NCT01852851

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
528

participants targeted

Target at P75+ for not_applicable rheumatoid-arthritis

Timeline
12mo left

Started Jun 2013

Longer than P75 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Jun 2013May 2027

First Submitted

Initial submission to the registry

April 13, 2012

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

May 14, 2013

Completed
18 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
11.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Expected
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

11.8 years

First QC Date

April 13, 2012

Last Update Submit

April 27, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (9)

  • Temporary work cessation

    Up to 5 years

  • Occasional work absence

    Up to 5 years

  • Reduction in usual amount of time worked

    Up to 5 years

  • Changes in employment risk factors

    Up to 5 years

  • At-work productivity

    Up to 5 years

  • +4 more secondary outcomes

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

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

Control Group

NO INTERVENTION

The control group will receive "usual care" and receive printed educational materials about work and arthritis.

Interventions

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.

Intervention Group

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arthritis Research Centre

Richmond, British Columbia, V6X 2C7, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Arthritis, RheumatoidSpondylitis, AnkylosingLupus Erythematosus, SystemicArthritis, PsoriaticSpondylarthropathies

Interventions

Employment

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesAxial SpondyloarthritisSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesAnkylosisPsoriasisSkin Diseases, PapulosquamousSkin Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Diane Lacaille, MD, FRCPC, MHSc

    University of British Columbia and Arthritis Research Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 13, 2012

First Posted

May 14, 2013

Study Start

June 1, 2013

Primary Completion

March 1, 2025

Study Completion (Estimated)

May 1, 2027

Last Updated

May 1, 2026

Record last verified: 2026-04

Locations