Effectiveness of a School-Based Hand Sanitizer Program on Reducing Asthma Exacerbations

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Other: Active Hand Sanitizer

• Registration Number: NCT00528814
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

Asthma is a common, serious illness among children in the United States. Improving hand cleanliness and hygiene may prevent the spread of viruses that can cause asthma exacerbations. This study will evaluate the effectiveness of a school-based hand sanitizer program at reducing the frequency of exacerbations in children with asthma.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2007-09-10
• Study First Submitted QC: 2007-09-10
• Study First Posted: 2007-09-12
• Study Start: 2009-01
• Primary Completion: 2011-05
• Study Completion: 2012-05
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-22
• Last Update Posted: 2017-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 527

Inclusion Criteria

• Diagnosed with asthma
• Enrolled in a participating elementary school

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Two Step Hand-Hygiene	Active Hand Sanitizer	Hand washing plus hand sanitizer

Primary Outcome Measures

Name	Time	Method
Asthma exacerbations	Measured at Years 1 and 2

Trial Locations

Locations (1)

University of Alabama at Birmingham, Lung Health Center; 🇺🇸 Birmingham, Alabama, United States