A Randomized Controlled Trial of a School Disinfection and Hand Hygiene Program

August 9, 2007 updated by: Boston Children's Hospital
The objective of the trial is to assess the impact of a disinfection and hand hygiene program on absenteeism in elementary school classrooms. Students in intervention classrooms will use alcohol-based hand sanitizers at school, and their classrooms will be disinfected using quaternary ammonium wipes. We hypothesize that the use of disinfectants and hand hygiene products in elementary school classrooms will reduce absenteeism.

Study Overview

Study Type

Interventional

Enrollment (Actual)

285

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital Boston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Member of a designated elementary school classroom in the Avon school system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Intervention classrooms received alcohol-based hand sanitizer and disinfecting wipes.
NO_INTERVENTION: 2
No hand sanitizer or disinfecting wipes were used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absenteeism rate due to gastrointestinal or respiratory illness during the study period.
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Bacterial colony counts and the presence of selected viruses on classroom surfaces.
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Thomas J Sandora, MD, MPH, Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Study Completion (ACTUAL)

May 1, 2006

Study Registration Dates

First Submitted

August 9, 2007

First Submitted That Met QC Criteria

August 9, 2007

First Posted (ESTIMATE)

August 10, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

August 10, 2007

Last Update Submitted That Met QC Criteria

August 9, 2007

Last Verified

August 1, 2007

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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