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Trial record 1 of 1 for:    NCT00378989
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The Effectiveness of Health Advice and Occupational Health Intervention on Work Ability

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ClinicalTrials.gov Identifier: NCT00378989
Recruitment Status : Completed
First Posted : September 21, 2006
Last Update Posted : February 10, 2015
Sponsor:
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
University of Helsinki
Information provided by (Responsible Party):
Simo Taimela, Evalua International

Tracking Information
First Submitted Date  ICMJE September 19, 2006
First Posted Date  ICMJE September 21, 2006
Last Update Posted Date February 10, 2015
Study Start Date  ICMJE September 2004
Actual Primary Completion Date October 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2015)
Sickness absence during the 12-month follow-up [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 19, 2006)
  • Sickness absence during the 12-month follow-up
  • Disability retirement during the 24-month follow-up
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2006)
Self-reported health problems, working ability and healthcare utilisation at 12-month follow-up
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effectiveness of Health Advice and Occupational Health Intervention on Work Ability
Official Title  ICMJE The Effectiveness and Cost-effectiveness of Health Advice and Occupational Health Intervention on Work Ability. Two Randomised Trials.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Signs and Symptoms
Intervention  ICMJE Behavioral: Consultation at the occupational health services
Consultation at the occupational health services
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Consultation at the occupational health services
  • No Intervention: Control
    Care as usual
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 9, 2015)
418
Original Enrollment  ICMJE
 (submitted: September 19, 2006)
2100
Actual Study Completion Date  ICMJE October 2006
Actual Primary Completion Date October 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Permanent job
  • Age 18 to 60 years

Exclusion Criteria:

  • Pension granted
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00378989
Other Study ID Numbers  ICMJE EVA2XRCT
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Simo Taimela, Evalua International
Study Sponsor  ICMJE Evalua International
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Simo P Taimela, MD, PhD Evalua International
PRS Account Evalua International
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP