Personal Spirometer and Electrical Impedance Tomography: agreement with clinic attendance tests (SpiroEIT)

The materials provided to the patient are as follows • Participant information sheet (sent via email, hard copy provided on first appointment) • Consent form (signed hard copy to take home) • Harry Perkins Map (sent via email) • Participant Instruction Sheet (hard copy to take home) • SpiroHome device, with 2x AAA batteries and single patient use mouthpiece • Email links and information on how to download the SpiroHome app Potential participants are identified by their treating respiratory team. Healthy participants volunteer themselves through contacting our investigator phone number found on flyers around the University of Western Australia, or Sir Charles Gairdner Hospital staff areas. If they have expressed interest in research and consent to their contact details to be provided to us, we contact them by phone call. On phone contact, participants are verbally informed about the study aims and requirements, and have the opportunity to ask questions. If they express interest and consent, they are screened for study eligibility over the phone and an email is sent to them with the Participant Information sheet and a Harry Perkins Map. If agreeable and eligible for the study, participants are enrolled and a date is set for their first appointment. A text reminder is sent to them the week of their appointment with the option to cancel, reschedule, or confirm attendance. On arrival to their first appointment, the study is discussed in detail with the opportunity for participants to ask questions. Participants receive a hard copy of the Participant Information sheet and Participant Instruction Sheet and are encouraged to read it. Two consent forms are signed by both researcher and participant, allowing both to maintain an original. Participant weight and height are then recorded, and they are randomised into either Desktop spirometry first or SpiroHome device first. Participants are then coached in spirometry and receive the physical materials of: 1. SpiroHome device (bluetooth-linked to mobile app SpiroHome, and to the confidential clinician/researcher platform: SpiroCloud database) 2. 2 x AAA batteries within the device 3. Single patient use disposable mouthpiece And receive the free software material downloaded through their smart phone of: 1. SpiroHome application (InoFab) After completing Spirometry on both the Desktop and SpiroHome device. Participants will then be asked to do part B of the study if they consented to that part. Electrodes will be attached to the participant in a single (16) and or multiple (32) plane around the chest. Once the electrodes are connected to the participant, system checks will occur with the software to ensure it is working. Researcher will instruct participant to have 5 min of normal breathing and then various gentle deep breaths. This only happens during clinic visit 1 and will take approximately 15mins. The outcomes of the part B will be sex, height, chest circumference, delta impedance (ventilation/lung aeration) during tidal and deep breathing. Global inhomogeneity index (standard deviation of impedance divided by median impedance for given lung region will also be assessed. This will only happen at clinic visit 1. Participants are booked for their next appointment in 3 weeks for part A only. Participants are advised to undergo spirometry on their SpiroHome device at their convenience, twice weekly for the following 3 weeks. At their second and final appointment, participants return their SpiroHome device, complete a written Exit Questionnaire, and are given $20 in cash for reimbursement of their parking and petrol. The intervention during the appointments are delivered by either: Interventions in the community (spirometry on the SpiroHome device) are administered by the participant only. First clinic appointment: Spirometry on Desktop device, and Spirometry on SpiroHome device. Time commitment 45 minutes. Twice weekly home spirometry at the participants leisure, on the SpiroHome device (total of 6). Time commitment 5 minutes each. Second clinic appointment: Return of the spirometer and completion of exit survey and reimbursement: time commitment 10 minutes Location of Clinic appointments: Institute of Respiratory Health, level 2 clinic rooms, The Harry Perkins Institute, 6 Verdun st, Nedlands 6009 Location of spirometry in the community: at the participants discretion. Adherence and spirometry technique are secondary trial outcomes which are being measured. We actively avoid assessing adherence and technique outcomes during the community intervention period in order to prevent investigator bias and get “real world” data on participants. Following data collection, we assess adherence and technique through the SpiroCloud platform where the participants SpiroHome data including date and time of spirometry, and whether they reached American Thoaric Society/European Respiratory Society (ATS/ERS) acceptability and repeatability criteria for each spirometry manoeuvre, is confidentially stored. Participants have access to their own data through their SpiroHome apps and have the option to download PDF print-outs through the SpiroHome app. Participants are given the option to participate in either Part A alone, or both Parts A and B. We have deemed it important to randomise participants on their first clinical appointment into whether they receive Desktop Spirometry first, or SpiroHome spirometry first. This will reduce the influence spirometry coaching will have on the data and the number of spirometry trials required to achieve ATS/ERS acceptability and repeatability criteria.