Employment and Arthritis: Making it Work (MIW)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01852851|
Recruitment Status : Active, not recruiting
First Posted : May 14, 2013
Last Update Posted : May 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis Ankylosing Spondylitis Lupus Erythematosus, Systemic Psoriatic Arthritis Other Connective Tissue Diseases Spondylarthropathy||Behavioral: Employment and Arthritis: Making it Work||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||528 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|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|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2023|
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
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.
No Intervention: Control Group
The control group will receive "usual care" and receive printed educational materials about work and arthritis.
- 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)
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01852851
|Canada, British Columbia|
|Arthritis Research Centre|
|Richmond, British Columbia, Canada, V6X 2C7|
|Principal Investigator:||Diane Lacaille, MD, FRCPC, MHSc||University of British Columbia and Arthritis Research Centre|