Trial Outcomes & Findings for STOPFLU: Is it Possible to Reduce the Number of Days Off in Office Work by Improved Hand-hygiene? (NCT NCT00821509)
NCT ID: NCT00821509
Last Updated: 2012-03-08
Results Overview
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.
COMPLETED
NA
683 participants
At the end of the entire study period (16 months)
2012-03-08
Participant Flow
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)
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
Participant milestones
| Measure |
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
|
Control
No change in hygiene behaviour
|
|---|---|---|---|
|
Overall Study
STARTED
|
257
|
202
|
224
|
|
Overall Study
COMPLETED
|
245
|
191
|
190
|
|
Overall Study
NOT COMPLETED
|
12
|
11
|
34
|
Reasons for withdrawal
| Measure |
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
|
Control
No change in hygiene behaviour
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
12
|
11
|
34
|
Baseline Characteristics
STOPFLU: Is it Possible to Reduce the Number of Days Off in Office Work by Improved Hand-hygiene?
Baseline characteristics by cohort
| Measure |
Hand Washing
n=257 Participants
Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent hand washing in office and at home
|
Disinfectant Rubbing
n=202 Participants
Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent rubbing of hands with alcohol containing disinfectant in office and at home
|
Control
n=224 Participants
No change in hygiene behaviour
|
Total
n=683 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
257 Participants
n=5 Participants
|
202 Participants
n=7 Participants
|
224 Participants
n=5 Participants
|
683 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
185 Participants
n=5 Participants
|
153 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
501 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
182 Participants
n=4 Participants
|
|
Region of Enrollment
Finland
|
257 participants
n=5 Participants
|
202 participants
n=7 Participants
|
224 participants
n=5 Participants
|
683 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At the end of the entire study period (16 months)Population: 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
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.
Outcome measures
| Measure |
Hand Washing
n=15014 Reported follow-up weeks
Participants received behavioural instructions how to limit transmission of infections and were recommended to wash hand frequently
|
Disinfectant Rubbing
n=11986 Reported follow-up weeks
Participants received behavioural instructions how to limit transmission of infections and were recommended to clean their hands frequently with an alcohol containing disinfectant solution
|
Control
n=11644 Reported follow-up weeks
Participants were advised not to change their hand hygiene habits
|
|---|---|---|---|
|
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
|
625 sick-leave episodes
|
418 sick-leave episodes
|
405 sick-leave episodes
|
PRIMARY outcome
Timeframe: At the end of the study period (16 months)Population: 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
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.
Outcome measures
| Measure |
Hand Washing
n=15014 Follow-up weeks
Participants received behavioural instructions how to limit transmission of infections and were recommended to wash hand frequently
|
Disinfectant Rubbing
n=11986 Follow-up weeks
Participants received behavioural instructions how to limit transmission of infections and were recommended to clean their hands frequently with an alcohol containing disinfectant solution
|
Control
n=11644 Follow-up weeks
Participants were advised not to change their hand hygiene habits
|
|---|---|---|---|
|
Cumulative Number of Reported Episodes of Infectious Disease in the Arm Over the Total Number of Follow-up Weeks in the Arm
|
1451 Disease episodes
|
1288 Disease episodes
|
1214 Disease episodes
|
Adverse Events
Hand Washing
Disinfectant Rubbing
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Tapani Hovi, Project Leader
National Institute for Health and Welfare
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place