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

Sponsor
Women and Infants Hospital of Rhode Island (Other)
Overall Status
Completed
CT.gov ID
NCT01288703
Collaborator
(none)
20
Enrollment
1
Location
18
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Computerized-Adaptive Testing: Feasibility In Women With Pelvic Floor Disorders
    Study Start Date :
    Aug 1, 2010
    Actual Primary Completion Date :
    Jan 1, 2011
    Actual Study Completion Date :
    Feb 1, 2012

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Women & Infants Hospital Division of Urogynecology Providence Rhode Island United States 02903

    Sponsors and Collaborators

    • Women and Infants Hospital of Rhode Island

    Investigators

    • Principal Investigator: Vivian W Sung, MD, MPH, Women & Infants Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vivian Sung, Principal Investigator, Women and Infants Hospital of Rhode Island
    ClinicalTrials.gov Identifier:
    NCT01288703
    Other Study ID Numbers:
    • 10-0050
    First Posted:
    Feb 2, 2011
    Last Update Posted:
    May 28, 2014
    Last Verified:
    May 1, 2014
    Keywords provided by Vivian Sung, Principal Investigator, Women and Infants Hospital of Rhode Island
    urinary incontinence
    Additional relevant MeSH terms:
    Urinary Incontinence
    Enuresis
    Pelvic Floor Disorders

    Study Results

    No Results Posted as of May 28, 2014