Condition category
Infections and Infestations
Date applied
12/08/2020
Date assigned
12/08/2020
Last edited
12/08/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Recent research into coronavirus has shown that members of the public can play a crucial role in controlling infection outbreaks in their homes by adopting simple behaviours such as handwashing, cleaning surfaces, wearing of face coverings and social distancing. Despite public health advice, evidence shows most people need to change their behaviour to help prevent infection.
Germ Defence is an interactive website (https://www.germdefence.org) which uses behaviour change techniques to supplement public health advice. It was developed during the swine 'flu pandemic using theory, evidence and extensive feedback from members of the public. It was then trialled in over 20,000 patients and shown to reduce the number and severity of infections of users and members of their household. Germ Defence has recently been updated for use in the COVID-19 pandemic. The website helps users with pre-planning about effective isolation of an infected household member; personalised goal setting for increasing a range of infection control behaviours; changing the home environment to support new habits and problem-solving to overcome barriers.
This study will examine the effects of randomising dissemination of the Germ Defence website via GP practices on rates of respiratory infection including COVID-19 and seasonal 'flu.

Who can participate?
The researchers are not looking to recruit individual participants for this study. Instead, they will work with GP practices in England and ask them to promote the Germ Defence intervention to all their patients aged 18 and over.

What does the study involve?
The researchers will contact every GP practice in England and ask them to support this study. This will involve each practice sharing a weblink to Germ Defence website with their adult patients. Half of the practices will be randomly chosen and asked to send out the Germ Defence link to their patients in the Autumn of 2020. These practices will be known as the immediate implementation group or intervention arm. The other half of the practices will be contacted to send out Germ Defence in February 2021. These practices will be known as the delayed implementation group or usual care arm. The researchers will assess usage of the Germ Defence weblink from anonymous data produced by the website. They will then use anonymised NHS data collected as part of routine care to compare whether infection rates are lower in practices that sent Germ Defence information to their patients immediately compared with rates in those that didn’t send the information until later.

What are the possible benefits and risks of participating?
Germ Defence has been designed so that anyone can use and benefit from its information and ideas on how to lower their risk of catching COVID-19. This includes specific techniques for handwashing (when, where and how to wash hands effectively), keeping a safe distance, and not touching the face, as well as information to help people decide if they need to wear face coverings and how to minimise the amount of virus that they are exposed to. The website also provides advice on how people might look after family and friends who are ill whilst still protecting themselves. The researchers are not aware of any risks that might arise from taking part in the study.

Where is the study run from?
The study will be run by the University of Bristol with support from colleagues at the University of Southampton, University of Bath, NIHR Applied Research Collaboration West, NIHR Clinical Research Network West of England and NHS Bristol, North Somerset & South Gloucestershire Clinical Commissioning Group (UK)

When is the study starting and how long is it expected to run for?
October 2020 to April 2021

Who is funding the study?
1. UK Research and Innovation (UKRI) (UK)
2. National Institute of Health Research (NIHR) Applied Research Collaboration (ARC West) (UK)
3. NIHR Health Protection Research Unit (HPRU) in Behavioural Science and Evaluation (UK)

Who is the main contact?
Dr Melanie Chalder
germdefence-study@bristol.ac.uk

Trial website

https://www.germdefence.org

Contact information

Type

Scientific

Primary contact

Dr Jeremy Horwood

ORCID ID

http://orcid.org/0000-0001-7092-4960

Contact details

NIHR ARC West
9th floor Whitefriars
Lewins Mead
Bristol
BS1 2NT
United Kingdom
-
germdefence-study@bristol.ac.uk

Type

Public

Additional contact

Dr Melanie Chalder

ORCID ID

http://orcid.org/0000-0003-1964-2815

Contact details

University of Bristol
Canynge Hall
39 Whatley Road
Bristol
BS8 2PR
United Kingdom
-
germdefence-study@bristol.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 46740, IRAS 287978, UKRI (MRC) MC_PC_19068, UoB 2020-3213

Study information

Scientific title

Primary care implementation of Germ Defence: a digital behaviour change intervention to improve infection control during the COVID-19 pandemic

Acronym

COVID-19 GDI

Study hypothesis

Germ Defence implementation will decrease the number of respiratory tract infection diagnoses - including COVID-19 - recorded in primary care.

The Germ Defence digital behaviour change website has already proven effective at reducing the spread of viral infections such as colds and flu (Little et al, 2015). It is possible that Germ Defence could also protect people from other respiratory tract infections and so increase the capability and capacity of the health service to cope with the number of patients using it. However, although the Germ Defence intervention has been updated to be relevant to COVID-19, we have no evidence that it will be effective. By disseminating the intervention randomly via GP practices to patients, we can examine the effects of implementing Germ Defence across primary care for all respiratory tract infections including those with a COVID-19 diagnosis.

