The ANCA Vasculitis Questionnaire (AAV-PRO©)

Completed

• Conditions: Churg-Strauss Syndrome (CSS); Granulomatosis With Polyangiitis (Wegener's) (GPA); Microscopic Polyangiitis (MPA); ANCA-Associated Vasculitis (AAV); Wegener Granulomatosis (WG); Vasculitis; Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss) (EGPA)
• Interventions: Other: Online questionnaire

• Registration Number: NCT02507024
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-15
• Study First Submitted QC: 2015-07-21
• Study First Posted: 2015-07-23
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 280

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention	Online questionnaire	The online questionnaire includes questions about how ANCA-associated vasculitis effects patients quality of life.

Primary Outcome Measures

Name	Time	Method
Completion of AAV-PRO questionnaire.	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.

Trial Locations

Locations (2)

University of South Florida; 🇺🇸 Tampa, Florida, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States