Clinical trial NCT01728090: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Upper Respiratory Infections
Influenza
Common Cold
Keywords: handwashing
hand sanitizer
absenteeism
school age children
preschool children
Lead sponsor: Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Spain
First posted: 2012-11-16
Enrollment: 1640
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: School absenteeism rate caused by upper respiratory infection
timeFrame: One academic year (eight months follow-up)
Secondary outcomes:
measure: Average duration of absence
timeFrame: One academic year (eight months follow-up)
Other outcomes:
Locations:
Study officials:
affiliation: Department of Health of Andalusia
name: Ernestina Azor, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: