VCRC Patient Contact Registry Patient-Reported Data Validation Study

Sponsor

University of South Florida (Other)

Overall Status

Completed

CT.gov ID

NCT02190942

Collaborator

Wayne State University (Other), University of Pittsburgh (Other), University of Pennsylvania (Other), Boston University (Other)

198

Enrollment

Location

61.6

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Behcet's Disease Churg-Strauss Syndrome Giant Cell Arteritis Wegener Granulomatosis Microscopic Polyangiitis Polyarteritis Nodosa Takayasu's Arteritis

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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

198 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

VCRC Validation of Patient-Reported Diagnostic Data

Actual Study Start Date :

May 1, 2014

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Jun 18, 2019

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Validation of the currently utilized VCRC Patient Contact Registry Questionnaire [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 Outcome Measures

Evaluate diagnostic accuracy of specific questions [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.