OsteoarthritisNCT00485914
Work Interventions to Improve Employment Outcomes for Persons With Rheumatoid Arthritis and Osteoarthritis
A study testing On-site work evaluation and Educational material in people with Osteoarthritis and Rheumatoid Arthritis, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
To determine if worksite based functional evaluation/intervention provided by occupational therapists improves employment outcomes for persons with arthritis. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Rheumatoid Arthritis
- What is being tested?
- On-site work evaluation and Educational material
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Rheumatoid arthritis or osteoarthritis diagnosed by a rheumatologist
- Competitively employed; full or part time
- Reporting arthritis-related employment difficulties
- Agree to participate in a work site evaluation
Who cannot join
- Systemic complications of RA (e.g., vasculitis)
- Organic Brain Syndrome
- Uncontrolled psychiatric disorders
- Uncontrolled medical conditions (e.g., active cancer)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri-Columbia
Columbia, Missouri, 65212
About this study
Official title: Worksite Vocational Rehabilitation Intervention to Improve Employment Outcomes for Persons With Arthritis?
To determine if worksite based functional evaluation/intervention provided by occupational therapists improves employment outcomes for persons with arthritis.
Read the detailed description
Arthritis is second only to heart disease as a cause of work-related disability with significant financial costs associated with the loss of work for persons with arthritis. Many persons with arthritis have physical impairments which affect their ability to work, with 50% of persons with rheumatoid arthritis leaving employment within 10 years of diagnosis. Risk factors predicting employability, length of employment and worksite accommodations for workers with arthritis have been well documented. Variables predicting work cessation include blue collar jobs and more physically demanding jobs, an older age of the worker, lower education, perceived job strain, social support of co-workers and supervisors, job satisfaction, and self-efficacy. Recent studies of self-report by persons with arthritis identified the use of worksite accommodations such as others providing assistance at work, job autonomy, time flexibility, and use of special equipment. Unknown is the effect of on-site work interventions. The need exists to determine if the provision of strategies for physical accommodations, worksite modifications, and assistive technologies at the individual's job site improves the ability of persons with arthritis to continue working.
This is a randomized clinical trial to investigate the efficacy of a worksite based intervention to improve the employment outcomes of persons with rheumatoid (RA) or osteoarthritis (OA). Persons with RA or OA who have arthritis related work difficulties will have an occupational therapist provide a worksite evaluation and subsequent training in strategies to accommodate arthritis related physical impairments and improve job performance and satisfaction. Participants in control group will be provided with educational printed materials related for a self-initiated worksite evaluation of musculoskeletal and environmental risks at the worksite for persons with arthritis.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis
- Being tested
- On-site work evaluation, Educational material
- Keywords
- employment, work
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On-site work evaluationBehavioural
Researchers will measure the effects of worksite assessment through an on-site work evaluation by an occupational therapist on a person's job satisfaction, capacity to perform work duties, income, health status, and psychological well-being. The scope of the information will be through one-to-one contact and an individualized work plan. The strategies will include recommendations for work behaviors, ergonomic and body mechanics considerations, and modifications for job tasks, equipment, and space.
Educational materialBehavioural
Researchers will measure the effects of worksite assessment through educational materials on a person's job satisfaction, capacity to perform work duties, income, health status, and psychological well-being. The scope of the information will be through educational materials to develop strategies to compensate. The strategies will include recommendations for work behaviors, ergonomic and body mechanics considerations, and modifications for job tasks, equipment, and space.
| Study group | Role | What they receive |
|---|---|---|
| On-site work evaluation | Experimental | Participants will receive one-to-one contact with an occupational therapist and an individualized work plan Receives: Behavioral: On-site work evaluation |
| Educational material | Active comparator | Participants will receive educational materials to develop strategies to compensate for limitations caused by their condition Receives: Behavioral: Educational material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arthritis Impact Measurement Scale-2, Brief Symptom Inventory, Job Satisfaction Survey, Occupational Data information, Work History, Employment Status, Financial Information
Measured: Scores at baseline, 3, 6, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2007 (estimated)
- Study startOct 2003
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Education
- Responsible party
- Sponsor
- Investigators
- George Johnstone, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00485914
- Sponsor's protocol ID
- H133B031120-Project 3
- Status last verified
- Oct 2016
- First submitted
- 11 Jun 2007
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Worksite Vocational Rehabilitation Intervention to Improve Employment Outcomes for Persons With Arthritis?
