Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2026-01-05 @ 6:33 PM
Study NCT ID:
NCT02476292
Status:
COMPLETED
Last Update Posted:
2016-01-28
First Post:
2015-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Vasculitis on Employment and Income
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D056647', 'term': 'Systemic Vasculitis'}, {'id': 'D001528', 'term': 'Behcet Syndrome'}, {'id': 'D020293', 'term': 'Vasculitis, Central Nervous System'}, {'id': 'C565141', 'term': 'Cryoglobulinemia, Familial Mixed'}, {'id': 'D013700', 'term': 'Giant Cell Arteritis'}, {'id': 'D014890', 'term': 'Granulomatosis with Polyangiitis'}, {'id': 'D011695', 'term': 'IgA Vasculitis'}, {'id': 'D055953', 'term': 'Microscopic Polyangiitis'}, {'id': 'D010488', 'term': 'Polyarteritis Nodosa'}, {'id': 'D013625', 'term': 'Takayasu Arteritis'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014606', 'term': 'Uveitis, Anterior'}, {'id': 'D015864', 'term': 'Panuveitis'}, {'id': 'D014605', 'term': 'Uveitis'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D056660', 'term': 'Hereditary Autoinflammatory Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001167', 'term': 'Arteritis'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D056648', 'term': 'Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis'}, {'id': 'D011693', 'term': 'Purpura'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D007105', 'term': 'Immune Complex Diseases'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D059345', 'term': 'Cerebral Small Vessel Diseases'}, {'id': 'D001015', 'term': 'Aortic Arch Syndromes'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 426}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-26', 'studyFirstSubmitDate': '2015-06-12', 'studyFirstSubmitQcDate': '2015-06-18', 'lastUpdatePostDateStruct': {'date': '2016-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentages of patients with different types of vasculitis who report negative impact of the disease on employment status, productivity, and income.', 'timeFrame': 'one day', 'description': 'Self-reported change in employment status, productivity, and income from the time of diagnosis to the present.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Vasculitis', 'Systemic Vasculitis', "Behcet's Disease", 'CNS Vasculitis', 'Cryoglobulinemic Vasculitis', 'Eosinophilic Granulomatosis', 'Temporal Arteritis', 'Wegener Granulomatosis', 'Henoch-Schoenlein Purpura', 'Microscopic Polyangiitis', 'Polyarteritis Nodosa (PAN)', "Takayasu's Arteritis", 'Urticarial Vasculitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn about the impact of vasculitis on employment and income in patients with different systemic vasculitides. All patients enrolled in the Vasculitis Clinical Research Consortium (VCRC) Patient Contact Registry, living in USA or Canada, and followed for more than 1 year since the vasculitis diagnosis will be invited via email to participate in this study, based on an online survey.', 'detailedDescription': "All individuals with vasculitis participating in the VCRC contact patient registry, living in the USA or Canada, and with a follow-up period of ≥1 year since the diagnosis of vasculitis will be invited by email to complete an online questionnaire. They will be asked several questions about their disease, their employment and work status before diagnosis and over the course of their disease, their work capacity and the financial impact on their lives.\n\nThe survey data will be stored by the Rare Diseases Clinical Research Network's Data Management and Coordinating Center (DMCC) at the University of South Florida. The data will be de-identified. Names or other personal health information will not be collected. If a participant is enrolled in the Vasculitis Patient-Powered Research Network (V-PPRN) University of South Florida (USF) Institutional Review Board Pro00018514, the participant can choose to provide their email address. Upon conclusion of the study period, the data will be sent to the VCRC Principal Investigator and the Protocol 5536 Co-Principal Investigators. All data collected will be sent to the database of Genotypes and Phenotypes (dbGaP) to be stored indefinitely per the Rare Disease Clinical Research Network (RDCRN) Data Sharing Policy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All individuals with vasculitis participating in the VCRC Patient Contact Registry, living in the USA or Canada, and with a follow-up period ≥1 year since the diagnosis of vasculitis.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of a systemic vasculitis: VCRC Patient Contact Registry includes patients with Behcet's disease, CNS vasculitis, Cryoglobulinemic vasculitis (Cryoglobulinemia), eosinophilic granulomatosis with polyangiitis (Churg-Strauss) (CSS), giant cell (temporal) arteritis (GCA), granulomatosis with polyangiitis (Wegener's) (GPA), Henoch-Schönlein purpura (IgA vasculitis), microscopic polyangiitis (MPA), polyarteritis nodosa (PAN), Takayasu arteritis (TAK), and urticarial vasculitis.\n* Age ≥18 years old\n* Living in USA or Canada\n* Vasculitis diagnosis made ≥1 year ago\n* Language requirements: questionnaire will be in English only\n\nExclusion Criteria:\n\n* Inability to provide informed consent and complete survey"}, 'identificationModule': {'nctId': 'NCT02476292', 'briefTitle': 'Impact of Vasculitis on Employment and Income', 'organization': {'class': 'OTHER', 'fullName': 'University of South Florida'}, 'officialTitle': 'Impact of Vasculitis on Employment and Income. An Online Survey of Participants in the VCRC Patient Contact Registry', 'orgStudyIdInfo': {'id': 'VCRC 5536'}}, 'armsInterventionsModule': {'interventions': [{'name': 'online questionnaire', 'type': 'OTHER', 'description': 'The online questionnaire includes questions about vasculitis, employment and work status before diagnosis and over the course of the disease, work capacity and the financial impact of vasculitis.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida Data Management and Coordinating Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Christian Pagnoux, MD, MPH, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Toronto'}, {'name': 'Peter A. Merkel, MD, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Pennsylvania'}, {'name': 'Lillian Barra, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Western Ontario, Canada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Western Ontario, Canada', 'class': 'OTHER'}, {'name': 'University of Pennsylvania', 'class': 'OTHER'}, {'name': 'University of Toronto', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}