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Effect Evaluation of the Work Rehabilitation Effort "Best iLag"

Primary Purpose

Musculoskeletal Pain, Work Related Illnesses, Burnout, Professional

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Group-based activity
Individual activity
Sponsored by
NORCE Norwegian Research Centre AS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Pain focused on measuring Return to work, Work rehabilitation, Sick-leave

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Uni Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Individual activity

Group-based activity

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 30, 2016
Last Updated
September 28, 2019
Sponsor
NORCE Norwegian Research Centre AS
Collaborators
Norwegian Labour and Welfare Administration Tromso
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1. Study Identification

Unique Protocol Identification Number
NCT02945397
Brief Title
Effect Evaluation of the Work Rehabilitation Effort "Best iLag"
Official Title
Effect Evaluation of the Work Rehabilitation Effort "Best iLag"
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
April 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NORCE Norwegian Research Centre AS
Collaborators
Norwegian Labour and Welfare Administration Tromso

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain, Work Related Illnesses, Burnout, Professional
Keywords
Return to work, Work rehabilitation, Sick-leave

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individual activity
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group-based activity
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group-based activity
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Individual activity
Intervention Description
Regular follow-up from welfare authority as well as a 3 month membership card at a given gym.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Subjective health complaints measured through questionnaire data.
Description
Subjective health complaints inventory
Time Frame
15 months
Title
Fatigue measured through questionnaire data.
Description
Chalder fatigue questionnaire
Time Frame
15 months
Title
Self-rated health measured through questionnaire data.
Description
Global health question
Time Frame
15 months
Title
Sleep measured through questionnaire data.
Description
Sleep (single items)
Time Frame
15 months
Title
Alcohol use measured through questionnaire data.
Description
The Alcohol Use Disorders Identification Test
Time Frame
15 months
Title
Quality of life measured through questionnaire data.
Description
EQ-5D (Health-related quality of life + visual analogue scale)
Time Frame
15 months
Title
Regular exercise measured through questionnaire data.
Description
Regular exercise (single items)
Time Frame
15 months
Title
Bullying measured through questionnaire data.
Description
Bullying (single items)
Time Frame
15 months
Title
Social support measured through questionnaire data.
Description
Non-directive and Directive Support Survey
Time Frame
15 months
Title
Coping measured through questionnaire data.
Description
Theoretically Originated Measure of Cognitive Activation Theory of Stress
Time Frame
15 months
Title
Work readiness measured through questionnaire data.
Description
Readiness for Return to Work Scale.
Time Frame
15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torill Tveito
Organizational Affiliation
Uni Research Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uni Research
City
Bergen
ZIP/Postal Code
5014
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect Evaluation of the Work Rehabilitation Effort "Best iLag"

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