Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
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 (Responsible Party):
Simo Taimela, Evalua International
ClinicalTrials.gov Identifier:
NCT00378989
First received: September 19, 2006
Last updated: February 9, 2015
Last verified: February 2015

September 19, 2006
February 9, 2015
September 2004
October 2005   (final data collection date for primary outcome measure)
Sickness absence during the 12-month follow-up [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Sickness absence during the 12-month follow-up
  • Disability retirement during the 24-month follow-up
Complete list of historical versions of study NCT00378989 on ClinicalTrials.gov Archive Site
Not Provided
Self-reported health problems, working ability and healthcare utilisation at 12-month follow-up
Not Provided
Not Provided
 
The Effectiveness of Health Advice and Occupational Health Intervention on Work Ability
The Effectiveness and Cost-effectiveness of Health Advice and Occupational Health Intervention on Work Ability. Two Randomised Trials.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Signs and Symptoms
Behavioral: Consultation at the occupational health services
Consultation at the occupational health services
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
418
October 2006
October 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Permanent job
  • Age 18 to 60 years

Exclusion Criteria:

  • Pension granted
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00378989
EVA2XRCT
No
Simo Taimela, Evalua International
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
Principal Investigator: Simo P Taimela, MD, PhD Evalua International
Evalua International
February 2015

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