Occupational Health Clinical Trial
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
Verified date | April 2021 |
Source | Norwegian University of Science and Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 300 |
Est. completion date | January 2022 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Norway | Hysnes Rehabilitation Centre | Rissa | |
Norway | St. Olavs University Hospital | Trondheim |
Lead Sponsor | Collaborator |
---|---|
Norwegian University of Science and Technology | St. Olavs Hospital |
Norway,
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/s10926-018-98 — View 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 — View 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 Randomi — View 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. — View 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. — View 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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Health economics from the societal perspective | Cost-effectiveness, cost-utility and cost-benefit methods. | 1 year | |
Primary | time until full sustainable return-to-work (RTW) | return-to-work i.e. for at least 4 weeks without relapse | 1 year | |
Primary | Total number of sickness absence days | after enrollment in the study (i.e. after pre-screening) | 1 year | |
Secondary | Sickness absence days | 3 years | ||
Secondary | sickness absence days | 5 years | ||
Secondary | Health related quality of life | 1 year | ||
Secondary | Subjective health complaints | Pain, depression, anxiety, and other subjective complaints | 1 year | |
Secondary | Physical activity | 1 year | ||
Secondary | physical, social and emotional functional status | 1 year | ||
Secondary | Psychological and social factors at work | 1 year | ||
Secondary | readiness for return to work | 1 year | ||
Secondary | fear avoidance beliefs | 1 year | ||
Secondary | psychological flexibility and acceptance | 1 year | ||
Secondary | share of workers at work | 1 year |
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