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Completed

NCT Number: NCT02945397

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.

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Key information

Conditions

Musculoskeletal Pain Behavior Behavioral Symptoms Burnout, Professional Burnout, Psychological Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Occupational Diseases Occupational Stress Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress, Psychological Work Related Illnesses

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uni Research

Bergen, 5014, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group-based activity

Behavioral

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.

Individual activity

Behavioral

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

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.

    Time frame: 15 months

    Subjective health complaints inventory

  2. Fatigue measured through questionnaire data.

    Time frame: 15 months

    Chalder fatigue questionnaire

  3. Self-rated health measured through questionnaire data.

    Time frame: 15 months

    Global health question

  4. Sleep measured through questionnaire data.

    Time frame: 15 months

    Sleep (single items)

  5. Alcohol use measured through questionnaire data.

    Time frame: 15 months

    The Alcohol Use Disorders Identification Test

  6. Quality of life measured through questionnaire data.

    Time frame: 15 months

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

  7. Regular exercise measured through questionnaire data.

    Time frame: 15 months

    Regular exercise (single items)

  8. Bullying measured through questionnaire data.

    Time frame: 15 months

    Bullying (single items)

  9. Social support measured through questionnaire data.

    Time frame: 15 months

    Non-directive and Directive Support Survey

  10. Coping measured through questionnaire data.

    Time frame: 15 months

    Theoretically Originated Measure of Cognitive Activation Theory of Stress

  11. Work readiness measured through questionnaire data.

    Time frame: 15 months

    Readiness for Return to Work Scale.

Sponsors and collaborators

Lead sponsor

NORCE Norwegian Research Centre AS

Other

Collaborators

  • Norwegian Labour and Welfare Administration Tromso

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Oct 26, 2016
Registry last updated
Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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