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: December 19, 2012
Last verified: December 2012
  Purpose

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


Condition
Urinary Incontinence

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Computerized-Adaptive Testing: Feasibility In Women With Pelvic Floor Disorders

Resource links provided by NLM:


Further study details as provided by Women and Infants Hospital of Rhode Island:

Primary Outcome Measures:
  • 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.


Enrollment: 20
Study Start Date: August 2010
Study Completion Date: February 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01288703

Locations
United States, Rhode Island
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
  More Information

No publications provided

Responsible Party: Vivian Sung, Principal Investigator, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT01288703     History of Changes
Other Study ID Numbers: 10-0050
Study First Received: January 28, 2011
Last Updated: December 19, 2012
Health Authority: United States: Federal Government

Keywords provided by Women and Infants Hospital of Rhode Island:
urinary incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014