Condition category
Mental and Behavioural Disorders
Date applied
15/10/2014
Date assigned
20/11/2014
Last edited
26/11/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Musculoskeletal disorders and common mental disorders are the main reasons for long-term sickness absence and disability. Many of these conditions have no or few medical explanations, and many patients are suffering from two or more disorders/ailments at the same time (co-morbidity). The main aim of occupational rehabilitation programs is to help people with such disabilities to return to work (RTW). However, knowledge regarding how well these programs work is very limited, and we know even less about which programs are best suited for which patients. Here, we want to compare the performance of two occupational rehabilitation programs in Norway, and examine if a particular type of patient will benefit more from the one or the other program. We will measure how many people return to work, how much they start and then stop work again and costs to society in general. We will also look at their state of health over time, quality of life, how well they perform when at work and their own belief in being able to RTW.

Who can participate?
Employed or self-employed adults aged 18-55 who are referred to occupational rehabilitation by a physician, and who live within a distance of 200 km from Porsgrunn, Norway. They must have musculoskeletal disorders and/or common mental health disorders, such as stress, anxiety and depression. In addition they must have been sick-listed for a minimum of six weeks last year

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 receive treatment in an outpatient occupational rehabilitation clinic at Sykehuset Telemark in Porsgrunn (STHF-intervention). Those in group 2 receive treatment in an inpatient occupational rehabilitation clinic in Rauland (AiR-intervention). The treatments (interventions) at both clinics are comprehensive and delivered by interdisciplinary teams consisting of a physician, physiotherapist, psychologist or a specialized nurse and an occupational counselor/work consultant. The inpatient intervention has in addition a physical education teacher, a nutrition counselor, a riding instructor and a recreation instructor. The inpatient intervention runs for 4 weeks and for about 35 hours/week, while the outpatient intervention has a duration of about 3 months, with the number of days and hours per week varies according to the need of the participant. Both clinics use cognitive, behavioral and educational approaches to increase the participants’ self-efficacy (belief in themselves), improve their health and quality of life, reduce fear of movement and increase their ability and readiness for returning to work. Interaction with relevant stakeholders is part of the rehabilitation process (e.g. employer, general practitioner, family and NAV). The inpatient intervention is more group-based and intensive than the outpatient intervention. The outpatient intervention on the other hand, is individually tailored, has closer collaboration with the workplace, and collaborates with local services to offer physical exercise or cognitive therapy if needed.

What are the possible benefits and risks of participating?
By participating in the study, the participants will get a comprehensive occupational rehabilitation service in the specialist health care whether they get the inpatient or outpatient intervention. We are not able to tell whether they would benefit more from the one or the other intervention. There are no risks involved in participating in the study.

Where is the study run from?
AiR - the National Centre for Occupational Rehabilitation (Norway)

When is study starting and how long is it expected to run for?
April 2014 to December 2024

Who is funding the study?
1. AiR - the National Centre for Occupational Rehabilitation (Norway)
2. The South- East Regional Health Authority (Helse Sør-Øst RHF) (Norway)
3. Kommunal Landspensjonskasse (KLP) (Norway)

Who is the main contact?
1. Chris Jensen
chris.jensen@air.no
2. Monica Eftedal
monica.eftedal@air.no

Trial website

Contact information

Type

Scientific

Primary contact

Dr Chris Jensen

ORCID ID

Contact details

AiR - the National Centre for Occupational Rehabilitation
Haddlandsvegen 20
Rauland
3864
Norway
+47 919 17 918
chris.jensen@air.no

Type

Public

Additional contact

Dr Monica Eftedal

ORCID ID

http://orcid.org/0000-0003-0123-3706

Contact details

AiR - the National Centre for Occupational Rehabilitation
Haddlandsvegen 20
Rauland
3864
Norway
+4795064879
monica.eftedal@air.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Project number: 2013126, Helse Sør-Øst RHF

Study information

Scientific title

Comparing effects of two interdisciplinary occupational rehabilitation programs for people with musculoskeletal disorders, common mental disorders or both – a randomized clinical trial

Acronym

STAiR

Study hypothesis

Musculoskeletal disorders and mental health problems are the main reasons for long-term sickness absence and disability in Norway, as in other western countries. Several occupational rehabilitation programs, both inpatient and outpatient, offer services to these patient-groups, but few effect studies are completed. More research are needed to increase the knowledge of what kind of training and rehabilitation programs provides the most effective service for different patient groups. In this study, we will evaluate the effectiveness of two occupational rehabilitation interventions through a pragmatic randomized clinical trial (RCT), where the main outcome is return to work (RTW). Several secondary outcomes are also included. It is a mixed method study.
Aims of the study are:
1. To evaluate the effectiveness of two occupational rehabilitation programs in Norway with regard to differences in
1.1. Stable RTW (work min 4 weeks after RTW) (register data)
1.2. Trajectories in and out of work during a 5 year follow-up (register data)
1.3. Cost effectiveness/utility/benefit (register + survey data)
1.4. Experienced quality of life (survey data)
1.5. Experienced health and work ability (survey data)
1.6. Readiness for return to work (survey data)
1.7. Return to work self-efficacy (survey data)
1.8. Return to work fear avoidance (survey data)
Survey data are collected at baseline, 4 weeks, 3, 6, 12 and 24 months. The participants are followed with register data until 5 years after inclusion in the project.
1. Investigate if any sub-groups of patients benefit more from a specific type of intervention, e.g. differences by gender, age, education, health complexity
2. By use of process evaluation investigate possible underlying mechanisms pertaining to inpatient and outpatient occupational rehabilitation program outcomes, and explain barriers and facilitators for return to work as program providers, key stakeholders and users experience them
3. To compare RTW outcomes for the clinics with the results of a group drawn from the register of the Norwegian Labor and Welfare Service