Ethics approval

Submission pending

Study design

Single-centre two-arm cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

No participant information sheet available

Condition

Respiratory tract infections including COVID-19 (SARS-CoV-2 infection)

Intervention

Germ Defence is a digital behavioural change intervention to improve infection control.

The Germ Defence content was developed using theoretical modelling and qualitative research (Yardley et al. 2011), in line with the person-based approach (Yardley et al., 2015), drawing principally on the theory of planned behaviour (Ajzen, 1985), Leventhal’s common-sense model of illness (Leventhal, 2016) and protection motivation theory (Rippetoe, 1987). Intervention content, design and structure were optimised iteratively using in-depth qualitative ‘think-aloud’ interviews with members of the general public in order to ensure the intervention was accessible, credible and motivating for as many people as possible (Yardley et al. 2015). Based on process evaluations of the original randomised controlled trial (Little et al., 2015) and previous public dissemination activities (Ainsworth et al., 2017), Germ Defence has been updated and streamlined for use since the coronavirus pandemic, including translation into 20 languages (including Traditional and Simple Chinese), and broadening the infection control behaviours that were recommended. The intervention is a single session, designed to be easily accessible with no sign-up or password required, and the consent process placed within the website privacy policy. Data collection is unobtrusive and kept to a minimum to reduce dropout.

Germ Defence seeks to increase users’ perceived risk by emphasising the personal and social health consequences of contracting RTIs including COVID-19. These are followed by messages to increase skills and confidence to reduce exposure to the virus. The Germ Defence content is tailored such that a user selects one of four streams that is relevant to the user’s situation:
1. To protect themselves generally
2. To protect others if the user was showing symptoms
3. To protect themselves if household member(s) showed symptoms; or
4. To protect a household member who is at high risk

Content is tailored in this way to encourage users to adopt behaviours appropriate to the perceived level and pattern of risk in their household. Clear and detailed advice is then provided for self-isolating, social distancing, disinfecting and/or cleaning, wearing face-coverings, and putting items aside that may have viruses on them such as shopping/packages, to the extent that users feel is appropriate for the perceived risk. These pages also contain ideas and information on how to structure the home and engage in behaviours safely. The website can be accessed for free at https://www.germdefence.org.

All GP practices in England will be randomised on a 1:1 basis by the independent Bristol Randomised Trials Collaboration (BRTC) unit. CCGs in England will be divided into blocks according to region, and equal numbers in each block will be randomly allocated to intervention or usual care. The randomisation schedule will be generated in Stata statistical software by a statistician not otherwise involved in the enrolment of general practices into the study. The researchers will ask staff at GP practices randomised to the intervention arm to share the link to Germ Defence with all adult patients registered at their practice during the 4-month trial implementation period and care will otherwise follow current standard management. Patients at GP practices randomised to the usual care arm will receive current standard management for the trial period after which they will be given a link to the Germ Defence intervention by their practices. The outcome data from patients in practices promoting the Germ Defence intervention will be compared with the outcome data of patients in 'usual care' practices as part of this efficient, pragmatic trial.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Respiratory tract infection diagnoses measured using routine GPES [general practice extraction service] for pandemic planning and research (COVID-19) data at baseline and 4 months

Secondary outcome measures

1. Incidence of COVID-19 diagnoses measured using routine GPES [general practice extraction service] for pandemic planning and research (COVID-19) data at baseline and 4 months
2. Incidence of COVID-19 symptom presentation measured using routine GPES [general practice extraction service] for pandemic planning and research (COVID-19) data at baseline and 4 months
3. Incidence of gastrointestinal infections measured using routine GPES [general practice extraction service] for pandemic planning and research (COVID-19) data at baseline and 4 months
4. Number of primary care consultations measured using routine GPES [general practice extraction service] for pandemic planning and research (COVID-19) data at baseline and 4 months
5. Antibiotic usage measured using routine GPES [general practice extraction service] for pandemic planning and research (COVID-19) data at baseline and 4 months
6. Hospital admissions measured using routine GPES [general practice extraction service] for pandemic planning and research (COVID-19) data at baseline and 4 months
7. Uptake of GP practices disseminating Germ Defence to their patients measured using website analytics at baseline and 4 months
8. Usage of Germ Defence by individuals granted access to the website by their GP practice measured using website analytics at baseline and 4 months

Overall trial start date

30/03/2020

Overall trial end date

30/04/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

No individual patients will be recruited to this trial. However, all GP practices in England will be asked to support the study by promoting the use of the Germ Defence website to their adult patients either on 01/10/2020 (intervention arm) or after 31/01/2021 (usual care arm)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

All GP practices in England will be asked to support the trial (n = 6822)

