Clinical trial NCT01288703: Computerized-Adaptive Testing: Feasibility In Women With Pelvic Floor Disorders (CAT)
Official title: Computerized-Adaptive Testing: Feasibility In Women With Pelvic Floor Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence
Keywords: urinary incontinence
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
First posted: 2011-02-02
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary Outcome Measure
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Women & Infants Hospital Division of Urogynecology
state: Rhode Island
Study officials:
affiliation: Women & Infants Hospital
name: Vivian W Sung, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sung VW, Marques F, Rogers RR, Williams DA, Myers DL, Clark MA. Content validation of the patient-reported outcomes measurement information system (PROMIS) framework in women with urinary incontinence. Neurourol Urodyn. 2011 Apr;30(4):503-9. doi: 10.1002/nau.21048. Epub 2011 Mar 11.