Employment and Arthritis: Making it Work (MIW)

• ClinicalTrials.gov Identifier: NCT01852851
• Recruitment Status: Active, not recruiting
• First Posted: May 14, 2013
• Last Update Posted: May 17, 2018
• Sponsor: University of British Columbia
• 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: April 13, 2012
• First Posted Date: May 14, 2013
• Last Update Posted Date: May 17, 2018
• Study Start Date: June 2013
• Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Employment and Arthritis: Making it Work
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• Rheumatoid Arthritis
• Ankylosing Spondylitis
• Lupus Erythematosus, Systemic
• Psoriatic Arthritis
• Other Connective Tissue Diseases
• Spondylarthropathy

Intervention

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

• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: May 11, 2018): 528
• Original Estimated Enrollment (submitted: May 9, 2013): 526
• Estimated Study Completion Date: June 2023
• Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 59 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT01852851
• Other Study ID Numbers: H11-03527
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Diane Lacaille, University of British Columbia
• Study Sponsor: University of British Columbia

Collaborators

• Canadian Institutes of Health Research (CIHR)
• University of Toronto
• University of Calgary
• Simon Fraser University

Investigators

• 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