The Effectiveness of Health Advice and Occupational Health Intervention on Work Ability
Recruitment status was Active, not recruiting
|First Received Date ICMJE||September 19, 2006|
|Last Updated Date||September 19, 2006|
|Start Date ICMJE||September 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
||Self-reported health problems, working ability and healthcare utilisation at 12-month follow-up|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|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.|
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.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Condition ICMJE||Signs and Symptoms|
|Study Arm (s)||Not Provided|
|Publications *||Taimela S, Aronen P, Malmivaara A, Sintonen H, Tiekso J, Aro T. Effectiveness of a targeted occupational health intervention in workers with high risk of sickness absence: baseline characteristics and adherence as effect modifying factors in a randomized controlled trial. J Occup Rehabil. 2010 Mar;20(1):14-20.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Completion Date||May 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 60 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Finland|
|NCT Number ICMJE||NCT00378989|
|Other Study ID Numbers ICMJE||EVA2XRCT|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Evalua International|
|Information Provided By||Evalua International|
|Verification Date||September 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP