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

Gastroenteritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00821509
• Other study ID #: KTL460-8
• Status: Completed
• Phase: N/A
• First received: January 12, 2009
• Last updated: February 6, 2012
• Start date: January 2009
• Est. completion date: December 2011

Study information

• Verified date: February 2012
• Source: National Institute for Health and Welfare, Finland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ministry of Social Affairs and Health
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 683
• Est. completion date: December 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Volunteers working in defined units

Exclusion Criteria:

• Persons with open wounds or chronic eczema in hands

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gastroenteritis
• Respiratory Infection
• Respiratory Tract Infections

Intervention

Behavioral:
• Hand washing
Instructions for proper coughing and sneezing, and for reduced hand shaking, frequent hand washing in office and at home
• 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

Locations

Country	Name	City	State
Finland	National Institute for Health and Wellfare (THL)	Helsinki

Sponsors (11)

Lead Sponsor	Collaborator
National Institute for Health and Welfare, Finland	Berner Oy, Farmos Oy, Finnish Institute of Occupational Health, Finnish Work Environment Fund, Kesko Oyj, Nordea Bank Finland Plc, Outokumpu, Outokumpu Technogy Oyj, S-Pankki, Suomen Osuuskauppojen Keskuskunta (SOK)

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At the end of the entire study period (16 months)	No
Primary	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.	At the end of the study period (16 months)	No