The ANCA Vasculitis Questionnaire (AAV-PRO©)

Vasculitis Clinical Trial

— AAV-PRO  

Official title:

The ANCA Vasculitis Questionnaire (AAV-PRO©)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02507024
• Other study ID #: VCRC 5537
• Status: Completed
• Phase: N/A
• First received: July 15, 2015
• Last updated: May 1, 2017
• Start date: July 2015
• Est. completion date: December 2016

Study information

• Verified date: May 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• ANCA-Associated Vasculitis (AAV)
• Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
• Churg-Strauss Syndrome
• Churg-Strauss Syndrome (CSS)
• Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss) (EGPA)
• Granulomatosis with Polyangiitis
• Granulomatosis With Polyangiitis (Wegener's) (GPA)
• Microscopic Polyangiitis
• Microscopic Polyangiitis (MPA)
• Systemic Vasculitis
• Vasculitis
• Wegener Granulomatosis (WG)

Intervention

Other:
• Online questionnaire

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of South Florida	Tampa	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	University of Oxford, University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months

External Links

•   V-PPRN Study Overview