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Employment and Arthritis: Making it Work (MIW)

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ClinicalTrials.gov Identifier: NCT01852851
Recruitment Status : Active, not recruiting
First Posted : May 14, 2013
Last Update Posted : May 17, 2018
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
University of Toronto
University of Calgary
Simon Fraser University
Information provided by (Responsible Party):
Diane Lacaille, University of British Columbia

Tracking Information
First Submitted Date  ICMJE April 13, 2012
First Posted Date  ICMJE May 14, 2013
Last Update Posted Date May 17, 2018
Study Start Date  ICMJE June 2013
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2013)
  • Efficacy analysis of at work productivity [ Time Frame: 2 years post intervention ]
    Primary outcome for efficacy analysis of at-work productivity will be measured using the Work Instability Scale (WIS)
  • Efficacy analysis of work cessation [ Time Frame: Over 5 years of follow up ]
    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.
  • Cost effectiveness analysis of at work productivity [ Time Frame: 2 years post intervention ]
    Primary outcome for cost effectiveness analysis of at work productivity will be measured using the Work Productivity and Activity Impairment (WPAI)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2013)
  • Temporary work cessation [ Time Frame: Up to 5 years ]
    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
  • Occasional work absence [ Time Frame: Up to 5 years ]
    Number of days missed from work per year, measured by self report
  • Reduction in usual amount of time worked [ Time Frame: Up to 5 years ]
    Reduction in hours per week worked per year, measured by self report
  • Changes in employment risk factors [ Time Frame: Up to 5 years ]
    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
  • At-work productivity [ Time Frame: Up to 5 years ]
    Evaluating maintenance of effect on at work productivity over 5 years using the Work Instability Scale (WIS)
  • At work productivity [ Time Frame: Up to 5 years ]
    Evaluating maintenance of effect on at work productivity over 5 years using the Work Productivity and Activity Impairment (WPAI)
  • At work productivity [ Time Frame: Up to 5 years ]
    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).
  • Cost utility analysis of at work productivity [ Time Frame: 2 years post intervention ]
    Outcome for cost utility analysis of at work productivity will be quality adjusted life year (QALY) measured using EQ-5D.
  • Cost utility analysis of at work productivity [ Time Frame: 2 years post intervention ]
    Outcome for cost utility analysis of at work productivity will be quality adjusted life year (QALY) measured using SF-6D.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Employment and Arthritis: Making it Work
Official Title  ICMJE Employment and Arthritis: Making it Work: A Randomized Controlled Trial Evaluating an On-line Program to Help People With Inflammatory Arthritis Remain Employed
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Rheumatoid Arthritis
  • Ankylosing Spondylitis
  • Lupus Erythematosus, Systemic
  • Psoriatic Arthritis
  • Other Connective Tissue Diseases
  • Spondylarthropathy
Intervention  ICMJE Behavioral: Employment and Arthritis: Making it Work
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.
Study Arms  ICMJE
  • Active Comparator: Intervention Group
    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
    Intervention: Behavioral: Employment and Arthritis: Making it Work
  • No Intervention: Control Group
    The control group will receive "usual care" and receive printed educational materials about work and arthritis.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 11, 2018)
528
Original Estimated Enrollment  ICMJE
 (submitted: May 9, 2013)
526
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Between ages 18 and 59 years
  • Able to read and write English
  • Have inflammatory arthritis confirmed by a rheumatologist (Rheumatoid Arthritis, Ankylosing Spondylitis, Lupus Erythematosus, Systemic, Psoriatic Arthritis, Other Connective Tissue Diseases and Spondylarthropathy)
  • Have access to a computer, a web-cam, a headset and a printer, or willingness to purchase these items
  • 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

Exclusion Criteria:

  • Individuals who are not working
  • Individuals on sick leave, short term or long term work disability
  • Students
  • People performing unpaid work such as volunteer work or taking care of family
  • People planning to retire in the next six years
  • Individuals unable to provide informed consent
  • Individuals living outside of British Columbia, Alberta, Ontario
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 59 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01852851
Other Study ID Numbers  ICMJE H11-03527
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Diane Lacaille, University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE
  • Canadian Institutes of Health Research (CIHR)
  • University of Toronto
  • University of Calgary
  • Simon Fraser University
Investigators  ICMJE
Principal Investigator: Diane Lacaille, MD, FRCPC, MHSc University of British Columbia and Arthritis Research Centre
PRS Account University of British Columbia
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP