VCRC Patient Contact Registry Patient-Reported Data Validation Study

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.

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Key information

Conditions

Behcet's Disease Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Aortic Arch Syndromes Aortic Diseases Arteritis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behcet Syndrome Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Small Vessel Diseases Cerebrovascular Disorders Churg-Strauss Syndrome Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Genetic Diseases, Inborn Giant Cell Arteritis Granuloma Granulomatosis with Polyangiitis Hemic and Lymphatic Diseases Hereditary Autoinflammatory Diseases Immune System Diseases Lung Diseases Lung Diseases, Interstitial Lymphatic Diseases Lymphoproliferative Disorders Microscopic Polyangiitis Mouth Diseases Nervous System Diseases Panuveitis Polyarteritis Nodosa Respiratory Tract Diseases Skin Diseases Skin Diseases, Genetic Skin Diseases, Vascular Skin and Connective Tissue Diseases Stomatognathic Diseases Systemic Vasculitis Takayasu Arteritis Takayasu's Arteritis Uveal Diseases Uveitis Uveitis, Anterior Vascular Diseases Vasculitis Vasculitis, Central Nervous System Wegener Granulomatosis

Sex eligibility

All sexes

Study type

Observational

Primary location

University of South Florida Data Management Coordinating Center

Tampa, Florida, 33612, United States

About this study

Via email, consent was obtained from at least 20 randomly selected patients with the seven forms of vasculitis detailed above in the VCRC Patient Contact Registry who have completed the Diagnostic Questionnaire. The form was sent in PDF format to the patient, who either printed out or emailed the form to his or her primary vasculitis provider to complete. This form included the same questions in the patient questionnaire, with minor reformatting and a few expanded details to verify the patient-provided data (please see appendix B). If the 20 questionnaires are not returned one month after the initial recruitment email to the Patient Contact Registry participants, 20 additional participants with the seven forms of vasculitis will be selected randomly and will be asked to participate in this study. The survey data is stored by the Rare Diseases Clinical Research Network's (RDCRN) Data Management and Coordinating Center (DMCC) at the University of South Florida. The data is de-identified. Names or other personal health information were not collected. Upon conclusion of the study period, the data will be sent to Dr. Kathleen McKinnon. All data collected will be sent to the database of Genotypes and Phenotypes (dbGaP) to be stored indefinitely.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Validation of the currently utilized VCRC Patient Contact Registry Questionnaire

Time frame: Up to 24 months from the date of the last patient assessment

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.

Secondary outcomes

Evaluate diagnostic accuracy of specific questions

Time frame: Up to 24 months form the last patient assessment received

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.

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Collaborators

Boston University
University of Pennsylvania
University of Pittsburgh
Wayne State University

Registry information

Official study title

VCRC Validation of Patient-Reported Diagnostic Data

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2019
First posted: Jul 15, 2014
Registry last updated: Oct 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed