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

NCT ID: NCT01288703

Last Updated: 2014-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-02-29

Brief Summary

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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

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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

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Urinary Incontinence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Women and Infants Hospital of Rhode Island

OTHER

Sponsor Role lead

Responsible Party

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Vivian Sung

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vivian W Sung, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Women & Infants Hospital

Locations

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Women & Infants Hospital Division of Urogynecology

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 21400574 (View on PubMed)

Other Identifiers

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10-0050

Identifier Type: -

Identifier Source: org_study_id

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