Stopping Upper Respiratory Infections and Flu in the Family: The Stuffy Trial (STUFFY)
Stopping URIs and Flu in the Family: The Stuffy Trial
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
New York
-
New York, New York, Stany Zjednoczone, 10032
- Columbia University School of Nursing
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Inny: Education (Control Group)
Participants received written educational materials (English or Spanish) on prevention and treatment of upper respiratory infections (URIs) and influenza.
|
Educational materials (English or Spanish) on prevention and treatment of upper respiratory infections (URIs) and influenza.
|
|
Inny: Education + Hand Sanitizer
Participants received the same educational materials plus alcohol-based hand sanitizer (multiple sizes) for use at home, work, and school.
|
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.
|
|
Inny: 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).
|
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).
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Rates of virologically confirmed influenza and influenza vaccination
Ramy czasowe: 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
Ramy czasowe: 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.
Ramy czasowe: 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)
|
Współpracownicy i badacze
Śledczy
- Główny śledczy: Elaine Larson, RN,PhD, Columbia University School of Nursing
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Szacowany)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Infekcje
- Zakażenia wirusem RNA
- Choroby wirusowe
- Choroby Układu Oddechowego
- Infekcje Picornaviridae
- Infekcje dróg oddechowych
- Zwyczajne przeziębienie
- Sprzęt chirurgiczny
- Sprzęt i materiały eksploatacyjne
- Czynniki społeczno -ekonomiczne
- Charakterystyka populacji
- Wyprodukowane materiały
- Technologia, przemysł i rolnictwo
- Urządzenia ochronne
- Osobisty sprzęt ochronny
- Strój chirurgiczny
- Sprzęt i materiały, szpital
- Status edukacyjny
- Maski
Inne numery identyfikacyjne badania
- CDC-NCEZID-5033
- 1U01CI000442-01 (Grant/umowa NIH USA)
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .