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

NCT ID: NCT00528814

Last Updated: 2017-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

527 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-05-31

Brief Summary

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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

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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.

Conditions

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Asthma

Keywords

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Hand Sanitizer Respiratory Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Two Step Hand-Hygiene

Hand washing plus hand sanitizer

Group Type EXPERIMENTAL

Active Hand Sanitizer

Intervention Type OTHER

Active Hand Sanitizer

Usual Care Hand Hygiene

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Active Hand Sanitizer

Active Hand Sanitizer

Intervention Type OTHER

Other Intervention Names

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Purell

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with asthma
* Enrolled in a participating elementary school
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Blue Cross Blue Shield

OTHER

Sponsor Role collaborator

Schering-Plough

INDUSTRY

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William Bailey, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham, Lung Health Center

Locations

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University of Alabama at Birmingham, Lung Health Center

Birmingham, Alabama, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 23069487 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21730079 (View on PubMed)

Other Identifiers

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R01HL086972

Identifier Type: NIH

Identifier Source: secondary_id

View Link

519

Identifier Type: -

Identifier Source: org_study_id