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Journey of Patients With Vasculitis From First Symptom to Diagnosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03410290
Recruitment Status : Completed
First Posted : January 25, 2018
Last Update Posted : June 6, 2018
Information provided by (Responsible Party):
Peter Merkel, University of Pennsylvania

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.

Condition or disease Intervention/treatment
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 Other: Online Questionnaire

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Study Type : Observational [Patient Registry]
Actual Enrollment : 456 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: The Journey of Patients With Vasculitis From First Symptom to Diagnosis
Actual Study Start Date : January 11, 2018
Actual Primary Completion Date : May 21, 2018
Actual Study Completion Date : May 21, 2018

Group/Cohort Intervention/treatment
Group 1
The online questionnaire includes questions about factors that impacted a patients diagnosis of vasculitis.
Other: Online Questionnaire
The online questionnaire includes questions about factors that impacted a patients diagnosis of vasculitis.

Primary Outcome Measures :
  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. [ Time Frame: 1 day ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   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:

  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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03410290

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United States, Florida
University of South Florida
Tampa, Florida, United States, 33612
Sponsors and Collaborators
University of Pennsylvania
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Study Chair: Antoine Sreih, MD University of Pennsylvania
Study Director: Peter A Merkel, MD, MPH University of Pennsylvania
Additional Information:
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Responsible Party: Peter Merkel, Chief, Division of Rheumatology, Professor of Medicine and Epidemiology, University of Pennsylvania Identifier: NCT03410290    
Other Study ID Numbers: VCRC5538/V-PPRN4
First Posted: January 25, 2018    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Polymyalgia Rheumatica
Behcet Syndrome
Granulomatosis with Polyangiitis
Giant Cell Arteritis
Microscopic Polyangiitis
Vasculitis, Central Nervous System
Systemic Vasculitis
Takayasu Arteritis
Aortic Arch Syndromes
Purpura, Schoenlein-Henoch
Polyarteritis Nodosa
Churg-Strauss Syndrome
Blood Coagulation Disorders
Hematologic Diseases
Pathologic Processes
Skin Manifestations
Vascular Diseases
Cardiovascular Diseases
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Uveal Diseases
Eye Diseases
Hereditary Autoinflammatory Diseases