Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-30 @ 6:34 AM
Study NCT ID:
NCT01288703
Status:
COMPLETED
Last Update Posted:
2014-05-28
First Post:
2011-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Computerized-Adaptive Testing: Feasibility In Women With Pelvic Floor Disorders (CAT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-27', 'studyFirstSubmitDate': '2011-01-28', 'studyFirstSubmitQcDate': '2011-02-01', 'lastUpdatePostDateStruct': {'date': '2014-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Outcome Measure', 'timeFrame': '1 day', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['urinary incontinence'], 'conditions': ['Urinary Incontinence']}, 'referencesModule': {'references': [{'pmid': '21400574', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this pilot-study is to evaluate the feasibility and acceptability of PROMIS computerized-adaptive testing in women with urinary incontinence.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Able to read English\n* Diagnosis of urinary incontinence\n* Age 18 or older\n\nExclusion Criteria:\n\n* Unable to read English or cognitive limitations making it difficult for study participants to complete PROMIS questionnaires'}, 'identificationModule': {'nctId': 'NCT01288703', 'acronym': 'CAT', 'briefTitle': 'Computerized-Adaptive Testing: Feasibility In Women With Pelvic Floor Disorders (CAT)', 'organization': {'class': 'OTHER', 'fullName': 'Women and Infants Hospital of Rhode Island'}, 'officialTitle': 'Computerized-Adaptive Testing: Feasibility In Women With Pelvic Floor Disorders', 'orgStudyIdInfo': {'id': '10-0050'}}, 'contactsLocationsModule': {'locations': [{'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Women & Infants Hospital Division of Urogynecology', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Vivian W Sung, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Women & Infants Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Women and Infants Hospital of Rhode Island', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Vivian Sung', 'investigatorAffiliation': 'Women and Infants Hospital of Rhode Island'}}}}