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

Sponsor
Evalua International (Other)
Overall Status
Completed
CT.gov ID
NCT00378989
Collaborator
Mutual Pension Insurance Company Ilmarinen (Other), The Finnish Funding Agency for Technology and Innovation (TEKES) (Other), Sitra, the Finnish Innovation Fund (Other), Pfizer (Industry), Finnish Office for Health Technology Assessment, FinOHTA/Stakes (Other), University of Helsinki (Other)
418
Enrollment
1
Location
2
Arms
25
Duration (Months)
16.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Consultation at the occupational health services
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
418 participants
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.
Study Start Date :
Sep 1, 2004
Actual Primary Completion Date :
Oct 1, 2005
Actual Study Completion Date :
Oct 1, 2006

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Sickness absence during the 12-month follow-up [12 months]

Eligibility Criteria

Criteria

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

  • Permanent job

  • Age 18 to 60 years

Exclusion Criteria:
  • Pension granted

Contacts and Locations

Locations

Site City State Country Postal Code
1 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
  • University of Helsinki

Investigators

  • Principal Investigator: Simo P Taimela, MD, PhD, Evalua International

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Simo Taimela, MD, Evalua International
ClinicalTrials.gov Identifier:
NCT00378989
Other Study ID Numbers:
  • EVA2XRCT
First Posted:
Sep 21, 2006
Last Update Posted:
Feb 10, 2015
Last Verified:
Feb 1, 2015

Study Results

No Results Posted as of Feb 10, 2015