Effect Evaluation of the Work Rehabilitation Effort "Best iLag"

Musculoskeletal Pain Clinical Trial

Official title:

Effect Evaluation of the Work Rehabilitation Effort "Best iLag"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02945397
• Other study ID #: Best iLag
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: April 1, 2019

Study information

• Verified date: September 2019
• Source: NORCE Norwegian Research Centre AS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: April 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Burnout, Professional
• Musculoskeletal Pain
• Work Related Illnesses

Intervention

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

Locations

Country	Name	City	State
Norway	Uni Research	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
NORCE Norwegian Research Centre AS	Norwegian Labour and Welfare Administration Tromso

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days at work during follow-up period measured through data from the Norwegian Labour and Welfare Administration´s databases.		7 years
Secondary	Subjective health complaints measured through questionnaire data.	Subjective health complaints inventory	15 months
Secondary	Fatigue measured through questionnaire data.	Chalder fatigue questionnaire	15 months
Secondary	Self-rated health measured through questionnaire data.	Global health question	15 months
Secondary	Sleep measured through questionnaire data.	Sleep (single items)	15 months
Secondary	Alcohol use measured through questionnaire data.	The Alcohol Use Disorders Identification Test	15 months
Secondary	Quality of life measured through questionnaire data.	EQ-5D (Health-related quality of life + visual analogue scale)	15 months
Secondary	Regular exercise measured through questionnaire data.	Regular exercise (single items)	15 months
Secondary	Bullying measured through questionnaire data.	Bullying (single items)	15 months
Secondary	Social support measured through questionnaire data.	Non-directive and Directive Support Survey	15 months
Secondary	Coping measured through questionnaire data.	Theoretically Originated Measure of Cognitive Activation Theory of Stress	15 months
Secondary	Work readiness measured through questionnaire data.	Readiness for Return to Work Scale.	15 months