Effect Evaluation of the Work Rehabilitation Effort "Best iLag"

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

Study Overview

• Status: Completed
• Conditions: Musculoskeletal Pain; Burnout, Professional; Work Related Illnesses
• Intervention / Treatment: Behavioral: Individual activity; Behavioral: Group-based activity

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.

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway, 5014
    • Uni Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Regular follow-up from welfare authority as well as a 3 month membership card at a given gym.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: NORCE Norwegian Research Centre AS
• Collaborators: Norwegian Labour and Welfare Administration Tromso
• Investigators: Principal Investigator: Torill Tveito, Uni Research Health

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: September 30, 2016
• First Submitted That Met QC Criteria: October 24, 2016
• First Posted (Estimate): October 26, 2016

Study Record Updates

• Last Update Posted (Actual): October 1, 2019
• Last Update Submitted That Met QC Criteria: September 28, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Return to work; Sick-leave; Work rehabilitation
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Stress, Psychological; Occupational Stress; Occupational Diseases; Burnout, Psychological; Burnout, Professional; Musculoskeletal Pain
• Other Study ID Numbers: Best iLag

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO