Stopping Upper Respiratory Infections and Flu in the Family: The Stuffy Trial - NCT00448981-10032 (Clinical Trial 165730)
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New York |
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State:
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NY |
| Zip Code: |
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10032 |
| Conditions: |
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Respiratory Tract Infections - Common Cold |
| Purpose: |
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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.
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| Study summary: |
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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 |
| Criteria: |
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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 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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December 29, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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