Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000478213
Ethics application status
Approved
Date submitted
11/03/2009
Date registered
17/06/2009
Date last updated
18/11/2019
Date data sharing statement initially provided
18/11/2019
Date results information initially provided
18/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Hand sanitisers for reducing illness absences in primary school children
Scientific title
A cluster randomised controlled trial to investigate the effectiveness of hand sanitisers in addition to an education session on hand hygiene alone for reducing illness absences in primary school children in the South Island of New Zealand
Secondary ID [1] 299845 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood illnesses that lead to school absence 4448 0
Childhood respiratory illness 4449 0
Childhood gastrointestinal illness 4450 0
Condition category
Condition code
Public Health 4717 4717 0 0
Epidemiology
Infection 4718 4718 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single 15-20 minute education session on hand hygiene delivered in classrooms late in school term 1. Session consists of interactive teaching about hand hygiene and the use of a cream that glows under ultraviolet light. Two children from each class will be asked to rub this cream on their hands then wash their hands, and an ultraviolet torch will be used to illustrate the fact that usual handwashing often misses parts of the hands. The message will be that handwashing needs to be done thoroughly. Pupils will also be shown how to use the hand sanitiser at this session, in preparation for terms 2 and 3.

In terms 2 and 3, hand sanitiser dispensers will be placed in primary school classrooms. Teachers will be asked to ensure that children use the hand sanitiser at least twice a day - at the beginning of lunch and morning break - and also after coughing or sneezing in the classroom. This amounts to at least twice-daily use for a total of 20 weeks over the two school terms. Alsoft solution will be supplied in 'no-touch' dispensers.
Intervention code [1] 4194 0
Prevention
Intervention code [2] 4195 0
Behaviour
Comparator / control treatment
A single 15-20 minute education session on hand hygiene delivered in classrooms late in school term 1. Session consists of interactive teaching about hand hygiene and the use of a cream that glows under ultraviolet light. Two children from each class will be asked to rub this cream on their hands then wash their hands, and an ultraviolet torch will be used to illustrate the fact that usual handwashing often misses parts of the hands. The message will be that handwashing needs to be done thoroughly.
Control group
Active

Outcomes
Primary outcome [1] 5587 0
Absence from school due to any illness. Injury and infestation (headlice, scabies) are excluded. Information will be collected from the school roll on all absences and parents who have given consent to be contacted following their children's absences ('follow-up children') will be contacted for confirmation except where it is clear that the child was not unwell (e.g. on holiday, at a funeral, etc). An absence episode is defined as a group of days of absence with no gaps of non-absence of more than 2 days.
Timepoint [1] 5587 0
Absence information will be collected from each school once a week from the first week of term 2; a total of 20 weeks over the two terms. Parents who have consented to be followed up post absence will be telephoned on a week day 8 to 9 days after the date of the first day of absence from school.
Secondary outcome [1] 9413 0
Absence due to respiratory illness among follow-up children. Information will be collected from the school roll on all absences and parents of follow-up children who have been absent will be contacted for confirmation except where it is clear that the child was not unwell (e.g. on holiday, at a funeral, etc). The nature of the illness will be ascertained by asking questions about symptoms. An absence episode is defined as a group of days of absence with no gaps of non-absence of more than 2 days.
Timepoint [1] 9413 0
Absence information will be collected from each school once a week from the first week of term 2; a total of 20 weeks over the two terms. Parents who have consented to be followed up post absence will be telephoned on a week day 8 to 9 days after the date of the first day of absence from school.
Secondary outcome [2] 9414 0
Absence due to gastrointestinal illness among follow-up children. Information will be collected from the school roll on all absences and parents of follow-up children who have been absent will be contacted for confirmation except where it is clear that the child was not unwell (e.g. on holiday, at a funeral, etc). The nature of the illness will be ascertained by asking questions about symptoms. An absence episode is defined as a group of days of absence with no gaps of non-absence of more than 2 days.
Timepoint [2] 9414 0
Absence information will be collected from each school once a week from the first week of term 2; a total of 20 weeks over the two terms. Parents who have consented to be followed up post absence will be telephoned on a week day 8 to 9 days after the date of the first day of absence from school.
Secondary outcome [3] 9415 0
Length of absence epidsode due to any illness in days. Injury and infestation (headlice, scabies) are excluded. Information will be collected from the school roll on all absences and parents of follow-up children who have been absent will be contacted for confirmation except where it is clear that the child was not unwell (e.g. on holiday, at a funeral, etc). An absence episode is defined as a group of days of absence with no gaps of non-absence of more than 2 days.
Timepoint [3] 9415 0
Absence information will be collected from each school once a week from the first week of term 2; a total of 20 weeks over the two terms. Parents who have consented to be followed up post absence will be telephoned on a week day 8 to 9 days after the date of the first day of absence from school.
Secondary outcome [4] 9416 0
Number of family members who become ill within one week of the participating child's illness onset will be collected during the follow-up interview.
Timepoint [4] 9416 0
Parents who have consented to be followed up post absence will be telephoned on a week day 8 to 9 days after the date of the first day of absence from school.

Eligibility
Key inclusion criteria
School level inclusion:
(i) At least 100 children of primary school age (school years 1 to 6; children will generally range in age from 5 years to 11 years) at November 2008.
(ii) Schools not currently using hand-sanitiser products or are willing to not use hand-sanitiser products for the period of the trial.
(iii) Schools are within the City boundaries of Christchurch, Dunedin, or Invercargill in New Zealand.
(iv) The principal of the school consents to the school being included in the trial.

