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Impact of Vasculitis on Employment and Income

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ClinicalTrials.gov Identifier: NCT02476292
Recruitment Status : Completed
First Posted : June 19, 2015
Last Update Posted : January 28, 2016
Sponsor:
Collaborators:
University of Western Ontario, Canada
University of Pennsylvania
University of Toronto
Information provided by (Responsible Party):
University of South Florida

Brief Summary:
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.

Condition or disease Intervention/treatment
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 Other: online questionnaire

Detailed Description:

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.

The 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.


Study Type : Observational
Actual Enrollment : 426 participants
Time Perspective: Prospective
Official Title: Impact of Vasculitis on Employment and Income. An Online Survey of Participants in the VCRC Patient Contact Registry
Study Start Date : June 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016



Intervention Details:
  • Other: online questionnaire
    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.


Primary Outcome Measures :
  1. Percentages of patients with different types of vasculitis who report negative impact of the disease on employment status, productivity, and income. [ Time Frame: one day ]
    Self-reported change in employment status, productivity, and income from the time of diagnosis to the present.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • 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.
  • Age ≥18 years old
  • Living in USA or Canada
  • Vasculitis diagnosis made ≥1 year ago
  • Language requirements: questionnaire will be in English only

Exclusion Criteria:

  • Inability to provide informed consent and complete survey

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02476292


Locations
United States, Florida
University of South Florida Data Management and Coordinating Center
Tampa, Florida, United States, 33612
Sponsors and Collaborators
University of South Florida
University of Western Ontario, Canada
University of Pennsylvania
University of Toronto
Investigators
Study Chair: Christian Pagnoux, MD, MPH, MSc University of Toronto
Study Chair: Peter A. Merkel, MD, MPH University of Pennsylvania
Study Chair: Lillian Barra, MD, PhD University of Western Ontario, Canada

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT02476292     History of Changes
Other Study ID Numbers: VCRC 5536
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Behcet Syndrome
Purpura
Vasculitis
Arteritis
Systemic Vasculitis
Granulomatosis with Polyangiitis
Takayasu Arteritis
Aortic Arch Syndromes
Microscopic Polyangiitis
Purpura, Schoenlein-Henoch
Polyarteritis Nodosa
Giant Cell Arteritis
Vasculitis, Central Nervous System
Cryoglobulinemia
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Panuveitis
Uveitis
Uveal Diseases
Eye Diseases
Hereditary Autoinflammatory Diseases