Pollution monitoring in the CF-Tracker study

The CF-Tracker study is designed to help us understand why people with cystic fibrosis (CF) experience exacerbations. Some of the factors which have been suggested as making exacerbations more likely are air pollution and moulds. Most research into pollution and health has focused on outdoor air pollution. However, about 90% of our time is spent in indoors such as our homes, but we know very little about indoor environments and how this may affect our health. In this part of the CF-Tracker study we would like to use home pollution monitors and mould monitors to understand whether differences in exposures at home can help explain differences in exacerbations.

What will happen when taking part?

After we visit your home to deliver and set up pollution sensors:

·         The pollution sensors will stay in your home for twelve months to enable us to capture changes over the seasons

·         We will also visit your home (on 3 occasions) to sample the air.

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Additional considerations to taking part in the sub-study

Are there any benefits to taking part in this study?

In the short-term, it is unlikely that you will receive direct benefits. However, the main advantage is that you will be helping us and other scientists to understand more about the health of people with CF and the impact of the home environment.

 At the end of the study (when the 12 months of monitoring has been completed), we can provide you with a personalised report of the monitoring. You will be asked if this is something you would like to receive when the sensors are collected.  

What are the risks of being in the study?

If you take part in the sub-study and we collect automated data from the sensors and monitors placed in your home, there is minimal risk to you. All information will be used anonymously so no one will know that this information relates to you.

What are the costs of the sub-study?

There are no costs to you participating in the study. You will receive £50 to reimburse you for your time and any costs incurred (e.g. the sensors are plugged in and will use a small amount of electricity). This will be paid at the end of the study when the sensors are collected back in, or pro-rata if this study arm is completed early.

Do you have to take part?

No, participation is completely voluntary. You are being asked to consider this because you have already agreed to take part in the Tracker study. Like the Tracker study, this additional study arm is also optional. Whether you decide to take part in this study arm is entirely up to you.

It is up to you to decide whether you’d like to take part. It will not affect the standard of care you receive if you do not wish to take part. 

Can you ask to be withdrawn from the study at any point?

Yes, if you sign up and then change your mind, you are free to withdraw from the sub-study at any time and without giving a reason. This will not affect your care in any way.

If you withdraw from the study, we will ask you in helping us collect the sensors from you at a time that is convenient to you.

What happens to your information if you withdraw?

If you do decide to withdraw then any information from the sensors and monitors already collected will remain and be used in the study.  This will all be anonymised. No further data collected will be performed and we will not contact you again about this sub-study. 

Using your information and data for research purposes

What will happen to the information we collect?

Air quality data and the sensor serial number will be uploaded securely to AirGradient’s server. No personally identifiable information will be shared with the AirGradient.

The Tracker study team will keep a copy of the serial sensor serial number and will link this non-identifiable air quality data to other information we will collect from you (e.g. questionnaires and test / procedure results from main Tracker study). These linked data will be held in our secure servers at University of Manchester, identified only by your study ID number. We will keep a record of your contact details in a separate locked and secure database. This means that if the sensors become disconnected, we can get in touch with you to check they are plugged in or to arrange to replace them if there are problems.

All the data you provide will be treated in the strictest confidence and will be processed for research use subject to UK Data Protection regulations. Your data will be stored securely and confidentially. We will de-identify the research data we collect, so you cannot be identified from it. For more information about how we handle your personal information, please see the main Tracker Participant Information Sheet.