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Hands up for Max! Hand Hygiene study in Primary Schools
ISRCTN ISRCTN93576146
DOI 10.1186/ISRCTN93576146
ClinicalTrials.gov identifier
EudraCT number
Public title Hands up for Max! Hand Hygiene study in Primary Schools
Scientific title Cluster randomised controlled trial to test the effectiveness of an educational intervention to promote hand washing in reducing absenteeism in primary schools
Acronym N/A
Serial number at source PB-PG-1207-15212
Study hypothesis 1. Is the Hands up for Max! educational hand washing intervention effective in reducing absenteeism, through reducing the spread of infectious illness, in primary school pupils and staff?
2. What percentage pupil and staff absence is due to infectious illness?
3. Is there a difference in hand washing behaviour, knowledge and attitudes between pupils and staff in the intervention and control arms of the trial?
4. Is the Hands for Max! resource cost effective?
5. What can a detailed process evaluation tell us about intervention delivery, hand washing facilities in schools, and pupil and staff hand washing behaviour, knowledge, and attitudes?
Lay summary Not provided at time of registration
Ethics approval University of Bristol, Faculty of Medicine and Dentistry Committee for Ethics approved in January 2009 (ref: 080908)
Study design Pragmatic cluster randomised controlled single centre trial
Countries of recruitment United Kingdom
Disease/condition/study domain Hand hygiene
Participants - inclusion criteria 1. Maintained primary schools (including infant and junior schools) and special schools in the South West of England
2. Pupils aged 5 - 11 years, either sex
Participants - exclusion criteria Independent primary schools and pupil referral units in the South West of England.
Anticipated start date 01/09/2009
Anticipated end date 31/08/2011
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 176 primary schools (178 recruited)
Interventions Intervention arm: Hands up for Max! hand washing intervention delivered in primary schools during autumn term 2009 in addition to usual hygiene education.

Control arm: Usual hygiene education continued during autumn term 2009. Hands up for Max! resource offered to schools in autumn term 2010 after all follow-up data for trial completed.

Absence data collected for intervention and control schools for school year 2008/2009 as baseline measure (pre intervention), and absence data for school year 2009/2010 as follow-up data (post intervention).
Primary outcome measure(s) Pupil and staff absence measured using routine absence data for schools available from the Department for Education. Pupil and staff absence due to infectious illness measured using data collected over 3 months (Jan - April 2010) in a sample of participating schools (sub-study schools, n = 24).
Secondary outcome measure(s) 1. Pupil and staff hand washing behaviour, knowledge, and attitudes measured using self-report questionnaires completed in sub-study schools (n = 24) during March - May 2010
2. Economic evaluation completed using data collected on NHS and wider workforce costs as a result of absence due to illness in sub-study schools (n = 24), collected over 3 months (Jan - April 2010)
3. Process evaluation including:
3.1. Observations of hand washing facilities
3.2. Observation of intervention delivery
3.3. Exploration of hand washing behaviour
3.4. Knowledge and attitudes through interviews with teachers and focus groups with pupils
The process evaluation was completed over 3 months: November 2009 - January 2010.
Sources of funding National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme (ref: PB-PG-1207-15212)
Trial website
Publications 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23947388
Contact name Prof  Rona  Campbell
  Address School of Social and Community Medicine
University of Bristol
Canynge Hall
39 Whatley Road
  City/town Bristol
  Zip/Postcode BS8 2PS
  Country United Kingdom
Sponsor University of Bristol (UK)
  Address Research and Enterprise Development (RED) Office
3rd Floor, Senate House
Tyndall Avenue
  City/town Bristol
  Zip/Postcode BS8 1TH
  Country United Kingdom
  Sponsor website: http://www.bristol.ac.uk/
Date applied 05/10/2010
Last edited 22/08/2013
Date ISRCTN assigned 17/11/2010
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