Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
University of Toronto
University of Calgary
Simon Fraser University
Information provided by (Responsible Party):
Diane Lacaille, University of British Columbia

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : June 2013
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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)

  2. 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.

  3. 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)


Secondary Outcome Measures :
  1. 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

  2. Occasional work absence [ Time Frame: Up to 5 years ]
    Number of days missed from work per year, measured by self report

  3. 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

  4. 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

  5. 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)

  6. 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)

  7. 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).

  8. 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.

  9. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Layout table for location information
Canada, British Columbia
Arthritis Research Centre
Richmond, British Columbia, Canada, V6X 2C7
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
University of Toronto
University of Calgary
Simon Fraser University
Investigators
Layout table for investigator information
Principal Investigator: Diane Lacaille, MD, FRCPC, MHSc University of British Columbia and Arthritis Research Centre
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Diane Lacaille, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT01852851    
Other Study ID Numbers: H11-03527
First Posted: May 14, 2013    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Spondylitis
Arthritis
Arthritis, Psoriatic
Spondylitis, Ankylosing
Spondylarthropathies
Connective Tissue Diseases
Lupus Erythematosus, Systemic
Joint Diseases
Musculoskeletal Diseases
Autoimmune Diseases
 Immune System Diseases
Bone Diseases, Infectious
Infection
Bone Diseases
Spinal Diseases
Spondylarthritis
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Ankylosis