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Pictorial Representation of Illness and Self Measure (PRISM)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01707186
First received: October 11, 2012
Last updated: May 2, 2017
Last verified: May 2017
  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 ]
    Questionnaires


Enrollment: 220
Study Start Date: October 2012
Estimated Study Completion Date: June 30, 2018
Estimated Primary Completion Date: June 30, 2017 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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

Locations
United Kingdom
Nuffield Orthopaedic Centre
Oxford, United Kingdom, OX3 7HE
Sponsors and Collaborators
University of Oxford
UCB Pharma
Investigators
Principal Investigator: Peter Taylor, FRCP, PhD University of Oxford
  More Information

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: May 2, 2017

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

ClinicalTrials.gov processed this record on June 22, 2017