Consent
After you have read this participant information leaflet and have had the opportunity to speak with your local research team, you will be asked to sign a consent form if you decide to take part in the ASPECT study. This will be done either face-to-face, via telephone or online by the research team. If the research team receive your consent online, you will need to provide your email address.
Whichever way you consent to the study, you will be given a copy of the signed consent form to keep for your information.
Allocation to one of the two groups
We will put everyone who takes part into one of two groups using a process called randomisation. Randomisation means that participants will be put into a group randomly, so that each participant has an equal chance of being in either group. Like tossing a coin. We do this so there is a fair comparison between the groups.
The two groups you could be randomised to:
- Aspirin to be taken every day for 3 months
- No aspirin (current standard care)
Both groups will receive usual care for their pneumonia.
Neither you nor the research team can choose which group you go into, so it is important that you only agree to take part if you are prepared to be in either group.
Data collection
We will collect some baseline information from you which will include medical history, ethnicity, smoking history, sex, date of birth and NHS number. Personal information like an email address or telephone number will also be collected.
Treatment
If you are in the aspirin group you will be given the aspirin by the research team, which can be started straight away.
The dose taken will be 150mg a day and then it drops down to 75mg a day. This is a very low and safe dose. When people take aspirin as a painkiller it is taken in 300-600mg doses, with a maximum of 3,600mg in one day.
First 7 days: You will be asked to take 2 tablets of aspirin every day. This is a dose of 150mg.
Day 8-91: You will be asked to take 1 tablet of aspirin every day. This is a lower dose of 75mg.
Remote follow up data collection
Once you leave the hospital you will not be contacted by the study team, unless you are asked to complete the questionnaire (see next paragraph). If you are in the aspirin group, you will be expected to take all the tablets provided without receiving reminders from the study team. The study team will provide you with a diary which you can use to help you keep track of this.
Information about you will be collected through databases remotely and the research team will not need to contact you directly. We will collect information about any hospital admissions that may have happened during your time on the study. We may also look at data recorded prior to your admission.
To be part of the study you will have to consent to give the research team permission to collect this information from NHS databases, including NHS digital care records.
Questionnaires (the first 2,000 participants only)
The central study team will contact the first 2,000 participants to ask them to complete a questionnaire 3 months after joining the study. The questionnaire can be completed online, or by phone or on paper for participants that don’t have access to the internet. It will take roughly 15 minutes to complete.
The questionnaire will ask about whether you have had any hospital admissions and whether the aspirin has been taken as prescribed.
Hospital visits
You will not have to attend any additional hospital visits as part of the study