The ANCA Vasculitis Questionnaire (AAV-PRO©)

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Wegener’s Granulomatosis
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Brief Title

The ANCA Vasculitis Questionnaire (AAV-PRO©)

Official Title

The ANCA Vasculitis Questionnaire (AAV-PRO©)

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 Type

Observational [Patient Registry]

Primary Outcome

Completion of AAV-PRO questionnaire.

Condition

Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss) (EGPA)

Intervention

Online questionnaire

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Other

Estimated Enrollment

280

Start Date

July 2015

Completion Date

December 2016

Primary Completion Date

December 2016

Eligibility 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)

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Joanna Robson, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT02507024

Organization ID

VCRC 5537

Responsible Party

Sponsor

Study Sponsor

University of Pennsylvania

Collaborators

 University of Oxford

Study Sponsor

Joanna Robson, MD, Principal Investigator, University of Oxford

Verification Date

May 2017