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Improving Vocational Outcomes in Arthritis

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ClinicalTrials.gov Identifier: NCT00000407
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : January 6, 2016
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE November 3, 1999
First Posted Date  ICMJE November 4, 1999
Last Update Posted Date January 6, 2016
Study Start Date  ICMJE January 1997
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2013)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00000407 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Vocational Outcomes in Arthritis
Official Title  ICMJE Improving Vocational Outcomes in Arthritis
Brief 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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Arthritis
  • Musculoskeletal Diseases
  • Rheumatic Diseases
Intervention  ICMJE
  • Behavioral: Vocational counseling intervention
  • Behavioral: Reading materials for control participants
  • Behavioral: Standard of care
    No education or behavioral intervention
Study Arms  ICMJE
  • Active Comparator: Enrollment Intervention
    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.
    Interventions:
    • Behavioral: Vocational counseling intervention
    • Behavioral: Reading materials for control participants
  • Placebo Comparator: Usual Care
    Intervention: Behavioral: Standard of care
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 5, 2013)
326
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
325
Study Completion Date  ICMJE December 2001
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Resident of Alabama
  • Previously employed
  • Currently unemployed due to musculoskeletal disability
  • Feel capable of work
  • Want to work

Exclusion Criteria:

  • Not a resident of Alabama
  • Unable to work
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00000407
Other Study ID Numbers  ICMJE P60AR020614( U.S. NIH Grant/Contract )
P60AR020614 ( U.S. NIH Grant/Contract )
NIAMS-024
Sub: EEHSR3
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators  ICMJE
Principal Investigator: Richard S. Maisiak, PhD, MSPH University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP