Pictorial Representation of Illness and Self Measure (PRISM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by University of Oxford
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01707186
First received: October 11, 2012
Last updated: June 18, 2015
Last verified: June 2015
  Purpose

PRISM (Pictorial Representation of Illness and Self Measure) has been developed since the mid-1990s; the task was first developed as a simple measure of how a person was coping with his or her experience of illness. This is an international, multicentre study to evaluate the PRISM tool for the assessment of suffering in rheumatoid arthritis at different stages of the illness and the effect of treatment intervention. There are 5 sites: Berlin, Oxford, Limoges, Montreal and Queensland. The study will recruit 200 patients in total.

In addition to the procedures for the patient's routine clinical visit, the patients will be invited to answer a series of questionnaires and donate 20ml blood sample. Patients will be asked to attend 3 times over 24 weeks


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pictorial Representation of Illness and Self Measure

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • PRISM/PRISM+ [ Time Frame: 30 September 2015 ] [ Designated as safety issue: No ]
    Questionnaires


Estimated Enrollment: 200
Study Start Date: October 2012
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1A
Early phase, requiring change in treatment
Group 2
Established phase, stable treatment
Group 2A
Established phase, requiring a change in treatment
Group 1
Early phase, stable treatment

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with rheumatoid arthritis from hospital clinics

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.
  • Written confirmed diagnosed of rheumatoid arthritis

Exclusion Criteria:

  • A diagnosis of any of the following:
  • Multiple sclerosis
  • Motor neurone disease
  • Parkinson's disease
  • Alzheimer's disease
  • Depression or anxiety disorders as identified using the Patient depression screening questions from the patient health questionnaire 9 (PHQ9).
  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: NCT01707186

Contacts
Contact: Joanne MacDonald +441865 737211 joanne.macdonald@ndorms.ox.ac.uk

Locations
United Kingdom
Nuffield Orthopaedic Centre Recruiting
Oxford, United Kingdom, OX3 7HE
Contact: Joanne MacDonald    +441865 737211    joanne.macdonald@ndorms.ox.ac.uk   
Contact: Peter Taylor    +441865 227323    peter.taylor@kennedy.ox.ac.uk   
Principal Investigator: Peter C Taylor, FRCP, PhD         
Sponsors and Collaborators
University of Oxford
UCB Pharma
Investigators
Principal Investigator: Peter Taylor, FRCP, PhD University of Oxford
  More Information

No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01707186     History of Changes
Other Study ID Numbers: 2010930
Study First Received: October 11, 2012
Last Updated: June 18, 2015
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Arthritis
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 01, 2015