- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01707186
Pictorial Representation of Illness and Self Measure (PRISM)
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
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Oxford, United Kingdom, OX3 7HE
- Nuffield Orthopaedic Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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).
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
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Group 1A
Early phase, requiring change in treatment
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Group 2
Established phase, stable treatment
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Group 2A
Established phase, requiring a change in treatment
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Group 1
Early phase, stable treatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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PRISM/PRISM+
Time Frame: 30 September 2015
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Questionnaires
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30 September 2015
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Peter Taylor, FRCP, PhD, University of Oxford
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010930
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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