PRO Development for ANCA Associated Vasculitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by University of Oxford
Sponsor:
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01729624
First received: October 25, 2012
Last updated: November 14, 2012
Last verified: November 2012
  Purpose

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


Condition
Wegener Granulomatosis
Microscopic Polyangiitis
Churg-Strauss Syndrome

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 50
Study Start Date: September 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with ANCA-associated vasculitis seen at the Oxford University Hospitals NHS Trust.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01729624

Contacts
Contact: Joanna C Robson, MBBS PhD 01865227329 joanna.robson@ndorms.ox.ac.uk
Contact: Raashid Luqmani, DM FRCP, FRCP(E) 01865227807 raashid.luqmani@ndorms.ox.ac.uk

Locations
United Kingdom
University of Oxford Recruiting
Oxford, Oxfordshire, United Kingdom, OX37LD
Principal Investigator: Joanna C Robson, MBBS PhD         
Sponsors and Collaborators
University of Oxford
  More Information

No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01729624     History of Changes
Other Study ID Numbers: Rec No: 12/SW/0252
Study First Received: October 25, 2012
Last Updated: November 14, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Oxford:
Wegener Granulomatosis
Microscopic Polyangiitis
Churg-Strauss Syndrome
Antibodies, Antineutrophil Cytoplasmic

Additional relevant MeSH terms:
Churg-Strauss Syndrome
Vasculitis
Systemic Vasculitis
Wegener Granulomatosis
Syndrome
Microscopic Polyangiitis
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Autoimmune Diseases
Immune System Diseases
Disease
Pathologic Processes
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Granuloma
Lymphoproliferative Disorders
Lymphatic Diseases
Antibodies, Antineutrophil Cytoplasmic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014