NCT02541890

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

August 13, 2021

Status Verified

August 1, 2021

Enrollment Period

2.3 years

First QC Date

August 18, 2015

Last Update Submit

August 7, 2021

Conditions

Mental DisordersMusculoskeletal DiseasesFatigue Syndrome, Chronic

Keywords

RehabilitationReturn to Work

Outcome Measures

Primary Outcomes (2)

  • Number of days on sick-leave

    Register data from the national health and welfare services

    12 months

  • Time until sustainable return to work

    Register data from the national health and welfare services

    12 months

Secondary Outcomes (10)

  • Use of health services. Questionnaire. "How much of this health/social service have you used during the last 4 months?"

    12 months

  • Pain. Questionnaire

    12 months

  • Health related quality of life. Questionnaire

    12 months

  • Psychological flexibility and acceptance. Questionnaire

    5 months

  • Return to work self efficacy. Questionnaire.

    5 months

  • +5 more secondary outcomes

Study Arms (2)

Work place intervention

EXPERIMENTAL

Work place intervention in addition to rehabilitation program.

Behavioral: Work place intervention

Rehabilitation program only

NO INTERVENTION

Rehabilitation program without intervention at the work place.

Interventions

Work place interventionBEHAVIORAL

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.

Work place intervention

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nowegian University of Science and Technology, Department of public health

Trondheim, 7491, Norway

Location

Related Publications (3)

  • 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.

    PMID: 29402253BACKGROUND

  • 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.

    PMID: 31834410RESULT

  • 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.

    PMID: 34278973RESULT

MeSH Terms

Conditions

Mental DisordersMusculoskeletal DiseasesFatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Muscular DiseasesEncephalomyelitisNeuroinflammatory DiseasesNervous System DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marius S Fimland, PhD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2015

First Posted

September 4, 2015

Study Start

April 1, 2015

Primary Completion

July 1, 2017

Study Completion

March 1, 2018

Last Updated

August 13, 2021

Record last verified: 2021-08

Locations

NO(1)