Pilot Testing of the Worldwide Yearly Screening for Hypospadias
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility: Participant Count to Summarize answers of the Care Planning Tool
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Feasibility: Participant Count to Summarize answers of the Care Planning Tool
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Provider Acceptability: Usability Scale(Data collected after participating patient completes questionnaire, up to approximately 3 months.)