Assessment of Tender & Swollen Joints Count Score Performed by a Rheumatologist And Rheumatology Nurses in Patients With RA and PsA.
NCT ID: NCT02556034
Last Updated: 2019-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
80 participants
OBSERVATIONAL
2015-09-30
2018-11-16
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Disease evaluation
Rheumatoid arthritis evaluations.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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 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
18 Years
ALL
Yes
Sponsors
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Janssen Inc.
INDUSTRY
Isabelle Fortin
OTHER
Responsible Party
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Isabelle Fortin
Rheumatologist
Principal Investigators
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NABIL CHAKER, BIOLOGIST
Role: STUDY_DIRECTOR
CENTRE DE RHUMATOLOGIE DE L'EST DU QUEBEC
ISABELLE FORTIN, MD
Role: PRINCIPAL_INVESTIGATOR
CENTRE DE RHUMATOLOGIE DE L'EST DU QUEBEC
FRÉDÉRIC BANVILLE, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Université de Montréal
Locations
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Centre de Rhumatologie de L'Est Du Quebec
Rimouski, Quebec, Canada
Countries
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References
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Smolen JS, Aletaha D, Bijlsma JW, Breedveld FC, Boumpas D, Burmester G, Combe B, Cutolo M, de Wit M, Dougados M, Emery P, Gibofsky A, Gomez-Reino JJ, Haraoui B, Kalden J, Keystone EC, Kvien TK, McInnes I, Martin-Mola E, Montecucco C, Schoels M, van der Heijde D; T2T Expert Committee. Treating rheumatoid arthritis to target: recommendations of an international task force. Ann Rheum Dis. 2010 Apr;69(4):631-7. doi: 10.1136/ard.2009.123919. Epub 2010 Mar 9.
Atar D, Birkeland KI, Uhlig T. 'Treat to target': moving targets from hypertension, hyperlipidaemia and diabetes to rheumatoid arthritis. Ann Rheum Dis. 2010 Apr;69(4):629-30. doi: 10.1136/ard.2010.128462. No abstract available.
Anderson J, Caplan L, Yazdany J, Robbins ML, Neogi T, Michaud K, Saag KG, O'Dell JR, Kazi S. Rheumatoid arthritis disease activity measures: American College of Rheumatology recommendations for use in clinical practice. Arthritis Care Res (Hoboken). 2012 May;64(5):640-7. doi: 10.1002/acr.21649.
Scott IC, Scott DL. Joint counts in inflammatory arthritis. Clin Exp Rheumatol. 2014 Sep-Oct;32(5 Suppl 85):S-7-12. Epub 2014 Oct 30.
Radner H, Grisar J, Smolen JS, Stamm T, Aletaha D. Value of self-performed joint counts in rheumatoid arthritis patients near remission. Arthritis Res Ther. 2012 Mar 14;14(2):R61. doi: 10.1186/ar3777.
Cheung PP, Ruyssen-Witrand A, Gossec L, Paternotte S, Le Bourlout C, Mazieres M, Dougados M. Reliability of patient self-evaluation of swollen and tender joints in rheumatoid arthritis: A comparison study with ultrasonography, physician, and nurse assessments. Arthritis Care Res (Hoboken). 2010 Aug;62(8):1112-9. doi: 10.1002/acr.20178.
Tillett W, Shaddick G, Korendowych E, de Vries CS, McHugh N. Joint count reliability in psoriatic arthritis observational trials--an unreported problem. Rheumatology (Oxford). 2012 Jul;51(7):1333-4. doi: 10.1093/rheumatology/kes095. Epub 2012 May 4. No abstract available.
Janta I, Naredo E, Martinez-Estupinan L, Nieto JC, De la Torre I, Valor L, Estopinan L, Bello N, Hinojosa M, Gonzalez CM, Lopez-Longo J, Monteagudo I, Montoro M, Carreno L. Patient self-assessment and physician's assessment of rheumatoid arthritis activity: which is more realistic in remission status? A comparison with ultrasonography. Rheumatology (Oxford). 2013 Dec;52(12):2243-50. doi: 10.1093/rheumatology/ket297. Epub 2013 Sep 17.
Barton JL, Criswell LA, Kaiser R, Chen YH, Schillinger D. Systematic review and metaanalysis of patient self-report versus trained assessor joint counts in rheumatoid arthritis. J Rheumatol. 2009 Dec;36(12):2635-41. doi: 10.3899/jrheum.090569. Epub 2009 Nov 16.
Levy G, Cheetham C, Cheatwood A, Burchette R. Validation of patient-reported joint counts in rheumatoid arthritis and the role of training. J Rheumatol. 2007 Jun;34(6):1261-5. Epub 2007 Apr 15.
Cheung PP, Dougados M, Andre V, Balandraud N, Chales G, Chary-Valckenaere I, Dernis E, Gill G, Gilson M, Guis S, Mouterde G, Pavy S, Pouyol F, Marhadour T, Richette P, Ruyssen-Witrand A, Soubrier M, Nguyen M, Gossec L. The learning curve of nurses for the assessment of swollen and tender joints in rheumatoid arthritis. Joint Bone Spine. 2014 Mar;81(2):154-9. doi: 10.1016/j.jbspin.2013.06.006. Epub 2013 Aug 6.
Farragher TM, Lunt M, Plant D, Bunn DK, Barton A, Symmons DP. Benefit of early treatment in inflammatory polyarthritis patients with anti-cyclic citrullinated peptide antibodies versus those without antibodies. Arthritis Care Res (Hoboken). 2010 May;62(5):664-75. doi: 10.1002/acr.20207.
Pincus T, Segurado OG. Most visits of most patients with rheumatoid arthritis to most rheumatologists do not include a formal quantitative joint count. Ann Rheum Dis. 2006 Jun;65(6):820-2. doi: 10.1136/ard.2005.044230. Epub 2005 Nov 16.
Cheung PP, Gossec L, Mak A, March L. Reliability of joint count assessment in rheumatoid arthritis: a systematic literature review. Semin Arthritis Rheum. 2014 Jun;43(6):721-9. doi: 10.1016/j.semarthrit.2013.11.003. Epub 2013 Nov 13.
Other Identifiers
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CNTO148ART4009
Identifier Type: -
Identifier Source: org_study_id
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