Ethics approval

Local medical ethics committee REK, Norway, 03/01/2014, ref. 2011/934 REK vest

Study design

Pragmatic, randomized clinical trial (assessor blinded) with a mixed method approach.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Available in Norwegian at request.

Condition

Musculoskeletal disorders (MSD) and/or common mental health problems, co-morbidity

Intervention

Participants are randomly allocated into one of two groups.
1. Outpatient: Interventions and education are individually tailored. Follow up by an individual coordinator.
1.1. Interdisciplinary work ability assessment
1.2. Goal setting RTW: meeting between team and patient, 1 hour
1.3. Cognitive approaches, one to one or in groups, 1-10 hours
1.4. Physical exercise, one to one or in groups, 1-10 hours
1.5. Education and lecturing regarding self-care and pain management, 2x4 hours
1.6. Individual counselling work capacity and RTW with work counselor, 1 hour
1.7. Contact with workplace and other stakeholders through meetings and phone
1.8. Collaboration with local services to offer physical exercise, cognitive therapy or follow-up at the work place if needed
2. Inpatient:
2.1. Interdisciplinary work ability assessment
2.2. Goal setting RTW: Group-based process work, 6 hours
2.3. Cognitive approaches, individual consultation and coaching, 4-15 hours
2.4. Cognitive approaches, group (some patients), 2-4 hours
2.5. Physical exercise, groups, 43-51 hours
2.6. Education and lecturing regarding self-care, pain management, nutrition etc., 7 hours
2.7. Individual counselling work capacity and RTW with work counselor, 1 hour
2.8. Different leisure activities
2.9. Contact with workplace and other stakeholders, usually by phone

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Stable return to work; defined as 4 weeks without relapse, register data
2. Trajectories in and out of work (full/partial work participation, sickness benefits, work assessment allowances or disability pension), register data

Survey data collected at baseline, 4 weeks, 3, 6, 12 and 24 months. The participants are followed with register data until 5 years after inclusion in the project.

Secondary outcome measures

1. Cost effectiveness/utility/benefit – SF-6D and register data
2. Quality of life; health – SF-36
3. Work ability, work ability index (WAI)
4. Readiness for return to work Readiness for return-to-work (RRTW)
5. Return to work self-efficacy, Return-to-work self-efficacy scale (RTWSE-19)
6. Return to work fear avoidance, Fear-Avoidence Belief Questionnaire

Survey data collected at baseline, 4 weeks, 3, 6, 12 and 24 months. The participants are followed with register data until 5 years after inclusion in the project.

Overall trial start date

01/01/2013

Overall trial end date

31/12/2024

Reason abandoned

Eligibility

Participant inclusion criteria

1. MSDs or common mental health problems such as stress, anxiety and depression, or a combination of these. The participants may have other health complaints in addition (e.g. diabetes, coronary diseases, mild/moderate COPD)
2. In need of a service beyond what the locale health service can provide
3. Age between 18 – 55 years
4. At least 6 weeks sick-leave during the last 12 months related to actual health complaints
5. Fluent in Norwegian and able to fill out a questionnaire

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

1. Severe psychological disorders (e.g. schizophrenia and other psychotic disorder, bipolar disorder, personality disorders)
2. A progressive disorder that most likely involves a rapid reduction in work ability
3. Conditions where there is a medical contraindication for physical activity
4. Pregnancy
5. Substance addiction
6. Applying for disability pension
7. Never been working, or never been in employment

Recruitment start date

10/04/2014

Recruitment end date

31/12/2017

Locations

Countries of recruitment

Norway

Trial participating centre

AiR - the National Centre for Occupational Rehabilitation
Rauland
3864
Norway

Sponsor information

Organisation

AiR - the National Centre for Occupational Rehabilitation (Norway)

Sponsor details

Haddlandsvegen 20
Rauland
3864
Norway
+47 919 17 918
chris.jensen@air.no

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

AiR - the National Centre for Occupational Rehabilitation (Norway)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The South- East Regional Health Authority (Helse Sør-Øst RHF) (Norway)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Kommunal Landspensjonskasse (KLP) (Norway)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We intend to publish two protocols in 2015:
One for the main study and one for the process evaluation

Intention to publish date

01/06/2015

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes