Condition category
Not Applicable
Date applied
05/10/2010
Date assigned
17/11/2010
Last edited
22/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Rona Campbell

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PB-PG-1207-15212

Study information

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

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?

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 measures

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.

Overall trial start date

01/09/2009

Overall trial end date

31/08/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

176 primary schools (178 recruited)

Participant exclusion criteria

Independent primary schools and pupil referral units in the South West of England.

Recruitment start date

01/09/2009

Recruitment end date

31/08/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Social and Community Medicine
Bristol
BS8 2PS
United Kingdom

Sponsor information

Organisation

University of Bristol (UK)

Sponsor details

Research and Enterprise Development (RED) Office
3rd Floor
Senate House
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom

Sponsor type

University/education

Website

http://www.bristol.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme (ref: PB-PG-1207-15212)

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23947388

Publication citations

  1. Results

    Chittleborough CR, Nicholson AL, Young E, Bell S, Campbell R, Implementation of an educational intervention to improve hand washing in primary schools: process evaluation within a randomised controlled trial., BMC Public Health, 2013, 13, 757, doi: 10.1186/1471-2458-13-757.

Additional files

Editorial Notes