Clinical trial NCT03410290: Journey of Patients With Vasculitis From First Symptom to Diagnosis
Official title: The Journey of Patients With Vasculitis From First Symptom to Diagnosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2018-01-25
Enrollment: 456
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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:

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 -

Primary outcomes:
measure: 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.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of Pennsylvania
name: Antoine Sreih, MD
role: STUDY_CHAIR
affiliation: University of Pennsylvania
name: Peter A Merkel, MD, MPH
role: STUDY_DIRECTOR
References: