Clinical trial NCT01852851: Employment and Arthritis: Making it Work
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
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis
Ankylosing Spondylitis
Lupus Erythematosus, Systemic
Psoriatic Arthritis
Other Connective Tissue Diseases
Spondylarthropathy
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: University of Toronto
name: University of Calgary
name: Simon Fraser University
First posted: 2013-05-14
Enrollment: 528
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Efficacy analysis of at work productivity
timeFrame: 2 years post intervention
measure: Efficacy analysis of work cessation
timeFrame: Over 5 years of follow up
measure: Cost effectiveness analysis of at work productivity
timeFrame: 2 years post intervention
Secondary outcomes:
measure: Temporary work cessation
timeFrame: Up to 5 years
measure: Occasional work absence
timeFrame: Up to 5 years
measure: Reduction in usual amount of time worked
timeFrame: Up to 5 years
measure: Changes in employment risk factors
timeFrame: Up to 5 years
measure: At-work productivity
timeFrame: Up to 5 years
measure: At work productivity
timeFrame: Up to 5 years
measure: At work productivity
timeFrame: Up to 5 years
measure: Cost utility analysis of at work productivity
timeFrame: 2 years post intervention
measure: Cost utility analysis of at work productivity
timeFrame: 2 years post intervention
Other outcomes:
Locations:
city: Richmond
country: Canada
facility: Arthritis Research Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia and Arthritis Research Centre
name: Diane Lacaille, MD, FRCPC, MHSc
role: PRINCIPAL_INVESTIGATOR
References:
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.