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Completed

NCT Number: NCT01288703

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

The objective of this pilot-study is to evaluate the feasibility and acceptability of PROMIS computerized-adaptive testing in women with urinary incontinence.

Completed

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Women & Infants Hospital Division of Urogynecology

Providence, Rhode Island, 02903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Primary Outcome Measure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Women and Infants Hospital of Rhode Island

Other

Registry information

Official study title

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

Acronym: CAT

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Feb 2, 2011
Registry last updated
May 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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