Rheumatoid ArthritisNCT00000416
Prevention of Arthritis-Related Work Disability
A study testing Rehabilitation counseling in people with Rheumatoid Arthritis and Systemic Lupus Erythematosus, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
People with rheumatic disorders (arthritis) often have trouble keeping their jobs. This study will look at whether vocational rehabilitation (VR) will improve the ability of employed people with arthritis to keep their jobs. Job retention VR services target key factors that increase the risk of job loss. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis, Systemic Lupus Erythematosus, Osteoarthritis, Knee
- What is being tested?
- Rehabilitation counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1997to Aug 2001
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must currently be employed full or part time
- Must live in selected communities in eastern Massachusetts
Who cannot join
- Plans to move from area
- Plans to have joint replacement surgery in next 6 months
- Plans to retire or go on disability within next 2 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University School of Medicine
Boston, Massachusetts, 02118
About this study
Official title: Prevention of Arthritis-Related Work Disability: A Trial of Job Retention Services Provided to Employed Persons With Arthritis
People with rheumatic disorders (arthritis) often have trouble keeping their jobs. This study will look at whether vocational rehabilitation (VR) will improve the ability of employed people with arthritis to keep their jobs. Job retention VR services target key factors that increase the risk of job loss. They aim to modify jobs to reduce barriers caused by functional limitations and disease symptoms, future career planning, and establish a partnership with a VR counselor for ongoing help.
We will conduct the study among patients with rheumatic disorders recruited in eastern Massachusetts. We will give 120 study participants job retention services provided by VR counselors. We will give another 120 participants literature about employment- related resources. We will compare the outcomes of the two groups to evaluate the usefulness of job retention services in preventing job loss in people with rheumatic disorders.
Read the detailed description
Job loss commonly occurs among people with rheumatic disorders. This study will determine whether vocational rehabilitation (VR) provided to employed people with rheumatic disorders will improve their ability to remain employed. VR is applied primarily to people who have already lost their jobs. However, using job retention VR services may prevent, or delay, the onset of employment work loss among people with rheumatic disorders. Job retention VR services target important employment-loss risk factors. They do so by modifying jobs to reduce barriers posed by functional limitations and symptoms, promoting future career planning, and establishing an alliance with a VR counselor for ongoing assistance.
The study is a randomized, controlled trial conducted among patients with rheumatic disorders recruited from the practices of rheumatologists in eastern Massachusetts.
We will randomly assign 120 study participants to receive job-retention services provided by VR counselors and 120 participants (controls) to receive literature about employment-related resources. We will assess intermediate outcome variables (self-efficacy, work limitations, and job accommodation-seeking behaviors) and the endpoint outcome variable, work instability (a measure that includes employment loss), immediately prior to the interventions and at 6-month intervals over a 24-month period after the interventions are carried out. We will compare the outcomes of the two groups to evaluate the usefulness of job retention services in forestalling work instability in this population.
- Conditions
- Rheumatoid Arthritis, Systemic Lupus Erythematosus, Osteoarthritis, Knee, Ankylosing Spondylitis
- Being tested
- Rehabilitation counseling
- Keywords
- Arthritis, Rheumatic disorders, Work-related disability, Vocational rehabilitation (VR), Job retention services, Work limitations, Work instability
- Medical subject headings
- Arthritis, Rheumatoid, Lupus Erythematosus, Systemic, Osteoarthritis, Knee, Spondylitis, Ankylosing, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation counselingOther
Provided in 2 in-person meetings and in follow-up phone calls
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation counseling | Experimental | Rehabilitation counseling
Experimental
Rehabilitation counseling was provided by rehabilitation counselors. They administered the Work Experience Survey; provided and discussed disability rights and responsibilities and provided career counseling they as needed. Receives: Other: Rehabilitation counseling |
| printed information | Active comparator | Active comparator
Control group participants received relevant printed information in the mail only; no rehabilitation counseling Receives: Other: Rehabilitation counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
job losses
Periods of work cessation of at least 6 months.
Measured: every 6 months for up to 42 months
Secondary outcomes (1)
limitation in ability to work
Extent of on the job limitation due to health condition as measured by the Work Limitations Questionnaire.
Measured: every 6 months for up to 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startSep 1997
- Primary completionAug 2001
- Study completionAug 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Boston University
- Responsible party
- Principal investigator, Saralynn J. Allaire, Boston University
- Investigators
- Saralynn J. Allaire, Sc.D., Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000416
- Sponsor's protocol ID
- P60AR020613
- Other IDs
- P60AR020613, NIAMS-012, EEHRS Project 3
- Status last verified
- Jul 2017
- First submitted
- 3 Nov 1999
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Allaire SH, Li W, LaValley,M: Work Problems reported by employed persons with reheumatic diseases and their association with work satisfaction. Arthritis Rheumatic 43:S128,2000
Allaire SH, Li W, LaValley, M. Can job retention vocational rehabilitation services reduce work disability among employed persons with rheumatic diseases? Arthritis Rheum 44 (supplement):S813, 2001.
Allaire SH. Update on work disability in rheumatic diseases. Curr Opin Rheumatol. 2001 Mar;13(2):93-8. doi: 10.1097/00002281-200103000-00001.
PubMed 11224732de Buck PD, Schoones JW, Allaire SH, Vliet Vlieland TP. Vocational rehabilitation in patients with chronic rheumatic diseases: a systematic literature review. Semin Arthritis Rheum. 2002 Dec;32(3):196-203. doi: 10.1053/sarh.2002.34609.
PubMed 12528084Allaire SH, Li W, LaValley MP. Reduction of job loss in persons with rheumatic diseases receiving vocational rehabilitation: a randomized controlled trial. Arthritis Rheum. 2003 Nov;48(11):3212-8. doi: 10.1002/art.11256.
