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Employment and Arthritis: Making it Work (MIW)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of British Columbia
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
University of Toronto
University of Calgary
Simon Fraser University
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01852851
First received: April 13, 2012
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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 Intervention
Rheumatoid Arthritis
Ankylosing Spondylitis
Lupus Erythematosus, Systemic
Psoriatic Arthritis
Other Connective Tissue Diseases
Spondylarthropathy
Behavioral: Employment and Arthritis: Making it Work

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Efficacy analysis of at work productivity [ Time Frame: 2 years post intervention ] [ Designated as safety issue: No ]
    Primary outcome for efficacy analysis of at-work productivity will be measured using the Work Instability Scale (WIS)

  • Efficacy analysis of work cessation [ Time Frame: Over 5 years of follow up ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 years post intervention ] [ Designated as safety issue: No ]
    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 Frame: Up to 5 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Number of days missed from work per year, measured by self report

  • Reduction in usual amount of time worked [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Reduction in hours per week worked per year, measured by self report

  • Changes in employment risk factors [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Evaluating maintenance of effect on at work productivity over 5 years using the Work Instability Scale (WIS)

  • At work productivity [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Evaluating maintenance of effect on at work productivity over 5 years using the Work Productivity and Activity Impairment (WPAI)

  • At work productivity [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 years post intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 years post intervention ] [ Designated as safety issue: No ]
    Outcome for cost utility analysis of at work productivity will be quality adjusted life year (QALY) measured using SF-6D.


Estimated Enrollment: 526
Study Start Date: June 2013
Estimated Study Completion Date: June 2023
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01852851

Contacts
Contact: Pamela A Rogers, MA 604-207-4016 progers@arthritisresearch.ca
Contact: Erin C Carruthers, BSc 604-207-4005 ecarruthers@arthritisresearch.ca

Locations
Canada, British Columbia
Arthritis Research Centre Recruiting
Richmond, British Columbia, Canada, V6X 2C7
Contact: Pamela A Rogers, MA    604-207-4016    progers@arthritisresearch.ca   
Contact: Erin C Carruthers, BSc    604-207-4005    ecarruthers@arthritisresearch.ca   
Principal Investigator: Diane Lacaille, MD, FRCPC, MHSc         
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
University of Toronto
University of Calgary
Simon Fraser University
Investigators
Principal Investigator: Diane Lacaille, MD, FRCPC, MHSc University of British Columbia and Arthritis Research Centre
  More Information

No publications provided by University of British Columbia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01852851     History of Changes
Other Study ID Numbers: H11-03527
Study First Received: April 13, 2012
Last Updated: July 28, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Arthritis, Rheumatoid
Connective Tissue Diseases
Lupus Erythematosus, Systemic
Spondylarthropathies
Spondylitis
Spondylitis, Ankylosing
Ankylosis
Autoimmune Diseases
Bone Diseases
Bone Diseases, Infectious
Immune System Diseases
Infection
Joint Diseases
Musculoskeletal Diseases
Psoriasis
Rheumatic Diseases
Skin Diseases
Skin Diseases, Papulosquamous
Spinal Diseases
Spondylarthritis

ClinicalTrials.gov processed this record on November 23, 2014