PRO Development for ANCA Associated Vasculitis

NCT01729624 | Unknown DMC

• 1 other identifier: Rec No: 12/SW/0252
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

A qualitative study using interviews with patients who have antineutrophil cytoplasm antibody (ANCA) associated vasculitis, to develop a patient reported outcome (PRO)measure

Conditions

Wegener Granulomatosis; Microscopic Polyangiitis; Churg-Strauss Syndrome

Keywords

Wegener Granulomatosis; Microscopic Polyangiitis; Churg-Strauss Syndrome; Antibodies, Antineutrophil Cytoplasmic

Outcome Measures

Primary Outcomes (1)

• This is a qualitative research study based on semi-quantitive exploratory patient interviews and therefore it is not appropriate to define only one outcome measure.

  The principle research objective: The investigators are going to interview patients with anti-neutrophil cytoplasm antibody associated vasculitis, to develop and pilot questionnaire items for a patient reported outcome measure specifically for their disease. The secondary research objective is to describe the impact of ANCA-associated vasculitis on the quality of life of patients attending the Oxford University Hospitals NHS Trust, based on individual anonymised interviews.

  No formal outcome measure therefore not applicable

Eligibility Criteria

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

Study Population

Patients with ANCA-associated vasculitis seen at the Oxford University Hospitals NHS Trust.

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study.
• Male or female
• Aged 18 years or above (no upper limit).
• Diagnosed with granulomatosis with polyangiitis- Wegeners (GPA), Churg Strauss Syndrome (CSS) or microscopic polyangiitis (MPA)and fulfil either Chapel Hill consensus conference definitions or American College of Rheumatology (ACR) classification criteria.

You may not qualify if:

• Unable or unwilling to give independent written informed consent
• Significant communication barrier e.g., inability to speak English
• Membership of the steering committee

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

University of Oxford

Oxford, Oxfordshire, OX37LD, United Kingdom

Location

MeSH Terms

Conditions

Granulomatosis with Polyangiitis; Microscopic Polyangiitis; Churg-Strauss Syndrome

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2012
• First Posted: November 20, 2012
• Study Start: September 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

GB (1)