Summary
Reconstructive surgery is advocated for most children with hypospadias, a condition in which the pee hold is not in the correct place on the penis, to prevent potentially serious cosmetic and functional problems. Parents faced with a decision about hypospadias repair encounter an irreversible choice with potentially lifelong consequences. Recent studies have identified decisional conflict (DC) and decisional regret (DR) as a significant problem for parents. Several recent guidelines on complex urologic topics suggest that shared decision-making (SDM) is the optimal approach. A pilot test of a decision aid website by parents potentially facing this decision will be conducted to measure pre- and post-outcomes, in order to develop a fuller understanding of how urologists can effectively provide parents with optimal decision support. Parents will answer questions via phone up to four time points, twice before (T1 and T2) and twice after seeing a urologist for a hypospadias referral (T3 and T4). If the urologist diagnoses hypospadias but recommends no surgery, the final data collection point will be three months after the urology visit. If the urologist recommends repair surgery, the final data collection point will be six months after surgery.
Interventions
- OTHER Decision Aid Website
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2021-06-09 |
| Est. Completion | 2022-10-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05056311
The ClinicalTrials.gov registry entry for NCT05056311 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Decision Aid Website is the first listed.
NCT05056311 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05056311 about?
NCT05056311 is a clinical study titled "Engaging Families to Improve the Care of Patients With Hypospadias". Reconstructive surgery is advocated for most children with hypospadias, a condition in which the pee hold is not in the correct place on the penis, to prevent potentially serious cosmetic and functional problems. Parents faced with a decision about hypospadias repair encounter an irreversible choice...
What is the current status of trial NCT05056311?
This trial is currently completed. It is a NA study. The enrollment target is 65 participants. The study started on 2021-06-09. Estimated completion is 2022-10-06.
What interventions are being tested in trial NCT05056311?
The interventions under investigation include: Decision Aid Website (OTHER).
Who is sponsoring clinical trial NCT05056311?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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