NCT00821509

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
683

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
3 months until next milestone

Results Posted

Study results publicly available

March 8, 2012

Completed
Last Updated

March 8, 2012

Status Verified

February 1, 2012

Enrollment Period

1.5 years

First QC Date

January 12, 2009

Results QC Date

October 5, 2011

Last Update Submit

February 6, 2012

Conditions

Keywords

virus infectionhygienetransmissionintervention

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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)

Study Arms (3)

Hand washing

ACTIVE COMPARATOR

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

Behavioral: Hand washing

Disinfectant rubbing

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

No change in hygiene behaviour

Interventions

Hand washingBEHAVIORAL

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

Hand washing

Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent rubbing of hands with alcohol containing disinfectant in office and at home

Disinfectant rubbing

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteers working in defined units

You may not qualify if:

  • Persons with open wounds or chronic eczema in hands

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute for Health and Wellfare (THL)

Helsinki, 00271, Finland

Location

Related Publications (6)

  • Jefferson T, Dooley L, Ferroni E, Al-Ansary LA, van Driel ML, Bawazeer GA, Jones MA, Hoffmann TC, Clark J, Beller EM, Glasziou PP, Conly JM. Physical interventions to interrupt or reduce the spread of respiratory viruses. Cochrane Database Syst Rev. 2023 Jan 30;1(1):CD006207. doi: 10.1002/14651858.CD006207.pub6.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Respiratory Tract InfectionsGastroenteritisVirus Diseases

Interventions

Hand Disinfection

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Hand HygieneHygienePublic HealthEnvironment and Public Health

Limitations and 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.

Results Point of Contact

Title
Tapani Hovi, Project Leader
Organization
National Institute for Health and Welfare

Study Officials

  • Tapani Hovi, MD PhD

    National Public Health Institute, Finland

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Leader

Study Record Dates

First Submitted

January 12, 2009

First Posted

January 13, 2009

Study Start

January 1, 2009

Primary Completion

July 1, 2010

Study Completion

December 1, 2011

Last Updated

March 8, 2012

Results First Posted

March 8, 2012

Record last verified: 2012-02

Locations