APRAN: Assessment of Tender & Swollen Joints Count Score Performed by a Rheumatologist And Rheumatology Nurses in Patients With RA and PsA.
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Disease evaluation Rheumatoid arthritis evaluations. |
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.
|
Outcome Measures
Primary Outcome Measures
- Accuracy of the nurse CDAI result compared to the rheumatologist CDAI result. [6 months]
To validate the accuracy of assessment of RA and PsA disease activity by a nurse trained in joint examination using the CDAI as compared to a rheumatologist's same assessment. The level of agreement between evaluators will be investigated using Cohen's Kappa, a statistic tool useful to the measurement of inter-rater agreement for qualitative traits.
- Accuracy of the nurse DAS-28 result compared to the rheumatologist DAS-28 result. [6 months]
To validate the accuracy of assessment of RA and PsA disease activity by a nurse trained in joint examination using the DAS-28 as compared to a rheumatologist's same assessment. The level of agreement between evaluators will be investigated using Cohen's Kappa, a statistic tool useful to the measurement of inter-rater agreement for qualitative traits.
Secondary Outcome Measures
- Comparison of TJC results between 3 raters. [6 months]
The TJC results from the patient self-assessment, nurse assessment and physician assessment are compared.
- Comparison of SJC results between 3 raters. [6 months]
The SJC results from the patient self-assessment, nurse assessment and physician assessment are compared.
- Comparison of VAS results between 3 raters. [6 months]
The VAS results from the patient self-assessment, nurse assessment and physician assessment are compared.
- Comparison of time taken by 3 raters to perform disease assessments. [6 months]
To compare the time taken by the rheumatologist, nurse and patient to complete each part of the joint count assessment and the VAS. An ANOVA will be used to verify if a significant difference is present in the assessment time between the different raters.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject is ≥18 years of age.
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Has at least one of the following diagnosis at screening
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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.
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Subject must have a diagnosis of active PsA by Classification Criteria for Psoriatic Arthritis (CASPAR) and has disease duration of more than 6 months.
- The subject must be able to provide written informed consent and to complete the study questionnaires.
Exclusion Criteria:
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Subject with DIP involvement in PsA
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Subject with predominant axial symptoms (spondyloarthropathy)
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Subject with fibromyalgia
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Subject involved in a concomitant study
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Subject currently takes ≥10 mg cortisone daily
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Subject has taken opioid analgesics within 12 hours of joint count assessment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre de Rhumatologie de L'Est Du Quebec | Rimouski | Quebec | Canada | G5L 8W1 |
Sponsors and Collaborators
- Isabelle Fortin
- Janssen Inc.
Investigators
- Study Director: NABIL CHAKER, BIOLOGIST, CENTRE DE RHUMATOLOGIE DE L'EST DU QUEBEC
- Principal Investigator: ISABELLE FORTIN, MD, CENTRE DE RHUMATOLOGIE DE L'EST DU QUEBEC
- Principal Investigator: FRÉDÉRIC BANVILLE, Ph.D, Université de Montréal
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CNTO148ART4009