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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02556034
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Isabelle Fortin
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

NABIL CHAKER, BIOLOGISTISABELLE FORTIN, MDFRÉDÉRIC BANVILLE, Ph.D
Principal Investigator Affiliation CENTRE DE RHUMATOLOGIE DE L'EST DU QUEBECCENTRE DE RHUMATOLOGIE DE L'EST DU QUEBECUniversité de Montréal
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rheumatoid Arthritis, Psoriatic Arthritis
Additional Details

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.

Contact a Trial Team

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International Sites

Rimouski, Quebec, Canada

Status

Recruiting

Address

Centre de Rhumatologie de L'Est Du Quebec

Rimouski, Quebec, G5L 8W1

Site Contact

NABIL CHAKER, BIOLOGIST

nabil.chaker@crequebec.ca

418 723 2445 #201

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