Stopping Upper Respiratory Infections and Flu in the Family: The Stuffy Trial (STUFFY)
Stopping URIs and Flu in the Family: The Stuffy Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10032
- Columbia University School of Nursing
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: Education (Control Group)
Participants received written educational materials (English or Spanish) on prevention and treatment of upper respiratory infections (URIs) and influenza.
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Educational materials (English or Spanish) on prevention and treatment of upper respiratory infections (URIs) and influenza.
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Otro: Education + Hand Sanitizer
Participants received the same educational materials plus alcohol-based hand sanitizer (multiple sizes) for use at home, work, and school.
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Educational materials (English or Spanish) on prevention and treatment of upper respiratory infections (URIs) and influenza.
Alcohol-based hand sanitizer provided in multiple sizes for use at home, work, and school.
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Otro: 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).
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Educational materials (English or Spanish) on prevention and treatment of upper respiratory infections (URIs) and influenza.
Alcohol-based hand sanitizer provided in multiple sizes for use at home, work, and school.
Surgical face masks with instructions for use when a household member develops influenza-like illness (ILI).
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Rates of virologically confirmed influenza and influenza vaccination
Periodo de tiempo: Throughout 19-month follow-up period
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Incidence of laboratory-confirmed influenza based on nasal swab specimens analyzed by viral culture or PCR; vaccination rates assessed via participant report.
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Throughout 19-month follow-up period
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Rates of influenza-like symptoms
Periodo de tiempo: Throughout 19-month follow-up period (symptoms reported at least twice weekly)
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Incidence of ILI episodes defined using CDC criteria (fever ≥37.8°C with cough and/or sore throat).
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Throughout 19-month follow-up period (symptoms reported at least twice weekly)
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Knowledge and attitudes about influenza and the common cold and antibiotic use practices.
Periodo de tiempo: Baseline and end of study (up to 19 months)
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Change in knowledge, attitudes, and practices (KAP) score based on a 10-item survey assessing understanding of transmission, prevention, and treatment.
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Baseline and end of study (up to 19 months)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Elaine Larson, RN,PhD, Columbia University School of Nursing
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimado)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Infecciones
- Infecciones por virus de ARN
- Enfermedades virales
- Enfermedades de las vías respiratorias
- Infecciones por Picornaviridae
- Infecciones del Tracto Respiratorio
- Resfriado comun
- Equipo quirúrgico
- Equipos y suministros
- Factores socioeconómicos
- Características de la población
- Materiales manufacturados
- Tecnología, industria y agricultura
- Dispositivos de protección
- Equipo de protección personal
- Atuendo quirúrgico
- Equipos y suministros, hospital
- Estado educativo
- Máscaras
Otros números de identificación del estudio
- CDC-NCEZID-5033
- 1U01CI000442-01 (Subvención/contrato del NIH de EE. UU.)
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