Respiratory InfectionNCT00821509
STOPFLU: Is it Possible to Reduce the Number of Days Off in Office Work by Improved Hand-hygiene?
A study testing Hand washing and Disinfectant rubbing in people with Respiratory Infection and Gastroenteritis, run by Finnish Institute for Health and Welfare at 1 site in Finland.
Trial summary
Improved hand hygiene is known to reduce transmission of both respiratory (RTI) and gastrointestinal infections (GTI) under "semi-closed" conditions such as hospitals, day-care centres and schools. It is not known if similar interventions would have the desired effect in a regular office work. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Infection, Gastroenteritis
- What is being tested?
- Hand washing and Disinfectant rubbing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 683 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2009to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers working in defined units
Who cannot join
- Persons with open wounds or chronic eczema in hands
Trial locations and contacts
1 site in 1 country.
Finland1 site
National Institute for Health and Wellfare (THL)
Helsinki, 00271
About this study
Improved hand hygiene is known to reduce transmission of both respiratory (RTI) and gastrointestinal infections (GTI) under "semi-closed" conditions such as hospitals, day-care centres and schools. It is not known if similar interventions would have the desired effect in a regular office work. This study is aiming to investigate this possibility by recruiting volunteers from several companies in the Helsinki Region. The two intervention groups will receive detailed instructions e.g. for proper coughing and sneezing, and for regular cleaning of hands with either standard liquid soap or with alcohol-based gel rubbing. Third group will serve as the control and is advised not to change their previous behaviour in this respect. The participants will report weekly possible RTI or GTI symptoms and related days off through internet. The study is planned to run about 18 months to cover the seasonal variation of the epidemics of the causative different viruses.
Read the detailed description
It is common knowledge that both respiratory tract infections (RTI) and gastrointestinal infections (GTI) cause a large part of short periods of days off from work, day care and school. In addition, because of the generally mild nature of the diseases, especially adults often come to work in spite of symptoms, and may therefore initiate transmission of infection among their colleagues. The chain of events from exposure to a pathogenic virus to subsequent infection and staying home because of infectious disease is a very complicated one, and is affected by many factors potentially causing variation, such as the multitude of causative agents, different individual histories of infections, variability of inter-personal contacts in work and various working- team feelings -influenced thresholds for staying home etc. Therefore, we aim to recruit at least 24 operationally distinct volunteer groups, each including at least 50 persons, and to continue the intervention about 18 months.
A virus transmission "risk-index" will be calculated for each group based on potential participant questionnaires enquiring, among other things, about numbers and ages of children, their possible out-of-home day care, personal properties such as smoking, chronic diseases, and potential differences in contacts during daily work. The 24 groups will be divided in groups of three most similar ones, and members each triplet then randomised in one the intervention groups or the control (see brief summary).
Data collection is based on self-reporting through Monday-morning electronic reports using a standard form. The from is enquiring about possible exposure to persons suffering from RTI or GTI, and possible own symptoms of the same diseases during the preceding 7 day period (including weekends and other holidays). The form will require daily records offering all possible combinations of the following categories: healthy-with symptoms, working normally-day off, own disease-child ill-other reason for day off.
Etiology of the symptoms will not be searched for on individual basis in this study but a connection to RTI virus epidemiology is built by a sentinel surveillance, where occupational health clinics located in the premises of the participating companies send a standard number of weekly specimens collected from employees visiting the clinic. For possible GTI outbreaks a standard outbreak investigation principle will be followed, including 3-5 specimens. from typical patients will be collected. Common causative agents of the diseases will be searched for using real-time PCR techniques.
- Conditions
- Respiratory Infection, Gastroenteritis
- Being tested
- Hand washing, Disinfectant rubbing
- Keywords
- virus infection, hygiene, transmission, intervention
- Medical subject headings
- Respiratory Tract Infections, Gastroenteritis, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand washingBehavioural
Instructions for proper coughing and sneezing, and for reduced hand shaking, frequent hand washing in office and at home
Disinfectant rubbingBehavioural
Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent rubbing of hands with alcohol containing disinfectant in office and at home
| Study group | Role | What they receive |
|---|---|---|
| Hand washing | Active comparator | Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent hand washing in office and at home Receives: Behavioral: Hand washing |
| Disinfectant rubbing | Active comparator | Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent rubbing of hands with alcohol containing disinfectant in office and at home Receives: Behavioral: Disinfectant rubbing |
| Control | No intervention | No change in hygiene behaviour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Number of Reported Days-off Episodes in the Arm Due to Own Infectious Disease Over the Total Number of Follow-up Weeks in the Arm
Participants reported weekly through an internet questionnaire symptoms of respiratory tract (RTI) or gastrointestinal tract infections (GTI) as well as whether they were working (if expected) or not, daily for the previous calendar week. Individual weekly reports were combined in a single continuum and successive days with both symptoms and absence from work were designated as days-off episodes due to own infectious disease. Number of these episodes in each trial arm was calculated and for the respective proportion, was divided by the total number of weekly reports collected in the arm.
