Brief Title
The ANCA Vasculitis Questionnaire (AAV-PRO©)
Official Title
The ANCA Vasculitis Questionnaire (AAV-PRO©)
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).
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.
Study Type
Observational [Patient Registry]
Primary Outcome
Completion of AAV-PRO questionnaire.
Condition
Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss) (EGPA)
Intervention
Online questionnaire
Study Arms / Comparison Groups
Intervention
Description: The online questionnaire includes questions about how ANCA-associated vasculitis effects patients quality of life.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
280
Start Date
July 2015
Completion Date
December 2016
Primary Completion Date
December 2016
Eligibility Criteria
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)
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Joanna Robson, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02507024
Organization ID
VCRC 5537
Responsible Party
Sponsor
Study Sponsor
University of Pennsylvania
Collaborators
University of Oxford
Study Sponsor
Joanna Robson, MD, Principal Investigator, University of Oxford
Verification Date
May 2017