- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01852851
Employment and Arthritis: Making it Work (MIW)
April 27, 2026 updated by: Diane Lacaille, University of British Columbia
Employment and Arthritis: Making it Work: A Randomized Controlled Trial Evaluating an On-line Program to Help People With Inflammatory Arthritis Remain Employed
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
528
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
British Columbia
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Richmond, British Columbia, Canada, V6X 2C7
- Arthritis Research Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 59 years (Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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
|
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.
|
|
No Intervention: Control Group
The control group will receive "usual care" and receive printed educational materials about work and arthritis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
2 years post intervention
|
|
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.
|
Over 5 years of follow up
|
|
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)
|
2 years post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Up to 5 years
|
|
Occasional work absence
Time Frame: Up to 5 years
|
Number of days missed from work per year, measured by self report
|
Up to 5 years
|
|
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
|
Up to 5 years
|
|
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
|
Up to 5 years
|
|
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)
|
Up to 5 years
|
|
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)
|
Up to 5 years
|
|
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).
|
Up to 5 years
|
|
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.
|
2 years post intervention
|
|
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.
|
2 years post intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Diane Lacaille, MD, FRCPC, MHSc, University of British Columbia and Arthritis Research Centre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
March 1, 2025
Study Completion (Estimated)
May 1, 2027
Study Registration Dates
First Submitted
April 13, 2012
First Submitted That Met QC Criteria
May 9, 2013
First Posted (Estimated)
May 14, 2013
Study Record Updates
Last Update Posted (Actual)
May 1, 2026
Last Update Submitted That Met QC Criteria
April 27, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Axial Spondyloarthritis
- Bone Diseases
- Musculoskeletal Diseases
- Arthritis
- Joint Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Autoimmune Diseases
- Immune System Diseases
- Spinal Diseases
- Ankylosis
- Skin Diseases, Papulosquamous
- Skin Diseases
- Spondylarthritis
- Spondylitis
- Psoriasis
- Skin and Connective Tissue Diseases
- Lupus Erythematosus, Systemic
- Spondylitis, Ankylosing
- Arthritis, Rheumatoid
- Arthritis, Psoriatic
- Spondylarthropathies
- Socioeconomic Factors
- Population Characteristics
- Employment
Other Study ID Numbers
- H11-03527
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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