Completed

Improving Vocational Outcomes in Arthritis

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Vocational counseling intervention

+ Reading materials for control participants
+ Standard of care
Behavioral
Who is being recruted

Arthritis

+ Musculoskeletal Diseases
+ Rheumatic Diseases
From 18 to 55 Years
+7 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled
Phase 2
Interventional
Study Start: January 1997

See protocol details

Summary

Principal SponsorUniversity of Alabama at Birmingham
Last updated: January 6, 2016
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 1997Actual date on which the first participant was enrolled.

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. 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.

Official TitleImproving Vocational Outcomes in Arthritis 
Principal SponsorUniversity of Alabama at Birmingham
Last updated: January 6, 2016
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
326 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

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
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same 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 placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
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.
Triple-blind: Participants, researchers, and outcome assessors do not 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 55 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
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases
Criteria
5 inclusion criteria required to participate
Resident of Alabama
Previously employed
Currently unemployed due to musculoskeletal disability
Feel capable of work

Show More Criteria

2 exclusion criteria prevent from participating
Not a resident of Alabama
Unable to work

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

50% chance 

of being blinded to the placebo group

Treatment Groups
Group I
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.
Group II
Placebo
Study Objectives
Primary Objectives

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.

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
University of Alabama at BirminghamBirmingham, United StatesSee the location
CompletedOne Study Center