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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02476292
Other study ID # VCRC 5536
Secondary ID
Status Completed
Phase N/A
First received June 12, 2015
Last updated January 26, 2016
Start date June 2015
Est. completion date January 2016

Study information

Verified date January 2016
Source University of South Florida
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 426
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Time Perspective: Prospective


Intervention

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.

Locations

Country Name City State
United States University of South Florida Data Management and Coordinating Center Tampa Florida

Sponsors (4)

Lead Sponsor Collaborator
University of South Florida University of Pennsylvania, University of Toronto, University of Western Ontario, Canada

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentages of patients with different types of vasculitis who report negative impact of the disease on employment status, productivity, and income. Self-reported change in employment status, productivity, and income from the time of diagnosis to the present. one day No
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