Computerized-Adaptive Testing: Feasibility In Women With Pelvic Floor Disorders (CAT)

Completed

• Conditions: Urinary Incontinence

• Registration Number: NCT01288703
• Lead Sponsor: Women and Infants Hospital of Rhode Island

Brief 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.

Study Timeline

• Study Start: 2010-08
• Primary Completion: 2011-01
• Study First Submitted: 2011-01-28
• Study First Submitted QC: 2011-02-01
• Study First Posted: 2011-02-02
• Study Completion: 2012-02
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-27
• Last Update Posted: 2014-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• Female
• Able to read English
• Diagnosis of urinary incontinence
• Age 18 or older

Exclusion Criteria

• Unable to read English or cognitive limitations making it difficult for study participants to complete PROMIS questionnaires

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome Measure	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.

Trial Locations

Locations (1)

Women & Infants Hospital Division of Urogynecology; 🇺🇸 Providence, Rhode Island, United States