Computerized-Adaptive Testing: Feasibility In Women With Pelvic Floor Disorders (CAT) (CAT)
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|ClinicalTrials.gov Identifier: NCT01288703|
Recruitment Status : Completed
First Posted : February 2, 2011
Last Update Posted : May 28, 2014
|Condition or disease|
Patient-reported outcomes (PRO's) are important to assess treatment progress in the field of pelvic floor disorders (PFDs), including urinary incontinence, pelvic organ prolapse, and fecal incontinence. The NIH has invested in the Patient-Reported Outcomes Measurement System (PROMIS) to revolutionize PRO measures. To date, PROMIS instruments and feasibility and acceptability of PROMIS and Computerized-Adaptive Testing (CAT) technology has not been well explored in women with PFDs and warrant further investigation. In recruiting sixty women, the investigators will conduct pilot-testing on the CAT mode of the PROMIS questionnaires, and compare participant's attitudes about the paper short-forms versus the CAT modes of administration.
The investigators will recruit 60 women with UI to participate in this study. Participants will be asked to complete both paper and CAT versions of PROMIS questionnaires covering the physical, social and mental health domains (Appendix 1). The time it takes to complete each version will be recorded. After completing the questionnaires, all participants will be interviewed, which will include a brief "Usability and Satisfaction Questionnaire"(Appendix 2), questions about technical problems, preferences, and the acceptability of each mode.
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||Computerized-Adaptive Testing: Feasibility In Women With Pelvic Floor Disorders|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||February 2012|
- Primary Outcome Measure [ Time Frame: 1 day ]To test the feasibility and acceptability of PROMIS and Computerized-Adaptive Testing (CAT) technology in women with Urinary incontinence. In recruiting sixty women, we will conduct pilot-testing on the CAT mode of the PROMIS questionnaires, and compare participant's attitudes about the paper short-forms versus the CAT modes of administration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01288703
|United States, Rhode Island|
|Women & Infants Hospital Division of Urogynecology|
|Providence, Rhode Island, United States, 02903|
|Principal Investigator:||Vivian W Sung, MD, MPH||Women & Infants Hospital|