- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00528814
Effectiveness of a School-Based Hand Sanitizer Program on Reducing Asthma Exacerbations
Effect of a School Based Hand Sanitizer Program on Asthma
Studieöversikt
Detaljerad beskrivning
In the United States, almost 9 million children have been diagnosed with asthma. It is a leading cause of hospitalizations and school absenteeism among children. Asthma symptoms are often seasonal, with the greatest number of exacerbations occurring in autumn and the fewest in mid-summer. Elementary school children are the most vulnerable to these seasonal changes, and many children experience an increase in exacerbations at the beginning of the school year. Recent research suggests that this seasonal peak in exacerbations is primarily caused by viral respiratory tract infections that are spread among children in school. Regular handwashing has been widely recognized as the most effective way to stop the spread of viruses and infectious illnesses. However, effective handwashing methods among school-age children can be inconsistent. Time constraints, a frequent lack of soap and towels, inconveniently located sinks, and water-saving faucets are all barriers to thorough handwashing. Improving hand hygiene through the use of antimicrobial rinse-free hand sanitizers in school classrooms may be a simple and effective way to reduce the risk of transmitting viruses that can cause asthma exacerbations. The purpose of this study is to evaluate the effectiveness of a school-based hand sanitizer program at decreasing exacerbations in children with asthma.
This study will enroll children with asthma who are attending one of the 32 participating schools. Each school will be randomly assigned to either use their usual hand hygiene practices in Year 1, followed by a two-step hand hygiene program including hand washing plus hand sanitizer in Year 2, or vice versa. Each participant will log in to an Internet-based data collection system on a daily basis to document their asthma symptoms and peak flow meter readings. Teachers will also log in daily to verify participants' data and to document participants' absences and the reason for the absence. Quick relief medication use will be recorded and measured through the use of a Doser device on participants' inhalers.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Alabama
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Birmingham, Alabama, Förenta staterna, 35233
- University of Alabama at Birmingham, Lung Health Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Diagnosed with asthma
- Enrolled in a participating elementary school
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Two Step Hand-Hygiene
Hand washing plus hand sanitizer
|
Active Hand Sanitizer
Andra namn:
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|
Inget ingripande: Usual Care Hand Hygiene
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Asthma exacerbations
Tidsram: Measured at Years 1 and 2
|
Measured at Years 1 and 2
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: William Bailey, MD, University of Alabama at Birmingham, Lung Health Center
Publikationer och användbara länkar
Allmänna publikationer
- Gerald LB, Gerald JK, Zhang B, McClure LA, Bailey WC, Harrington KF. Can a school-based hand hygiene program reduce asthma exacerbations among elementary school children? J Allergy Clin Immunol. 2012 Dec;130(6):1317-24. doi: 10.1016/j.jaci.2012.08.031. Epub 2012 Oct 12.
- Gerald LB, Gerald JK, McClure LA, Harrington K, Erwin S, Bailey WC. Redesigning a large school-based clinical trial in response to changes in community practice. Clin Trials. 2011 Jun;8(3):311-9. doi: 10.1177/1740774511403513.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 519
- R01HL086972 (U.S.S. NIH-anslag/kontrakt)
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