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

Isabelle Fortin

Status: Completed

Conditions: Psoriatic Arthritis; Rheumatoid Arthritis

Treatments: Other: Disease evaluation.

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02556034

CNTO148ART4009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Subject is ≥18 years of age.

2. Has at least one of the following diagnosis at screening

   • Subject has a diagnosis of RA as defined by the 1987- revised American College of Rheumatology (ACR)- classification criteria for RA and has disease duration of more than 6 months.
   • Subject must have a diagnosis of active PsA by Classification Criteria for Psoriatic Arthritis (CASPAR) and has disease duration of more than 6 months.

3. The subject must be able to provide written informed consent and to complete the study questionnaires.

Exclusion criteria

• Subject with DIP involvement in PsA
• Subject with predominant axial symptoms (spondyloarthropathy)
• Subject with fibromyalgia
• Subject involved in a concomitant study
• Subject currently takes ≥10 mg cortisone daily
• Subject has taken opioid analgesics within 12 hours of joint count assessment

Trial design

80 participants in 1 patient group

Disease evaluation

Description:

Rheumatoid arthritis evaluations.

Treatment:

Other: Disease evaluation.