Stopping Upper Respiratory Infections and Flu in the Family: The Stuffy Trial (STUFFY)
Stopping URIs and Flu in the Family: The Stuffy Trial
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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New York
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New York, New York, Stati Uniti, 10032
- Columbia University School of Nursing
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Altro: 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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Altro: 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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Altro: 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).
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Rates of virologically confirmed influenza and influenza vaccination
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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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Collaboratori e investigatori
Investigatori
- Investigatore principale: Elaine Larson, RN,PhD, Columbia University School of Nursing
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stimato)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Infezioni
- Infezioni da virus a RNA
- Malattie virali
- Malattie delle vie respiratorie
- Infezioni da Picornaviridae
- Infezioni delle vie respiratorie
- Raffreddore
- Attrezzatura chirurgica
- Attrezzatura e forniture
- Fattori socioeconomici
- Caratteristiche della popolazione
- Materiali fabbricati
- Tecnologia, industria e agricoltura
- Dispositivi protettivi
- Attrezzatura di protezione personale
- Abbigliamento chirurgico
- Attrezzatura e forniture, ospedale
- Stato educativo
- Maschere
Altri numeri di identificazione dello studio
- CDC-NCEZID-5033
- 1U01CI000442-01 (Sovvenzione/contratto NIH degli Stati Uniti)
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