VCRC Patient Contact Registry Patient-Reported Data Validation Study

Giant Cell Arteritis Clinical Trial

Official title:

VCRC Validation of Patient-Reported Diagnostic Data

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02190942
• Other study ID #: 5535
• Status: Completed
• Start date: May 2014
• Est. completion date: June 18, 2019

Study information

• Verified date: October 2019
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: June 18, 2019
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arteritis
• Behcet Syndrome
• Behcet's Disease
• Churg-Strauss Syndrome
• Giant Cell Arteritis
• Granulomatosis with Polyangiitis
• Microscopic Polyangiitis
• Polyarteritis Nodosa
• Polymyalgia Rheumatica
• Takayasu Arteritis
• Takayasu's Arteritis
• Wegener Granulomatosis

Locations

Country	Name	City	State
United States	University of South Florida Data Management Coordinating Center	Tampa	Florida

Sponsors (5)

Lead Sponsor	Collaborator
University of South Florida	Boston University, University of Pennsylvania, University of Pittsburgh, Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluate diagnostic accuracy of specific questions	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 form the last patient assessment received