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

NCT02556034 | Completed

• 1 other identifier: CNTO148ART4009
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis; Psoriatic Arthritis

Outcome Measures

Primary Outcomes (2)

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

  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.

  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 Outcomes (4)

• Comparison of TJC results between 3 raters.

  6 months

• Comparison of SJC results between 3 raters.

  6 months

• Comparison of VAS results between 3 raters.

  6 months

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

  6 months

Study Arms (1)

Disease evaluation

Rheumatoid arthritis evaluations.

Other: Disease evaluation.

Interventions

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.

Disease evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Isabelle Fortin: lead
• Janssen Inc.: collaborator

Study Sites (1)

Centre de Rhumatologie de L'Est Du Quebec

Rimouski, Quebec, G5L 8W1, Canada

Location

Related Publications (14)

• 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.

  PMID: 20215140 RESULT

• 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.

  PMID: 20237122 RESULT

• 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.

  PMID: 22473918 RESULT

• 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.

  PMID: 25365082 RESULT

• 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.

  PMID: 22417647 RESULT

• 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.

  PMID: 20235213 RESULT

• 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.

  PMID: 22562935 RESULT

• 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.

  PMID: 24046468 RESULT

• 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.

  PMID: 19918045 RESULT

• 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.

  PMID: 17444590 RESULT

• 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.

  PMID: 23928236 RESULT

• 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.

  PMID: 20461787 RESULT

• 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.

  PMID: 16291813 RESULT

• 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.

  PMID: 24332117 RESULT

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Study Officials

• NABIL CHAKER, BIOLOGIST

  CENTRE DE RHUMATOLOGIE DE L'EST DU QUEBEC

  STUDY DIRECTOR

• ISABELLE FORTIN, MD

  CENTRE DE RHUMATOLOGIE DE L'EST DU QUEBEC

  PRINCIPAL INVESTIGATOR

• FRÉDÉRIC BANVILLE, Ph.D

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Rheumatologist

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: September 22, 2015
• Study Start: September 1, 2015
• Primary Completion: November 16, 2018
• Study Completion: November 16, 2018
• Last Updated: February 1, 2019

Record last verified: 2019-01

Locations

CA (1)