Computerized-Adaptive Testing: Feasibility In Women With Pelvic Floor Disorders (CAT)
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Purpose
The objective of this pilot-study is to evaluate the feasibility and acceptability of PROMIS computerized-adaptive testing in women with urinary incontinence.
| Condition |
|---|
|
Urinary Incontinence |
| Study Type: | Observational |
| 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.
| Enrollment: | 20 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
60 women seeking care for PFDs will be eligible. Women will be excluded if they are unable to read English or have cognitive limitations precluding the completion of PROMIS questionnaires.
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
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | Vivian Sung, Principal Investigator, Women and Infants Hospital of Rhode Island |
| ClinicalTrials.gov Identifier: | NCT01288703 History of Changes |
| Other Study ID Numbers: | 10-0050 |
| Study First Received: | January 28, 2011 |
| Last Updated: | December 19, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Women and Infants Hospital of Rhode Island:
|
urinary incontinence |
Additional relevant MeSH terms:
|
Urinary Incontinence Urination Disorders Urologic Diseases Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013