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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02541890
Other study ID # 2014/2279
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2015
Est. completion date March 2018

Study information

Verified date August 2021
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 175
Est. completion date March 2018
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Intervention

Behavioral:
Work place intervention
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.

Locations

Country Name City State
Norway Nowegian University of Science and Technology, Department of public health Trondheim

Sponsors (2)

Lead Sponsor Collaborator
Norwegian University of Science and Technology Trondheim University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (3)

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):194692 — View Citation

Rise MB, Skagseth M, Klevanger NE, Aasdahl L, Borchgrevink P, Jensen C, Tenggren H, Halsteinli V, Jacobsen TN, Løland 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. — View Citation

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;4 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of days on sick-leave Register data from the national health and welfare services 12 months
Primary Time until sustainable return to work Register data from the national health and welfare services 12 months
Secondary Use of health services. Questionnaire. "How much of this health/social service have you used during the last 4 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
Secondary Pain. Questionnaire Brief pain inventory (BPI). 160 participants 12 months
Secondary Health related quality of life. Questionnaire The 15D health-related quality of life instrument. 160 participants 12 months
Secondary Psychological flexibility and acceptance. Questionnaire Acceptance and action questionnaire and work acceptance and action questionnaire (AAQ2). 160 participants 5 months
Secondary Return to work self efficacy. Questionnaire. Return to work self-efficacy-19 (RTWSE-19). 160 participants. 5 months
Secondary Fear and avoidance beliefs about work. Questionnaire Fear Avoidance Belief Questionnaire (FABQ). 160 participants 5 months
Secondary Expectations about sick leave and return to work. Questionnaire 160 participants. "How long do you anticipate to be sick-listed (partly/fully)?" 3 questions. 5 months
Secondary Work ability. Single question 160 participants. "How will you rate your work ability?" (scale from 0 (no ability) to 10 (my best ability)). 5 months
Secondary Well-being at work. Single question 160 participants. "How happy are you at work?" (not at all, not so good, good. very good) 5 months
Secondary Readiness for return to work. Questionnaire 160 participants. Readiness for return to work (RRTW) questionnaire. 5 months
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