Participant exclusion criteria

1. GP practices outside England
2. Patients under the age of 18 years

Recruitment start date

01/10/2020

Recruitment end date

31/01/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NIHR Clinical Research Network West of England
Whitefriars Lewins Mead
Bristol
BS1 2NT
United Kingdom

Trial participating centre

NIHR Clinical Research Network North East and North Cumbria
Regent Point Regent Farm Road Gosforth
Newcastle-upon-Tyne
NE3 3HD
United Kingdom

Trial participating centre

NIHR Clinical Research Network North West Coast
iC1 Liverpool Science Park 131 Mount Pleasant
Liverpool
L3 5TF
United Kingdom

Trial participating centre

NIHR Clinical Research Network Yorkshire & Humber
Unit 1 Calder Close Calder Park
Wakefield
WF4 3BA
United Kingdom

Trial participating centre

NIHR Clinical Research Network Greater Manchester
Citylabs 1.0 Nelson Street
Manchester
M13 9NQ
United Kingdom

Trial participating centre

NIHR Clinical Research Network East MIdlands
Knighton Street Outpatients 1st Floor Leicester Royal Infirmary
Leicester
LE1 5WW
United Kingdom

Trial participating centre

NIHR Clinical Research Network West MIdlands
Birmingham Research Park Vincent Drive
Birmingham
B15 2SQ
United Kingdom

Trial participating centre

NIHR Clinical Research Network Thames Valley and South Midlands
Block 8, Nuffield Orthopaedic Centre Old Road Headington
Oxford
OX3 6HE
United Kingdom

Trial participating centre

NIHR Clinical Research Network Eastern
20 Rouen Road
Norwich
NR1 1QQ
United Kingdom

Trial participating centre

NIHR Clinical Research Network Kent, Surrey and Sussex
Bevendean House Room BE205 University of Brighton
Falmer
BN1 9PH
United Kingdom

Trial participating centre

NIHR Clinical Research Network Wessex
Unit 7 Berrywood Business Village Tollbar Way Hedge End
Southampton
SO30 2UN
United Kingdom

Trial participating centre

NIHR Clinical Research Network South West Peninsula
Plymouth Science Park 1 Davy Road Derriford
Plymouth
PL6 8BX.
United Kingdom

Trial participating centre

NIHR Clinical Research Network North Thames
170 Tottenham Court Road
London
W1T 7HA
United Kingdom

Trial participating centre

NIHR Clinical Research Network South London
16th Floor BRC Faculty Guy's Tower Guy's Hospital Great Maze Pond
London
SE1 9RT
United Kingdom

Trial participating centre

NIHR Clinical Research Network North West London
3rd Floor Administrative Block South Hammersmith Hospital Du Cane Road
London
W12 0HT
United Kingdom

Sponsor information

Organisation

University of Bristol

Sponsor details

Research and Enterprise Development
1 Cathedral Square
Bristol
BS1 5DD
United Kingdom
+44 (0)117 394 0177
adam.taylor@bristol.ac.uk

Sponsor type

University/education

Website

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

Funders

Funder type

Government

Funder name

UK Research and Innovation

Alternative name(s)

UKRI

Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations

Location

United Kingdom

Funder name

National Institute for Health Research, Applied Research Collaboration West (NIHR ARC West)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NIHR Health Protection Research Unit (HPRU) in Behavioural Science and Evaluation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Findings will be presented at primary care and behaviour change conferences e.g. those of the Society of Academic Primary Care (SAPC), the Royal College of General Practitioners (RCGP) and the UK Society for Behavioural Medicine (UKSBM).

Peer-reviewed journal papers will be produced reporting the results and submitted to high impact journals (e.g. British Journal of Public Health, British Journal of General Practice).

In order to influence policy and inform healthcare practice, the researchers will collaborate with University of Bristol’s Policy Bristol team and use their links with NHS England, the Royal College of General Practitioners (RCGP) and Public Health England (PHE) to disseminate their findings.

The researchers will also consider writing blog posts e.g. for GPOnline, Commissioning Elf and The Conversation.

A plain-language summary of the findings will be made available to study participants and members of the public via the Germ Defence website, GP practices and social media.

IPD sharing statement
Data will not be made available for sharing until after publication of the main results of the study. Thereafter, anonymised data will be made available for secondary research, conditional on assurance from the secondary researcher that the proposed use of the data is compliant with the Medical Research Council (MRC) Policy on Data Preservation and Sharing regarding scientific quality, ethical requirements and value for money. A minimum requirement with respect to scientific quality will be a publicly available pre-specified protocol describing the purpose, methods and analysis of the secondary research, e.g. a protocol for a Cochrane systematic review. Data requests should be made to the Principal Investigator Dr Jeremy Horwood by emailing germdefence-study@bristol.ac.uk.

Intention to publish date

31/12/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

12/08/2020: Trial's existence confirmed by the NIHR.