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Completed

NCT Number: NCT02556034

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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

Treatment and study plan

Disease evaluation.

Other

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.

Primary outcomes

  1. Accuracy of the nurse CDAI result compared to the rheumatologist CDAI result.

    Time frame: 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.

  2. Accuracy of the nurse DAS-28 result compared to the rheumatologist DAS-28 result.

    Time frame: 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 outcomes

  1. Comparison of TJC results between 3 raters.

    Time frame: 6 months

    The TJC results from the patient self-assessment, nurse assessment and physician assessment are compared.

  2. Comparison of SJC results between 3 raters.

    Time frame: 6 months

    The SJC results from the patient self-assessment, nurse assessment and physician assessment are compared.

  3. Comparison of VAS results between 3 raters.

    Time frame: 6 months

    The VAS results from the patient self-assessment, nurse assessment and physician assessment are compared.

  4. Comparison of time taken by 3 raters to perform disease assessments.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Isabelle Fortin

Other

Collaborators

  • Janssen Inc.

Registry information

Official study 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)

Acronym: APRAN

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 22, 2015
Registry last updated
Feb 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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