Improving Parental Support in Hypospadias Care
ConditionHypospadias
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of North Carolina, Chapel Hill
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years old
Fluent and literate in English or Spanish
Parent or legal guardian
Ability to consent
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Educational Website Developed by Study Team
Other interventionThis website was developed by the study team in previous research studies.
Basic Educational Website
Other interventionThis website is a basic education website about hypospadias.
Treatment groups
324 Participants
are divided into 2 treatment groupsGroup A: Enhanced Hypospadias EducationExperimental treatment 1 intervention
Group B: Basic Hypospadias EducationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Post-clinic visit, 1-30 days after the final clinic visit (T3)2
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.
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.Secondary outcomes
1
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.
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.2
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.
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)3
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.
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)4
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.
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 endSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of North Carolina, Chapel Hill
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Indiana University
Collaborator
Source ClinicalTrials.gov