Effectiveness of a Handwashing Programme in the Prevention of School Absenteeism Due to Respiratory Infections
Primary Purpose
Upper Respiratory Infections, Influenza, Common Cold
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
hand sanitizer
Sponsored by
About this trial
This is an interventional prevention trial for Upper Respiratory Infections focused on measuring handwashing, hand sanitizer, absenteeism, school age children, preschool children
Eligibility Criteria
Inclusion criteria:
- School children between the ages of 4 and 12 years old, enrolled in the above mentioned public schools,
- The parents/tutors signed an agreement after being informed of its content.
Exclusion criteria:
- Children with absenteeism due to a different cause from upper respiratory infections
- Children with chronic illnesses that could affect their likelihood of contracting an infection or the duration of their period of absence from school
- Children whose parents did not authorise their participation in the study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Hand sanitizer
Control
Arm Description
Intervention classrooms received alcohol-based hand sanitizer and a programme educational. Characteristics of the hydroalcoholic gel (ALCO ALOE GEL): chlorhexidine digluconate at 20% solution, phenoxyethanol 1%, benzalkonium chloride 0.%. aloe Barbadensis 5%, Renat ethyl alcohol 70%, excipients c.s.p. 100 ml. Alcohol of between 65 - 70% degrees, pondus Hydrogenium (pH) = 7-7,5.
No hand sanitizer or educational programme were used
Outcomes
Primary Outcome Measures
School absenteeism rate caused by upper respiratory infection
The incidence rate of respiratory infections was calculated dividing the number of episodes respiratory by the number of pupils during the period of this study who were susceptible to the infection.
Incidence rate ratio indicates (IRR): the ratio between incidence rate in both study groups.
Secondary Outcome Measures
Average duration of absence
The average duration of absence per child was calculated dividing the number of absence days due to respiratory infection by the total number of children during that period.
Full Information
NCT ID
NCT01728090
First Posted
November 13, 2012
Last Updated
November 16, 2012
Sponsor
Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
Collaborators
Ministry of Health, Spain
1. Study Identification
Unique Protocol Identification Number
NCT01728090
Brief Title
Effectiveness of a Handwashing Programme in the Prevention of School Absenteeism Due to Respiratory Infections
Official Title
Effectiveness of a Handwashing Programme in the Prevention of School Absenteeism Due to Respiratory Infections
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
Collaborators
Ministry of Health, Spain
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the study was to assess the effectiveness of a hand-washing programme using hand sanitizer in the prevention of school absenteeism due to upper respiratory infections. Students in intervention classrooms used hand sanitizers at schools and a programme educational on hand hygiene. The investigators hypothesize that the use de hand sanitizers in elementary school will reduce absenteeism due to upper respiratory infections.
Detailed Description
School absenteeism due to respiratory infections is one of the greatest problems in schools. Its high incidence and easy transmission among pupils have a great impact requiring a vast number of medical visits, hospitalisations, use of antibiotic and antipyretic treatments, symptomatic medication, etc. besides being a cause for school absenteeism and time off work for parents. Hand- washing is the most important and effective measure to prevent the transmission of infections. The investigators evaluated the effectiveness of a hand-washing programme using hand sanitizer in the prevention of school absenteeism due to upper respiratory infections.
A cluster randomised, controlled and open study of 2 cohorts of primary school children between the ages of 4 and 12, attending 5 Public Schools in a geographic area of the Almería province (Spain). This study was carried out throughout the 8 months of an academic year (October 2009 to May 2010). The experimental group washed their hands with soap and water, complemented with hand sanitizer, while the control group followed usual hand washing. The parents of both groups completed the survey on sociodemographic characteristics and questions about hand hygiene referred to when and how their children wash their hands Progenitors of children who were absent from school collected upper respiratory infections symptoms and handed in the completed form to the teacher. One Research assistant collected the absence sheets of the participating classes weekly, telephoned the parents of absent children to enquire about the cause of their absence, visited the classrooms and collaborated with the teachers in hand hygiene related activities.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Infections, Influenza, Common Cold
Keywords
handwashing, hand sanitizer, absenteeism, school age children, preschool children
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1640 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hand sanitizer
Arm Type
Experimental
Arm Description
Intervention classrooms received alcohol-based hand sanitizer and a programme educational.
Characteristics of the hydroalcoholic gel (ALCO ALOE GEL): chlorhexidine digluconate at 20% solution, phenoxyethanol 1%, benzalkonium chloride 0.%. aloe Barbadensis 5%, Renat ethyl alcohol 70%, excipients c.s.p. 100 ml. Alcohol of between 65 - 70% degrees, pondus Hydrogenium (pH) = 7-7,5.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No hand sanitizer or educational programme were used
Intervention Type
Other
Intervention Name(s)
hand sanitizer
Other Intervention Name(s)
ALCO ALOE GEL
Intervention Description
alcohol-based, hydroalcoholic gel
Primary Outcome Measure Information:
Title
School absenteeism rate caused by upper respiratory infection
Description
The incidence rate of respiratory infections was calculated dividing the number of episodes respiratory by the number of pupils during the period of this study who were susceptible to the infection.
Incidence rate ratio indicates (IRR): the ratio between incidence rate in both study groups.
Time Frame
One academic year (eight months follow-up)
Secondary Outcome Measure Information:
Title
Average duration of absence
Description
The average duration of absence per child was calculated dividing the number of absence days due to respiratory infection by the total number of children during that period.
Time Frame
One academic year (eight months follow-up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
School children between the ages of 4 and 12 years old, enrolled in the above mentioned public schools,
The parents/tutors signed an agreement after being informed of its content.
Exclusion criteria:
Children with absenteeism due to a different cause from upper respiratory infections
Children with chronic illnesses that could affect their likelihood of contracting an infection or the duration of their period of absence from school
Children whose parents did not authorise their participation in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ernestina Azor, MD, PhD
Organizational Affiliation
Department of Health of Andalusia
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of a Handwashing Programme in the Prevention of School Absenteeism Due to Respiratory Infections
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