Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-03-30 @ 7:45 PM
Study NCT ID:
NCT01852851
Status:
UNKNOWN
Last Update Posted:
2022-06-01
First Post:
2012-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Employment and Arthritis: Making it Work
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}, {'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D015535', 'term': 'Arthritis, Psoriatic'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}], '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': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004651', 'term': 'Employment'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 528}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-30', 'studyFirstSubmitDate': '2012-04-13', 'studyFirstSubmitQcDate': '2013-05-09', 'lastUpdatePostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy analysis of at work productivity', 'timeFrame': '2 years post intervention', 'description': 'Primary outcome for efficacy analysis of at-work productivity will be measured using the Work Instability Scale (WIS)'}, {'measure': 'Efficacy analysis of work cessation', 'timeFrame': 'Over 5 years of follow up', 'description': 'Primary outcome for efficacy analysis of work cessation is time to complete work cessation, defined as complete cessation of work due to any reason, for at least six months.'}, {'measure': 'Cost effectiveness analysis of at work productivity', 'timeFrame': '2 years post intervention', 'description': 'Primary outcome for cost effectiveness analysis of at work productivity will be measured using the Work Productivity and Activity Impairment (WPAI)'}], 'secondaryOutcomes': [{'measure': 'Temporary work cessation', 'timeFrame': 'Up to 5 years', 'description': 'Time to temporary cessation of work for any reason (E.g. sick leave or temporary work disability and short periods of unemployment) for more than 2 months but less than 6 months'}, {'measure': 'Occasional work absence', 'timeFrame': 'Up to 5 years', 'description': 'Number of days missed from work per year, measured by self report'}, {'measure': 'Reduction in usual amount of time worked', 'timeFrame': 'Up to 5 years', 'description': 'Reduction in hours per week worked per year, measured by self report'}, {'measure': 'Changes in employment risk factors', 'timeFrame': 'Up to 5 years', 'description': 'Changes from baseline in job satisfaction, self-efficacy at work, work-related risk factors for work disability (physical demand, job autonomy, difficulty commuting, self-employment and support from co-workers, employers and family), job accommodations and job type, measured by self report'}, {'measure': 'At-work productivity', 'timeFrame': 'Up to 5 years', 'description': 'Evaluating maintenance of effect on at work productivity over 5 years using the Work Instability Scale (WIS)'}, {'measure': 'At work productivity', 'timeFrame': 'Up to 5 years', 'description': 'Evaluating maintenance of effect on at work productivity over 5 years using the Work Productivity and Activity Impairment (WPAI)'}, {'measure': 'At work productivity', 'timeFrame': 'Up to 5 years', 'description': 'New scale being developed and validated to measure at work productivity. Based on a combination of Workplace Activity Limitations Scale (WALS) and Work Limitations Questionnaire (WLQ).'}, {'measure': 'Cost utility analysis of at work productivity', 'timeFrame': '2 years post intervention', 'description': 'Outcome for cost utility analysis of at work productivity will be quality adjusted life year (QALY) measured using EQ-5D.'}, {'measure': 'Cost utility analysis of at work productivity', 'timeFrame': '2 years post intervention', 'description': 'Outcome for cost utility analysis of at work productivity will be quality adjusted life year (QALY) measured using SF-6D.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis', 'Ankylosing Spondylitis', 'Lupus Erythematosus, Systemic', 'Psoriatic Arthritis', 'Other Connective Tissue Diseases', 'Spondylarthropathy']}, 'referencesModule': {'references': [{'pmid': '25043631', 'type': 'DERIVED', 'citation': 'Carruthers EC, Rogers P, Backman CL, Goldsmith CH, Gignac MA, Marra C, Village J, Li LC, Esdaile JM, Lacaille D. "Employment and arthritis: making it work" a randomized controlled trial evaluating an online program to help people with inflammatory arthritis maintain employment (study protocol). BMC Med Inform Decis Mak. 2014 Jul 21;14:59. doi: 10.1186/1472-6947-14-59.'}]}, 'descriptionModule': {'briefSummary': 'The investigators plan to conduct a randomized controlled trial to evaluate the effectiveness and the cost effectiveness of an on-line eLearning program (entitled Employment and Arthritis: Making it Work) designed to help people with inflammatory arthritis stay employed. The program also includes assessments with 1) an occupational therapist, and 2) a vocational rehabilitation counsellor at the end of the program to help participants identify and obtain necessary changes at work. People from three provinces will be recruited from collaborators\' patient and program recipient lists. The study group will receive the program intervention and the control group will receive "usual care" and printed educational material. All participants will be followed for five years. The effectiveness of the program at improving at work productivity and reducing work cessation will be evaluated compared to a control group receiving printed material on employment and arthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between ages 18 and 59 years\n* Able to read and write English\n* Have inflammatory arthritis confirmed by a rheumatologist (Rheumatoid Arthritis, Ankylosing Spondylitis, Lupus Erythematosus, Systemic, Psoriatic Arthritis, Other Connective Tissue Diseases and Spondylarthropathy)\n* Have access to a computer, a web-cam, a headset and a printer, or willingness to purchase these items\n* Are willing to travel to Vancouver, Kelowna, Victoria, Prince Rupert, Prince George, Cranbrook or Kamloops, Calgary, Toronto, Newmarket or Brampton for one visit with an occupational therapist\n\nExclusion Criteria:\n\n* Individuals who are not working\n* Individuals on sick leave, short term or long term work disability\n* Students\n* People performing unpaid work such as volunteer work or taking care of family\n* People planning to retire in the next six years\n* Individuals unable to provide informed consent\n* Individuals living outside of British Columbia, Alberta, Ontario'}, 'identificationModule': {'nctId': 'NCT01852851', 'acronym': 'MIW', 'briefTitle': 'Employment and Arthritis: Making it Work', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Employment and Arthritis: Making it Work: A Randomized Controlled Trial Evaluating an On-line Program to Help People With Inflammatory Arthritis Remain Employed', 'orgStudyIdInfo': {'id': 'H11-03527'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention Group', 'description': 'The intervention group will participate in the on-line eLearning program, an ergonomic assessment by an Occupational Therapist and job retention vocational counselling by a Vocational Rehabilitation Counsellor', 'interventionNames': ['Behavioral: Employment and Arthritis: Making it Work']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'The control group will receive "usual care" and receive printed educational materials about work and arthritis.'}], 'interventions': [{'name': 'Employment and Arthritis: Making it Work', 'type': 'BEHAVIORAL', 'description': 'A ten week on-line eLearning program designed to help people with inflammatory arthritis stay employed. The program consists of 1) 5 interactive web-based eLearning modules that participants will complete individually in between the weekly group sessions, 2) 5 weekly group sessions conducted as virtual real-time web-based group meetings led by a trained facilitator, 3) asynchronous communications such as a message board to facilitate additional interactions among participants, 4) consultations with an occupational therapist (in-person)for an ergonomic assessment, and a vocational rehabilitation counsellor (on-line consultation using web technology) for job retention vocational counselling.', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6X 2C7', 'city': 'Richmond', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Arthritis Research Centre', 'geoPoint': {'lat': 49.17003, 'lon': -123.13683}}], 'overallOfficials': [{'name': 'Diane Lacaille, MD, FRCPC, MHSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia and Arthritis Research Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}, {'name': 'University of Toronto', 'class': 'OTHER'}, {'name': 'University of Calgary', 'class': 'OTHER'}, {'name': 'Simon Fraser University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Diane Lacaille', 'investigatorAffiliation': 'University of British Columbia'}}}}