Completed

Prevention of Arthritis-Related Work Disability

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What is being tested

Rehabilitation counseling

Other
Who is being recruted

Rheumatoid Arthritis
+1

+ Systemic Lupus Erythematosus
+ Osteoarthritis, Knee
From 18 to 65 Years
+5 Eligibility Criteria
How is the trial designed

Prevention Study

Interventional
Study Start: September 1997

Summary

Principal SponsorBoston University Charles River Campus
Last updated: July 26, 2017
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 1997Actual date on which the first participant was enrolled.

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. 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.

Official TitlePrevention of Arthritis-Related Work Disability: A Trial of Job Retention Services Provided to Employed Persons With Arthritis 
Principal SponsorBoston University Charles River Campus
Last updated: July 26, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
242 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Participants, researchers, and outcome assessors do not know which treatment is being given. This helps reduce bias not just during the study, but also when the results are being evaluated.

Other Ways to Mask Information
Open-label
: Everyone knows which treatment is being given.

Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 65 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Rheumatoid Arthritis
Systemic Lupus Erythematosus
Osteoarthritis, Knee
Ankylosing Spondylitis
Criteria
2 inclusion criteria required to participate
Must currently be employed full or part time

Must live in selected communities in eastern Massachusetts

3 exclusion criteria prevent from participating
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
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.
Group II
Active Comparator
Active comparator Control group participants received relevant printed information in the mail only; no rehabilitation counseling
Study Objectives
Primary Objectives

Periods of work cessation of at least 6 months.
Secondary Objectives

Extent of on the job limitation due to health condition as measured by the Work Limitations Questionnaire.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Boston University School of MedicineBoston, United StatesSee the location

CompletedOne Study Center