VCRC Patient Contact Registry Patient-Reported Data Validation Study
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|ClinicalTrials.gov Identifier: NCT02190942|
Recruitment Status : Completed
First Posted : July 15, 2014
Last Update Posted : October 16, 2019
|Condition or disease|
|Behcet's Disease Churg-Strauss Syndrome Giant Cell Arteritis Wegener Granulomatosis Microscopic Polyangiitis Polyarteritis Nodosa Takayasu's Arteritis|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||198 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||VCRC Validation of Patient-Reported Diagnostic Data|
|Actual Study Start Date :||May 2014|
|Actual Primary Completion Date :||December 1, 2017|
|Actual Study Completion Date :||June 18, 2019|
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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT02190942
|United States, Florida|
|University of South Florida Data Management Coordinating Center|
|Tampa, Florida, United States, 33612|
|Study Chair:||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|