Worldwide Yearly Screening for Hypospadias

ConditionHypospadias
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age5-65
SponsorUniversity of Wisconsin, Madison

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males who have a documented history of repaired hypospadias.

3-5 Males, age 0-4 (with parental consent)

3-5 Males, age 5-10 (with parental consent and child assent)

3-5 Males, age 11-15 (with parental consent and child assent)

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • WYSH Web Application

    Other intervention

    Worldwide Yearly Screening for Hypospadias (WYSH) Web Application

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Male Participants with Repaired HypospadiasExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility: Participant Count to Summarize answers of the Care Planning Tool

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).

Time frame
Baseline, 3 weeks, 3 months
2

Acceptability: User Centered Metrics

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.

Time frame
Baseline, 3 weeks, 3 months
3

Acceptability: Cognitive Debriefing Measures

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.

Time frame
Baseline, 3 weeks, 3 months
4

Feasibility: System Usability Testing

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.

Time frame
Baseline, 3 weeks, 3 months

Secondary outcomes

1

Provider Acceptability: Usability Scale

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.

Time frame
Data collected after participating patient completes questionnaire, up to approximately 3 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Wisconsin, Madison

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator