Condition category
Infections and Infestations
Date applied
13/12/2012
Date assigned
21/12/2012
Last edited
21/12/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

Trial website

http://www.interventionsforskning.dk/hifive

Contact information

Type

Scientific

Primary contact

Prof Pernille Due

ORCID ID

Contact details

Øster Farimagsgade 5A
Copenhagen
1353
Denmark
+45 65 50 77 77
pdu@sdu.dk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Hi Five – a cluster-randomized controlled trial to reduce infections and improve hygiene and well-being among 6-15 year olds in Denmark

Acronym

Hi Five

Study hypothesis

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.

Ethics approval

Danish Data Protection Agency, 1 October 2011, ref: 2011-54-1240

Study design

Cluster-randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

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.

Condition

Hand hygiene, hand washing, infectious illness

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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.

Secondary outcome measures

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

Overall trial start date

01/09/2011

Overall trial end date

30/06/2013

Reason abandoned

Eligibility

Participant inclusion criteria

All pupils at participating schools enrolled in grade 0.-8

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

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

Participant exclusion criteria

1. Schools not run by municipalities (private schools)
2. Schools for children with special needs

Recruitment start date

01/09/2011

Recruitment end date

30/06/2013

Locations

Countries of recruitment

Denmark

Trial participating centre

Øster Farimagsgade 5A
Copenhagen
1353
Denmark

Sponsor information

Organisation

Tryg Foundation (TrygFonden) (Denmark)

Sponsor details

Lyngby Hovedgade 4
Floor 2
Kgs. Lyngby
DK- 2800
Denmark
+45 26 08 00
info@trygfonden.dk

Sponsor type

Government

Website

http://www.trygfonden.dk/

Funders

Funder type

Government

Funder name

Tryg Foundation (TrygFonden) (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes