MIW: Employment and Arthritis: Making it Work

Sponsor

University of British Columbia (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01852851

Collaborator

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

528

Enrollment

Location

Arms

120

Duration (Months)

4.4

Patients Per Site Per Month

Study Details

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.

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

528 participants

Allocation:

Randomized

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 :

Jun 1, 2013

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

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	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.

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

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.

Outcome Measures

Primary Outcome Measures

Efficacy analysis of at work productivity [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 [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 [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)

Secondary Outcome Measures

Temporary work cessation [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 [Up to 5 years]
Number of days missed from work per year, measured by self report
Reduction in usual amount of time worked [Up to 5 years]
Reduction in hours per week worked per year, measured by self report
Changes in employment risk factors [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 [Up to 5 years]
Evaluating maintenance of effect on at work productivity over 5 years using the Work Instability Scale (WIS)
At work productivity [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 [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 [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 [2 years post intervention]
Outcome for cost utility analysis of at work productivity will be quality adjusted life year (QALY) measured using SF-6D.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 59 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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