The ANCA Vasculitis Questionnaire (AAV-PRO©)

NCT ID: NCT02507024

Last Updated: 2017-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

280 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Intervention

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

Online questionnaire

Intervention Type OTHER

Interventions

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Online questionnaire

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Oxford

OTHER

Sponsor Role collaborator

University of South Florida

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joanna Robson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Peter A Merkel, MD, MPH

Role: STUDY_DIRECTOR

University of Pennsylvania

Locations

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University of South Florida

Tampa, Florida, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Related Links

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http://www.vpprn.org/AAV-PRO

V-PPRN Study Overview

Other Identifiers

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VCRC 5537

Identifier Type: -

Identifier Source: org_study_id

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