Clinical trial NCT02476292: Impact of Vasculitis on Employment and Income
Official title: Impact of Vasculitis on Employment and Income. An Online Survey of Participants in the VCRC Patient Contact Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: University of Western Ontario, Canada
name: University of Pennsylvania
name: University of Toronto
First posted: 2015-06-19
Enrollment: 426
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
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
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida Data Management and Coordinating Center
state: Florida
Study officials:
affiliation: University of Toronto
name: Christian Pagnoux, MD, MPH, MSc
role: STUDY_CHAIR
affiliation: University of Pennsylvania
name: Peter A. Merkel, MD, MPH
role: STUDY_CHAIR
affiliation: University of Western Ontario, Canada
name: Lillian Barra, MD, PhD
role: STUDY_CHAIR
References: