Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vivian Sung, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier:
NCT01288703
First received: January 28, 2011
Last updated: May 27, 2014
Last verified: May 2014

January 28, 2011
May 27, 2014
August 2010
January 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01288703 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Computerized-Adaptive Testing: Feasibility In Women With Pelvic Floor Disorders (CAT)
Computerized-Adaptive Testing: Feasibility In Women With Pelvic Floor Disorders

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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
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.

Urinary Incontinence
Not Provided
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
February 2012
January 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01288703
10-0050
No
Vivian Sung, Women and Infants Hospital of Rhode Island
Women and Infants Hospital of Rhode Island
Not Provided
Principal Investigator: Vivian W Sung, MD, MPH Women & Infants Hospital
Women and Infants Hospital of Rhode Island
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP