Hands up for Max! Hand Hygiene study in Primary Schools

ISRCTN	ISRCTN93576146
DOI	https://doi.org/10.1186/ISRCTN93576146
Protocol serial number	PB-PG-1207-15212
Sponsor	University of Bristol (UK)
Funder	National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme (ref: PB-PG-1207-15212)

Submission date: 05/10/2010
Registration date: 17/11/2010
Last edited: 22/08/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Rona Campbell
Scientific

School of Social and Community Medicine
University of Bristol
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom

Study information

Primary study design	Interventional
Study design	Pragmatic cluster randomised controlled single centre trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Cluster randomised controlled trial to test the effectiveness of an educational intervention to promote hand washing in reducing absenteeism in primary schools
Study objectives	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?
Ethics approval(s)	University of Bristol, Faculty of Medicine and Dentistry Committee for Ethics approved in January 2009 (ref: 080908)
Health condition(s) or problem(s) studied	Hand hygiene
Intervention	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).
Intervention type	Other
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).
Key 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.
Completion date	31/08/2011

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	5 Years
Upper age limit	11 Years
Sex	All
Target sample size at registration	176
Key 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
Key exclusion criteria	Independent primary schools and pupil referral units in the South West of England.
Date of first enrolment	01/09/2009
Date of final enrolment	31/08/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

School of Social and Community Medicine

Bristol
BS8 2PS
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/08/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes