NCT02556034

Assessment of Tender & Swollen Joints Count Score Performed by a Rheumatologist And Rheumatology Nurses in Patients With RA and PsA.

Assessment of Tender & Swollen Joints Count Score Performed by a Rheumatologist And Rheumatology Nurses in Patients With Rheumatoid Arthritis (RA) and Psoriatic Arthritis (PsA)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: Isabelle Fortin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Rheumatoid Arthritis
• Psoriatic Arthritis

Interventions

Type	Name	Description
OTHER	Disease evaluation.	Patients will complete a self-evaluation of 28 joint counts for swelling and tenderness and assess their disease activity on a Visual Analog Scale. A 28 joint count and VAS will then be assessed by a nurse and by a rheumatologist. 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.

Timeline

• Start date: 2015-09-01
• Primary completion: 2018-11-16
• Completion: 2018-11-16
• First posted: 2015-09-22
• Last updated: 2019-02-01

Locations

1 site across 1 country: Canada