Effect Evaluation of the Work Rehabilitation Effort "Best iLag"

September 28, 2019 updated by: NORCE Norwegian Research Centre AS
The study compares the effect of a group-based activity with an individual work-out activity on work participation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, 5014
        • Uni Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
Time Frame: 7 years
7 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NORCE Norwegian Research Centre AS

Collaborators

Norwegian Labour and Welfare Administration Tromso

Investigators

  • Principal Investigator: Torill Tveito, Uni Research Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Best iLag

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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