PRO Development for ANCA Associated Vasculitis

Status Active, not recruiting

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Churg-Strauss Syndrome
Microscopic Polyangiitis
Systemic Vasculitis
Vasculitis
Wegener Granulomatosis

Clinical Trial Details

NCT number	NCT01729624
Study type	Observational
Source	University of Oxford
Contact
Status	Active, not recruiting
Phase	N/A
Start date	September 2012
Completion date	August 2015

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.