Journey of Patients With Vasculitis From First Symptom to Diagnosis

Giant Cell Arteritis Clinical Trial

Official title:

The Journey of Patients With Vasculitis From First Symptom to Diagnosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03410290
• Other study ID #: VCRC5538/V-PPRN4
• Status: Completed
• Start date: January 11, 2018
• Est. completion date: May 21, 2018

Study information

• Verified date: June 2018
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 456
• Est. completion date: May 21, 2018
• Est. primary completion date: May 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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 -

Related Conditions & MeSH terms

• Arteritis
• Behcet Syndrome
• Behcet's Disease
• Churg-Strauss Syndrome
• CNS Vasculitis
• Cryoglobulinemia
• Cryoglobulinemic Vasculitis
• Eosinophilic Granulomatous Vasculitis
• Giant Cell Arteritis
• Granulomatosis with Polyangiitis
• Henoch Schonlein Purpura
• IgA Vasculitis
• Microscopic Polyangiitis
• Polyarteritis Nodosa
• Polymyalgia Rheumatica
• Purpura
• Purpura, Schoenlein-Henoch
• Systemic Vasculitis
• Takayasu Arteritis
• Temporal Arteritis
• Urticarial Vasculitis
• Vasculitis
• Vasculitis, Central Nervous System
• Wegener Granulomatosis

Intervention

Other:
• Online Questionnaire
The online questionnaire includes questions about factors that impacted a patients diagnosis of vasculitis.

Locations

Country	Name	City	State
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

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 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.	1 day

External Links

•   Vasculitis Patient-Powered Research Network