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

January 31, 2019 updated by: Isabelle Fortin

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Rimouski, Quebec, Canada, G5L 8W1
        • Centre de Rhumatologie de l'Est du Quebec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The target population will be subjects with active Rheumatoid Arthritis or Psoriatic Arthritis.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 months
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.
6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isabelle Fortin

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

November 16, 2018

Study Completion (Actual)

November 16, 2018

Study Registration Dates

First Submitted

September 15, 2015

First Submitted That Met QC Criteria

September 18, 2015

First Posted (Estimate)

September 22, 2015

Study Record Updates

Last Update Posted (Actual)

February 1, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNTO148ART4009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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