Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-28 @ 10:22 AM
Study NCT ID:
NCT00400868
Status:
COMPLETED
Last Update Posted:
2010-02-24
First Post:
2006-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Occupational Therapy in Patients With Rheumatoid Arthritis(RCT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-23', 'studyFirstSubmitDate': '2006-11-15', 'studyFirstSubmitQcDate': '2006-11-15', 'lastUpdatePostDateStruct': {'date': '2010-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'joint protection behavior', 'timeFrame': 'before/after intervention, 3,6,12 months follow up'}], 'secondaryOutcomes': [{'measure': 'General quality of life', 'timeFrame': 'before intervention, 3,6,12 months follow up'}, {'measure': 'Health related quality of life / physical functional ability', 'timeFrame': 'before intervention, 6,12 months follow up'}, {'measure': 'Self-Illness Separation SIS, derived from the PRISM (intervention group)', 'timeFrame': 'before/during/after intervention, 3,6,12 months follow up'}, {'measure': 'Goals achievement (intervention group)', 'timeFrame': 'during/after intervention, 3,6,12 months follow up'}, {'measure': 'Hand impairment status, including pain', 'timeFrame': 'before/during/after intervention, 3,6,12 months follow up'}, {'measure': 'Arthritis self-efficacy and JP-specific self-efficacy', 'timeFrame': 'before/after intervention, 3,6,12 months follow up'}, {'measure': 'Self-perceived disease activity', 'timeFrame': 'before intervention, 12 months follow up'}, {'measure': 'Clinical data', 'timeFrame': 'before intervention, 3, 12 months follow up'}]}, 'conditionsModule': {'keywords': ['rheumatoid arthritis, occupational therapy, joint protection'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare the short- and long-term effectiveness of an individualized, resource-oriented joint protection intervention with the standard, problem-oriented joint protection intervention for patients with rheumatoid arthritis.', 'detailedDescription': 'Joint Protection (JP)is an important intervention in the management of people with arthritis. Altering working methods (e.g. use of proximal joints, dynamic activities), energy conservation (balance between activity and rest) and using assistive devices should place less strain on joint structures weakened by the disease process. These strategies ought to decrease pain and stress on joints, improve function, and facilitate maintaining social roles.\n\nThe effectiveness of JP has been evaluated in a number of studies, all in a group setting. JP has beneficial short-term effects on pain and function in patients with established RA and moderate functional problems. Using assistive devices reduces pain during task performance in comparison to normal methods and altering working methods significantly reduces difficulties in activities of daily living (ADL). However this generally does not result in significant behavioral changes and a long-term impact on reducing pain and maintaining function may only be reached if JP is taught using behavioral education methods. Additionally, adherence of RA patients to different interventions is generally modest, which may well determine the effectiveness of any given intervention, especially in the long-term.\n\nAll previous studies were carried out in group settings, however, in Switzerland, standard JP education is provided on a one-to-one basis and an individualized education is assumed to be a promising approach.\n\nThis clinical trial aims to test the hypothesis that an individualized, resource-oriented JP education in RA patients leads to a better therapy success in the short and long-term, compared to problem-oriented standard JP education in terms of joint protection behavior. Secondary outcome parameters are self-perception, general and specific self-efficacy and general and health-related quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of RA according to ACR Guidelines (1988)\n* Actual hand pain on activity or history of wrist and/or metacarpophalangeal(MCP) joint pain and inflammation\n* Referred to OT for a Joint Protection intervention program\n* Willingness to comply with the randomly assigned treatment and informed consent\n* Functional Class: 2 to 4\n* German speaking/understanding/reading\n* Sufficient cognitive capacities to understand the aims and procedures of the proposed study and the requirements of participation\n\nExclusion Criteria:\n\n* Functional class 1 (anticipated self-exclusion, as patients in class 1 will not be referred to JP).\n* Severe finger, hand, elbow or shoulder deformities\n* Insufficient ability to understand, speak and read the German language\n* Insufficient cognitive capacities to understand the aims and procedures of the proposed study and the requirements of participation.'}, 'identificationModule': {'nctId': 'NCT00400868', 'briefTitle': 'Effectiveness of Occupational Therapy in Patients With Rheumatoid Arthritis(RCT)', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'A Randomized Controlled Study to Evaluate the Short- and Long-term Effectiveness of an Individualized Resource Oriented Occupational Therapy for Patients With Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'niedk_EK444_'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'standard joint protection education', 'description': 'psycho-educational joint protection vs. usual care (standard joint protection education)', 'interventionNames': ['Behavioral: psycho-educational Joint protection education']}], 'interventions': [{'name': 'psycho-educational Joint protection education', 'type': 'BEHAVIORAL', 'description': 'individualized psycho-educational joint protection education, 4-times over 3 weeks; one additional booster session 2 months later', 'armGroupLabels': ['standard joint protection education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'University Hospital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': '7317', 'city': 'Valens', 'country': 'Switzerland', 'facility': 'Rehabilitation Clinic', 'geoPoint': {'lat': 46.96658, 'lon': 9.47705}}, {'zip': '8008', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Schulthess Klinik', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'University Hospital', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Robert de Bie, Prof, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Maastricht NL'}, {'name': 'Karin Niedermann, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Zurich, CH'}, {'name': 'Stefan Buchi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital of Zurich, CH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Zürcher Rheumastifung, Zurich, Switzerland', 'class': 'OTHER'}, {'name': 'Gertrude and Wolfgang Schrader Dislich Foundation', 'class': 'OTHER'}, {'name': 'Swiss Ligue Against Rheumatism, Zurich, Switzerland', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Karin Niedermann, MPH', 'oldOrganization': 'University Hospital Zurich'}}}}