ArthritisPhase 2NCT00000407
Improving Vocational Outcomes in Arthritis
A Phase 2 study testing Vocational counseling intervention in people with Arthritis and Musculoskeletal Diseases, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The long-term objectives of this research project are to enhance program participation and improve the employment prospects of people with work disability due to arthritis and related musculoskeletal disorders (ARMD) who are actively seeking vocational (job-related) rehabilitation (VR) services. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Arthritis, Musculoskeletal Diseases, Rheumatic Diseases
- What is being tested?
- Vocational counseling intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 326 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1997to Dec 2001
- Phase
- Phase 2
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Resident of Alabama
- Previously employed
- Currently unemployed due to musculoskeletal disability
- Feel capable of work
- Want to work
Who cannot join
- Not a resident of Alabama
- Unable to work
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
The long-term objectives of this research project are to enhance program participation and improve the employment prospects of people with work disability due to arthritis and related musculoskeletal disorders (ARMD) who are actively seeking vocational (job-related) rehabilitation (VR) services.
This study is designed to compare the employment situations of a group of people receiving a two-part intervention and a group that is not receiving the intervention. The intervention consists of training sessions to help prospective VR clients with ARMD successfully enter and complete the VR program, and training sessions for a randomly selected group of VR professionals to help them serve VR clients with ARMD more effectively.
Read the detailed description
The long-term objectives of this research project are to enhance program participation and improve the vocational outcomes of people with work disability due to arthritis and related musculoskeletal disorders (ARMD) who are actively seeking vocational rehabilitation services.
Some researchers think that people with work disability due to ARMD seeking vocational rehabilitation (VR) services who are exposed to an "agency access intervention" are more likely to gain entrance to the VR system and be determined eligible for services than are similar people not exposed to the intervention. Further, they think that people with work disability due to ARMD who are determined to be eligible for VR services, and who are exposed to an "agency enhancement intervention" while receiving services, are more likely to become and remain employed upon completion of the VR program than are similar people not exposed to the intervention.
The research design is a randomized, controlled, field experiment comparing the vocational outcomes of a group receiving a two-part intervention to those not receiving the intervention. The design allows us to evaluate separately each component of the intervention. The intervention consists of training sessions to help prospective VR clients with ARMD successfully enter and complete the VR program, and training sessions for a randomly selected group of VR professionals to help them serve VR clients with ARMD more effectively.
If this intervention strategy can significantly increase (1) VR utilization rates; (2) post-service employment rates; and (3) length of post-service employment in a previously underserved group with historically poor VR outcomes, it could have a significant role in reducing the immense impact, nationally, of work disability due to ARMD.
- Conditions
- Arthritis, Musculoskeletal Diseases, Rheumatic Diseases
- Being tested
- Vocational counseling intervention, Reading materials for control participants, Standard of care
- Keywords
- Arthritis and related musculoskeletal disorders (ARMD), Vocational rehabilitation (VR), Agency enhancement intervention, Health care service evaluation, Musculoskeletal disability, Return to work, Outcomes research, Unemployment, Work disability
- Medical subject headings
- Arthritis, Musculoskeletal Diseases, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vocational counseling interventionBehavioural
Reading materials for control participantsBehavioural
Standard of careBehavioural
No education or behavioral intervention
| Study group | Role | What they receive |
|---|---|---|
| Enrollment Intervention | Active comparator | The intervention consists of training sessions to help prospective VR clients with ARMD successfully enter and complete the vocational rehabilitation (VR) program, and training sessions for a randomly selected group of VR professionals to help them serve VR clients with ARMD more effectively. Receives: Behavioral: Vocational counseling intervention; Behavioral: Reading materials for control participants |
| Usual Care | Placebo comparator | Not described Receives: Behavioral: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved vocational outcomes
The long-term objectives of this research project are to enhance program participation and improve the vocational outcomes of people with work disability due to arthritis and related musculoskeletal disorders (ARMD) who are actively seeking vocational rehabilitation services.
Measured: baseline to 30 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 startJan 1997
- Study completionDec 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 ArthritisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Richard S. Maisiak, PhD, MSPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000407
- Sponsor's protocol ID
- P60AR020614
- Other IDs
- P60AR020614, NIAMS-024, Sub: EEHSR3
- Status last verified
- Sep 2015
- First submitted
- 3 Nov 1999
- Last updated
- 6 Jan 2016
- Results posted
- No
Publications
M White, R Maisiak, P Fine and K Straaton. Factors associated with low vocational capability in persons with musculoskeletal work disability. Abstract in Arthritis and Rheumatism, 42(9):S222, 1999.
R Maisiak, P Fine, M White and K Straaton. Barriers to participation in state-federal vocational rehabilitation servies for persons with musculoskeletal disability Abstract in Arthritis and Rheumatism, 42(9):S222, 1999.
White M, Maisiak R, Overman L, Paolone F, and Fine P. Increased enrollment of persons unemployed due to musculoskeletal disability to vocational rehabilitation services. Arthritis and Rheumatism, 43(9):S285, 2000.
Maisiak R, White W, Overman L, Paolone F, and P Fine. Health status (SF-36) barriers to return to work for persons with musculoskeletal disability. Arthritis and Rheumatism, 43(9):S285,2000.
Maisiak R, White W, Overman L, Paolone F, and P Fine. Improved return to work for arthritis patients in a supplementary state-federal vocational rehabilitation program. Arthritis and Rheumatism,44(9):S211,2001.
