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PRO Development for ANCA Associated Vasculitis

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ClinicalTrials.gov 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

October 25, 2012
November 20, 2012
May 28, 2015
September 2012
August 2015   (Final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01729624 on ClinicalTrials.gov Archive Site
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PRO Development for ANCA Associated Vasculitis
A Qualitative Study Using Interviews With Patients Who Have Anti-neutrophil Cytoplasm Antibody (ANCA) Associated Vasculitis, to Develop a Patient Reported Outcome (PRO) Measure
A qualitative study using interviews with patients who have antineutrophil cytoplasm antibody (ANCA) associated vasculitis, to develop a patient reported outcome (PRO)measure

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.

Time Perspective: Prospective
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Non-Probability Sample
Patients with ANCA-associated vasculitis seen at the Oxford University Hospitals NHS Trust.
  • Wegener Granulomatosis
  • Microscopic Polyangiitis
  • Churg-Strauss Syndrome
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
August 2015
August 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
Rec No: 12/SW/0252
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University of Oxford
University of Oxford
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University of Oxford
May 2015