Improving Parental Support in Hypospadias Care
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Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Full 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 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.
Enrollment
Sex
Volunteers
Inclusion and exclusion criteria
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
324 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Ariel Lunsford, BA
Data sourced from clinicaltrials.gov
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