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CompletedNCT03410290Updated Jun 6, 2018

Journey of Patients With Vasculitis From First Symptom to Diagnosis

An observational study in Vasculitis, Systemic Vasculitis and Behcet's Disease, sponsored by University of Pennsylvania. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2018-06-06.

Sponsored by University of Pennsylvania · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
456
Sex
All
01

Study summary

This study seeks to understand the journey that patients eventually are diagnosed with vasculitis experience in the period prior to their formal diagnosis by a healthcare provider. Data elements of interest include average time from the onset of the first symptoms to the time a diagnosis of vasculitis is confirmed. Other aims include identifying factors associated with the time to diagnosis. These factors will be divided into: a) intrinsic factors, or so-called "patient-related factors", such as the type of vasculitis symptoms, patient demographics, socioeconomic status, patients' beliefs regarding the etiology of their symptoms, and other factors, and b) extrinsic factors, or "professional/health system factors", such as healthcare access, referral patterns, testing patterns, and other factors. Understanding such factors can guide future efforts to shorten delays in diagnosis and thereby improve outcomes. All analyses will be done for the population of patients with vasculitis as a whole and by individual types of vasculitis.

02

Conditions studied

  • Vasculitis
  • Systemic Vasculitis
  • Behcet's Disease
  • CNS Vasculitis
  • Cryoglobulinemic Vasculitis
  • Eosinophilic Granulomatous Vasculitis
  • Temporal Arteritis
  • Giant Cell Arteritis
  • Granulomatosis With Polyangiitis
  • Wegener Granulomatosis
  • Henoch Schonlein Purpura
  • IgA Vasculitis
  • Microscopic Polyangiitis
  • Polyarteritis Nodosa
  • Takayasu Arteritis
  • Urticarial Vasculitis
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All individuals with self-reported vasculitis participating in the Vasculitis Patient-Powered Research Network (V-PPRN) will be invited to join the study, with a target recruitment period of 3 months. This study is open to US and international participants.

Inclusion criteria

  1. Diagnosis of a systemic vasculitis: The V-PPRN includes patients with self-reported Behçet's disease, central nervous system vasculitis, cryoglobulinemic vasculitis, eosinophilic granulomatosis with polyangiitis (Churg-Strauss Syndrome, CSS), giant cell (temporal) arteritis (GCA), granulomatosis with polyangiitis (Wegener's, GPA), IgA vasculitis (Henoch-Schönlein Purpura), microscopic polyangiitis (MPA), polyarteritis nodosa (PAN), Takayasu's arteritis (TAK), and urticarial vasculitis.
  2. Language requirements: questionnaire will be in English only

Exclusion criteria

Exclusion Criteria:

  1. Inability to provide informed consent and complete survey in English
  2. Patients with a diagnosis of "other" type of vasculitis
  3. Patients with a "missing" diagnosis -
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
456 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Group 1

    The online questionnaire includes questions about factors that impacted a patients diagnosis of vasculitis.

    Other: Online Questionnaire

Interventions

  • OtherOnline Questionnaire

    The online questionnaire includes questions about factors that impacted a patients diagnosis of vasculitis.

05

What researchers measure

Primary outcomes

  1. Percentages of patients with different types of vasculitis who report a delay in their disease diagnosis from initial symptoms of vasculitis to establishment of a diagnosis of vasculitis, stratified by disease type.

    Analysis of how people fill in the questionnaire to determine the time from onset of symptoms of vasculitis to the first encounter with a healthcare provider for evaluation of those symptoms.

    Time frame: 1 day

06

Study locations

1 site
  • University of South Florida
    Tampa, Florida 33612, United States
07

References and documents

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03410290
Lead sponsor
University of Pennsylvania
Responsible party
Peter Merkel (Chief, Division of Rheumatology, Professor of Medicine and Epidemiology, University of Pennsylvania) — Principal investigator
First posted
Jan 25, 2018
Start date
Jan 11, 2018
Primary completion
May 21, 2018
Completion
May 21, 2018
Last update
Jun 6, 2018

Study contacts

Antoine Sreih, MD
study chair · University of Pennsylvania
Peter A Merkel, MD, MPH
study director · University of Pennsylvania

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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