Computerized-Adaptive Testing: Feasibility In Women With Pelvic Floor Disorders (CAT)
The objective of this pilot-study is to evaluate the feasibility and acceptability of PROMIS computerized-adaptive testing in women with urinary incontinence.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Computerized-Adaptive Testing: Feasibility In Women With Pelvic Floor Disorders|
- Primary Outcome Measure [ Time Frame: 1 day ] [ Designated as safety issue: No ]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.
|Study Start Date:||August 2010|
|Study Completion Date:||February 2012|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|