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.|
|ClinicalTrials.gov Identifier: NCT02507024|
Recruitment Status : Completed
First Posted : July 23, 2015
Last Update Posted : May 4, 2017
|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|
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]|
|Actual Enrollment :||280 participants|
|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|
The online questionnaire includes questions about how ANCA-associated vasculitis effects patients quality of life.
Other: Online questionnaire
- 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.
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): NCT02507024
|United States, Florida|
|University of South Florida|
|Tampa, Florida, United States, 33612|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Joanna Robson, MD||University of Oxford|
|Study Director:||Peter A Merkel, MD, MPH||University of Pennsylvania|