COVID-19 Germ Defence Implementation [COVID-19] [UPH]
Research type
Research Study
Full title
Primary care implementation of Germ Defence: A digital behaviour change intervention to improve infection control during the COVID-19 pandemic
IRAS ID
287978
Contact name
Jeremy Horwood
Contact email
Sponsor organisation
University of Bristol
ISRCTN Number
ISRCTN14602359
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
1 years, 9 months, 2 days
Research summary
Recent research into coronavirus has shown that members of the public can play a crucial role in controlling infection outbreaks, by adopting simple behaviours such as handwashing, cleaning surfaces, wearing face-coverings and social distancing. However, it is clear that most people need support to change their behaviour and prevent infection.\n \nThe Germ Defence website was originally developed during the swine ’flu pandemic and trialled in over 20,000 patients. It was shown to reduce the number and severity of infections of both the people who used it and members of their households (Little et al, 2015). Germ Defence has now been updated for use during the COVID-19 pandemic. The updated website helps users with:\n\n- planning for how to isolate an infected household member\n- personalised goal-setting to increase a range of infection control behaviours\n- changing their home environment to support new habits\n- problem-solving to overcome any barriers. \n\nThis project will consider the effects of promoting the Germ Defence website via GP practices on rates of respiratory infection including COVID-19 and seasonal ‘flu. We will contact every GP practice in England and ask them to share a link to the Germ Defence website with their adult patients. Half of the practices (known the ’intervention arm’ of the trial) will be randomly chosen to be contacted in Autumn 2020 and asked to immediately send out the Germ Defence link to their patients whilst the other half (known as the ’usual care arm’ of the trial) will be contacted and asked to send out the Germ Defence link in February 2021. We will assess usage of Germ Defence from anonymous data stored on its website. We will then use routinely collected NHS data to examine whether infection rates are lower in GP practices that sent Germ Defence to their patients as requested. [Study relying on COPI notice]
Lay summary of study results: A newly published randomised controlled trial (RCT) used an innovative trial design to rapidly roll out a behavioural intervention aimed at reducing infections during the COVID-19 pandemic. Though the trial’s results, published in Implementation Science, found the Germ Defence website did not appear to reduce infections during the pandemic, they do show how trusted research environments (TREs) can be used to evaluate new treatments safely and quickly.
This was the first RCT where follow up was conducted entirely within a TRE. The study’s novel design meant GP practices and patients did not have to return any data, as all analysis was conducted via the OpenSAFELY TRE. OpenSAFELY TRE gives researchers access to 40% of the English population’s anonymous health records.
Germ Defence is a behaviour change website that gives practical advice on how to reduce the spread of infection in the home. It was found to be effective in reducing the spread of seasonal and swine flu in a previous RCT.
During the trial, half of all GP practices in England were randomly selected to send out the Germ Defence website link to their patients in the autumn of 2020 (the intervention arm). The remaining practices were asked to do the same in spring 2021.
Researchers then looked at rates of respiratory infection, including coronavirus and seasonal flu, in both groups of practices. They also looked at other outcomes including how often people visited their GP and used antibiotics.
The study team gave every GP practice a unique link to the website that they could send on to their patients. Using these unique links meant the team could see whether the patients were accessing the intervention without the practices needing to report back.
Website statistics showed that around 460 practices shared their link with patients, who then went on to use the site over 300,000 times (with an average user satisfaction score of 7.52 out of 10). This was 16% of the practices invited, but the research team had hoped that at least 25% would participate. Participation below this level means no firm conclusions could be made about the effectiveness of the intervention.
While no evidence of a difference in infection rates was observed between the two groups, the findings are nevertheless important. The trial design allowed the team to safely recruit GP practices during the pandemic. They used several new techniques to reduce the burden on practices and improve the number who could take part in research. These included:
Recruiting practices via email, removing the lengthy process of contacting individual practices (although to avoid overwhelming practices this method should only be used when rapid enrolment is necessary) Using unique GP practice weblinks, which allowed researchers to understand how each practice used the intervention without needing to contact the practice Using national routinely collected patient record data accessed through OpenSAFELY, to analyse anonymised GP records securely.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
20/YH/0261
Date of REC Opinion
14 Aug 2020
REC opinion
Favourable Opinion