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The ANCA Vasculitis Questionnaire (AAV-PRO©) (AAV-PRO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02507024
Recruitment Status : Completed
First Posted : July 23, 2015
Last Update Posted : May 4, 2017
University of Oxford
University of South Florida
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
The aim of this project is to develop a disease specific patient reported outcome measure (PROM) for patients with AAV (the AAV-PRO). Investigators are developing and validating a questionnaire to assess quality of life in patients with ANCA-associated vasculitis (AAV). Patients with AAV have inflammation in the small blood vessels leading to involvement of a range of organs and can suffer from ongoing disease activity or treatment side effects. Quality of life can be measured by patient reported outcome measures (PROMs).

Condition or disease Intervention/treatment
Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss) (EGPA) Churg-Strauss Syndrome (CSS) Granulomatosis With Polyangiitis (Wegener's) (GPA) Wegener Granulomatosis (WG) Microscopic Polyangiitis (MPA) ANCA-Associated Vasculitis (AAV) Vasculitis Other: Online questionnaire

Detailed Description:

Patients with ANCA-associated vasculitis have inflammation in the small vessels that impact a range of organs and Investigators understand that patients may suffer ongoing disease activity, as well as side effects from the treatments. Assessing patients quality of life can be an important tool for conducting clinical trials for new treatments and medications.

Quality of life can be measured by questionnaires called "patient reported outcome measures" (PROM). What is a patient-reported outcome? Patient-reported outcomes, or PROs, are patients' feedback on what they are feeling or what they are able to do as participants are dealing with a chronic disease . Patient-reported outcomes are important because they provide doctors and researchers information about patients' quality of life. Questionnaires can be designed to measure specific PROs that are of specific importance to a disease and can provide much needed information on evaluating the effectiveness of health care. The aim of this survey is to develop a disease specific patient reported outcome measure, or PROM, for patients with AAV.

A small group of Investigators and Patient-Partners developed this survey for people with ANCA-associated vasculitis (the AAV-PRO). Investigators will invite patients with AAV to complete the questionnaire they have designed, called the AAV-PRO. By analysing how people fill in the questionnaire, Investigators will be able to find out how well the questions work, and whether they need to ask all of them.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 280 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: The ANCA Vasculitis Questionnaire (AAV-PRO©)
Actual Study Start Date : July 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Group/Cohort Intervention/treatment
The online questionnaire includes questions about how ANCA-associated vasculitis effects patients quality of life.
Other: Online questionnaire

Primary Outcome Measures :
  1. Completion of AAV-PRO questionnaire. [ Time Frame: 6 months ]
    Analysis of how people fill in the questionnaire to determine if these specific questions work, and whether we need to ask all of them.

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:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with AAV participating in the V-PPRN.

Inclusion Criteria:

  • Registered in the Vasculitis Patient-Powered Research Network (V-PPRN)
  • Patients greater than 18 years of age
  • Diagnosis of ANCA-associated vasculitis including: Eosinophilic Granulomatosis with Polyangiitis (also called Churg-Strauss Syndrome), Granulomatosis with Polyangiitis (also called Wegener's granulomatosis or GPA), Microscopic Polyangiitis (MPA)

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 identifier (NCT number): NCT02507024

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United States, Florida
University of South Florida
Tampa, Florida, United States, 33612
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
University of Oxford
University of South Florida
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Principal Investigator: Joanna Robson, MD University of Oxford
Study Director: Peter A Merkel, MD, MPH University of Pennsylvania

Additional Information:
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Responsible Party: University of Pennsylvania Identifier: NCT02507024    
Other Study ID Numbers: VCRC 5537
First Posted: July 23, 2015    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Granulomatosis with Polyangiitis
Microscopic Polyangiitis
Systemic Vasculitis
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Churg-Strauss Syndrome
Vascular Diseases
Cardiovascular Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Autoimmune Diseases
Immune System Diseases
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lymphoproliferative Disorders
Lymphatic Diseases