Brief Title
VCRC Patient Contact Registry Patient-Reported Data Validation Study
Official Title
VCRC Validation of Patient-Reported Diagnostic Data
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.
Detailed Description
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.
Study Type
Observational [Patient Registry]
Primary Outcome
Validation of the currently utilized VCRC Patient Contact Registry Questionnaire
Secondary Outcome
Evaluate diagnostic accuracy of specific questions
Condition
Behcet's Disease
Study Arms / Comparison Groups
Vasculitis Contact Registry Patients
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
198
Start Date
May 2014
Completion Date
June 18, 2019
Primary Completion Date
December 1, 2017
Eligibility Criteria
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
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Kathleen McKinnon, DO, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02190942
Organization ID
5535
Responsible Party
Sponsor
Study Sponsor
University of South Florida
Collaborators
Wayne State University
Study Sponsor
Kathleen McKinnon, DO, Study Chair, Henry Ford/Wayne State University
Verification Date
October 2019