Stopping URIs and Flu in the Family: The Stuffy Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,788
- 试验地点
- 1
- 主要终点
- Rates of virologically confirmed influenza and influenza vaccination
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Education (Control Group)
Participants received written educational materials (English or Spanish) on prevention and treatment of upper respiratory infections (URIs) and influenza.
干预措施: Education (Behavioral)
Education + Hand Sanitizer
Participants received the same educational materials plus alcohol-based hand sanitizer (multiple sizes) for use at home, work, and school.
干预措施: Education (Behavioral)
Education + Hand Sanitizer
Participants received the same educational materials plus alcohol-based hand sanitizer (multiple sizes) for use at home, work, and school.
干预措施: Hand Sanitizer (Device)
Education + Hand Sanitizer + Face Masks
Participants received educational materials, hand sanitizer, and surgical face masks with instructions for use when a household member developed influenza-like illness (ILI).
干预措施: Education (Behavioral)
Education + Hand Sanitizer + Face Masks
Participants received educational materials, hand sanitizer, and surgical face masks with instructions for use when a household member developed influenza-like illness (ILI).
干预措施: Hand Sanitizer (Device)
Education + Hand Sanitizer + Face Masks
Participants received educational materials, hand sanitizer, and surgical face masks with instructions for use when a household member developed influenza-like illness (ILI).
干预措施: Face Masks (Device)
结局指标
主要结局
Rates of virologically confirmed influenza and influenza vaccination
时间窗: 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
时间窗: 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.
时间窗: 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.
次要结局
未报告次要终点