Stopping Upper Respiratory Infections and Flu in the Family: The Stuffy Trial

Respiratory Tract Infections Clinical Trial

— STUFFY  

Official title:

Stopping URIs and Flu in the Family: The Stuffy Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00448981
• Other study ID #: CDC-NCEZID-5033
• Secondary ID: 1U01CI000442-01
• Status: Completed
• Phase: N/A
• First received: March 16, 2007
• Last updated: October 1, 2012
• Start date: November 2006
• Est. completion date: June 2008

Study information

• Verified date: October 2012
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

Although 'colds' and seasonal influenza are clinically very different diseases from pandemic influenza, they share common transmission pathways and the community level interventions needed to reduce both seasonal flu, common viral upper respiratory infections and pandemic influenza are likely to be similar.

Aims of this project are to compare the impact of two household level interventions (an alcohol based hand sanitizer with or without face masks) on six outcomes: incidence and strains of virologically confirmed influenza in study households; rates of symptoms; number of secondary cases in households; antibiotic use practices for symptoms of influenza and other viral upper respiratory infections; household member knowledge of prevention and treatment strategies for pandemic influenza and viral upper respiratory infections; and rates of influenza vaccination among household members.

450 households in northern Manhattan (primarily recently immigrated Hispanics) will be randomized to three groups: control (receiving only a pamphlet on influenza prevention), alcohol hand sanitizer, and sanitizer plus face masks. Symptoms of influenza will be monitored daily for 15 months using ecological momentary assessment technology. Virologic cultures will be obtained from persons with flu symptoms (fever >100 degrees F., sore throat and/or cough). Antibiotic use practices, knowledge, and vaccination rates will be assessed by survey using piloted, psychometrically sound instruments. For this cluster randomization design with randomized intervention on the household level, outcomes will be measured at the individual and household level using generalized linear mixed model for counts response with a Poisson distribution and other appropriate multivariate techniques to control for confounding.

Comparison(s): The purpose of this study is to try to reduce the transmission of colds and flu among household members with one of three interventions: comparison of transmission in groups receiving educational material only to a group receiving educational material and instructed to use alcohol hand sanitizers to a group receiving educational material and instructed to use alcohol hand sanitizers as well as face masks when somebody has symptoms of the flu

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2788
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Households which include at least three persons, at least one of whom is a preschool child, living in Northern Manhattan, have a telephone, speak Spanish or English

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Common Cold
• Infection
• Respiratory Tract Infections

Intervention

Behavioral:
• Hand hygiene and educational material

Device:
• Mask, alcohol and hand sanitizer

Locations

Country	Name	City	State
United States	Columbia University School of Nursing	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of virologically confirmed influenza and influenza vaccination
Primary	Rates of influenza-like symptoms
Primary	Knowledge and attitudes about influenza and the common cold and antibiotic use practices.