Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448981
Status:
COMPLETED
Last Update Posted:
2012-10-02
First Post:
2007-03-16
Brief Title:
Stopping Upper Respiratory Infections and Flu in the Family The Stuffy Trial
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Stopping URIs and Flu in the Family The Stuffy Trial
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STUFFY
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 andor 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
Comparisons 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
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 andor 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
Comparisons 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1U01CI000442-01 | NIH | None | httpsreporternihgovquickSearch1U01CI000442-01 |