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

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ClinicalTrials.gov Identifier: NCT02556034
Recruitment Status : Completed
First Posted : September 22, 2015
Last Update Posted : February 1, 2019
Sponsor:
Collaborator:
Janssen Inc.
Information provided by (Responsible Party):
Isabelle Fortin, Centre de Rhumatologie de l'Est du Québec

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
Rheumatoid Arthritis Psoriatic Arthritis Other: Disease evaluation.

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.

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official 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)
Study Start Date : September 2015
Actual Primary Completion Date : November 16, 2018
Actual Study Completion Date : November 16, 2018


Group/Cohort 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The target population will be subjects with active Rheumatoid Arthritis or Psoriatic Arthritis.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556034


Locations
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Canada, Quebec
Centre de Rhumatologie de L'Est Du Quebec
Rimouski, Quebec, Canada, G5L 8W1
Sponsors and Collaborators
Isabelle Fortin
Janssen Inc.
Investigators
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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
Publications of Results:

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Responsible Party: Isabelle Fortin, Rheumatologist, Centre de Rhumatologie de l'Est du Québec
ClinicalTrials.gov Identifier: NCT02556034    
Other Study ID Numbers: CNTO148ART4009
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases