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.|
|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
|Condition or disease|
|Wegener Granulomatosis Microscopic Polyangiitis Churg-Strauss Syndrome|
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 Type :||Observational|
|Estimated Enrollment :||50 participants|
|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|
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01729624
|University of Oxford|
|Oxford, Oxfordshire, United Kingdom, OX37LD|