Signs and SymptomsNCT00378989
The Effectiveness of Health Advice and Occupational Health Intervention on Work Ability
A study testing Consultation at the occupational health services in people with Signs and Symptoms, run by Evalua International at 1 site in Finland.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Signs and Symptoms
- What is being tested?
- Consultation at the occupational health services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 418 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2004to Oct 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Permanent job
- Age 18 to 60 years
Who cannot join
- Pension granted
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Signs and Symptoms
- Being tested
- Consultation at the occupational health services
- Medical subject headings
- Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consultation at the occupational health servicesBehavioural
Consultation at the occupational health services
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | A letter with personal feedback of the results of a health risk appraisal and invitation to a consultation at the occupational health services. Receives: Behavioral: Consultation at the occupational health services |
| Control | No intervention | Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sickness absence during the 12-month follow-up
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2006 (estimated)
- Study startSep 2004
- Primary completionOct 2005
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Signs and SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 418 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evalua International
- Sponsor type
- University, hospital or other
- Collaborators
- Mutual Pension Insurance Company Ilmarinen, The Finnish Funding Agency for Technology and Innovation, Sitra, the Finnish Innovation Fund, Pfizer, Finnish Office for Health Technology Assessment, FinOHTA/Stakes, University of Helsinki
- Responsible party
- Principal investigator, Simo Taimela, Evalua International
- Investigators
- Simo P Taimela, MD, PhD, Principal investigator, Evalua International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00378989
- Sponsor's protocol ID
- EVA2XRCT
- Status last verified
- Feb 2015
- First submitted
- 19 Sep 2006
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Taimela S, Laara E, Malmivaara A, Tiekso J, Sintonen H, Justen 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. doi: 10.1136/oem.2006.027789. Epub 2007 Feb 15.
PubMed 17303674Taimela S, Malmivaara A, Justen S, Laara 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 Apr;65(4):236-41. doi: 10.1136/oem.2007.032706. Epub 2007 Aug 6.
PubMed 17681994Taimela S, Justen S, Aronen P, Sintonen H, Laara 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 Environ Med. 2008 Apr;65(4):242-8. doi: 10.1136/oem.2007.033167. Epub 2007 Oct 12.
PubMed 17933885Taimela 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. doi: 10.1007/s10926-009-9221-0.
PubMed 20012343
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Cost-effectiveness of Health Advice and Occupational Health Intervention on Work Ability. Two Randomised Trials.
- ClinicalTrials.gov ID
- NCT00378989
- Acronym / sponsor ID
- EVA2XRCT
- Conditions
- Signs and Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 418 participants (actual)
- Lead sponsor
- Evalua InternationalUniversity, hospital or other
- Collaborators
- Mutual Pension Insurance Company Ilmarinen, The Finnish Funding Agency for Technology and Innovation, Sitra, the Finnish Innovation Fund, Pfizer, Finnish Office for Health Technology Assessment, FinOHTA/Stakes, University of Helsinki
- Study start
- Sep 2004
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 21 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: Consultation at the occupational health servicesA letter with personal feedback of the results of a health risk appraisal and invitation to a consultation at the occupational health services. |
| Control | No intervention | –Care as usual |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Permanent job
- Age 18 to 60 years
Key exclusion criteria (1 listed)
- Pension granted
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Consultation at the occupational health servicesConsultation at the occupational health services | Behavioural | Intervention |
Primary outcome
Sickness absence during the 12-month follow-up
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
- Background: PubMed 17303674Taimela S, Laara E, Malmivaara A, Tiekso J, Sintonen H, Justen 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. doi: 10.1136/oem.2006.027789. Epub 2007 Feb 15.
- Results publication: PubMed 17681994Taimela S, Malmivaara A, Justen S, Laara 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 Apr;65(4):236-41. doi: 10.1136/oem.2007.032706. Epub 2007 Aug 6.
- Results publication: PubMed 17933885Taimela S, Justen S, Aronen P, Sintonen H, Laara 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 Environ Med. 2008 Apr;65(4):242-8. doi: 10.1136/oem.2007.033167. Epub 2007 Oct 12.
- Results publication: PubMed 20012343Taimela 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. doi: 10.1007/s10926-009-9221-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simo P Taimela, MD, PhD principal investigator
Evalua International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consultation at the occupational health services in people with Signs and Symptoms, run by Evalua International at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sickness absence during the 12-month follow-up (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00378989, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2015.