Clinical trial NCT02945397: Effect Evaluation of the Work Rehabilitation Effort "Best iLag"
Official title: Effect Evaluation of the Work Rehabilitation Effort "Best iLag"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Pain
Work Related Illnesses
Burnout, Professional
Keywords: Return to work
Work rehabilitation
Sick-leave
Lead sponsor: NORCE Norwegian Research Centre AS
Sponsor class: OTHER
Collaborators: name: Norwegian Labour and Welfare Administration Tromso
First posted: 2016-10-26
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of days at work during follow-up period measured through data from the Norwegian Labour and Welfare Administration´s databases.
timeFrame: 7 years
Secondary outcomes:
measure: Subjective health complaints measured through questionnaire data.
timeFrame: 15 months
measure: Fatigue measured through questionnaire data.
timeFrame: 15 months
measure: Self-rated health measured through questionnaire data.
timeFrame: 15 months
measure: Sleep measured through questionnaire data.
timeFrame: 15 months
measure: Alcohol use measured through questionnaire data.
timeFrame: 15 months
measure: Quality of life measured through questionnaire data.
timeFrame: 15 months
measure: Regular exercise measured through questionnaire data.
timeFrame: 15 months
measure: Bullying measured through questionnaire data.
timeFrame: 15 months
measure: Social support measured through questionnaire data.
timeFrame: 15 months
measure: Coping measured through questionnaire data.
timeFrame: 15 months
measure: Work readiness measured through questionnaire data.
timeFrame: 15 months
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Uni Research
Study officials:
affiliation: Uni Research Health
name: Torill Tveito
role: PRINCIPAL_INVESTIGATOR
References: