VCRC Patient Contact Registry Patient-Reported Data Validation Study

NCT ID: NCT02190942

Last Updated: 2019-10-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 198 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2019-06-18

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wayne State University

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: collaborator

University of South Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathleen McKinnon, DO

Role: STUDY_CHAIR

Henry Ford/Wayne State University

Ximena D. Ruiz, MD

Role: STUDY_CHAIR

University of Pittsburgh

Peter A. Merkel, MD, MPH

Role: STUDY_CHAIR

University of Pennsylvania

Jennifer L. Harris, MSPH, CCRP

Role: STUDY_CHAIR

University of South Florida

Locations

University of South Florida Data Management Coordinating Center

Tampa, Florida, United States

Countries

United States

Other Identifiers

5535

Identifier Type: -

Identifier Source: org_study_id