VCRC Patient Contact Registry Patient-Reported Data Validation Study
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Cardiology, Cardiology, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/19/2018 |
| Start Date: | May 2014 |
| End Date: | July 2019 |
VCRC Validation of Patient-Reported Diagnostic Data
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.
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.
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.
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.
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
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