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STOPFLU: Is it Possible to Reduce the Number of Days Off in Office Work by Improved Hand-hygiene?

This study has been completed.
Sponsor:
Collaborators:
The 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
Information provided by (Responsible Party):
Tapani Hovi, National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier:
NCT00821509
First received: January 12, 2009
Last updated: February 6, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Respiratory Infection
Gastroenteritis
Behavioral: Hand washing
Behavioral: Disinfectant rubbing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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?

Resource links provided by NLM:


Further study details as provided by National Institute for Health and Welfare, Finland:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 683
Study Start Date: January 2009
Study Completion Date: December 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hand washing
Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent hand washing in office and at home
Behavioral: Hand washing
Instructions for proper coughing and sneezing, and for reduced hand shaking, frequent hand washing in office and at home
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
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
No Intervention: Control
No change in hygiene behaviour

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Volunteers working in defined units

Exclusion Criteria:

  • Persons with open wounds or chronic eczema in hands
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00821509

Locations
Finland
National Institute for Health and Wellfare (THL)
Helsinki, Finland, 00271
Sponsors and Collaborators
National Institute for Health and Welfare, Finland
The 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
Investigators
Study Director: Tapani Hovi, MD PhD National Public Health Institute, Finland
  More Information

No publications provided

Responsible Party: Tapani Hovi, Project Leader, National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier: NCT00821509     History of Changes
Other Study ID Numbers: KTL460-8
Study First Received: January 12, 2009
Results First Received: October 5, 2011
Last Updated: February 6, 2012
Health Authority: Finland: Ministry of Social Affairs and Health

Keywords provided by National Institute for Health and Welfare, Finland:
virus infection
hygiene
transmission
intervention

Additional relevant MeSH terms:
Gastroenteritis
Infection
Respiratory Tract Infections
Digestive System Diseases
Gastrointestinal Diseases
Respiratory Tract Diseases
Disinfectants
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014