Employment and Arthritis: Making it Work

Rheumatoid Arthritis Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01852851
• Other study ID #: H11-03527
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2013
• Est. completion date: June 2023

Study information

• Verified date: May 2022
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 528
• Est. completion date: June 2023
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

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

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.

Locations

Country	Name	City	State
Canada	Arthritis Research Centre	Richmond	British Columbia

Sponsors (5)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Institutes of Health Research (CIHR), Simon Fraser University, University of Calgary, University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy analysis of at work productivity	Primary outcome for efficacy analysis of at-work productivity will be measured using the Work Instability Scale (WIS)	2 years post intervention
Primary	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.	Over 5 years of follow up
Primary	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)	2 years post intervention
Secondary	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	Up to 5 years
Secondary	Occasional work absence	Number of days missed from work per year, measured by self report	Up to 5 years
Secondary	Reduction in usual amount of time worked	Reduction in hours per week worked per year, measured by self report	Up to 5 years
Secondary	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	Up to 5 years
Secondary	At-work productivity	Evaluating maintenance of effect on at work productivity over 5 years using the Work Instability Scale (WIS)	Up to 5 years
Secondary	At work productivity	Evaluating maintenance of effect on at work productivity over 5 years using the Work Productivity and Activity Impairment (WPAI)	Up to 5 years
Secondary	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).	Up to 5 years
Secondary	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.	2 years post intervention
Secondary	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.	2 years post intervention