- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT06966375
Verdensomspennende årlig screening for hypospadier (WYSH)
Pilottesting av den verdensomspennende årlige screeningen for hypospadier
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.
Studieoversikt
Detaljert beskrivelse
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.]
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Haley Lange
- Telefonnummer: wysh@urology.wisc.edu
- E-post: wysh@urology.wisc.edu
Studiesteder
-
-
Wisconsin
-
Madison, Wisconsin, Forente stater, 53792
- Rekruttering
- UW School of Medicine and Public Health
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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 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)
- 3-5 Males, age 16-20 (with parent consent, child assent until age 18)
- 3-5 Males, age 21-65
Exclusion Criteria:
-
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Male Participants with Repaired Hypospadias
|
Worldwide Yearly Screening for Hypospadias (WYSH) Web Application |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Feasibility: Participant Count to Summarize answers of the Care Planning Tool
Tidsramme: 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). |
Baseline, 3 weeks, 3 months
|
|
Acceptability: User Centered Metrics
Tidsramme: 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. |
Baseline, 3 weeks, 3 months
|
|
Acceptability: Cognitive Debriefing Measures
Tidsramme: 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. |
Baseline, 3 weeks, 3 months
|
|
Feasibility: System Usability Testing
Tidsramme: 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. |
Baseline, 3 weeks, 3 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Provider Acceptability: Usability Scale
Tidsramme: 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. |
Data collected after participating patient completes questionnaire, up to approximately 3 months.
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Vinaya Bhatia, MD, UW School of Medicine and Public Health
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Kjønnssykdommer
- Kjønnssykdommer, mannlige
- Mannlige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Medfødte abnormiteter
- Urogenitale abnormiteter
- Penile sykdommer
- Medfødte, arvelige og neonatale sykdommer og abnormiteter
- Hypospadier
Andre studie-ID-numre
- 2025-0402
- A539800 (Annen identifikator: UW Madison)
- 2K12DK100022-06 (U.S. NIH-stipend/kontrakt)
- Protocol Version 9/25/26 (Annen identifikator: UW Madison)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Individual participant data collected during pilot testing, after deidentification, will be accessible in the form of text, tables, publications, figures, etc. to disseminate efficacy of the Care Planning tool within the application.
IPD-delingstidsramme
Deidentified individual personal data and supporting information will be made available immediately after publication.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
Legemiddel- og utstyrsinformasjon, studiedokumenter
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