Assessment of Tender & Swollen Joints Count Score Performed by a Rheumatologist And Rheumatology Nurses in Patients With Rheumatoid Arthritis (RA) and Psoriatic Arthritis (PsA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Accuracy of the nurse CDAI result compared to the rheumatologist CDAI result.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is ≥18 years of age.
- •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.
- •The subject must be able to provide written informed consent and to complete the study questionnaires.
排除标准
- •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
研究组 & 干预措施
Disease evaluation
Rheumatoid arthritis evaluations.
干预措施: Disease evaluation. (Other)
结局指标
主要结局
Accuracy of the nurse CDAI result compared to the rheumatologist CDAI result.
时间窗: 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.
时间窗: 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.
次要结局
- Comparison of TJC results between 3 raters.(6 months)
- Comparison of SJC results between 3 raters.(6 months)
- Comparison of VAS results between 3 raters.(6 months)
- Comparison of time taken by 3 raters to perform disease assessments.(6 months)
研究者
Isabelle Fortin
Rheumatologist
Centre de Rhumatologie de l'Est du Québec
