Pictorial Representation of Illness and Self Measure

NCT ID: NCT01707186

Last Updated: 2019-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-18

Study Completion Date

2018-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1A

Early phase, requiring change in treatment

No interventions assigned to this group

Group 2

Established phase, stable treatment

No interventions assigned to this group

Group 2A

Established phase, requiring a change in treatment

No interventions assigned to this group

Group 1

Early phase, stable treatment

No interventions assigned to this group

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Pharma

INDUSTRY

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Taylor, FRCP, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

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Nuffield Orthopaedic Centre

Oxford, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2010930

Identifier Type: -

Identifier Source: org_study_id

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