Rheumatoid Arthritis Clinical Trial
Official title:
Assessment of Tender & Swollen Joints Count Score Performed by a Rheumatologist And Rheumatology Nurses in Patients With Rheumatoid Arthritis (RA) and Psoriatic Arthritis (PsA)
This study will establish a comparison in follow-up care of 100 patients between Health Care Practitioners, more specifically the rheumatologist and a trained nurse. The study objective is to show consistency of evaluation between two different health care professionals, a physician and a nurse.
This study involves one site in Canada. Patients will complete a self-evaluation of 28 joint
counts for swelling (SJC) and tenderness (TJC) and assess their disease activity on a Visual
Analog Scale (VAS). A 28 joint count and VAS will then be assessed by a nurse and by a
rheumatologist. Clinical Disease Activity Index (CDAI) and Disease Activity Severity 28 - C
Reactive protein (DAS28-CRP) will be calculated from each data set.
The same rheumatologist will examine all patients and two nurses will each randomly assess
half the total enrolled patients. The nurse will be blinded to the patient's joint count and
VAS, and similarly, the rheumatologist will be blinded to both the patient and nurse's
assessments. The setting includes 2 nurses with different educational background: one
technician and one bachelor.
The training provided to the nurses in this study allows them to master the basis of the
physical exam, joint count and history of the rheumatoid patient as well as to learn the
pertinent laboratory parameters. It is a 14-hour course in which the patient is examined
through observation, palpation, assessment of mobility and stability and specific movement.
Diagnostic tools such as the Simplified Disease Activity Index (SDAI), Health Assessment
Questionnaire Disability Index (HAQ), CDAI and DAS-28 are included in the patient evaluation.
Each enrolled patient will receive a 5-minute training in joint assessment by the nurse. The
use of the mannequin for joint assessment of swelling and tenderness will be reviewed.
Objective signs of disease such as swelling, redness and heat will be explained as well as
the difference between inflammation and bony swelling, the latter being indicative of
osteoarthritis.
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