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

Primary Purpose

Respiratory Infection, Gastroenteritis

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Hand washing
Disinfectant rubbing
Sponsored by
Finnish Institute for Health and Welfare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Infection focused on measuring virus infection, hygiene, transmission, intervention

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Volunteers working in defined units

Exclusion Criteria:

  • Persons with open wounds or chronic eczema in hands

Sites / Locations

  • National Institute for Health and Wellfare (THL)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Hand washing

Disinfectant rubbing

Control

Arm Description

Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent hand washing in office and at home

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 change in hygiene behaviour

Outcomes

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
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
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.

Secondary Outcome Measures

Full Information

First Posted
January 12, 2009
Last Updated
February 6, 2012
Sponsor
Finnish Institute for Health and Welfare
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
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1. Study Identification

Unique Protocol Identification Number
NCT00821509
Brief Title
STOPFLU: Is it Possible to Reduce the Number of Days Off in Office Work by Improved Hand-hygiene?
Official Title
STOPFLU: Is it Possible to Reduce the Number of Days Off in Office Work by Improved Hand-hygiene?
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Finnish Institute for Health and Welfare
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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Infection, Gastroenteritis
Keywords
virus infection, hygiene, transmission, intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
683 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hand washing
Arm Type
Active Comparator
Arm Description
Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent hand washing in office and at home
Arm Title
Disinfectant rubbing
Arm Type
Active Comparator
Arm Description
Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent rubbing of hands with alcohol containing disinfectant in office and at home
Arm Title
Control
Arm Type
No Intervention
Arm Description
No change in hygiene behaviour
Intervention Type
Behavioral
Intervention Name(s)
Hand washing
Intervention Description
Instructions for proper coughing and sneezing, and for reduced hand shaking, frequent hand washing in office and at home
Intervention Type
Behavioral
Intervention Name(s)
Disinfectant rubbing
Intervention Description
Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent rubbing of hands with alcohol containing disinfectant in office and at home
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
At the end of the entire study period (16 months)
Title
Cumulative Number of Reported Episodes of Infectious Disease in the Arm Over the Total Number of Follow-up Weeks in the Arm
Description
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.
Time Frame
At the end of the study period (16 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Volunteers working in defined units Exclusion Criteria: Persons with open wounds or chronic eczema in hands
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tapani Hovi, MD PhD
Organizational Affiliation
National Public Health Institute, Finland
Official's Role
Study Director
Facility Information:
Facility Name
National Institute for Health and Wellfare (THL)
City
Helsinki
ZIP/Postal Code
00271
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
33215698
Citation
Jefferson 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.
Results Reference
derived
PubMed Identifier
28068912
Citation
Hovi 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.
Results Reference
derived
PubMed Identifier
27852324
Citation
Hovi 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.
Results Reference
derived
PubMed Identifier
25879224
Citation
Hovi 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.
Results Reference
derived
PubMed Identifier
20525328
Citation
Savolainen-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.
Results Reference
derived

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