NCT02476292

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
426

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 19, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

7 months

First QC Date

June 12, 2015

Last Update Submit

January 26, 2016

Conditions

VasculitisSystemic VasculitisBehcet's DiseaseCNS VasculitisCryoglobulinemic VasculitisEosinophilic GranulomatosisTemporal ArteritisWegener GranulomatosisHenoch-Schoenlein PurpuraMicroscopic PolyangiitisPolyarteritis Nodosa (PAN)Takayasu's ArteritisUrticarial Vasculitis

Outcome Measures

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.

    one day

Interventions

online questionnaireOTHER

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Inability to provide informed consent and complete survey

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Florida Data Management and Coordinating Center

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

VasculitisSystemic VasculitisBehcet SyndromeVasculitis, Central Nervous SystemCryoglobulinemia, Familial MixedGiant Cell ArteritisGranulomatosis with PolyangiitisIgA VasculitisMicroscopic PolyangiitisPolyarteritis NodosaTakayasu Arteritis

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesMouth DiseasesStomatognathic DiseasesUveitis, AnteriorPanuveitisUveitisUveal DiseasesEye DiseasesHereditary Autoinflammatory DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, VascularAutoimmune Diseases of the Nervous SystemNervous System DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesAutoimmune DiseasesImmune System DiseasesArteritisLung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesAnti-Neutrophil Cytoplasmic Antibody-Associated VasculitisPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemostatic DisordersHemorrhagic DisordersImmune Complex DiseasesHypersensitivityHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and SymptomsCerebral Small Vessel DiseasesAortic Arch SyndromesAortic Diseases

Study Officials

  • 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

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2015

First Posted

June 19, 2015

Study Start

June 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 28, 2016

Record last verified: 2016-01

Locations

US(1)