CompletedNot Applicable

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

United States2,788 participantsStarted 2006-11

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Households with at least three members * At least one preschool or elementary school-aged child in the household * Residence in Northern Manhattan * Ability to speak English or Spanish * Access to a telephone * Willingness to participate in regular symptom reporting and home visits * Not routinely using alcohol-based hand sanitizer at baseline Exclusion Criteria: * Households with fewer than three members * No preschool or elementary school-aged child in the household * Inability to communicate in English or Spanish * No access to a telephone * Unwillingness or inability to comply with study procedures * Routine use of alcohol-based hand sanitizer prior to enrollment

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rates of virologically confirmed influenza and influenza vaccination

Timeframe: Throughout 19-month follow-up period

Rates of influenza-like symptoms

Timeframe: Throughout 19-month follow-up period (symptoms reported at least twice weekly)

Knowledge and attitudes about influenza and the common cold and antibiotic use practices.

Timeframe: Baseline and end of study (up to 19 months)

Trial details

NCT IDNCT00448981

SponsorCenters for Disease Control and Prevention

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2008-06

View on ClinicalTrials.gov More Respiratory Tract Infections trials