White M, Maisiak R, Overman L, Paolone F, and Fine P. Development of a work motivation scale for predicting return to work of arthritis patients. Arthritis and Rheumatism,44(9):S165,2001.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Vocational Outcomes in Arthritis
- ClinicalTrials.gov ID
- NCT00000407
- Acronym / sponsor ID
- P60AR020614
- Conditions
- Arthritis, Musculoskeletal Diseases, Rheumatic Diseases
- Keywords
- Arthritis and related musculoskeletal disorders (ARMD), Vocational rehabilitation (VR), Agency enhancement intervention, Health care service evaluation, Musculoskeletal disability, Return to work, Outcomes research, Unemployment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Jan 1997
- Study completion
- Dec 2001
- 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.
The long-term objectives of this research project are to enhance program participation and improve the employment prospects of people with work disability due to arthritis and related musculoskeletal disorders (ARMD) who are actively seeking vocational (job-related) rehabilitation (VR) services.
This study is designed to compare the employment situations of a group of people receiving a two-part intervention and a group that is not receiving the intervention. The intervention consists of training sessions to help prospective VR clients with ARMD successfully enter and complete the VR program, and training sessions for a randomly selected group of VR professionals to help them serve VR clients with ARMD more effectively.
Detailed description
The long-term objectives of this research project are to enhance program participation and improve the vocational outcomes of people with work disability due to arthritis and related musculoskeletal disorders (ARMD) who are actively seeking vocational rehabilitation services.
Some researchers think that people with work disability due to ARMD seeking vocational rehabilitation (VR) services who are exposed to an "agency access intervention" are more likely to gain entrance to the VR system and be determined eligible for services than are similar people not exposed to the intervention. Further, they think that people with work disability due to ARMD who are determined to be eligible for VR services, and who are exposed to an "agency enhancement intervention" while receiving services, are more likely to become and remain employed upon completion of the VR program than are similar people not exposed to the intervention.
The research design is a randomized, controlled, field experiment comparing the vocational outcomes of a group receiving a two-part intervention to those not receiving the intervention. The design allows us to evaluate separately each component of the intervention. The intervention consists of training sessions to help prospective VR clients with ARMD successfully enter and complete the VR program, and training sessions for a randomly selected group of VR professionals to help them serve VR clients with ARMD more effectively.
If this intervention strategy can significantly increase (1) VR utilization rates; (2) post-service employment rates; and (3) length of post-service employment in a previously underserved group with historically poor VR outcomes, it could have a significant role in reducing the immense impact, nationally, of work disability due to ARMD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enrollment Intervention | Active comparator | Behavioral: Vocational counseling intervention, Behavioral: Reading materials for control participantsThe intervention consists of training sessions to help prospective VR clients with ARMD successfully enter and complete the vocational rehabilitation (VR) program, and training sessions for a randomly selected group of VR professionals to help them serve VR clients with ARMD more effectively. |
| Usual Care | Placebo comparator | Behavioral: Standard of care |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Resident of Alabama
- Previously employed
- Currently unemployed due to musculoskeletal disability
- Feel capable of work
- Want to work
Key exclusion criteria (2 listed)
- Not a resident of Alabama
- Unable to work
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 |
|---|---|---|
| Vocational counseling intervention | Behavioural | Enrollment Intervention |
| Reading materials for control participants | Behavioural | Enrollment Intervention |
| Standard of careNo education or behavioral intervention | Behavioural | Usual Care |
Primary outcome
Improved vocational outcomes
Time frame: baseline to 30 months
The long-term objectives of this research project are to enhance program participation and improve the vocational outcomes of people with work disability due to arthritis and related musculoskeletal disorders (ARMD) who are actively seeking vocational rehabilitation services.
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 6 Jan 2016.
- BackgroundM White, R Maisiak, P Fine and K Straaton. Factors associated with low vocational capability in persons with musculoskeletal work disability. Abstract in Arthritis and Rheumatism, 42(9):S222, 1999.
- BackgroundR Maisiak, P Fine, M White and K Straaton. Barriers to participation in state-federal vocational rehabilitation servies for persons with musculoskeletal disability Abstract in Arthritis and Rheumatism, 42(9):S222, 1999.
- BackgroundWhite M, Maisiak R, Overman L, Paolone F, and Fine P. Increased enrollment of persons unemployed due to musculoskeletal disability to vocational rehabilitation services. Arthritis and Rheumatism, 43(9):S285, 2000.
- BackgroundMaisiak R, White W, Overman L, Paolone F, and P Fine. Health status (SF-36) barriers to return to work for persons with musculoskeletal disability. Arthritis and Rheumatism, 43(9):S285,2000.
- BackgroundMaisiak R, White W, Overman L, Paolone F, and P Fine. Improved return to work for arthritis patients in a supplementary state-federal vocational rehabilitation program. Arthritis and Rheumatism,44(9):S211,2001.
- BackgroundWhite M, Maisiak R, Overman L, Paolone F, and Fine P. Development of a work motivation scale for predicting return to work of arthritis patients. Arthritis and Rheumatism,44(9):S165,2001.
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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.
Richard S. Maisiak, PhD, MSPH principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vocational counseling intervention in people with Arthritis and Musculoskeletal Diseases, run by University of Alabama at Birmingham 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 5 inclusion and 2 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 6 Jan 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Improved vocational outcomes (time frame: baseline to 30 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 NCT00000407, 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 6 Jan 2016; AzTrials last refreshed its copy on 4 Nov 2026.