Measured: At the end of the entire study period (16 months)
Cumulative Number of Reported Episodes of Infectious Disease in the Arm Over the Total Number of Follow-up Weeks in the Arm
Participants reported weekly through an internet questionnaire symptoms of respiratory tract (RTI) or gastrointestinal tract infections (GTI). Individual weekly reports were combined in a single continuum and successive days with either RTI or GTI symptoms were designated as disease episodes due. Numbers of RTI, GTI and either episodes in each trial arm were calculated, and for the respective proportion, were divided by the total number of weekly reports collected in the arm.
Measured: At the end of the study period (16 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJul 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Respiratory InfectionStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 683 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finnish Institute for Health and Welfare
- Sponsor type
- Other government
- Collaborators
- Finnish Work Environment Fund, Finnish Institute of Occupational Health, Berner Oy, Farmos Oy, Kesko Oyj, Nordea Bank Finland Plc, Outokumpu, Outokumpu Technogy Oyj, Suomen Osuuskauppojen Keskuskunta (SOK), S-Pankki
- Responsible party
- Principal investigator, Tapani Hovi, Finnish Institute for Health and Welfare
- Investigators
- Tapani Hovi, MD PhD, Study director, National Public Health Institute, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821509
- Sponsor's protocol ID
- KTL460-8
- Status last verified
- Feb 2012
- First submitted
- 12 Jan 2009
- Last updated
- 8 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Jefferson T, Dooley L, Ferroni E, Al-Ansary LA, van Driel ML, Bawazeer GA, Jones MA, Hoffmann TC, Clark J, Beller EM, Glasziou PP, Conly JM. Physical interventions to interrupt or reduce the spread of respiratory viruses. Cochrane Database Syst Rev. 2023 Jan 30;1(1):CD006207. doi: 10.1002/14651858.CD006207.pub6.
PubMed 36715243Jefferson T, Del Mar CB, Dooley L, Ferroni E, Al-Ansary LA, Bawazeer GA, van Driel ML, Jones MA, Thorning S, Beller EM, Clark J, Hoffmann TC, Glasziou PP, Conly JM. Physical interventions to interrupt or reduce the spread of respiratory viruses. Cochrane Database Syst Rev. 2020 Nov 20;11(11):CD006207. doi: 10.1002/14651858.CD006207.pub5.
PubMed 33215698Hovi T, Ollgren J, Savolainen-Kopra C. Intensified hand-hygiene campaign including soap-and-water wash may prevent acute infections in office workers, as shown by a recognized-exposure -adjusted analysis of a randomized trial. BMC Infect Dis. 2017 Jan 9;17(1):47. doi: 10.1186/s12879-016-2157-z.
PubMed 28068912Hovi T, Ollgren J, Haapakoski J, Savolainen-Kopra C. Development of a prognostic model based on demographic, environmental and lifestyle information for predicting incidences of symptomatic respiratory or gastrointestinal infection in adult office workers. Trials. 2016 Nov 16;17(1):545. doi: 10.1186/s13063-016-1668-7.
PubMed 27852324Hovi T, Ollgren J, Haapakoski J, Amiryousefi A, Savolainen-Kopra C. Exposure to persons with symptoms of respiratory or gastrointestinal infection and relative risk of disease: self-reported observations by controls in a randomized intervention trial. Trials. 2015 Apr 17;16:168. doi: 10.1186/s13063-015-0691-4.
PubMed 25879224Savolainen-Kopra C, Haapakoski J, Peltola PA, Ziegler T, Korpela T, Anttila P, Amiryousefi A, Huovinen P, Huvinen M, Noronen H, Riikkala P, Roivainen M, Ruutu P, Teirila J, Vartiainen E, Hovi T. STOPFLU: is it possible to reduce the number of days off in office work by improved hand-hygiene? Trials. 2010 Jun 4;11:69. doi: 10.1186/1745-6215-11-69.
