Clinical trial NCT01926574: Evaluation of Return to Work Rehabilitation
Official title: Evaluation of Inpatient-return- To-work, Multicomponent, Rehabilitation Programs for Persons Temporary Out of Work With Musculoskeletal-, Unspecific-, and/or Common Mental Health Disorders; Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sick Leave
Occupational Health
Keywords: absenteeism
rehabilitation
return to work
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2013-08-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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. Aim of this study is to investigate whether a group based rehabilitation program for musculoskeletal, mental or unspecific complaints can facilitate return-to-work (RTW), thereby testing two multicomponent return-to-work RTW rehabilitation programs.


Eligibility criteria: Inclusion Criteria:

* living in the counties of Trøndelag
* on sick leave 2-12 months
* current sick leave status of 50% - 100%
* ICPC-2 (International Classification of Primary Care, Second edition) diagnosis within the L (musculoskeletal), P (psychiatric) or A (unspecific disorders) categories

Exclusion Criteria:

* alcohol or drug abuse
* serious somatic or psychological disorders
* a specific disorder requiring specialized treatment
* pregnancy
* currently participating in another treatment program
* insufficient Norwegian speaking or writing skills to participate in group session and fill out questionnaires
* scheduled for surgery within the next 6 months
* serious problems with functioning in a group setting

Primary outcomes:
measure: time until full sustainable return-to-work (RTW)
timeFrame: 1 year
measure: Total number of sickness absence days
timeFrame: 1 year
Secondary outcomes:
measure: Sickness absence days
timeFrame: 3 years
measure: sickness absence days
timeFrame: 5 years
measure: Health related quality of life
timeFrame: 1 year
measure: Subjective health complaints
timeFrame: 1 year
measure: Physical activity
timeFrame: 1 year
measure: physical, social and emotional functional status
timeFrame: 1 year
measure: Psychological and social factors at work
timeFrame: 1 year
measure: readiness for return to work
timeFrame: 1 year
measure: fear avoidance beliefs
timeFrame: 1 year
measure: psychological flexibility and acceptance
timeFrame: 1 year
measure: share of workers at work
timeFrame: 1 year
Other outcomes:
measure: Health economics from the societal perspective
timeFrame: 1 year
Locations:
city: Rissa
country: Norway
facility: Hysnes Rehabilitation Centre
city: Trondheim
country: Norway
facility: St. Olavs University Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Roar Johnsen, phd prof
role: STUDY_DIRECTOR
References:
citation: Fimland MS, Vasseljen O, Gismervik S, Rise MB, Halsteinli V, Jacobsen HB, Borchgrevink PC, Tenggren H, Johnsen R. Occupational rehabilitation programs for musculoskeletal pain and common mental health disorders: study protocol of a randomized controlled trial. BMC Public Health. 2014 Apr 16;14:368. doi: 10.1186/1471-2458-14-368.
citation: Aasdahl L, Pape K, Vasseljen O, Johnsen R, Gismervik S, Halsteinli V, Fleten N, Nielsen CV, Fimland MS. Effect of Inpatient Multicomponent Occupational Rehabilitation Versus Less Comprehensive Outpatient Rehabilitation on Sickness Absence in Persons with Musculoskeletal- or Mental Health Disorders: A Randomized Clinical Trial. J Occup Rehabil. 2018 Mar;28(1):170-179. doi: 10.1007/s10926-017-9708-z.
citation: Nordstoga AL, Mork PJ, Steiro Fimland M. Improved cardiorespiratory fitness after occupational rehabilitation in merged diagnostic groups. Ann Occup Environ Med. 2018 Feb 28;30:16. doi: 10.1186/s40557-018-0227-y. eCollection 2018.
citation: Aasdahl L, Pape K, Vasseljen O, Johnsen R, Fimland MS. Improved Expectations About Length of Sick Leave During Occupational Rehabilitation Is Associated with Increased Work Participation. J Occup Rehabil. 2019 Sep;29(3):475-482. doi: 10.1007/s10926-018-9808-4.
citation: Aasdahl L, Pape K, Vasseljen O, Johnsen R, Gismervik S, Jensen C, Fimland MS. Effects of Inpatient Multicomponent Occupational Rehabilitation versus Less Comprehensive Outpatient Rehabilitation on Somatic and Mental Health: Secondary Outcomes of a Randomized Clinical Trial. J Occup Rehabil. 2017 Sep;27(3):456-466. doi: 10.1007/s10926-016-9679-5.
citation: Skagseth M, Fimland MS, Ivar Lund Nilsen T, Aasdahl L. Physical activity after inpatient occupational rehabilitation: Secondary outcomes of two randomized controlled trials. Scand J Med Sci Sports. 2020 Feb;30(2):339-348. doi: 10.1111/sms.13577. Epub 2019 Oct 30.