- ClinicalTrials.gov ID
- NCT00485914
- Acronym / sponsor ID
- H133B031120-Project 3
- Conditions
- Osteoarthritis, Rheumatoid Arthritis
- Keywords
- employment, work
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- U.S. Department of Education
- Study start
- Oct 2003
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 13 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if worksite based functional evaluation/intervention provided by occupational therapists improves employment outcomes for persons with arthritis.
Detailed description
Arthritis is second only to heart disease as a cause of work-related disability with significant financial costs associated with the loss of work for persons with arthritis. Many persons with arthritis have physical impairments which affect their ability to work, with 50% of persons with rheumatoid arthritis leaving employment within 10 years of diagnosis. Risk factors predicting employability, length of employment and worksite accommodations for workers with arthritis have been well documented. Variables predicting work cessation include blue collar jobs and more physically demanding jobs, an older age of the worker, lower education, perceived job strain, social support of co-workers and supervisors, job satisfaction, and self-efficacy. Recent studies of self-report by persons with arthritis identified the use of worksite accommodations such as others providing assistance at work, job autonomy, time flexibility, and use of special equipment. Unknown is the effect of on-site work interventions. The need exists to determine if the provision of strategies for physical accommodations, worksite modifications, and assistive technologies at the individual's job site improves the ability of persons with arthritis to continue working.
This is a randomized clinical trial to investigate the efficacy of a worksite based intervention to improve the employment outcomes of persons with rheumatoid (RA) or osteoarthritis (OA). Persons with RA or OA who have arthritis related work difficulties will have an occupational therapist provide a worksite evaluation and subsequent training in strategies to accommodate arthritis related physical impairments and improve job performance and satisfaction. Participants in control group will be provided with educational printed materials related for a self-initiated worksite evaluation of musculoskeletal and environmental risks at the worksite for persons with arthritis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| On-site work evaluation | Experimental | Behavioral: On-site work evaluationParticipants will receive one-to-one contact with an occupational therapist and an individualized work plan |
| Educational material | Active comparator | Behavioral: Educational materialParticipants will receive educational materials to develop strategies to compensate for limitations caused by their condition |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Rheumatoid arthritis or osteoarthritis diagnosed by a rheumatologist
- Competitively employed; full or part time
- Reporting arthritis-related employment difficulties
- Agree to participate in a work site evaluation
Key exclusion criteria (4 listed)
- Systemic complications of RA (e.g., vasculitis)
- Organic Brain Syndrome
- Uncontrolled psychiatric disorders
- Uncontrolled medical conditions (e.g., active cancer)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| On-site work evaluationResearchers will measure the effects of worksite assessment through an on-site work evaluation by an occupational therapist on a person's job satisfaction, capacity to perform work duties, income, health status, and psychological well-being. The scope of the information will be through one-to-one contact and an individualized work plan. The strategies will include recommendations for work behaviors, ergonomic and body mechanics considerations, and modifications for job tasks, equipment, and space. | Behavioural | On-site work evaluation |
| Educational materialResearchers will measure the effects of worksite assessment through educational materials on a person's job satisfaction, capacity to perform work duties, income, health status, and psychological well-being. The scope of the information will be through educational materials to develop strategies to compensate. The strategies will include recommendations for work behaviors, ergonomic and body mechanics considerations, and modifications for job tasks, equipment, and space. | Behavioural | Educational material |
Primary outcome
Arthritis Impact Measurement Scale-2, Brief Symptom Inventory, Job Satisfaction Survey, Occupational Data information, Work History, Employment Status, Financial Information
Time frame: Scores at baseline, 3, 6, 12, 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Johnstone, PhD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On-site work evaluation and Educational material in people with Osteoarthritis and Rheumatoid Arthritis, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arthritis Impact Measurement Scale-2, Brief Symptom Inventory, Job Satisfaction Survey, Occupational Data information, Work History, Employment Status, Financial Information (time frame: Scores at baseline, 3, 6, 12, 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2016.