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

30. April 2026 aktualisiert von: Centers for Disease Control and Prevention

Stopping URIs and Flu in the Family: The Stuffy Trial

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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

Studientyp

Interventionell

Einschreibung (Tatsächlich)

2788

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • New York
      • New York, New York, Vereinigte Staaten, 10032
        • Columbia University School of Nursing

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Sonstiges: Education (Control Group)
Participants received written educational materials (English or Spanish) on prevention and treatment of upper respiratory infections (URIs) and influenza.
Verhalten: Education
Educational materials (English or Spanish) on prevention and treatment of upper respiratory infections (URIs) and influenza.
Sonstiges: Education + Hand Sanitizer
Participants received the same educational materials plus alcohol-based hand sanitizer (multiple sizes) for use at home, work, and school.
Verhalten: Education
Educational materials (English or Spanish) on prevention and treatment of upper respiratory infections (URIs) and influenza.
Gerät: Hand Sanitizer
Alcohol-based hand sanitizer provided in multiple sizes for use at home, work, and school.
Sonstiges: 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).
Verhalten: Education
Educational materials (English or Spanish) on prevention and treatment of upper respiratory infections (URIs) and influenza.
Gerät: Hand Sanitizer
Alcohol-based hand sanitizer provided in multiple sizes for use at home, work, and school.
Gerät: Face Masks
Surgical face masks with instructions for use when a household member develops influenza-like illness (ILI).

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Rates of virologically confirmed influenza and influenza vaccination
Zeitfenster: 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.
Throughout 19-month follow-up period
Rates of influenza-like symptoms
Zeitfenster: 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).
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.
Zeitfenster: 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.
Baseline and end of study (up to 19 months)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Centers for Disease Control and Prevention

Ermittler

  • Hauptermittler: Elaine Larson, RN,PhD, Columbia University School of Nursing

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. November 2006

Primärer Abschluss (Tatsächlich)

1. Juni 2008

Studienabschluss (Tatsächlich)

1. Juni 2008

Studienanmeldedaten

Zuerst eingereicht

16. März 2007

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

16. März 2007

Zuerst gepostet (Geschätzt)

19. März 2007

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. April 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CDC-NCEZID-5033
  • 1U01CI000442-01 (US NIH Stipendium/Vertrag)

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