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

Primary Purpose

Respiratory Tract Infections, Common Cold

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hand hygiene and educational material
Mask, alcohol and hand sanitizer
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Tract Infections focused on measuring Preventing upper respiratory tract infections, Preventing influenza, Preventing the common cold, Hand hygiene and upper respiratory infections, Mask use in preventing upper respiratory infections

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Columbia University School of Nursing

Outcomes

Primary Outcome Measures

Rates of virologically confirmed influenza and influenza vaccination
Rates of influenza-like symptoms
Knowledge and attitudes about influenza and the common cold and antibiotic use practices.

Secondary Outcome Measures

Full Information

First Posted
March 16, 2007
Last Updated
October 1, 2012
Sponsor
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT00448981
Brief Title
Stopping Upper Respiratory Infections and Flu in the Family: The Stuffy Trial
Acronym
STUFFY
Official Title
Stopping URIs and Flu in the Family: The Stuffy Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Tract Infections, Common Cold
Keywords
Preventing upper respiratory tract infections, Preventing influenza, Preventing the common cold, Hand hygiene and upper respiratory infections, Mask use in preventing upper respiratory infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2788 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Hand hygiene and educational material
Intervention Type
Device
Intervention Name(s)
Mask, alcohol and hand sanitizer
Primary Outcome Measure Information:
Title
Rates of virologically confirmed influenza and influenza vaccination
Title
Rates of influenza-like symptoms
Title
Knowledge and attitudes about influenza and the common cold and antibiotic use practices.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elaine Larson, RN,PhD
Organizational Affiliation
Columbia University School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University School of Nursing
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20881023
Citation
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.
Results Reference
derived

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

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