What is Germ Defence and who is running it?

Germ Defence is a website that gives simple advice to reduce the spread of COVID-19 in the home. It was designed by doctors, scientists and psychologists and tested with 20,000 people during the swine ‘flu pandemic of 2009. It has been updated for use during the COVID-19 pandemic by researchers based at the Universities of Bristol, Bath and Southampton.

Who has approved the study?

The study was approved by Yorkshire & The Humber (Leeds West) Research Ethics Committee on behalf of the Health Research Authority (reference 20/YH/0261). Chris Whitty, the Chief Medical Officer (CMO) for England, has made this a national priority project (i.e. UPHR badged) and it also has the support of the Royal College of General Practitioners (RCGP). We have registered the trial with the ISRCTN registry under the ID number 14602359.

What are practices being asked to do? 

As part of a randomised controlled trial, we have asked half the GP practices in England to send a weblink to the Germ Defence website to all their patients aged 16 and over, to find out how well Germ Defence works against COVID-19. Afterwards, we will look at national NHS data to see if patients from the practices who were given the weblink have less COVID-19 (and other cold/’flu viruses) than patients from the practices who weren’t. We have then offered Germ Defence to the other practices who weren’t contacted initially so that they too can offer it to their patients.

Do practices need to be set up as sites to take part?

No, practices do not need to be set up as sites. There is no recruitment target for this study.

Not all practices are ‘research active’. Does that matter?

No, we have asked all practices in England to take part. Germ Defence has been developed for all patients and we hope that as many people as possible will use it to limit the spread of COVID-19, reduce infection severity/duration and reduce unnecessary or inappropriate healthcare utilisation.

If practices are ‘research active’ what is their incentive for taking part?

If practices were randomised into the 'intervention arm' of the trial and successfully shared Germ Defence details with their patients, then they will be credited with one recruit as part of the Research Sites Initiative (RSI) scheme. Those practices in the ‘usual care’ arm of the trial will not receive any recruitment credit. However, all practices who share the Germ Defence information will be potentially helping to limit the spread of COVID-19 and reduce consultations. 

Will practices be eligible for service support costs?

No, service support costs are not provided for this study. 

Do patients need to give consent to take part? 

No, patients don’t need to give consent – they can just follow the Germ Defence weblink that their practice gave them. 

Is sending the Germ Defence weblink to patients in line with General Data Protection Regulation (GDPR)?

We have sought advice on this from the NIHR Clinical Research Network and NHS-X and both have assured us that sending out details of this non-commercial website is in line with GDPR.

Will Germ Defence be using patients’ personal data?

No, we won’t be collecting any personal data about anyone. 

What is the CRN role in the study? 

As an Urgent Public Health Research study, Germ Defence has been adopted onto the NIHR CRN Portfolio and given high priority. However, it is unusual in that there is no site recruitment or patient consent to support. 

How will using Germ Defence help patients? 

During the swine ‘flu pandemic of 2009, people who used Germ Defence had fewer cold/’flu infections and the infections they had were less severe. People also saw their doctor less often. Following the update of Germ Defence for COVID-19 - which is caught in the same way as other viruses - we want to find out how effective Germ Defence is.

Is Germ Defence safe for patients?

There is no evidence that Germ Defence causes any harm for patients. It has previously been trialled in 20,000 people and was specifically developed with the help of patients. We have conducted many interviews with patients to make sure it is as acceptable and effective as possible. Although Germ Defence was effective in a trial of 20,000 people during the 2009 swine ‘flu pandemic, it has been adapted for use with COVID-19 and has not yet been proven to work. The randomised controlled trial will help to show whether it is effective and whether it can be used in the future.

Will supporting Germ Defence make more work for practices?

When Germ Defence was trialled in 2009 during the swine ‘flu pandemic, it reduced the number of patient consultations in the group that was randomised to receive it. Our recent pilot work about the updated website has not suggested any increase in practice contact from patients after sending the recommended text message out to them. We have made this study as easy as possible for practices, with no sign-up required. They do not need to send any data to the research team or follow up any patients. 

Will sending texts to patients cost practices financially?

We are unable to reimburse practices for any financial costs of sending out the text message. We hope that by reducing COVID-19 frequency/severity and consultation frequency, sending out this text message will benefit practices and the healthcare system in the long-term. One option to avoid any financial burden would be to send out the weblink to Germ Defence to patients by e-mail. We have provided a sample e-mail for practices to use.

Can practices edit the text message for their patients?

We ask that practices do not remove anything from the text message, nor edit it too much. We strongly recommend that practices test out the text with a colleague to check that it is appropriately formatted before sending it out to patients.

What if patients don’t speak or read English well? 

Germ Defence is available in more than 20 languages, and these translations can be accessed from the main page on the Germ Defence website. if practices would like to send our text message to patients in a language other than English, we have suggested some translations.

Can practices share the link with other practices?

Every practice should use the specific weblink that we send them. We ask that practices DO NOT share weblinks as we have randomly selected practices to take part in the study and will be comparing healthcare outcomes in different areas using nationally available NHS data.

If a practice is part of a Primary Care Network (PCN) can it send the text out to all the other practices in that network?

We ask that practices DO NOT do this - each practice should use the weblink that they received via e-mail from us.

Should patients send the Germ Defence weblink on to their friends and family? 

We ask that patients send details about the Germ Defence website to others using the ‘share’ button at the end of the Germ Defence website or print out our infographic and give it to people who don’t use the internet.

What if patients can’t use or don’t have access to the internet? 

We understand that an advice website like Germ Defence will not be the best way to reach all patients, but we are unable to provide an alternative in this study. We need the information about Germ Defence to be sent out using some digital or electronic methods (via text, e-mail or social media) because the study is promoting an online intervention. We have summarised the key information using an infographic, although this will still need someone (e.g. family or friend) to access the website on behalf of those patients initially.

Staff at practices are worried about texting patients as they are already receiving a lot of texts from practices

It is up to practices if they choose to send this text out to their patients. We have piloted the Germ Defence intervention with many patients who have said they found it acceptable and useful.

Staff at practices do not want to send a text message to patients

If practices do not want to send a text message, they can e-mail patients or share the weblink via social media or on their practice website. However, our piloting work has suggested that texting is the best way to get this information to patients.

Practices do not have all their patients' mobile numbers registered in order to text them

We have provided an infographic in the Germ Defence website, so if another household member (who is registered with the same practice) is able to access the website then they will be able to share this.

Further questions or concerns about Germ Defence?

Please contact the Germ Defence team by e-mailing: germdefence-study@bristol.ac.uk.