PubMed 20525328
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STOPFLU: Is it Possible to Reduce the Number of Days Off in Office Work by Improved Hand-hygiene?
- ClinicalTrials.gov ID
- NCT00821509
- Acronym / sponsor ID
- KTL460-8
- Conditions
- Respiratory Infection, Gastroenteritis
- Keywords
- virus infection, hygiene, transmission, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 683 participants (actual)
- Lead sponsor
- Finnish Institute for Health and WelfareOther government
- Collaborators
- Finnish Work Environment Fund, Finnish Institute of Occupational Health, Berner Oy, Farmos Oy, Kesko Oyj, Nordea Bank Finland Plc, Outokumpu, Outokumpu Technogy Oyj, Suomen Osuuskauppojen Keskuskunta (SOK), S-Pankki
- Study start
- Jan 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 13 Jan 2009 (estimated)
- Results
- Posted 8 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Improved hand hygiene is known to reduce transmission of both respiratory (RTI) and gastrointestinal infections (GTI) under "semi-closed" conditions such as hospitals, day-care centres and schools. It is not known if similar interventions would have the desired effect in a regular office work. This study is aiming to investigate this possibility by recruiting volunteers from several companies in the Helsinki Region. The two intervention groups will receive detailed instructions e.g. for proper coughing and sneezing, and for regular cleaning of hands with either standard liquid soap or with alcohol-based gel rubbing. Third group will serve as the control and is advised not to change their previous behaviour in this respect. The participants will report weekly possible RTI or GTI symptoms and related days off through internet. The study is planned to run about 18 months to cover the seasonal variation of the epidemics of the causative different viruses.
Detailed description
It is common knowledge that both respiratory tract infections (RTI) and gastrointestinal infections (GTI) cause a large part of short periods of days off from work, day care and school. In addition, because of the generally mild nature of the diseases, especially adults often come to work in spite of symptoms, and may therefore initiate transmission of infection among their colleagues. The chain of events from exposure to a pathogenic virus to subsequent infection and staying home because of infectious disease is a very complicated one, and is affected by many factors potentially causing variation, such as the multitude of causative agents, different individual histories of infections, variability of inter-personal contacts in work and various working- team feelings -influenced thresholds for staying home etc. Therefore, we aim to recruit at least 24 operationally distinct volunteer groups, each including at least 50 persons, and to continue the intervention about 18 months.
A virus transmission "risk-index" will be calculated for each group based on potential participant questionnaires enquiring, among other things, about numbers and ages of children, their possible out-of-home day care, personal properties such as smoking, chronic diseases, and potential differences in contacts during daily work. The 24 groups will be divided in groups of three most similar ones, and members each triplet then randomised in one the intervention groups or the control (see brief summary).
Data collection is based on self-reporting through Monday-morning electronic reports using a standard form. The from is enquiring about possible exposure to persons suffering from RTI or GTI, and possible own symptoms of the same diseases during the preceding 7 day period (including weekends and other holidays). The form will require daily records offering all possible combinations of the following categories: healthy-with symptoms, working normally-day off, own disease-child ill-other reason for day off.
Etiology of the symptoms will not be searched for on individual basis in this study but a connection to RTI virus epidemiology is built by a sentinel surveillance, where occupational health clinics located in the premises of the participating companies send a standard number of weekly specimens collected from employees visiting the clinic. For possible GTI outbreaks a standard outbreak investigation principle will be followed, including 3-5 specimens. from typical patients will be collected. Common causative agents of the diseases will be searched for using real-time PCR techniques.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hand washing | Active comparator | Behavioral: Hand washingInstructions for proper coughing and sneezing, and for reduced hand shaking; frequent hand washing in office and at home |
| Disinfectant rubbing | Active comparator | Behavioral: Disinfectant rubbingInstructions for proper coughing and sneezing, and for reduced hand shaking; frequent rubbing of hands with alcohol containing disinfectant in office and at home |
| Control | No intervention | –No change in hygiene behaviour |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Volunteers working in defined units
Key exclusion criteria (1 listed)
- Persons with open wounds or chronic eczema in hands
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 |
|---|---|---|
| Hand washingInstructions for proper coughing and sneezing, and for reduced hand shaking, frequent hand washing in office and at home | Behavioural | Hand washing |
| Disinfectant rubbingInstructions for proper coughing and sneezing, and for reduced hand shaking; frequent rubbing of hands with alcohol containing disinfectant in office and at home | Behavioural | Disinfectant rubbing |
Primary outcome
Cumulative Number of Reported Days-off Episodes in the Arm Due to Own Infectious Disease Over the Total Number of Follow-up Weeks in the Arm
Time frame: At the end of the entire study period (16 months)
Participants reported weekly through an internet questionnaire symptoms of respiratory tract (RTI) or gastrointestinal tract infections (GTI) as well as whether they were working (if expected) or not, daily for the previous calendar week. Individual weekly reports were combined in a single continuum and successive days with both symptoms and absence from work were designated as days-off episodes due to own infectious disease. Number of these episodes in each trial arm was calculated and for the respective proportion, was divided by the total number of weekly reports collected in the arm.
