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

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ClinicalTrials.gov Identifier: NCT00448981
Recruitment Status : Completed
First Posted : March 19, 2007
Last Update Posted : October 2, 2012
Sponsor:
Information provided by (Responsible Party):
Centers for Disease Control and Prevention

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.

Condition or disease Intervention/treatment Phase
Respiratory Tract Infections Common Cold Behavioral: Hand hygiene and educational material Device: Mask, alcohol and hand sanitizer Not Applicable

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2788 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Stopping URIs and Flu in the Family: The Stuffy Trial
Study Start Date : November 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Rates of virologically confirmed influenza and influenza vaccination
  2. Rates of influenza-like symptoms
  3. Knowledge and attitudes about influenza and the common cold and antibiotic use practices.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00448981


Locations
United States, New York
Columbia University School of Nursing
New York, New York, United States, 10032
Sponsors and Collaborators
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Elaine Larson, RN,PhD Columbia University School of Nursing

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00448981     History of Changes
Other Study ID Numbers: CDC-NCEZID-5033
1U01CI000442-01 ( U.S. NIH Grant/Contract )
First Posted: March 19, 2007    Key Record Dates
Last Update Posted: October 2, 2012
Last Verified: October 2012

Keywords provided by Centers for Disease Control and Prevention:
Preventing upper respiratory tract infections
Preventing influenza
Preventing the common cold
Hand hygiene and upper respiratory infections
Mask use in preventing upper respiratory infections

Additional relevant MeSH terms:
Infection
Communicable Diseases
Respiratory Tract Infections
Common Cold
Respiratory Tract Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Hand Sanitizers
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants