PRO Development for ANCA Associated Vasculitis

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Brief Title

PRO Development for ANCA Associated Vasculitis

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

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
    

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.
    


Study Type

Observational


Primary Outcome

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.


Condition

Wegener Granulomatosis



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

50

Start Date

September 2012

Completion Date

August 2015

Primary Completion Date

August 2015

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT01729624

Organization ID

Rec No: 12/SW/0252


Responsible Party

Sponsor

Study Sponsor

University of Oxford


Study Sponsor

, , 


Verification Date

May 2015