NCT01707186

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 16, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

October 18, 2012

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

April 30, 2019

Status Verified

October 1, 2017

Enrollment Period

4.7 years

First QC Date

October 11, 2012

Last Update Submit

April 29, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • PRISM/PRISM+

    Questionnaires

    30 September 2015

Study Arms (4)

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 Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with rheumatoid arthritis from hospital clinics

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nuffield Orthopaedic Centre

Oxford, OX3 7HE, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Peter Taylor, FRCP, PhD

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2012

First Posted

October 16, 2012

Study Start

October 18, 2012

Primary Completion

June 30, 2017

Study Completion

June 30, 2018

Last Updated

April 30, 2019

Record last verified: 2017-10

Locations