An observational study in Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss) (EGPA), Churg-Strauss Syndrome (CSS) and Granulomatosis With Polyangiitis (Wegener's) (GPA), sponsored by University of Pennsylvania. Completed at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-04.
Sponsored by University of Pennsylvania · Observational
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).
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.
61 studies on the registry are indexed under Churg-Strauss Syndrome; 17 are open to participants now.
This study's enrollment of 280 is above the median of 239 across 30 observational studies indexed under Churg-Strauss Syndrome.
Browse Churg-Strauss Syndrome studies →University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 235 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 109 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with AAV participating in the V-PPRN.
Inclusion Criteria:
The online questionnaire includes questions about how ANCA-associated vasculitis effects patients quality of life.
Other: Online questionnaire
Completion of AAV-PRO questionnaire.
Analysis of how people fill in the questionnaire to determine if these specific questions work, and whether we need to ask all of them.
Time frame: 6 months
Plan to share: No
Ran from Jul 2015 to primary completion in Dec 2016, 17 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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