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
|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|
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|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|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|
- 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.
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
|United States, New York|
|Columbia University School of Nursing|
|New York, New York, United States, 10032|
|Principal Investigator:||Elaine Larson, RN,PhD||Columbia University School of Nursing|