Journey of Patients With Vasculitis From First Symptom to Diagnosis

• ClinicalTrials.gov Identifier: NCT03410290
• Recruitment Status: Completed
• First Posted: January 25, 2018
• Last Update Posted: June 6, 2018
• Sponsor: University of Pennsylvania
• Information provided by (Responsible Party): Peter Merkel, University of Pennsylvania

Study Description

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

Study Design

• 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

Groups and Cohorts

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.

Outcome Measures

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.

Eligibility Criteria

• 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.

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 -

Contacts and Locations

Locations

United States, Florida

University of South Florida

Tampa, Florida, United States, 33612

Sponsors and Collaborators

University of Pennsylvania

Investigators

• Study Chair: Antoine Sreih, MD; University of Pennsylvania
• Study Director: Peter A Merkel, MD, MPH; University of Pennsylvania

More Information

Additional Information:

Vasculitis Patient-Powered Research Network 

• Responsible Party: Peter Merkel, Chief, Division of Rheumatology, Professor of Medicine and Epidemiology, University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT03410290
• Other Study ID Numbers: VCRC5538/V-PPRN4
• First Posted: January 25, 2018
• Last Update Posted: June 6, 2018
• Last Verified: June 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Polymyalgia Rheumatica; Behcet Syndrome; Granulomatosis with Polyangiitis; Giant Cell Arteritis; Microscopic Polyangiitis; Vasculitis, Central Nervous System; Vasculitis; Arteritis; Systemic Vasculitis; Takayasu Arteritis; Aortic Arch Syndromes; Purpura, Schoenlein-Henoch; Polyarteritis Nodosa; Churg-Strauss Syndrome; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemorrhage; Pathologic Processes; Skin Manifestations; Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Skin Diseases, Vascular; Skin Diseases