VCRC Patient Contact Registry Patient-Reported Data Validation Study

NCT02190942 | Completed

• 1 other identifier: 5535
• Study Type: observational
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to provide validation of patient-reported data in the VCRC Patient Contact Registry by comparing patient-reported data with data provided by the physician who is the primary provider caring for the patient's vasculitis. Patients enrolled in the Patient Contact Registry with Behcet's disease, eosinophilic granulomatosis with polyangiitis (Churg-Strauss) (EGPA), giant cell arteritis (GCA), granulomatosis with polyangiitis (Wegener's) (GPA), microscopic polyangiitis (MPA), polyarteritis nodosa (PAN), and Takayasu's arteritis (TAK) were invited via email to participate in this study.

Conditions

Behcet's Disease; Churg-Strauss Syndrome; Giant Cell Arteritis; Wegener Granulomatosis; Microscopic Polyangiitis; Polyarteritis Nodosa; Takayasu's Arteritis

Outcome Measures

Primary Outcomes (1)

• Validation of the currently utilized VCRC Patient Contact Registry Questionnaire

  The outcome measure(s) will be evaluated based on the cross-sectional online questionnaire. The questionnaire is the only study procedure for this online patient contact registry protocol and will be the sole analysis tool for both the primary and secondary outcome measures.

  Up to 24 months from the date of the last patient assessment

Secondary Outcomes (1)

• Evaluate diagnostic accuracy of specific questions

  Up to 24 months form the last patient assessment received

Study Arms (1)

Vasculitis Contact Registry Patients

Consent will be obtained from at least 20 randomly selected patients with each of the following self-identified diagnoses in the VCRC Patient Contact Registry: Behçet's disease, EGPA, GCA, GPA, MPA, PAN and TAK that have already completed the VCRC Diagnostic Questionnaires. Permission will be obtained to contact subjects' primary vasculitis care providers to request that the providers complete an online version of this questionnaire (or print copy, if they prefer), and request specific chart items from their office to further verify the data.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consent will be obtained from at least 20 randomly selected patients with each of the following self-identified diagnoses in the VCRC Patient Contact Registry: Behçet's disease, EGPA, GCA, GPA, MPA, PAN and TAK that have already completed the VCRC Diagnostic Questionnaires. Permission will be obtained to contact subjects' primary vasculitis care providers to request that the providers complete an online version of this questionnaire (or print copy, if they prefer), and request specific chart items from their office to further verify the data. The sensitivity and specificity for various combinations of the diagnostic questions to predict vasculitis and to confirm type of vasculitis will be calculated using physician diagnosis / chart review as the gold standard.

You may qualify if:

• At least 20 patients with each of the following self-identified diagnoses in the VCRC Patient Contact Registry: Behçet's disease, EGPA, GCA, GPA, MPA, PAN, and TAK who have completed the online questionnaires.

You may not qualify if:

• Inability to provide informed consent and complete survey
• Patients whose diagnosis of vasculitis was not confirmed by a physician
• Patients who did not complete the initial questionnaire in its entirety

Sponsors & Collaborators

• University of South Florida: lead
• Wayne State University: collaborator
• University of Pittsburgh: collaborator
• University of Pennsylvania: collaborator
• Boston University: collaborator

Study Sites (1)

University of South Florida Data Management Coordinating Center

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Behcet Syndrome; Churg-Strauss Syndrome; Giant Cell Arteritis; Granulomatosis with Polyangiitis; Microscopic Polyangiitis; Polyarteritis Nodosa; Takayasu Arteritis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Systemic Vasculitis; Granuloma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Autoimmune Diseases; Immune System Diseases; Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Arteritis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Cerebral Small Vessel Diseases; Aortic Arch Syndromes; Aortic Diseases

Study Officials

• Kathleen McKinnon, DO

  Henry Ford/Wayne State University

  STUDY CHAIR

• Ximena D. Ruiz, MD

  University of Pittsburgh

  STUDY CHAIR

• Peter A. Merkel, MD, MPH

  University of Pennsylvania

  STUDY CHAIR

• Jennifer L. Harris, MSPH, CCRP

  University of South Florida

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2014
• First Posted: July 15, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: June 18, 2019
• Last Updated: October 16, 2019

Record last verified: 2019-10

Locations

US (1)