Common Cold, Respiratory Tract Infections
Conditions
Keywords
Preventing upper respiratory tract infections, Preventing influenza, Preventing the common cold, Hand hygiene and upper respiratory infections, Mask use in preventing upper respiratory infections
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 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
Interventions
BEHAVIORALEducation
Educational materials (English or Spanish) on prevention and treatment of upper respiratory infections (URIs) and influenza.
DEVICEHand Sanitizer
Alcohol-based hand sanitizer provided in multiple sizes for use at home, work, and school.
DEVICEFace Masks
Surgical face masks with instructions for use when a household member develops influenza-like illness (ILI).
Sponsors
Centers for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of virologically confirmed influenza and influenza vaccination | Throughout 19-month follow-up period | Incidence of laboratory-confirmed influenza based on nasal swab specimens analyzed by viral culture or PCR; vaccination rates assessed via participant report. |
| Rates of influenza-like symptoms | Throughout 19-month follow-up period (symptoms reported at least twice weekly) | Incidence of ILI episodes defined using CDC criteria (fever ≥37.8°C with cough and/or sore throat). |
| Knowledge and attitudes about influenza and the common cold and antibiotic use practices. | Baseline and end of study (up to 19 months) | Change in knowledge, attitudes, and practices (KAP) score based on a 10-item survey assessing understanding of transmission, prevention, and treatment. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORElaine Larson, RN,PhD
Columbia University School of Nursing
Outcome results
None listed