- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00448981
Stopping Upper Respiratory Infections and Flu in the Family: The Stuffy Trial (STUFFY)
Stopping URIs and Flu in the Family: The Stuffy Trial
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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New York
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New York, New York, United States, 10032
- Columbia University School of Nursing
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Rates of virologically confirmed influenza and influenza vaccination
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Rates of influenza-like symptoms
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Knowledge and attitudes about influenza and the common cold and antibiotic use practices.
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Collaborators and Investigators
Investigators
- Principal Investigator: Elaine Larson, RN,PhD, Columbia University School of Nursing
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDC-NCEZID-5033
- 1U01CI000442-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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