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PRO Development for ANCA Associated Vasculitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01729624
Recruitment Status : Unknown
Verified May 2015 by University of Oxford.
Recruitment status was:  Active, not recruiting
First Posted : November 20, 2012
Last Update Posted : May 28, 2015
Information provided by (Responsible Party):
University of Oxford

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

Condition or disease
Wegener Granulomatosis Microscopic Polyangiitis Churg-Strauss Syndrome

Detailed Description:

Patients with antineutrophil cytoplasmic antibody (ANCA) associated vasculitis (AAV) have inflammation in the small blood vessels leading to involvement in different body areas, e.g., the kidneys, lungs and skin. Untreated, the risk of death is over 80%; with current treatment, patients often suffer from ongoing disease activity, damage or treatment side effects which have a negative impact on quality of life. Because patients with AAV can have a wide range of disease features, the investigators hypothesise that general patient reported outcome (PROs) measurements, may not be specific enough to describe the full impact on quality of life.

The main objective of this project is to start from patients' experiences to develop a disease specific PRO for patients with AAV. Patients diagnosed with AAV will be recruited through clinics or inpatients at the Oxford University Hospitals (OUH) National Health Service (NHS) Trust, or, if the patients have previously consented to be contacted about future studies, through the Diagnostic and Classification of Vasculitis (DCVAS) or The Characterisation and Determinants of Quality of Life in ANCA Associated Vasculitis (VasQoL) study databases. After informed consent is obtained, individual patient interviews will be conducted; these will last for approximately one hour and will be recorded and transcribed. Themes will be independently extracted and amalgamated by the researchers. Approximately 25 patients with different types of ANCAassociated vasculitis and varying disease duration will be interviewed until saturation, i.e., no new substantive themes emerge. These themes will then evolve into individual candidate questionnaire items. Candidate items will be piloted on approximately 25 different patients with AAV using questionnaires and interviews, until no further comments arise, to produce a final set of candidate questionnaire items. The duration of the study 1.5 years.

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Study Type : Observational
Estimated Enrollment : 50 participants
Time Perspective: Prospective
Official Title: A Qualitative Study Using Interviews With Patients Who Have Anti-neutrophil Cytoplasm Antibody (ANCA) Associated Vasculitis, to Develop a Patient Reported Outcome (PRO) Measure
Study Start Date : September 2012
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : August 2015

Primary Outcome Measures :
  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. [ Time Frame: No formal outcome measure therefore not applicable ]

    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with ANCA-associated vasculitis seen at the Oxford University Hospitals NHS Trust.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01729624

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United Kingdom
University of Oxford
Oxford, Oxfordshire, United Kingdom, OX37LD
Sponsors and Collaborators
University of Oxford

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Responsible Party: University of Oxford Identifier: NCT01729624    
Other Study ID Numbers: Rec No: 12/SW/0252
First Posted: November 20, 2012    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015
Keywords provided by University of Oxford:
Wegener Granulomatosis
Microscopic Polyangiitis
Churg-Strauss Syndrome
Antibodies, Antineutrophil Cytoplasmic
Additional relevant MeSH terms:
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Granulomatosis with Polyangiitis
Microscopic Polyangiitis
Systemic Vasculitis
Churg-Strauss Syndrome
Vascular Diseases
Cardiovascular Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Autoimmune Diseases
Immune System Diseases
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunologic Factors
Physiological Effects of Drugs