NCT00448981

Brief Summary

Colds and flu cause much loss of work and school. The purpose of this study is to try to reduce the transmission of colds and flu among household members with one of three interventions: some educational material, educational material and use of alcohol hand sanitizers, and educational material and use of alcohol hand sanitizers as well as face masks when somebody has symptoms of the flu. We will recruit 450 households in Northern Manhattan and each household will be randomly assigned to one of these three groups. We will then follow these households for 15 months to see how often they get cold and flu symptoms. We will also look at antibiotic use practices for symptoms of colds and influenza ; household member knowledge of prevention and treatment strategies for pandemic influenza and viral URIs; and rates of influenza vaccination among household members. When someone in the study has serious flu symptoms such as a high fever and cough or sore throat, we will also obtain a nasal culture (by swabbing the nose) to see if there is flu virus present.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,788

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2006

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

November 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 19, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

1.6 years

First QC Date

March 16, 2007

Last Update Submit

April 30, 2026

Conditions

Keywords

Preventing upper respiratory tract infectionsPreventing influenzaPreventing the common coldHand hygiene and upper respiratory infectionsMask use in preventing upper respiratory infections

Outcome Measures

Primary Outcomes (3)

  • Rates of virologically confirmed influenza and influenza vaccination

    Incidence of laboratory-confirmed influenza based on nasal swab specimens analyzed by viral culture or PCR; vaccination rates assessed via participant report.

    Throughout 19-month follow-up period

  • Rates of influenza-like symptoms

    Incidence of ILI episodes defined using CDC criteria (fever ≥37.8°C with cough and/or sore throat).

    Throughout 19-month follow-up period (symptoms reported at least twice weekly)

  • Knowledge and attitudes about influenza and the common cold and antibiotic use practices.

    Change in knowledge, attitudes, and practices (KAP) score based on a 10-item survey assessing understanding of transmission, prevention, and treatment.

    Baseline and end of study (up to 19 months)

Study Arms (3)

Education (Control Group)

OTHER

Participants received written educational materials (English or Spanish) on prevention and treatment of upper respiratory infections (URIs) and influenza.

Behavioral: Education

Education + Hand Sanitizer

OTHER

Participants received the same educational materials plus alcohol-based hand sanitizer (multiple sizes) for use at home, work, and school.

Behavioral: EducationDevice: Hand Sanitizer

Education + Hand Sanitizer + Face Masks

OTHER

Participants received educational materials, hand sanitizer, and surgical face masks with instructions for use when a household member developed influenza-like illness (ILI).

Behavioral: EducationDevice: Hand SanitizerDevice: Face Masks

Interventions

EducationBEHAVIORAL

Educational materials (English or Spanish) on prevention and treatment of upper respiratory infections (URIs) and influenza.

Education (Control Group)Education + Hand SanitizerEducation + Hand Sanitizer + Face Masks

Alcohol-based hand sanitizer provided in multiple sizes for use at home, work, and school.

Education + Hand SanitizerEducation + Hand Sanitizer + Face Masks

Surgical face masks with instructions for use when a household member develops influenza-like illness (ILI).

Education + Hand Sanitizer + Face Masks

Eligibility Criteria

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

You may qualify if:

  • Households with at least three members
  • At least one preschool or elementary school-aged child in the household
  • Residence in Northern Manhattan
  • Ability to speak English or Spanish
  • Access to a telephone
  • Willingness to participate in regular symptom reporting and home visits
  • Not routinely using alcohol-based hand sanitizer at baseline

You may not qualify if:

  • Households with fewer than three members
  • No preschool or elementary school-aged child in the household
  • Inability to communicate in English or Spanish
  • No access to a telephone
  • Unwillingness or inability to comply with study procedures
  • Routine use of alcohol-based hand sanitizer prior to enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University School of Nursing

New York, New York, 10032, United States

Location

Related Publications (1)

  • Cohen B, Ferng YH, Wong-McLoughlin J, Jia H, Morse SS, Larson EL. Predictors of flu vaccination among urban Hispanic children and adults. J Epidemiol Community Health. 2012 Mar;66(3):204-9. doi: 10.1136/jech.2009.099879. Epub 2010 Sep 29.

MeSH Terms

Conditions

Respiratory Tract InfectionsCommon Cold

Interventions

Educational StatusMasks

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract DiseasesPicornaviridae InfectionsRNA Virus InfectionsVirus Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsSurgical AttireEquipment and Supplies, HospitalEquipment and SuppliesProtective DevicesPersonal Protective EquipmentSurgical EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Elaine Larson, RN,PhD

    Columbia University School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2007

First Posted

March 19, 2007

Study Start

November 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

May 5, 2026

Record last verified: 2026-04

Locations