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CompletedNCT02476292Updated Jan 28, 2016

Impact of Vasculitis on Employment and Income

An observational study in Vasculitis, Systemic Vasculitis and Behcet's Disease, sponsored by University of South Florida. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-01-28.

Sponsored by University of South Florida · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
426
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

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

Exclusion Criteria:

  • Inability to provide informed consent and complete survey
04

Study design

Time perspective
Prospective
Enrollment
426 participants (actual)
Patient registry
No

Interventions

  • Otheronline 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: one day

06

Study locations

1 site
  • University of South Florida Data Management and Coordinating Center
    Tampa, Florida 33612, United States
07

Registry details

Key details

Study ID
NCT02476292
Lead sponsor
University of South Florida
Collaborators
University of Western Ontario, Canada, University of Pennsylvania, University of Toronto
Responsible party
Sponsor
First posted
Jun 19, 2015
Start date
Jun 2015
Primary completion
Jan 2016
Completion
Jan 2016
Last update
Jan 28, 2016

Study contacts

Christian Pagnoux, MD, MPH, MSc
study chair · University of Toronto
Peter A. Merkel, MD, MPH
study chair · University of Pennsylvania
Lillian Barra, MD, PhD
study chair · University of Western Ontario, Canada

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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