Pictorial Representation of Illness and Self Measure

Rheumatoid Arthritis Clinical Trial

— PRISM  

Official title:

Pictorial Representation of Illness and Self Measure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01707186
• Other study ID #: 2010930
• Status: Completed
• Start date: October 18, 2012
• Est. completion date: June 30, 2018

Study information

• Verified date: October 2017
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
United Kingdom	Nuffield Orthopaedic Centre	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	UCB Pharma

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PRISM/PRISM+	Questionnaires	30 September 2015