Clinical Trials Directory

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.