Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2026-02-22 @ 7:02 AM
Study NCT ID:
NCT02326532
Status:
UNKNOWN
Last Update Posted:
2020-09-09
First Post:
2014-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incorporation of Patient Reported Outcomes Data in the Care of US Veterans With Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 143}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-08', 'studyFirstSubmitDate': '2014-12-09', 'studyFirstSubmitQcDate': '2014-12-22', 'lastUpdatePostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'physician/lab-derived instruments of clinical efficacy as measured by DAS28 change and DAS28 remission.', 'timeFrame': '1 year', 'description': 'Physician/lab-derived instruments of clinical efficacy as measured by DAS28 change and DAS28 remission.'}], 'secondaryOutcomes': [{'measure': 'patient satisfaction', 'timeFrame': '1 year', 'description': 'Patient reported satisfaction with medical care. A validated patient satisfaction survey will be collected at study completion with the Leeds Satisfaction Questionnaire.'}, {'measure': 'medication compliance', 'timeFrame': '1 year', 'description': 'Degree of medication compliance. Medication compliance will be assessed by the medication possession ratio (MPR) of Methotrexate (MTX), a drug most Rheumatoid Arthritis (RA) patients are prescribed. The VA Pharmacy Benefits Management (PBM) database collects information on medications dispensed and when refills are needed. Thus, a delay in refill will reflect MTX non-compliance. If it MTX is discontinued due to an adverse reaction, it is noted in the electronic medical record. The MPR is calculated as the number of days of prescribed MTX divided by the total number of days of a course.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis', 'Veterans'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'The overall goal of this proposal is to address barriers to the use of patient reported outcome (PRO) data in the Dept. of Veterans Affairs (VA) health care system.', 'detailedDescription': "This is a randomized, controlled, single-blinded study that compares outcome data in patients for whom PRO data either is or is not made available to the treating physician. The question addressed by this proposal is whether patient reported outcome (PRO) data change patient's outcomes. The hypothesis is that the availability of these data in the form of the patient-completed Multidimensional Health Assessment Questionnaire/routine assessment of patient index data (MDHAQ/RAPID3) questionnaire will change patient-centric outcomes such as patient reported well-being, patient satisfaction and medication compliance."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* US veteran\n* Within North Florida/South Georgia (NF/SG) Veterans Integrated Service Network\n\nExclusion Criteria:\n\n* Outside of service network\n* Non-veteran'}, 'identificationModule': {'nctId': 'NCT02326532', 'acronym': 'PRO', 'briefTitle': 'Incorporation of Patient Reported Outcomes Data in the Care of US Veterans With Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'North Florida Foundation for Research and Education'}, 'officialTitle': 'Incorporation of Patient Reported Outcomes Data in the Care of US Veterans With Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'IRB2014002 18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRO data utilized', 'description': 'PRO data derived from the patient-completed MDHAQ/RAPID3 questionnaire will be collected from this arm and provided to the treating physicians.', 'interventionNames': ['Other: PRO data utilized']}, {'type': 'SHAM_COMPARATOR', 'label': 'PRO data not utilized', 'description': 'PRO data derived from the patient-completed MDHAQ/RAPID3 questionnaire will be collected from this arm but will not be provided to the treating physicians.', 'interventionNames': ['Other: PRO data not utilized']}], 'interventions': [{'name': 'PRO data utilized', 'type': 'OTHER', 'description': 'Data collected from a patient-completed MDHAQ/RAPID3 questionnaire is provided to the treating physician.', 'armGroupLabels': ['PRO data utilized']}, {'name': 'PRO data not utilized', 'type': 'OTHER', 'description': 'Data collected from a patient-completed MDHAQ/RAPID3 questionnaire is not provided to the treating physician.', 'armGroupLabels': ['PRO data not utilized']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Malcom Randall VAMC', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Michael R Bubb, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Veterans Health Administration, University of Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'North Florida Foundation for Research and Education', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}, {'name': 'US Department of Veterans Affairs', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}