Journal article
Redesigning a large school-based clinical trial in response to changes in community practice
Clinical trials (London, England), v 8(3)
Jun 2011
PMID: 21730079
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
Background
Asthma exacerbations are seasonal with
the greatest risk in elementary-age students occurring shortly after returning
to school following summer break. Recent research suggests that this seasonality
in children is primarily related to viral respiratory tract infections. Regular
hand washing is the most effective method to prevent the spread of viral
respiratory infections; unfortunately, achieving hand washing recommendations in
schools is difficult. Therefore, we designed a study to evaluate the effect of
hand sanitizer use in elementary schools on exacerbations among children with
asthma.
Purpose
To describe the process of redesigning the
trial in response to changes in the safety profile of the hand sanitizer as well
as changes in hand hygiene practice in the schools.
Methods
The original trial was a randomized,
longitudinal, subject-blinded, placebo-controlled, community-based crossover
trial. The primary aim was to evaluate the incremental effectiveness of hand
sanitizer use in addition to usual hand hygiene practices to decrease asthma
exacerbations in elementary-age children. Three events occurred that required
major modifications to the original study protocol: (1) safety concerns arose
regarding the hand sanitizer’s active ingredient; (2) no substitute placebo hand
sanitizer was available; and (3) community preferences changed regarding hand
hygiene practices in the schools.
Results
The revised protocol is a randomized,
longitudinal, community-based crossover trial. The primary aim is to evaluate
the incremental effectiveness of a two-step hand hygiene process (hand hygiene
education plus institutionally provided alcohol-based hand sanitizer) versus
usual care to decrease asthma exacerbations. Enrollment was completed in May
2009 with 527 students from 30 schools. The intervention began in August 2009
and will continue through May 2011. Study results should be available at the end
of 2011.
Limitations
The changed design does not allow us to
directly measure the effectiveness of hand sanitizer use as a supplement to
traditional hand washing practices.
Conclusions
The need to balance a rigorous study
design with one that is acceptable to the community requires investigators to be
actively involved with community collaborators and able to adapt study protocols
to fit changing community practices.
Metrics
Details
- Title
- Redesigning a large school-based clinical trial in response to changes in community practice
- Creators
- Lynn B Gerald - Mel and Enid Zuckerman College of Public Health, and the Arizona Respiratory Center, University of Arizona, Tucson, AZ, USAJoe K Gerald - Mel and Enid Zuckerman College of Public Health, and the Arizona Respiratory Center, University of Arizona, Tucson, AZ, USALeslie A McClure - Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USAKathy Harrington - Lung Health Center, University of Alabama at Birmingham, Birmingham, AL, USASue Erwin - Lung Health Center, University of Alabama at Birmingham, Birmingham, AL, USAWilliam C Bailey - Lung Health Center, University of Alabama at Birmingham, Birmingham, AL, USA
- Publication Details
- Clinical trials (London, England), v 8(3)
- Publisher
- SAGE Publications; Sage UK: London, England
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Epidemiology and Biostatistics
- Web of Science ID
- WOS:000292394500007
- Scopus ID
- 2-s2.0-79960224156
- Other Identifier
- 991014877964504721
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- Collaboration types
- Domestic collaboration
- Web of Science research areas
- Medicine, Research & Experimental