Student level inclusion (follow-up children):
(i) Parents/guardians are able to read and understand spoken English to a level where they can read the study information sheet, complete the consent form, and respond to telephone interviews. This will be assessed from a question on the consent form.
(ii) Attending a year 1 to 6 class in one of the included schools, at the beginning of the second school term in 2009 (end April).
Minimum age
5 Years
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
School level exclusion:
(i) Special needs schools.

Student level exclusion (follow-up children):
(i) Children of the principal investigators and study personnel of the trial.
(ii) Children of families that the principal of the primary school directs us not to approach.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The principals of all primary schools in within the city boundaries of Christchurch, Dunedin, and Invercargill will be approached to participate in the trial in November 2008. Schools meeting the inclusion and exclusion criteria will be randomised, all at once, within stratum, to receive either the intervention or the control. Three strata will be defined by geographical area (Christchurch, Dunedin, Invercargill). The trial statistician (Joanne McKenzie) will implement the randomisation. She will only be provided with school codes and district and will randomise schools to either “A” or “B”, so as to remain blinded to the group allocation. Patricia Priest will randomly allocate “A” and “B” to the intervention and control group, prior to receiving the allocation list.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number for each school will be generated using the statistical package Stata/MP 10.1 for Windows (StataCorp. 2007. Stata Statistical Software: Release 10. College Station, TX: StataCorp LP). Within stratum, schools will be sorted by the random number. The first half of the schools within each stratum will be allocated to intervention “A”, and the second half to intervention “B”.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/03/2009
Actual
17/03/2009
Date of last participant enrolment
Anticipated
Actual
15/06/2009
Date of last data collection
Anticipated
Actual
25/09/2009
Sample size
Target
3400
Accrual to date
Final
2443
Recruitment outside Australia
Country [1] 1664 0
New Zealand
State/province [1] 1664 0
Canterbury
Country [2] 1665 0
New Zealand
State/province [2] 1665 0
Otago
Country [3] 1666 0
New Zealand
State/province [3] 1666 0
Southland

Funding & Sponsors
Funding source category [1] 4641 0
Government body
Name [1] 4641 0
Health Research Council of New Zealand
Country [1] 4641 0
New Zealand
Primary sponsor type
Individual
Name
Dr Patricia Priest
Address
Department of Preventive and Social Medicine, University of Otago, PO Box 913, Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 4185 0
Individual
Name [1] 4185 0
Joanne McKenzie
Address [1] 4185 0
Monash Institute of Health Services Research, Monash Medical Centre, Locked Bag 29, Clayton VIC 3168
Country [1] 4185 0
Australia
Secondary sponsor category [2] 4186 0
Individual
Name [2] 4186 0
Dr Rick Audas
Address [2] 4186 0
Department of Preventive and Social Medicine, University of Otago, PO Box 913, Dunedin 9054
Country [2] 4186 0
New Zealand
Secondary sponsor category [3] 4187 0
Individual
Name [3] 4187 0
Dr Marion Poore
Address [3] 4187 0
Public Health South, Otago District Health Board, PO Box 5144, Dunedin
Country [3] 4187 0
New Zealand
Secondary sponsor category [4] 4188 0
Individual
Name [4] 4188 0
Dr Cheryl Brunton
Address [4] 4188 0
Public Health & General Practice, University of Otago, Christchurch, PO Box 43435, Christchurch
Country [4] 4188 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6677 0
New Zealand Mulit-Region Health and Disability Ethics Committee
Ethics committee address [1] 6677 0
Ministry of Health
PO Box 5013
Wellington 6145
Ethics committee country [1] 6677 0
New Zealand
Date submitted for ethics approval [1] 6677 0
Approval date [1] 6677 0
13/03/2009
Ethics approval number [1] 6677 0
MEC/09/01/005

Summary
Brief summary
This study will investigate the effectiveness and cost effectiveness of hand sanitisers in reducing absence from illness in primary schools during terms 2 and 3 of 2009 . The study's aims are:
1. To assess whether regular hand cleaning with hand sanitiser, as an adjunct to usual hand cleaning, reduces the incidence of illness absence in primary school pupils.
2. If illness is reduced, to measure the cost-effectiveness of the provision of hand sanitiser.
3. To measure the cost to families of children’s school absences that are due to illness, including activities that caregivers were unable to do because they had to stay home from work to care for the child and cases of illness in other members of the family.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29376 0
A/Prof Patricia Priest
Address 29376 0
Department of Preventive and Social Medicine, University of Otago, PO Box 913, Dunedin 9054
Country 29376 0
New Zealand
Phone 29376 0
+6434797204
Fax 29376 0
Email 29376 0
patricia.priest@otago.ac.nz
Contact person for public queries
Name 12623 0
A/Prof Patricia Priest
Address 12623 0
Department of Preventive and Social Medicine, University of Otago, PO Box 913, Dunedin 9054
Country 12623 0
New Zealand
Phone 12623 0
+64 3 479 9428
Fax 12623 0
+64 3 479 7298
Email 12623 0
lesley.reeves@otago.ac.nz
Contact person for scientific queries
Name 3551 0
A/Prof Patricia Priest
Address 3551 0
Department of Preventive and Social Medicine, University of Otago, PO Box 913, Dunedin 9054
Country 3551 0
New Zealand
Phone 3551 0
+64 3 4797204
Fax 3551 0
Email 3551 0
patricia.priest@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This trial completed in 2009. We had not received ethics approval for sharing data and nor was data sharing mentioned in the study information and consent form provided to participants. At this time we do not have the resources to go back to the ethics committee, nor create datasets and dictionaries that would be suitable for sharing.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Priest P, McKenzie J, Audas R, Poore M, Brunton C,... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseHand sanitiser provision for reducing illness absences in primary school children: A cluster randomised trial.2015https://dx.doi.org/10.1371/journal.pmed.1001700
N.B. These documents automatically identified may not have been verified by the study sponsor.