The ANCA Vasculitis Questionnaire (AAV-PRO©)

University of Pennsylvania

Status: Completed

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

Treatments: Other: Online questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT02507024

VCRC 5537

Details and patient eligibility

About

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).

Full 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.

Enrollment: 280 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

280 participants in 1 patient group

Intervention

Description:

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

Treatment:

Other: Online questionnaire