STOPFLU: Is it Possible to Reduce the Number of Days Off in Office Work by Improved Hand-hygiene?
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| ClinicalTrials.gov Identifier: NCT00821509 |
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Recruitment Status :
Completed
First Posted : January 13, 2009
Results First Posted : March 8, 2012
Last Update Posted : March 8, 2012
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Respiratory Infection Gastroenteritis | Behavioral: Hand washing Behavioral: Disinfectant rubbing | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 683 participants |
| Allocation: | Randomized |
| Intervention Model: | Factorial Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | STOPFLU: Is it Possible to Reduce the Number of Days Off in Office Work by Improved Hand-hygiene? |
| Study Start Date : | January 2009 |
| Actual Primary Completion Date : | July 2010 |
| Actual Study Completion Date : | December 2011 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Hand washing
Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent hand washing in office and at home
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Behavioral: Hand washing
Instructions for proper coughing and sneezing, and for reduced hand shaking, frequent hand washing in office and at home |
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Active Comparator: Disinfectant rubbing
Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent rubbing of hands with alcohol containing disinfectant in office and at home
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Behavioral: Disinfectant rubbing
Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent rubbing of hands with alcohol containing disinfectant in office and at home |
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No Intervention: Control
No change in hygiene behaviour
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- 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.
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Volunteers working in defined units
Exclusion Criteria:
- Persons with open wounds or chronic eczema in hands
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821509
| Finland | |
| National Institute for Health and Wellfare (THL) | |
| Helsinki, Finland, 00271 | |
| Study Director: | Tapani Hovi, MD PhD | National Public Health Institute, Finland |
| Responsible Party: | Tapani Hovi, Project Leader, Finnish Institute for Health and Welfare |
| ClinicalTrials.gov Identifier: | NCT00821509 |
| Other Study ID Numbers: |
KTL460-8 |
| First Posted: | January 13, 2009 Key Record Dates |
| Results First Posted: | March 8, 2012 |
| Last Update Posted: | March 8, 2012 |
| Last Verified: | February 2012 |
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virus infection hygiene transmission intervention |
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Respiratory Tract Infections Gastroenteritis Infections Respiratory Tract Diseases |
Gastrointestinal Diseases Digestive System Diseases Disinfectants Anti-Infective Agents |