The Effectiveness of Health Advice and Occupational Health Intervention on Work Ability

NCT ID: NCT00378989

Last Updated: 2015-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 418 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2006-10-31

Brief Summary

Study hypotheses were 1) Classification of the risk of sickness absence can be made with questionnaires addressing self-rated health problems; 2) Occupational health intervention of the employees at 'High Risk´ of sickness absence is more effective than usual care in controlling sickness absence; 3) Health advice intervention of the employees at 'Increased Risk´ of sickness absence is more effective than usual care in controlling sickness absence; 4) The interventions are cost-effective use of resources from the societal perspective.

Detailed Description

The study design is a longitudinal cohort study with two embedded randomised trials. The risk of sickness absence is classified on the basis of self-administered questionnaires, on the basis of a priori defined cut-off limits. Two randomised trials are performed in the subgroups of 'High Risk´ and 'Increased Risk´ of sickness absence. The study is performed within one corporation in Finland. All employees with permanent job and age between 18 and 60 years are invited to participate.

The worker's own occupational nurses and physicians execute the occupational health program for workers at 'High Risk´ for sickness absence. The employees in the "High Risk" intervention group receive a personal feedback of their health survey results in a letter, in which they are also invited to a consultation at the OHS. The main purpose of the consultation, during which the individual findings of the health survey are available for the OHS professionals, is the construction of an action plan, and if appropriate, referral to a medical specialist, or psychologist. The employees in the 'High Risk´ control group receive care as usual.

The intervention for workers at 'Increased Risk´ for sickness absence is executed as medical counselling over the telephone. The employees in the 'Increased Risk´ intervention group receive a personal feedback of their questionnaire results in a letter, in which they were also invited to call the phone advice centre in order to receive medical advice. The employees in the 'Increased Risk´ control group receive care as usual.

Sickness absence data is obtained from the employer's records, the baseline covering the one-year period before the intervention and the follow-up covering the one-year period after the intervention. Sickness absences are obtained without medical diagnoses. The study participants also fill in a health questionnaire including, among other questions, healthcare utilization variables at the one-year follow-up.

We will carry out an intention to treat analysis. We will use analysis of covariance (ANCOVA) to analyse sickness absence outcomes at 12 months, with corresponding baseline values and risk / treatment group as covariates. Economic evaluation will be performed alongside the randomised controlled trial within the 'High Risk´ group.

Conditions

Signs and Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention

A letter with personal feedback of the results of a health risk appraisal and invitation to a consultation at the occupational health services.

Group Type: ACTIVE_COMPARATOR

Consultation at the occupational health services

Intervention Type: BEHAVIORAL

Consultation at the occupational health services

Control

Care as usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Consultation at the occupational health services

Consultation at the occupational health services

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Permanent job
• Age 18 to 60 years

Exclusion Criteria

• Pension granted

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mutual Pension Insurance Company Ilmarinen

UNKNOWN

Sponsor Role: collaborator

The Finnish Funding Agency for Technology and Innovation (TEKES)

OTHER_GOV

Sponsor Role: collaborator

Sitra, the Finnish Innovation Fund

OTHER

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

Finnish Office for Health Technology Assessment, FinOHTA/Stakes

UNKNOWN

Sponsor Role: collaborator

University of Helsinki

OTHER

Sponsor Role: collaborator

Evalua International

OTHER

Sponsor Role: lead

Responsible Party

Simo Taimela

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simo P Taimela, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Evalua International

Locations

Evalua International Ltd. Oy

Espoo, , Finland

Countries

Finland

References

Taimela S, Laara E, Malmivaara A, Tiekso J, Sintonen H, Justen S, Aro T. Self-reported health problems and sickness absence in different age groups predominantly engaged in physical work. Occup Environ Med. 2007 Nov;64(11):739-46. doi: 10.1136/oem.2006.027789. Epub 2007 Feb 15.

Reference Type: BACKGROUND

PMID: 17303674 (View on PubMed)

Taimela S, Malmivaara A, Justen S, Laara E, Sintonen H, Tiekso J, Aro T. The effectiveness of two occupational health intervention programmes in reducing sickness absence among employees at risk. Two randomised controlled trials. Occup Environ Med. 2008 Apr;65(4):236-41. doi: 10.1136/oem.2007.032706. Epub 2007 Aug 6.

Reference Type: RESULT

PMID: 17681994 (View on PubMed)

Taimela S, Justen S, Aronen P, Sintonen H, Laara E, Malmivaara A, Tiekso J, Aro T. An occupational health intervention programme for workers at high risk for sickness absence. Cost effectiveness analysis based on a randomised controlled trial. Occup Environ Med. 2008 Apr;65(4):242-8. doi: 10.1136/oem.2007.033167. Epub 2007 Oct 12.

Reference Type: RESULT

PMID: 17933885 (View on PubMed)

Taimela S, Aronen P, Malmivaara A, Sintonen H, Tiekso J, Aro T. Effectiveness of a targeted occupational health intervention in workers with high risk of sickness absence: baseline characteristics and adherence as effect modifying factors in a randomized controlled trial. J Occup Rehabil. 2010 Mar;20(1):14-20. doi: 10.1007/s10926-009-9221-0.

Reference Type: RESULT

PMID: 20012343 (View on PubMed)

Other Identifiers

EVA2XRCT

Identifier Type: -

Identifier Source: org_study_id