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

• Sponsor: Finnish Institute for Health and Welfare (Other)
• Overall Status: Completed
• CT.gov ID: NCT00821509
• Collaborator: Finnish Work Environment Fund (Other), Finnish Institute of Occupational Health (Other), Berner Oy (Industry), Farmos Oy (Industry), Kesko Oyj (Other), Nordea Bank Finland Plc (Other), Outokumpu (Other), Outokumpu Technogy Oyj (Other), Suomen Osuuskauppojen Keskuskunta (SOK) (Other), S-Pankki (Other)
• Enrollment: 683
• Location: 1
• Arms: 3
• Duration (Months): 35
• Patients Per Site Per Month: 19.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Infection; Gastroenteritis	Behavioral: Hand washing; Behavioral: Disinfectant rubbing	N/A

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

• Study Type: Interventional
• 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: Jan 1, 2009
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. 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 [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.

2. Cumulative Number of Reported Episodes of Infectious Disease in the Arm Over the Total Number of Follow-up Weeks in the Arm [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institute for Health and Wellfare (THL)	Helsinki		Finland	00271

Sponsors and Collaborators

• Finnish Institute for Health and Welfare
• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tapani Hovi, Project Leader, Finnish Institute for Health and Welfare
• ClinicalTrials.gov Identifier: NCT00821509
• Other Study ID Numbers: KTL460-8
• First Posted: Jan 13, 2009
• Last Update Posted: Mar 8, 2012
• Last Verified: Feb 1, 2012

• Keywords provided by Tapani Hovi, Project Leader, Finnish Institute for Health and Welfare: virus infection; hygiene; transmission; intervention
• Additional relevant MeSH terms: Respiratory Tract Infections; Gastroenteritis; Disinfectants

Study Results

Participant Flow

Recruitment Details	Occupational health clinics of 6 corporations in the Helsinki region contacted in 2008; 21 study clusters identified with at least. 50 employees in common office work in each; Active recruitment by personal invitation to all members of the identified clusters (N=1270)in early January 2009 by emails including a designated risk interview (see below)
Pre-assignment Detail	Based on the cumulated acute infection risk (day-care of children, age, smoking, chronic CV- or lung disease, frequent business travel etc.)in each cluster the clusters were ranked according to the calculated risk index, and out of the 7 cluster triplets with most similar index, one was randomly allocated to each of the three study arms

Arm/Group Title	Hand Washing	Disinfectant Rubbing	Control
Arm/Group 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
Period Title: Overall Study
STARTED	257	202	224
COMPLETED	245	191	190
NOT COMPLETED	12	11	34

Baseline Characteristics

Arm/Group Title	Hand Washing	Disinfectant Rubbing	Control	Total
Arm/Group 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	Total of all reporting groups
Overall Participants	257	202	224	683
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	257 100%	202 100%	224 100%	683 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	185 72%	153 75.7%	163 72.8%	501 73.4%
Male	72 28%	49 24.3%	61 27.2%	182 26.6%
Region of Enrollment (participants) [Number]
Finland	257 100%	202 100%	224 100%	683 100%

Outcome Measures

1. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

Number of participants given is the number at the onset. There were both lost-to-follow-up and new recruits. The analysis is, however, based on episodes of days-off in entire arm during the entire follow-up time rather than on individual participants

Arm/Group Title	Hand Washing	Disinfectant Rubbing	Control
Arm/Group Description	Participants received behavioural instructions how to limit transmission of infections and were recommended to wash hand frequently	Participants received behavioural instructions how to limit transmission of infections and were recommended to clean their hands frequently with an alcohol containing disinfectant solution	Participants were advised not to change their hand hygiene habits
Measure Participants	257	202	224
Measure Reported follow-up weeks	15014	11986	11644
Number [sick-leave episodes]	625	418	405

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hand Washing, Control
	Comments	According to the null hypothesis the proportion of weeks with an onset of days-off period in neither of the intervention arms was different from that of control. No in advance power calculations were done.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	proportion test
	Comments	The test was carried out using the proportions calculated from the number of sick-leave episodes over the number o total follow-up weeks in each arm
Method of Estimation	Estimation Parameter	ratio of proportions
	Estimated Value	1.03
	Confidence Interval	() %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

Number of participants given is the number at the onset. There were both lost-to-follow-up and new recruits. The analysis is, however, based on episodes of days-off in entire arm during the entire follow-up time rather than on individual participants

Arm/Group Title	Hand Washing	Disinfectant Rubbing	Control
Arm/Group Description	Participants received behavioural instructions how to limit transmission of infections and were recommended to wash hand frequently	Participants received behavioural instructions how to limit transmission of infections and were recommended to clean their hands frequently with an alcohol containing disinfectant solution	Participants were advised not to change their hand hygiene habits
Measure Participants	257	202	224
Measure Follow-up weeks	15014	11986	11644
Number [Disease episodes]	1451	1288	1214

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hand Washing, Control
	Comments	According to the null hypothesis the proportion of weeks with an onset of an infectious disease period in neither of the intervention arms was different from that of control. No in advance power calculations were done.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.04
	Comments
	Method	proportion test
	Comments
Method of Estimation	Estimation Parameter	ratio of proportions
	Estimated Value	0.933
	Confidence Interval	() %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Entire follow up period of 16 months
Arm/Group Title	Hand Washing		Disinfectant Rubbing		Control
Arm/Group 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
All Cause Mortality
	Hand Washing		Disinfectant Rubbing		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Hand Washing		Disinfectant Rubbing		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/257 (0%)		0/202 (0%)		0/224 (0%)
Other (Not Including Serious) Adverse Events
	Hand Washing		Disinfectant Rubbing		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/257 (0%)		0/202 (0%)		0/224 (0%)

Limitations/Caveats

In a pre-study interview, 90% stated "when I have cold I usually come to work if I only can". Participants in the intervention arms, but not those of the control arm, were advised to stay home when sick: possible contribution to outcome measure 1.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.