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CompletedNCT02945397Updated Oct 1, 2019

Effect Evaluation of the Work Rehabilitation Effort "Best iLag"

An interventional study of Group-based activity and Individual activity in Musculoskeletal Pain, Work Related Illnesses and Burnout, Professional, sponsored by NORCE Norwegian Research Centre AS. Completed at 1 site in Norway. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-01.

Sponsored by NORCE Norwegian Research Centre AS · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 8 months after the study started (first participant enrolled Jan 2015, registered Sep 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
168
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The study compares the effect of a group-based activity with an individual work-out activity on work participation.

Read the detailed description

The study is an RCT comparing the effect of a group-based intervention with an individual work-out intervention on work participation. The target group is persons who are at risk of leaving the work force due to health issues, and people currently outside the work force. The interventions have a time-span of 3 months. Survey data will be collected at baseline, after three months (after intervention has ended), and after 15 months. Survey data include information on lifestyle, self-reported health, subjective health complaints and readiness for work. Register data on employment and welfare benefits will be collected from two years in advance of inclusion, and five years after inclusion. According to power calculations, the study will need 322 participants.

In addition to the effect evaluation, a process evaluation will also be performed. The process evaluation will examine content quality and adherence to guidelines, as well as feasibility of the group intervention. The process evaluation will consist of some survey data as well as interviews with service providers and participants.

02

Conditions studied

  • Musculoskeletal Pain
  • Work Related Illnesses
  • Burnout, Professional

Keywords

  • Return to work
  • Work rehabilitation
  • Sick-leave
03

In context

Musculoskeletal Pain

493 studies on the registry are indexed under Musculoskeletal Pain; 113 are open to participants now.

This study's enrollment of 168 is above the median of 69 across 346 interventional studies indexed under Musculoskeletal Pain.

Browse Musculoskeletal Pain studies →

Lead sponsor

NORCE Norwegian Research Centre AS is the lead sponsor of 23 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Desire to work
  • Understand Norwegian sufficiently to complete surveys

Exclusion criteria

Exclusion Criteria:

  • Not able to participate in the interventions due to personal or health-related constraints.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
168 participants (actual)

Study arms

  • Active comparator
    Individual activity

    The individual activity consists of a 3 month membership card at a given gym. This is in addition to regular follow-up from welfare authorities.

    Behavioral: Individual activity

  • Active comparator
    Group-based activity

    The group-based activity consists of a 3 month group activity with weekly gatherings, focusing on coping, goal-setting and relevant information regarding available public services. This is in addition to regular follow-up from welfare authorities.

    Behavioral: Group-based activity

Interventions

  • BehavioralGroup-based activity

    Regular follow-up from welfare authority as well as a 3 month group activity with weekly gatherings, focusing on coping, goal-setting and relevant information regarding available public services.

  • BehavioralIndividual activity

    Regular follow-up from welfare authority as well as a 3 month membership card at a given gym.

06

What researchers measure

Primary outcomes

  1. Number of days at work during follow-up period measured through data from the Norwegian Labour and Welfare Administration´s databases.

    Time frame: 7 years

Secondary outcomes

  1. Subjective health complaints measured through questionnaire data.

    Subjective health complaints inventory

    Time frame: 15 months

  2. Fatigue measured through questionnaire data.

    Chalder fatigue questionnaire

    Time frame: 15 months

  3. Self-rated health measured through questionnaire data.

    Global health question

    Time frame: 15 months

  4. Sleep measured through questionnaire data.

    Sleep (single items)

    Time frame: 15 months

  5. Alcohol use measured through questionnaire data.

    The Alcohol Use Disorders Identification Test

    Time frame: 15 months

  6. Quality of life measured through questionnaire data.

    EQ-5D (Health-related quality of life + visual analogue scale)

    Time frame: 15 months

  7. Regular exercise measured through questionnaire data.

    Regular exercise (single items)

    Time frame: 15 months

  8. Bullying measured through questionnaire data.

    Bullying (single items)

    Time frame: 15 months

  9. Social support measured through questionnaire data.

    Non-directive and Directive Support Survey

    Time frame: 15 months

  10. Coping measured through questionnaire data.

    Theoretically Originated Measure of Cognitive Activation Theory of Stress

    Time frame: 15 months

  11. Work readiness measured through questionnaire data.

    Readiness for Return to Work Scale.

    Time frame: 15 months

07

Study locations

1 site
  • Uni Research
    Bergen, 5014, Norway
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02945397
Lead sponsor
NORCE Norwegian Research Centre AS
Collaborators
Norwegian Labour and Welfare Administration Tromso
Responsible party
Sponsor
First posted
Oct 26, 2016
Start date
Jan 2015
Primary completion
Apr 1, 2019
Completion
Apr 1, 2019
Last update
Oct 1, 2019

Study contacts

Torill Tveito
principal investigator · Uni Research Health

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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