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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
Sponsor:
Collaborators:
Wayne State University
University of Pittsburgh
University of Pennsylvania
Boston University
Information provided by (Responsible Party):
University of South Florida

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
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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 198 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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


Group/Cohort
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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. The sensitivity and specificity for various combinations of the diagnostic questions to predict vasculitis and to confirm type of vasculitis will be calculated using physician diagnosis / chart review as the gold standard.
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

Information from the National Library of Medicine

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


Locations
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United States, Florida
University of South Florida Data Management Coordinating Center
Tampa, Florida, United States, 33612
Sponsors and Collaborators
University of South Florida
Wayne State University
University of Pittsburgh
University of Pennsylvania
Boston University
Investigators
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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

Additional Information:

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Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT02190942     History of Changes
Other Study ID Numbers: 5535
First Posted: July 15, 2014    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Polymyalgia Rheumatica
Giant Cell Arteritis
Behcet Syndrome
Granulomatosis with Polyangiitis
Microscopic Polyangiitis
Arteritis
Takayasu Arteritis
Aortic Arch Syndromes
Churg-Strauss Syndrome
Polyarteritis Nodosa
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Systemic Vasculitis
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Panuveitis
Uveitis
Uveal Diseases
Eye Diseases
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases
Skin Diseases, Vascular
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders