Do smart inhalers improve medication adherence and reduce asthma exacerbations for children aged 5-9 years?: A Randomised Controlled Trial

Child and parent/guardian dyads will attend a one-off 45 to 60-minute face-to-face consultation with a Research Assistant at the Hunter Medical Research Institute. The Research Assistant will provide dyads with a pair of FindAir smart inhaler devices (one for their preventer inhaler and one for their reliever inhaler) which attach to the top of the child's usual asthma inhalers. The FindAir smart devices are an add-on to conventional preventer/reliever inhaler devices. Conventional inhaler devices generally have a dose counter which indicates the number of doses of medication remaining in the inhaler. In contrast, the FindAir smart devices automatically record every time the asthma inhalers are used, including the time of use and number of doses taken. The Research Assistant will assist dyads in the intervention group to install and set up the FindAir Asthma Diary App on their smart device and provide education in how to use the devices and the App. The FindAir smart devices connect via blue tooth to the FindAir Diary App. After setup, the App provides automatic alerts/reminders on the smart device when the child is due to take their inhaler, provides visual feedback on adherence to preventer medication and asthma control based on the child's use of their reliever medication, and indicates the date on which each inhaler will need to be replaced. With parental consent, the FindAir Diary App will also be setup to allow the research team and the child's General Practitioner (GP) to view the child's inhaler use data via unique access codes, accessed via a web-based platform. The research team will contact the child's GP to provide details about how to access and use the GP FindAir Platform to view their patient's inhaler use data. GPs or their nominated practice nurse/manager will be asked to monitor their patient's inhaler use data on a monthly basis to assess asthma care flags (i.e. a continuing pattern of non-adherence to the preventer medication schedule outlined in the child’s Asthma Control Plan or increased reliever bronchodilator use lasting 2 or more days in a row). Where a care flag is identified, the child’s GP may request an appointment with the child and their parent/carer if appropriate. The research team will also undertake monthly monitoring of the child's inhaler use to assess asthma care flags. If a care flag related to a pattern of non-adherence with asthma preventer medication is detected, the research team will notify parents via SMS (more than 2 days of preventer medication in a row missed) or phone call (more than 4 days of preventer medication in a row missed). The notification will inform parents that the smart device data is showing that their child has missed using their preventer medication for more than 2/4 days in a row, and reinforce that regular use of the preventer is important for helping to reduce asthma symptoms and keeping their child feeling well. If a care flag related to poor asthma control is detected (i.e. use of their reliever medication for 2 or more days in a row and occurring 4 or more times during a one-month period), the research team will notify parents via phone call, with a recommendation that they may wish to make an appointment for their child with their GP. With GP consent, the research team will also notify GPs in the case of a care flag related to poor asthma control, with a recommendation that the GP schedule an appointment with their patient if appropriate. The Research Assistant will also phone parents at 2 weeks and 3 months after the baseline survey and device/App set up meeting to respond to any questions or issues dyads might have encountered. In addition, the Research Assistant will phone parent/guardians if the FindAir data indicates that the smart devices are not connected to child’s preventer and reliever inhalers for 5 or more days in a row during the intervention period and assist parent/guardians to reconnect the devices if necessary. The total duration of involvement in the study is 14 months, with the FindAir devices estimated to have a (non-replaceable) battery life of 12 months.