Trials / Completed
CompletedNCT01288703
Computerized-Adaptive Testing: Feasibility In Women With Pelvic Floor Disorders (CAT)
Computerized-Adaptive Testing: Feasibility In Women With Pelvic Floor Disorders
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 20 (actual)
- Sponsor
- Women and Infants Hospital of Rhode Island · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The objective of this pilot-study is to evaluate the feasibility and acceptability of PROMIS computerized-adaptive testing in women with urinary incontinence.
Detailed description
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.
Conditions
Timeline
- Start date
- 2010-08-01
- Primary completion
- 2011-01-01
- Completion
- 2012-02-01
- First posted
- 2011-02-02
- Last updated
- 2014-05-28
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01288703. Inclusion in this directory is not an endorsement.