PubMed 14613285Allaire SH, Niu J, Lavalley MP. Employment and Satisfaction Outcomes From a Job Retention Intervention Delivered to Persons with Chronic Diseases. Rehabilitation Counseling Bulletin 48(2):100-109, 2005
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Arthritis-Related Work Disability: A Trial of Job Retention Services Provided to Employed Persons With Arthritis
- ClinicalTrials.gov ID
- NCT00000416
- Acronym / sponsor ID
- P60AR020613
- Conditions
- Rheumatoid Arthritis, Systemic Lupus Erythematosus, Osteoarthritis, Knee, Ankylosing Spondylitis
- Keywords
- Arthritis, Rheumatic disorders, Work-related disability, Vocational rehabilitation (VR), Job retention services, Work limitations, Work instability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Boston University
- Study start
- Sep 1997
- Primary completion
- Aug 2001 (actual)
- Study completion
- Aug 2001 (actual)
- First posted
- 4 Nov 1999 (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.
People with rheumatic disorders (arthritis) often have trouble keeping their jobs. This study will look at whether vocational rehabilitation (VR) will improve the ability of employed people with arthritis to keep their jobs. Job retention VR services target key factors that increase the risk of job loss. They aim to modify jobs to reduce barriers caused by functional limitations and disease symptoms, future career planning, and establish a partnership with a VR counselor for ongoing help.
We will conduct the study among patients with rheumatic disorders recruited in eastern Massachusetts. We will give 120 study participants job retention services provided by VR counselors. We will give another 120 participants literature about employment- related resources. We will compare the outcomes of the two groups to evaluate the usefulness of job retention services in preventing job loss in people with rheumatic disorders.
Detailed description
Job loss commonly occurs among people with rheumatic disorders. This study will determine whether vocational rehabilitation (VR) provided to employed people with rheumatic disorders will improve their ability to remain employed. VR is applied primarily to people who have already lost their jobs. However, using job retention VR services may prevent, or delay, the onset of employment work loss among people with rheumatic disorders. Job retention VR services target important employment-loss risk factors. They do so by modifying jobs to reduce barriers posed by functional limitations and symptoms, promoting future career planning, and establishing an alliance with a VR counselor for ongoing assistance.
The study is a randomized, controlled trial conducted among patients with rheumatic disorders recruited from the practices of rheumatologists in eastern Massachusetts.
We will randomly assign 120 study participants to receive job-retention services provided by VR counselors and 120 participants (controls) to receive literature about employment-related resources. We will assess intermediate outcome variables (self-efficacy, work limitations, and job accommodation-seeking behaviors) and the endpoint outcome variable, work instability (a measure that includes employment loss), immediately prior to the interventions and at 6-month intervals over a 24-month period after the interventions are carried out. We will compare the outcomes of the two groups to evaluate the usefulness of job retention services in forestalling work instability in this population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation counseling | Experimental | Other: Rehabilitation counselingRehabilitation counseling Experimental Rehabilitation counseling was provided by rehabilitation counselors. They administered the Work Experience Survey; provided and discussed disability rights and responsibilities and provided career counseling they as needed. |
| printed information | Active comparator | Other: Rehabilitation counselingActive comparator Control group participants received relevant printed information in the mail only; no rehabilitation counseling |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must currently be employed full or part time
- Must live in selected communities in eastern Massachusetts
Key exclusion criteria (3 listed)
- Plans to move from area
- Plans to have joint replacement surgery in next 6 months
- Plans to retire or go on disability within next 2 years
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 |
|---|---|---|
| Rehabilitation counselingProvided in 2 in-person meetings and in follow-up phone calls | Other | Rehabilitation counseling, printed information |
Primary outcome
job losses
Time frame: every 6 months for up to 42 months
Periods of work cessation of at least 6 months.
1 secondary outcome
limitation in ability to work
Time frame: every 6 months for up to 42 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 26 Jul 2017.
- BackgroundAllaire SH, Li W, LaValley,M: Work Problems reported by employed persons with reheumatic diseases and their association with work satisfaction. Arthritis Rheumatic 43:S128,2000
- BackgroundAllaire SH, Li W, LaValley, M. Can job retention vocational rehabilitation services reduce work disability among employed persons with rheumatic diseases? Arthritis Rheum 44 (supplement):S813, 2001.
- Background: PubMed 11224732Allaire SH. Update on work disability in rheumatic diseases. Curr Opin Rheumatol. 2001 Mar;13(2):93-8. doi: 10.1097/00002281-200103000-00001.
- Background: PubMed 12528084de Buck PD, Schoones JW, Allaire SH, Vliet Vlieland TP. Vocational rehabilitation in patients with chronic rheumatic diseases: a systematic literature review. Semin Arthritis Rheum. 2002 Dec;32(3):196-203. doi: 10.1053/sarh.2002.34609.
- Results publication: PubMed 14613285Allaire SH, Li W, LaValley MP. Reduction of job loss in persons with rheumatic diseases receiving vocational rehabilitation: a randomized controlled trial. Arthritis Rheum. 2003 Nov;48(11):3212-8. doi: 10.1002/art.11256.
- Results publicationAllaire SH, Niu J, Lavalley MP. Employment and Satisfaction Outcomes From a Job Retention Intervention Delivered to Persons with Chronic Diseases. Rehabilitation Counseling Bulletin 48(2):100-109, 2005
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
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.
Saralynn J. Allaire, Sc.D. principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation counseling in people with Rheumatoid Arthritis and Systemic Lupus Erythematosus, run by Boston University Charles River Campus 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 2 inclusion and 3 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 26 Jul 2017. 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?
job losses (time frame: every 6 months for up to 42 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000416, which also lists 6 linked publications.
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 26 Jul 2017.