Employment and Arthritis: Making it Work (MIW)
Primary Purpose
Rheumatoid Arthritis, Ankylosing Spondylitis, Lupus Erythematosus, Systemic
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Employment and Arthritis: Making it Work
Sponsored by
About this trial
This is an interventional supportive care trial for Rheumatoid Arthritis
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
Sites / Locations
- Arthritis Research Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intervention Group
Control Group
Arm 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
The control group will receive "usual care" and receive printed educational materials about work and arthritis.
Outcomes
Primary Outcome Measures
Efficacy analysis of at work productivity
Primary outcome for efficacy analysis of at-work productivity will be measured using the Work Instability Scale (WIS)
Efficacy analysis of work cessation
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
Primary outcome for cost effectiveness analysis of at work productivity will be measured using the Work Productivity and Activity Impairment (WPAI)
Secondary Outcome Measures
Temporary work cessation
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
Number of days missed from work per year, measured by self report
Reduction in usual amount of time worked
Reduction in hours per week worked per year, measured by self report
Changes in employment risk factors
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
Evaluating maintenance of effect on at work productivity over 5 years using the Work Instability Scale (WIS)
At work productivity
Evaluating maintenance of effect on at work productivity over 5 years using the Work Productivity and Activity Impairment (WPAI)
At work productivity
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
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
Outcome for cost utility analysis of at work productivity will be quality adjusted life year (QALY) measured using SF-6D.
Full Information
NCT ID
NCT01852851
First Posted
April 13, 2012
Last Updated
May 30, 2022
Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR), University of Toronto, University of Calgary, Simon Fraser University
1. Study Identification
Unique Protocol Identification Number
NCT01852851
Brief Title
Employment and Arthritis: Making it Work
Acronym
MIW
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 Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2013 (undefined)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR), University of Toronto, University of Calgary, Simon Fraser University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Ankylosing Spondylitis, Lupus Erythematosus, Systemic, Psoriatic Arthritis, Other Connective Tissue Diseases, Spondylarthropathy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
528 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Active Comparator
Arm 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
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group will receive "usual care" and receive printed educational materials about work and arthritis.
Intervention Type
Behavioral
Intervention Name(s)
Employment and Arthritis: Making it Work
Intervention 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.
Primary Outcome Measure Information:
Title
Efficacy analysis of at work productivity
Description
Primary outcome for efficacy analysis of at-work productivity will be measured using the Work Instability Scale (WIS)
Time Frame
2 years post intervention
Title
Efficacy analysis of work cessation
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.
Time Frame
Over 5 years of follow up
Title
Cost effectiveness analysis of at work productivity
Description
Primary outcome for cost effectiveness analysis of at work productivity will be measured using the Work Productivity and Activity Impairment (WPAI)
Time Frame
2 years post intervention
Secondary Outcome Measure Information:
Title
Temporary work cessation
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
Time Frame
Up to 5 years
Title
Occasional work absence
Description
Number of days missed from work per year, measured by self report
Time Frame
Up to 5 years
Title
Reduction in usual amount of time worked
Description
Reduction in hours per week worked per year, measured by self report
Time Frame
Up to 5 years
Title
Changes in employment risk factors
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
Time Frame
Up to 5 years
Title
At-work productivity
Description
Evaluating maintenance of effect on at work productivity over 5 years using the Work Instability Scale (WIS)
Time Frame
Up to 5 years
Title
At work productivity
Description
Evaluating maintenance of effect on at work productivity over 5 years using the Work Productivity and Activity Impairment (WPAI)
Time Frame
Up to 5 years
Title
At work productivity
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).
Time Frame
Up to 5 years
Title
Cost utility analysis of at work productivity
Description
Outcome for cost utility analysis of at work productivity will be quality adjusted life year (QALY) measured using EQ-5D.
Time Frame
2 years post intervention
Title
Cost utility analysis of at work productivity
Description
Outcome for cost utility analysis of at work productivity will be quality adjusted life year (QALY) measured using SF-6D.
Time Frame
2 years post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diane Lacaille, MD, FRCPC, MHSc
Organizational Affiliation
University of British Columbia and Arthritis Research Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arthritis Research Centre
City
Richmond
State/Province
British Columbia
ZIP/Postal Code
V6X 2C7
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
25043631
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.
Results Reference
derived
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Employment and Arthritis: Making it Work
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