The ANCA Vasculitis Questionnaire (AAV-PRO©)

NCT02507024 | Completed

• 1 other identifier: VCRC 5537
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 2

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Intervention

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

Other: Online questionnaire

Interventions

Online questionnaire OTHER

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with AAV participating in the V-PPRN.

You may qualify if:

• 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)

Sponsors & Collaborators

• University of Pennsylvania: lead
• University of Oxford: collaborator
• University of South Florida: collaborator

Study Sites (2)

University of South Florida

Tampa, Florida, 33612, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

• V-PPRN Study Overview

MeSH Terms

Conditions

Churg-Strauss Syndrome; Granulomatosis with Polyangiitis; Microscopic Polyangiitis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Vasculitis

Condition Hierarchy (Ancestors)

Systemic Vasculitis; Vascular Diseases; Cardiovascular Diseases; Granuloma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Cerebral Small Vessel Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Joanna Robson, MD

  University of Oxford

  PRINCIPAL INVESTIGATOR

• Peter A Merkel, MD, MPH

  University of Pennsylvania

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2015
• First Posted: July 23, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 4, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)