NCT00425893

Brief Summary

This study will test the effectiveness of face masks and hand cleaning in preventing the spread of influenza within households

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6,069

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2007

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

First Submitted

Initial submission to the registry

January 19, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 23, 2007

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

April 13, 2012

Status Verified

April 1, 2012

Enrollment Period

1.6 years

First QC Date

January 19, 2007

Last Update Submit

April 12, 2012

Conditions

Influenza

Keywords

influenzamaskstransmissionhand hygienenon-pharmacologic interventions

Outcome Measures

Primary Outcomes (1)

  • secondary influenza infection

    7 days

Study Arms (3)

1

ACTIVE COMPARATOR

health education

Other: health education

2

EXPERIMENTAL

hand hygiene

Behavioral: hand hygiene

3

EXPERIMENTAL

masks and hand hygiene

Behavioral: hand hygieneDevice: face masks

Interventions

hand hygieneBEHAVIORAL

alcohol-based hand wash

23
health educationOTHER

Proper nutrition, etc.

1
face masksDEVICE

face masks

3

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Member of family with influenza infected member

You may not qualify if:

  • Age less than 2 yr

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hong Kong

Hong Kong, Hong Kong, China

Location

Related Publications (2)

  • 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.

    PMID: 19652172DERIVED

  • 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.

    PMID: 18461182DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Hand HygieneMasks

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

HygieneTherapeuticsPublic HealthEnvironment and Public HealthSurgical AttireEquipment and Supplies, HospitalEquipment and SuppliesProtective DevicesPersonal Protective EquipmentSurgical EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Benjamin J Cowling, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

January 19, 2007

First Posted

January 23, 2007

Study Start

February 1, 2007

Primary Completion

September 1, 2008

Study Completion

November 1, 2008

Last Updated

April 13, 2012

Record last verified: 2012-04

Locations

CN(1)