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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Evalua International.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Mutual Pension Insurance Company Ilmarinen
The Finnish Funding Agency for Technology and Innovation (TEKES)
Finnish National Fund for Research and Development Sitra
Pfizer
Finnish Office for Health Technology Assessment, FinOHTA/Stakes
Helsinki University
Information provided by:
Evalua International
ClinicalTrials.gov Identifier:
NCT00378989
First received: September 19, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted
  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
Behavioral: Medical counselling over the telephone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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 Evalua International:

Primary Outcome Measures:
  • Sickness absence during the 12-month follow-up
  • Disability retirement during the 24-month follow-up

Secondary Outcome Measures:
  • Self-reported health problems, working ability and healthcare utilisation at 12-month follow-up

Estimated Enrollment: 2100
Study Start Date: September 2004
Estimated Study Completion Date: May 2006
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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Permanent job
  • Age 18 to 60 years

Exclusion Criteria:

  • Pension granted
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378989

Locations
Finland
Evalua International Ltd. Oy
Vantaa, Finland, 01530
Sponsors and Collaborators
Evalua International
Mutual Pension Insurance Company Ilmarinen
The Finnish Funding Agency for Technology and Innovation (TEKES)
Finnish National Fund for Research and Development Sitra
Pfizer
Finnish Office for Health Technology Assessment, FinOHTA/Stakes
Helsinki University
Investigators
Principal Investigator: Simo P Taimela, MD, PhD Evalua International
  More Information

No publications provided by Evalua International

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00378989     History of Changes
Other Study ID Numbers: EVA2XRCT
Study First Received: September 19, 2006
Last Updated: September 19, 2006
Health Authority: Finland: Ethics Committee

Additional relevant MeSH terms:
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014