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

Signs and Symptoms Clinical Trial

Official title:

The Effectiveness and Cost-effectiveness of Health Advice and Occupational Health Intervention on Work Ability. Two Randomised Trials.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00378989
• Other study ID #: EVA2XRCT
• Status: Completed
• Phase: N/A
• First received: September 19, 2006
• Last updated: February 9, 2015
• Start date: September 2004
• Est. completion date: October 2006

Study information

• Verified date: February 2015
• Source: Evalua International
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 418
• Est. completion date: October 2006
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Permanent job

• Age 18 to 60 years

Exclusion Criteria:

• Pension granted

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Signs and Symptoms

Intervention

Behavioral:
• Consultation at the occupational health services
Consultation at the occupational health services

Locations

Country	Name	City	State
Finland	Evalua International Ltd. Oy	Espoo

Sponsors (7)

Lead Sponsor	Collaborator
Evalua International	Finnish Office for Health Technology Assessment, FinOHTA/Stakes, Helsinki University, Mutual Pension Insurance Company Ilmarinen, Pfizer, Sitra, the Finnish Innovation Fund, The Finnish Funding Agency for Technology and Innovation (TEKES)

Country where clinical trial is conducted

Finland, 

References & Publications (4)

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 — View Citation

Taimela S, Justén S, Aronen P, Sintonen H, Läärä E, Malmivaara A, Tiekso J, Aro T. An occupational health intervention programme for workers at high risk for sickness absence. Cost effectiveness analysis based on a randomised controlled trial. Occup Envir — View Citation

Taimela S, Läärä E, Malmivaara A, Tiekso J, Sintonen H, Justén S, Aro T. Self-reported health problems and sickness absence in different age groups predominantly engaged in physical work. Occup Environ Med. 2007 Nov;64(11):739-46. Epub 2007 Feb 15. — View Citation

Taimela S, Malmivaara A, Justén S, Läärä E, Sintonen H, Tiekso J, Aro T. The effectiveness of two occupational health intervention programmes in reducing sickness absence among employees at risk. Two randomised controlled trials. Occup Environ Med. 2008 A — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sickness absence during the 12-month follow-up		12 months	No