Effect Evaluation of the Work Rehabilitation Effort Best iLag

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

Detailed Description
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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.

Official Title
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Effect Evaluation of the Work Rehabilitation Effort Best iLag

Conditions
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Musculoskeletal Pain, Work Related Illnesses, Burnout, Professional

Intervention / Treatment
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* Behavioral: Group-based activity
* Behavioral: Individual activity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Desire to work Understand Norwegian sufficiently to complete surveys Exclusion Criteria: Not able to participate in the interventions due to personal or health-related constraints.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Individual activity<br>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<br>* Regular follow-up from welfare authority as well as a 3 month membership card at a given gym.<br>|
| Active Comparator: Group-based activity<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days at work during follow-up period measured through data from the Norwegian Labour and Welfare Administration´s databases. |  | 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective health complaints measured through questionnaire data. | Subjective health complaints inventory | 15 months | 
| Fatigue measured through questionnaire data. | Chalder fatigue questionnaire | 15 months | 
| Self-rated health measured through questionnaire data. | Global health question | 15 months | 
| Sleep measured through questionnaire data. | Sleep (single items) | 15 months | 
| Alcohol use measured through questionnaire data. | The Alcohol Use Disorders Identification Test | 15 months | 
| Quality of life measured through questionnaire data. | EQ-5D (Health-related quality of life + visual analogue scale) | 15 months | 
| Regular exercise measured through questionnaire data. | Regular exercise (single items) | 15 months | 
| Bullying measured through questionnaire data. | Bullying (single items) | 15 months | 
| Social support measured through questionnaire data. | Non-directive and Directive Support Survey | 15 months | 
| Coping measured through questionnaire data. | Theoretically Originated Measure of Cognitive Activation Theory of Stress | 15 months | 
| Work readiness measured through questionnaire data. | Readiness for Return to Work Scale. | 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Return to work, Work rehabilitation, Sick-leave