Cumulative Number of Reported Episodes of Infectious Disease in the Arm Over the Total Number of Follow-up Weeks in the Arm
Time frame: At the end of the study period (16 months)
Participants reported weekly through an internet questionnaire symptoms of respiratory tract (RTI) or gastrointestinal tract infections (GTI). Individual weekly reports were combined in a single continuum and successive days with either RTI or GTI symptoms were designated as disease episodes due. Numbers of RTI, GTI and either episodes in each trial arm were calculated, and for the respective proportion, were divided by the total number of weekly reports collected in the arm.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36715243Jefferson T, Dooley L, Ferroni E, Al-Ansary LA, van Driel ML, Bawazeer GA, Jones MA, Hoffmann TC, Clark J, Beller EM, Glasziou PP, Conly JM. Physical interventions to interrupt or reduce the spread of respiratory viruses. Cochrane Database Syst Rev. 2023 Jan 30;1(1):CD006207. doi: 10.1002/14651858.CD006207.pub6.
- Derived from this study: PubMed 33215698Jefferson T, Del Mar CB, Dooley L, Ferroni E, Al-Ansary LA, Bawazeer GA, van Driel ML, Jones MA, Thorning S, Beller EM, Clark J, Hoffmann TC, Glasziou PP, Conly JM. Physical interventions to interrupt or reduce the spread of respiratory viruses. Cochrane Database Syst Rev. 2020 Nov 20;11(11):CD006207. doi: 10.1002/14651858.CD006207.pub5.
- Derived from this study: PubMed 28068912Hovi T, Ollgren J, Savolainen-Kopra C. Intensified hand-hygiene campaign including soap-and-water wash may prevent acute infections in office workers, as shown by a recognized-exposure -adjusted analysis of a randomized trial. BMC Infect Dis. 2017 Jan 9;17(1):47. doi: 10.1186/s12879-016-2157-z.
- Derived from this study: PubMed 27852324Hovi T, Ollgren J, Haapakoski J, Savolainen-Kopra C. Development of a prognostic model based on demographic, environmental and lifestyle information for predicting incidences of symptomatic respiratory or gastrointestinal infection in adult office workers. Trials. 2016 Nov 16;17(1):545. doi: 10.1186/s13063-016-1668-7.
- Derived from this study: PubMed 25879224Hovi T, Ollgren J, Haapakoski J, Amiryousefi A, Savolainen-Kopra C. Exposure to persons with symptoms of respiratory or gastrointestinal infection and relative risk of disease: self-reported observations by controls in a randomized intervention trial. Trials. 2015 Apr 17;16:168. doi: 10.1186/s13063-015-0691-4.
- Derived from this study: PubMed 20525328Savolainen-Kopra C, Haapakoski J, Peltola PA, Ziegler T, Korpela T, Anttila P, Amiryousefi A, Huovinen P, Huvinen M, Noronen H, Riikkala P, Roivainen M, Ruutu P, Teirila J, Vartiainen E, Hovi T. STOPFLU: is it possible to reduce the number of days off in office work by improved hand-hygiene? Trials. 2010 Jun 4;11:69. doi: 10.1186/1745-6215-11-69.
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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.
Tapani Hovi, MD PhD study director
National Public Health Institute, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand washing and Disinfectant rubbing in people with Respiratory Infection and Gastroenteritis, run by Finnish Institute for Health and Welfare 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 1 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 8 Mar 2012. 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?
Yes. Results are posted in the registry (first posted 8 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cumulative Number of Reported Days-off Episodes in the Arm Due to Own Infectious Disease Over the Total Number of Follow-up Weeks in the Arm (time frame: At the end of the entire study period (16 months)). The study lists 2 primary outcomes in all. 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 NCT00821509, which also lists 6 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 8 Mar 2012.