Title: Investigation of a digital health solution providing real-time inhaler technique guidance.
Funder: Department of Health and Social Care

Abstract: Background Asthma is one of the most common chronic diseases and medication is typically given using inhalers. However, it is estimated that up to 90% of people make errors when using these, leading to poor symptom control and risks of serious asthma attacks, as well as side-effects and medication overuse. The Clip-Tone Buddy is a small plastic device fitted to the top of the patients inhaler which emits a specific sound with optimal inhaler use; this sound is detected by an accompanying mobile application (app) which provides real-time feedback to patients to improve their inhaler technique. Aims and objectives This study aims to evaluate the impact of the new Clip-Tone Buddy and app (known as the Clip-Tone System; CTS) on improving the proficiency of inhaler use by patients and the subsequent impact on their asthma control. We will also acquire information on patient and healthcare professionals' perceptions, opinions and use of the device, which will be crucial to inform future use and development. Methods The main part of this project involves a randomised controlled trial of the use of the CTS versus usual care in patients with asthma who are using pressurised metered dose inhalers (pMDIs). Participants will be primary care patients aged 16 years and over who are prescribed regular pMDI medication for asthma. After standard inhaler technique and asthma assessment, each of the participants will be randomised to either receive care as usual or to receive the CTS. All patients will be followed up at 1 month, 3 months and 6 months following enrolment. At each follow-up, inhaler technique will be assessed and scored using the established UK inhaler group checklist, asthma control questionnaire (ACQ-5) completed and any relevant unscheduled GP or hospital visits recorded. To show a difference of 30% in the proportion of participants with the correct inhaler technique at follow-up (Power=0.9, P=0.05), a sample size of 126 participants (63 per group), will be recruited, allowing for a 20% drop-out rate. A health economic assessment of the data will also take place. Secondary objectives of this project are dedicated towards developing an understanding of how patients and healthcare professionals perceive use of CTS in a real-world setting, obtaining feedback on strengths and any areas for future development. This aspect of the project will rely on the convening of separate diverse, representative patient and healthcare professional focus groups. Dissemination and Impact The planned research is intended to produce evidence to support a broad intended purpose of the CTS. It will allow for benefits to be understood and highlighted to users and potential customers. The outputs of the research will be published in a peer reviewed journal and presented at national and international conferences. Our primary aim is to develop a route to market through partnership with pharmaceutical companies manufacturing inhaler devices. The data produced during the planned study will inform, guide and solidify the future partnerships with these companies to allow for rapid uptake both within the U.K and globally.

Lay abstract: The study aim is to assess whether a new tool can help people to learn how to use their asthma inhaler better. The problem: Most medicines for asthma are given by inhaler so that medicine can directly reach the lungs and work better. However, we know it s difficult to use an inhaler properly and mistakes are often made. Poor inhaler technique has been linked to increased asthma symptoms, hospital admission and the need for more asthma medicines. To be certain patients are using their inhaler correctly, it is necessary for patients to be trained regularly; showing someone once is not enough! However, patients and their health care professionals are busy and opportunities to check and refresh inhaler technique are often limited. The solution: Clip-Tone is a small device fitted to the top of the patients inhaler which makes a very quiet whistle when used properly. This is used with the Clip-Tone Buddy app which detects the specific sound of the Clip-Tone along with the sound of the inhaler being pressed and provides real time feedback on the screen on how to improve inhaler technique. Together the device and app are known as the Clip-Tone System, CTS. How will the CTS be assessed: We will carry out a study to find out whether the CTS can improve and maintain inhaler technique over a 6-month period and improve asthma symptoms. We have designed a study to compare the CTS with the usual care asthmatics receive. The study will take place via video consultations allowing easy access to the study (face to face appointments will be available if needed). Once in the study, participants will be allocated at random into one of two groups, usual-care or the CTS group. Inhaler technique will be assessed in both groups at 1, 3 and 6 months and compared. Asthma symptoms will also be assessed. Participants can keep the CTS at the end of the study and those in the &ldquo;usual care&rdquo; group will be given the CTS at the end as a &ldquo;thank-you&rdquo;. In addition, over the course of the study we will hold focus (discussion) groups with other patients, participants from the CTS group once they have completed the 6-month study and health care professionals. We have enlisted the help of &ldquo;Vocal&rdquo;, a national centre for public engagement in research, to help with this. We have already engaged with patient groups to help develop the study. At the end of the study, the Clip-Tone System can be rapidly rolled out. It is a low-cost solution (

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: RESPIRATORY