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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00378989
First Posted: September 21, 2006
Last Update Posted: February 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Mutual Pension Insurance Company Ilmarinen
The Finnish Funding Agency for Technology and Innovation (TEKES)
Sitra, the Finnish Innovation Fund
Pfizer
Finnish Office for Health Technology Assessment, FinOHTA/Stakes
Helsinki University
Information provided by (Responsible Party):
Simo Taimela, Evalua International
  Purpose
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.

Condition Intervention
Signs and Symptoms Behavioral: Consultation at the occupational health services

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effectiveness and Cost-effectiveness of Health Advice and Occupational Health Intervention on Work Ability. Two Randomised Trials.

Further study details as provided by Simo Taimela, Evalua International:

Primary Outcome Measures:
  • Sickness absence during the 12-month follow-up [ Time Frame: 12 months ]

Enrollment: 418
Study Start Date: September 2004
Study Completion Date: October 2006
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intervention
A letter with personal feedback of the results of a health risk appraisal and invitation to a consultation at the occupational health services.
Behavioral: Consultation at the occupational health services
Consultation at the occupational health services
No Intervention: Control
Care as usual

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Permanent job
  • Age 18 to 60 years

Exclusion Criteria:

  • Pension granted
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00378989


Locations
Finland
Evalua International Ltd. Oy
Espoo, Finland, 20600
Sponsors and Collaborators
Evalua International
Mutual Pension Insurance Company Ilmarinen
The Finnish Funding Agency for Technology and Innovation (TEKES)
Sitra, the Finnish Innovation Fund
Pfizer
Finnish Office for Health Technology Assessment, FinOHTA/Stakes
Helsinki University
Investigators
Principal Investigator: Simo P Taimela, MD, PhD Evalua International
  More Information

Publications:
Responsible Party: Simo Taimela, MD, Evalua International
ClinicalTrials.gov Identifier: NCT00378989     History of Changes
Other Study ID Numbers: EVA2XRCT
First Submitted: September 19, 2006
First Posted: September 21, 2006
Last Update Posted: February 10, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Signs and Symptoms