Hypospadias
Conditions
Keywords
Hypospadias Complications, Quality of Life, Patient-Reported Outcomes
Brief summary
The purpose of this study is to recruit approximately 20 male participants who have a history of repaired hypospadias to test the feasibility and acceptability of the Care Planning Tool within the Worldwide Yearly Screening for Hypospadias (WYSH) Web Application.
Detailed description
Several studies show that patients who undergo hypospadias repair report significant functional and psychosexual issues in adolescence or adulthood (in more than 50% of cases). The Care Planning tool within the Worldwide Yearly Screening for Hypospadias (WYSH) Web Application, developed using expert level consensus from a Delphi Measure including stakeholders (psychologists, urologists, endocrinologists, patients/families), is designed to support the functional and psychosexual health of male youth and adults treated for hypospadias, to support their physical and mental health after repair. This is a pilot study of the WYSH intervention to access its feasibility and acceptability. \[Potential participants can enroll at their local clinic.\]
Interventions
OTHERWYSH Web Application
Worldwide Yearly Screening for Hypospadias (WYSH) Web Application
Sponsors
University of Wisconsin, Madison
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
5 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Males who have a documented history of repaired hypospadias. * Age groups targeted, based on recommended standards for user experience data from pilot studies: * 3-5 Males, age 5-10 (with parental consent and child assent) * 3-5 Males, age 11-15 (with parental consent and child assent) * 3-5 Males, age 16-20 (with parent consent, child assent until age 18) * 3-5 Males, age 21-65
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Participant Count to Summarize answers of the Care Planning Tool | Baseline, 3 weeks, 3 months | The Care Planning Tool within the Worldwide Yearly Screening for Hypospadias (WYSH) Application is a survey containing forty-eight questions regarding possible complications for participating patients (Subsections of penile function, voiding, sexual health, social functioning, psychological health, and doctor-patient communication). These questions will be completed by patients using a five point scale - "Never," "Rarely," "Sometimes," "Often," and "Always" - to populate a Care Plan highlighting areas of concern (with a threshold of two or more metrics above a "Sometimes" response). |
| Acceptability: User Centered Metrics | Baseline, 3 weeks, 3 months | Participating patients will complete a survey regarding the System Usability to determine ease of functionality throughout the application. This survey contains a scale for participants to graph their response from "Very Difficult" to "Very Easy" following the eleven questions of task completion. Additionally, there is a space provided for open-ended feedback. |
| Acceptability: Cognitive Debriefing Measures | Baseline, 3 weeks, 3 months | A team from the Wisconsin Surgical Outcomes Research Program (WiSOR) will complete a Cognitive Debriefing Interview with participating patients to assist in determining validation and comprehension. This interview consists of seven open-ended questions regarding participants' thought processes to provide an insight into areas of improvement for the application. Answers will be coded and themes summarized by participant count. |
| Feasibility: System Usability Testing | Baseline, 3 weeks, 3 months | The Center for User Experience will conduct masked System Usability Testing to provide user-based information on how to improve the online experience for young males and their caregivers and adult males. Usability will be assessed with a level of success rating from "Failure," "Success with a major issue," "Success with a minor issue," and "Complete Success," where minor or major issues and time taken are observed as the participating patient is completing the System Usability Scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Provider Acceptability: Usability Scale | Data collected after participating patient completes questionnaire, up to approximately 3 months. | Participating UW Clinicians will rate the recommendations received in each care plan from patients in a separate usability scale (Provider Acceptability) to improve the ability for continuity of care. Providers will complete a survey of questions surrounding format, output, and utility from "Strongly Disagree" to "Strongly Agree." Additionally, there is a space provided for feedback. |
Countries
United States
Contacts
CONTACTHaley Lange
PRINCIPAL_INVESTIGATORVinaya Bhatia, MD
UW School of Medicine and Public Health
Outcome results
None listed