Back to resultsA Randomised Controlled Trial of Face Masks and Hand Hygiene in Reducing Influenza Transmission in Households
Primary Purpose
Influenza
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
hand hygiene
health education
face masks
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring influenza, masks, transmission, hand hygiene, non-pharmacologic interventions
Eligibility Criteria
Inclusion Criteria:
- Member of family with influenza infected member
Exclusion Criteria:
- Age less than 2 yr
Sites / Locations
- University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
1
2
3
Arm Description
health education
hand hygiene
masks and hand hygiene
Outcomes
Primary Outcome Measures
secondary influenza infection
Secondary Outcome Measures
Full Information
NCT ID
NCT00425893
First Posted
January 19, 2007
Last Updated
April 12, 2012
Sponsor
Centers for Disease Control and Prevention
Collaborators
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00425893
Brief Title
A Randomised Controlled Trial of Face Masks and Hand Hygiene in Reducing Influenza Transmission in Households
Official Title
A Randomised Controlled Trial of Face Masks and Hand Hygiene in Reducing Influenza Transmission in Households
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
The University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will test the effectiveness of face masks and hand cleaning in preventing the spread of influenza within households
Detailed Description
Randomised controlled trial of surgical masks and alcohol hand wash among approximately 6069 Hong Kong residents who have a household member diagnosed with influenza. Influenza in index member and secondary infection will be documented with rapid influenza tests and PCR. Minimal risk to participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
influenza, masks, transmission, hand hygiene, non-pharmacologic interventions
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6069 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
health education
Arm Title
2
Arm Type
Experimental
Arm Description
hand hygiene
Arm Title
3
Arm Type
Experimental
Arm Description
masks and hand hygiene
Intervention Type
Behavioral
Intervention Name(s)
hand hygiene
Intervention Description
alcohol-based hand wash
Intervention Type
Other
Intervention Name(s)
health education
Intervention Description
Proper nutrition, etc.
Intervention Type
Device
Intervention Name(s)
face masks
Intervention Description
face masks
Primary Outcome Measure Information:
Title
secondary influenza infection
Time Frame
7 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Member of family with influenza infected member
Exclusion Criteria:
Age less than 2 yr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin J Cowling, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Hong Kong
City
Hong Kong
State/Province
Hong Kong
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
19652172
Citation
Cowling BJ, Chan KH, Fang VJ, Cheng CK, Fung RO, Wai W, Sin J, Seto WH, Yung R, Chu DW, Chiu BC, Lee PW, Chiu MC, Lee HC, Uyeki TM, Houck PM, Peiris JS, Leung GM. Facemasks and hand hygiene to prevent influenza transmission in households: a cluster randomized trial. Ann Intern Med. 2009 Oct 6;151(7):437-46. doi: 10.7326/0003-4819-151-7-200910060-00142. Epub 2009 Aug 3.
Results Reference
derived
PubMed Identifier
18461182
Citation
Cowling BJ, Fung RO, Cheng CK, Fang VJ, Chan KH, Seto WH, Yung R, Chiu B, Lee P, Uyeki TM, Houck PM, Peiris JS, Leung GM. Preliminary findings of a randomized trial of non-pharmaceutical interventions to prevent influenza transmission in households. PLoS One. 2008 May 7;3(5):e2101. doi: 10.1371/journal.pone.0002101.
Results Reference
derived
Learn more about this trial
A Randomised Controlled Trial of Face Masks and Hand Hygiene in Reducing Influenza Transmission in Households
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