Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-01 @ 6:29 AM
Study NCT ID:
NCT02556034
Status:
COMPLETED
Last Update Posted:
2019-02-01
First Post:
2015-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Tender & Swollen Joints Count Score Performed by a Rheumatologist And Rheumatology Nurses in Patients With RA and PsA.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D015535', 'term': 'Arthritis, Psoriatic'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-31', 'studyFirstSubmitDate': '2015-09-15', 'studyFirstSubmitQcDate': '2015-09-18', 'lastUpdatePostDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of the nurse CDAI result compared to the rheumatologist CDAI result.', 'timeFrame': '6 months', 'description': "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."}, {'measure': 'Accuracy of the nurse DAS-28 result compared to the rheumatologist DAS-28 result.', 'timeFrame': '6 months', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Comparison of TJC results between 3 raters.', 'timeFrame': '6 months', 'description': 'The TJC results from the patient self-assessment, nurse assessment and physician assessment are compared.'}, {'measure': 'Comparison of SJC results between 3 raters.', 'timeFrame': '6 months', 'description': 'The SJC results from the patient self-assessment, nurse assessment and physician assessment are compared.'}, {'measure': 'Comparison of VAS results between 3 raters.', 'timeFrame': '6 months', 'description': 'The VAS results from the patient self-assessment, nurse assessment and physician assessment are compared.'}, {'measure': 'Comparison of time taken by 3 raters to perform disease assessments.', 'timeFrame': '6 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis', 'Psoriatic Arthritis']}, 'referencesModule': {'references': [{'pmid': '20215140', 'type': 'RESULT', 'citation': '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': '20237122', 'type': 'RESULT', 'citation': "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': '22473918', 'type': 'RESULT', 'citation': "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': '25365082', 'type': 'RESULT', 'citation': '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': '22417647', 'type': 'RESULT', 'citation': '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': '20235213', 'type': 'RESULT', 'citation': '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': '22562935', 'type': 'RESULT', 'citation': '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': '24046468', 'type': 'RESULT', 'citation': "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': '19918045', 'type': 'RESULT', 'citation': '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': '17444590', 'type': 'RESULT', 'citation': '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': '23928236', 'type': 'RESULT', 'citation': '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': '20461787', 'type': 'RESULT', 'citation': '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': '16291813', 'type': 'RESULT', 'citation': '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': '24332117', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThe 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.\n\nThe 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.\n\nEach 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The target population will be subjects with active Rheumatoid Arthritis or Psoriatic Arthritis.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject is ≥18 years of age.\n2. Has at least one of the following diagnosis at screening\n\n * 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.\n * Subject must have a diagnosis of active PsA by Classification Criteria for Psoriatic Arthritis (CASPAR) and has disease duration of more than 6 months.\n3. The subject must be able to provide written informed consent and to complete the study questionnaires.\n\nExclusion Criteria:\n\n* Subject with DIP involvement in PsA\n* Subject with predominant axial symptoms (spondyloarthropathy)\n* Subject with fibromyalgia\n* Subject involved in a concomitant study\n* Subject currently takes ≥10 mg cortisone daily\n* Subject has taken opioid analgesics within 12 hours of joint count assessment'}, 'identificationModule': {'nctId': 'NCT02556034', 'acronym': 'APRAN', 'briefTitle': 'Assessment of Tender & Swollen Joints Count Score Performed by a Rheumatologist And Rheumatology Nurses in Patients With RA and PsA.', 'organization': {'class': 'OTHER', 'fullName': "Centre de Rhumatologie de l'Est du Québec"}, 'officialTitle': 'Assessment of Tender & Swollen Joints Count Score Performed by a Rheumatologist And Rheumatology Nurses in Patients With Rheumatoid Arthritis (RA) and Psoriatic Arthritis (PsA)', 'orgStudyIdInfo': {'id': 'CNTO148ART4009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Disease evaluation', 'description': 'Rheumatoid arthritis evaluations.', 'interventionNames': ['Other: Disease evaluation.']}], 'interventions': [{'name': 'Disease evaluation.', 'type': 'OTHER', 'description': "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.", 'armGroupLabels': ['Disease evaluation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G5L 8W1', 'city': 'Rimouski', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre de Rhumatologie de L'Est Du Quebec", 'geoPoint': {'lat': 48.44879, 'lon': -68.52396}}], 'overallOfficials': [{'name': 'NABIL CHAKER, BIOLOGIST', 'role': 'STUDY_DIRECTOR', 'affiliation': "CENTRE DE RHUMATOLOGIE DE L'EST DU QUEBEC"}, {'name': 'ISABELLE FORTIN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "CENTRE DE RHUMATOLOGIE DE L'EST DU QUEBEC"}, {'name': 'FRÉDÉRIC BANVILLE, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Montréal'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isabelle Fortin', 'class': 'OTHER'}, 'collaborators': [{'name': 'Janssen Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Rheumatologist', 'investigatorFullName': 'Isabelle Fortin', 'investigatorAffiliation': "Centre de Rhumatologie de l'Est du Québec"}}}}