- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02541890
Effects of Workplace Intervention in Occupational Rehabilitation on Return to Work
August 7, 2021 updated by: Norwegian University of Science and Technology
Effects of Workplace Intervention in Inpatient Occupational Rehabilitation on Return to Work for Persons With Somatic and/or Common Mental Health Problems. A Randomised Controlled Trial
Aim is to study the effect of a work place intervention during a multicomponent return-to-work rehabilitation program on return-to-work.
The intervention is compared with inpatient rehabilitation only, and participants will be recruited from the diagnostic groups dominating the sick-leave statistics, namely musculoskeletal disorders, common mental disorders (e.g.
stress, depression and anxiety), and unspecific disorders including chronic fatigue.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Long-term sick-listing from work has considerable impact on social function, on the families of the sick-listed persons, the companies they work for, and society as a whole.
Hence, the need for documented effective vocational rehabilitation programs is pressing.
Vocational rehabilitation services described in the scientific literature have been specific to one single or a specific group of medical conditions (e.g.low back pain).
In contrast, most people on sick leave have several health complaints, and many of the factors influencing sick leave are shared regardless of disorder (e.g.
social surroundings, workplace environment), calling for rehabilitation programs that can be employed for both musculoskeletal, unspecific and common mental disorders.
Research indicates that interventions on the work place might facilitate return to work.
The aim of this study is therefore to investigate the effect of a work place intervention during a multicomponent return-to-work rehabilitation program on return-to-work.
Study Type
Interventional
Enrollment (Actual)
175
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Trondheim, Norway, 7491
- Nowegian University of Science and Technology, Department of public health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Resident of Central Norway
- Sick-listed due to common mental disorders, musculoskeletal pain/problems, unspecific disorders and/or fatigue
- Sick-listed more than 50 %
- Sick-listed longer than 8 weeks
- Has employer and is willing to participate in a work place intervention during the rehabilitation program
Exclusion Criteria:
- is self-employed
- has, or is currently examined for, a serious somatic or psychiatric disorder
- suffers from substance abuse
- has trouble with participating in a group
- is in a rehabilitation process that will interfere with the occupational rehabilitation program
- function level is to weak to participate in the rehabilitation program
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Work place intervention
Work place intervention in addition to rehabilitation program.
|
Meeting at the work place including the patient, the employer and the rehabilitation therapist.
Aim of meeting is to discuss challenges and possibilities in the patient's return to work process and to make a plan for return to work.
|
No Intervention: Rehabilitation program only
Rehabilitation program without intervention at the work place.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of days on sick-leave
Time Frame: 12 months
|
Register data from the national health and welfare services
|
12 months
|
Time until sustainable return to work
Time Frame: 12 months
|
Register data from the national health and welfare services
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Use of health services. Questionnaire. "How much of this health/social service have you used during the last 4 months?"
Time Frame: 12 months
|
160 participants.
"How much of this health/social service have you used during the last 4 months?"
Somatic and mental health specialized care (in-patient and outpatient), general practitioner, psychologist, group therapy, physiotherapist, chiropractor, occupational rehabilitation, welfare services, complementary practitioner, emergency unit, ambulatory services, occupational health services, other treatment.
|
12 months
|
Pain. Questionnaire
Time Frame: 12 months
|
Brief pain inventory (BPI).
160 participants
|
12 months
|
Health related quality of life. Questionnaire
Time Frame: 12 months
|
The 15D health-related quality of life instrument.
160 participants
|
12 months
|
Psychological flexibility and acceptance. Questionnaire
Time Frame: 5 months
|
Acceptance and action questionnaire and work acceptance and action questionnaire (AAQ2).
160 participants
|
5 months
|
Return to work self efficacy. Questionnaire.
Time Frame: 5 months
|
Return to work self-efficacy-19 (RTWSE-19).
160 participants.
|
5 months
|
Fear and avoidance beliefs about work. Questionnaire
Time Frame: 5 months
|
Fear Avoidance Belief Questionnaire (FABQ).
160 participants
|
5 months
|
Expectations about sick leave and return to work. Questionnaire
Time Frame: 5 months
|
160 participants.
"How long do you anticipate to be sick-listed (partly/fully)?" 3 questions.
|
5 months
|
Work ability. Single question
Time Frame: 5 months
|
160 participants.
"How will you rate your work ability?"
(scale from 0 (no ability) to 10 (my best ability)).
|
5 months
|
Well-being at work. Single question
Time Frame: 5 months
|
160 participants.
"How happy are you at work?" (not at all, not so good, good.
very good)
|
5 months
|
Readiness for return to work. Questionnaire
Time Frame: 5 months
|
160 participants.
Readiness for return to work (RRTW) questionnaire.
|
5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Marius S Fimland, PhD, Norwegian University of Science and Technology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Rise MB, Skagseth M, Klevanger NE, Aasdahl L, Borchgrevink P, Jensen C, Tenggren H, Halsteinli V, Jacobsen TN, Loland SB, Johnsen R, Fimland MS. Design of a study evaluating the effects, health economics, and stakeholder perspectives of a multi-component occupational rehabilitation program with an added workplace intervention - a study protocol. BMC Public Health. 2018 Feb 5;18(1):219. doi: 10.1186/s12889-018-5130-5.
- Skagseth M, Fimland MS, Rise MB, Johnsen R, Borchgrevink PC, Aasdahl L. Effectiveness of adding a workplace intervention to an inpatient multimodal occupational rehabilitation program: A randomized clinical trial. Scand J Work Environ Health. 2020 Jul 1;46(4):356-363. doi: 10.5271/sjweh.3873. Epub 2019 Dec 13.
- Klevanger NE, Fimland MS, Rise MB. Aligning stakeholders' understandings of the return-to-work process: a qualitative study on workplace meetings in inpatient multimodal occupational rehabilitation. Int J Qual Stud Health Well-being. 2021 Dec;16(1):1946927. doi: 10.1080/17482631.2021.1946927.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2015
Primary Completion (Actual)
July 1, 2017
Study Completion (Actual)
March 1, 2018
Study Registration Dates
First Submitted
August 18, 2015
First Submitted That Met QC Criteria
September 2, 2015
First Posted (Estimate)
September 4, 2015
Study Record Updates
Last Update Posted (Actual)
August 13, 2021
Last Update Submitted That Met QC Criteria
August 7, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014/2279
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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