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ISRCTN
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ISRCTN19287682
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DOI
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10.1186/ISRCTN19287682
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Hi Five - a school based intervention to reduce infections and improve hygiene and well-being among school children
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Scientific title
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Hi Five – a cluster-randomized controlled trial to reduce infections and improve hygiene and well-being among 6-15 year olds in Denmark
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Acronym
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Hi Five
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Serial number at source
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N/A
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Study hypothesis
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An educational and cleaning intervention in Danish schools can improve hand hygiene and reduce the prevalence of infections by 20% among children in intervention schools compared to control schools, and positively influence the children’s wellbeing.
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Lay summary
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Lay summary under review 2
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Ethics approval
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Danish Data Protection Agency, 1 October 2011, ref: 2011-54-1240
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Study design
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Cluster-randomized controlled trial
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Countries of recruitment
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Denmark
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Disease/condition/study domain
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Hand hygiene, hand washing, infectious illness
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Participants - inclusion criteria
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All pupils at participating schools enrolled in grade 0.-8
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Participants - exclusion criteria
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1. Schools not run by municipalities (private schools)
2. Schools for children with special needs
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Anticipated start date
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01/09/2011
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Anticipated end date
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30/06/2013
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Status of trial
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Ongoing |
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Patient information material
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Only available in Danish. The information includes information material to parents, teachers and schools. Please use the contact details below to request a patient information sheet.
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Target number of participants
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7.527 pupils (4.940 in the intervention group, 2.714 in the control group) at 28 intervention schools and 15 control schools from 20 municipalities cross nationally
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Interventions
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The Hi Five intervention consists of three components:
1. Educational materials (5/6 lessons) tailored to three age groups: 0.-3. grade, 4.-6. grade and 7.-9. grade.
Subjects: 1. Introduction to microbes, 2. Spread of infections, 3. How to wash hands most effectively? 4. School toilets.
2. Daily hand washing before lunch
3. Extra cleaning of school toilets during the school day
Hi Five schools were randomized into either control or one of two intervention groups. 15 schools had no intervention (control),14 schools had education and daily hand washing before lunch and 14 schools had education, daily hand washing before lunch and extra cleaning of school toilets (in the school year 2012- 2013).
All pupils at the 28 intervention schools received the education course during the fall 2012.
Baseline data was collected December 2011 to April 2012. Follow-up data will be collected in December 2012 to April 2013. The effect of the intervention is measured on one class at each grade level at each school.
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Primary outcome measure(s)
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1. Frequency of absence episodes and the number of days absent due to infectious illness among pupils measured over five months (Dec. to April) at baseline and follow-up (SMS data form parents SMS registers of illness and infection).
2. Frequency of absence episodes from school last week due to infectious illness (data from pupils’ self-reported questionnaires).
Frequency of absence episodes and the number of days absent due to illness and infection will be analyzed at individual-, class- and school-level.
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Secondary outcome measure(s)
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1. Parents absence from work due to the pupils infectious illness (SMS registration)
2. Pupils hand washing behavior (before lunch, after toilet visit, use of soap etc.) (data from pupils’ self-reported questionnaires)
3. Pupils’ use of the school toilettes (data from pupils’ self-reported questionnaires)
4. Toilet facilities and cleaning standard of the schools toilets (bacteria samples, observations and photographs of/from the school toilets)
5. Pupils’ well-being (data from pupils’ self-reported questionnaires)
6. Pupils’ norms of and attitudes towards hand washing (data from pupils’ self-reported questionnaires)
7. Pupils’ knowledge of bacteria and spread of infectious illness (data from pupils’ self-reported questionnaires)
8. Frequency of teacher’s absence episodes and the number of days due to infectious illness measured over five months at baseline and follow-up (from SMS registration by teachers of own illness and infection)
9. Health economic evaluation (parent, child, teacher, school information)
Analyses in the project will have a special focus on subgroup analyses especially age, gender and socioeconomic position
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Sources of funding
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Tryg Foundation (TrygFonden) (Denmark)
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Trial website
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http://www.interventionsforskning.dk/hifive
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Publications
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Contact name
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Prof
Pernille
Due
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Address
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Øster Farimagsgade 5A
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City/town
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Copenhagen
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Zip/Postcode
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1353
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Country
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Denmark
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Tel
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+45 65 50 77 77
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Fax
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+45 39 20 80 10
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Email
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pdu@sdu.dk
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Sponsor
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Tryg Foundation (TrygFonden) (Denmark)
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Address
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Lyngby Hovedgade 4, Floor 2
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City/town
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Kgs. Lyngby
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Zip/Postcode
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DK- 2800
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Country
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Denmark
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Tel
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+45 26 08 00
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Email
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info@trygfonden.dk
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Sponsor website:
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http://www.trygfonden.dk/
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Date applied
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13/12/2012
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Last edited
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21/12/2012
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Date ISRCTN assigned
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21/12/2012
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