Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00821509
Recruitment Status : Completed
First Posted : January 13, 2009
Results First Posted : March 8, 2012
Last Update Posted : March 8, 2012
Sponsor:
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
Information provided by (Responsible Party):
Tapani Hovi, National Institute for Health and Welfare, Finland

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Respiratory Infection
Gastroenteritis
Interventions Behavioral: Hand washing
Behavioral: Disinfectant rubbing
Enrollment 683
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 Details 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
Hide 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 [1] 191 [2] 190 [3]
Not Completed 12 11 34
Reason Not Completed
Withdrawal by Subject             12             11             34
[1]
This is a result of 56 lost-to-follow-up and 44 new recruits
[2]
This is a result of 57 lost-to-follow-up and 46 new recruits
[3]
This is a result of 50 lost-to-follow-up and 16 new recruits
Arm/Group Title Hand Washing Disinfectant Rubbing Control Total
Hide 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 Number of Baseline Participants 257 202 224 683
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 257 participants 202 participants 224 participants 683 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
257
 100.0%
202
 100.0%
224
 100.0%
683
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 257 participants 202 participants 224 participants 683 participants
Female
185
  72.0%
153
  75.7%
163
  72.8%
501
  73.4%
Male
72
  28.0%
49
  24.3%
61
  27.2%
182
  26.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Finland Number Analyzed 257 participants 202 participants 224 participants 683 participants
257 202 224 683
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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 257 202 224
Overall Number of Units Analyzed
Type of Units Analyzed: Reported follow-up weeks
15014 11986 11644
Measure Type: Number
Unit of Measure: sick-leave episodes
625 418 405
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
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
Estimation Comments [Not Specified]
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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 257 202 224
Overall Number of Units Analyzed
Type of Units Analyzed: Follow-up weeks
15014 11986 11644
Measure Type: Number
Unit of Measure: Disease episodes
1451 1288 1214
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method proportion test
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of proportions
Estimated Value 0.933
Estimation Comments [Not Specified]
Time Frame Entire follow up period of 16 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Hand Washing Disinfectant Rubbing Control
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Hand Washing Disinfectant Rubbing Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/257 (0.00%)   0/202 (0.00%)   0/224 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Hand Washing Disinfectant Rubbing Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/257 (0.00%)   0/202 (0.00%)   0/224 (0.00%) 
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Tapani Hovi, Project Leader
Organization: National Institute for Health and Welfare
Phone: +358 400 517299
EMail: tapani.hovi@thl.fi
Layout table for additonal information
Responsible Party: Tapani Hovi, National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier: NCT00821509     History of Changes
Other Study ID Numbers: KTL460-8
First Submitted: January 12, 2009
First Posted: January 13, 2009
Results First Submitted: October 5, 2011
Results First Posted: March 8, 2012
Last Update Posted: March 8, 2012