ASSIST Study version 1
Research type
Research Study
Full title
Assessment of an electronic system of the impact on inhaler skills and technique
IRAS ID
312455
Contact name
Clare Murray
Contact email
Sponsor organisation
The University of Manchester, Research Governance, Ethics, and Integrity
ISRCTN Number
ISRCTN14411274
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Research Summary
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: The study will compare the CTS with the usual care asthmatics receive. The study will take place via video consultations allowing easy access to the study. Once in the study, participants (age≥16years) 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 “usual care” group will be given the CTS at the end as a “thank-you”.Summary of Results
Background. Inhaler therapy is the main form of treatment for many common chest diseases such as asthma and chronic obstructive airways disease (COPD) and is very effective if taken correctly. The most common type of inhaler used worldwide is the pressurised metered dose inhaler (pMDI). However, it is estimated that around 90% of pMDI users, have poor inhaler technique. How hard the patient breathes in and for how long are common mistakes and critical as to how well the drug is delivered to the lung. The Clip-Tone system (CTS; Clement Clarke, Clin-e-Cal), is a combined acoustic flow rate guidance signal and smartphone App. If the patient inhales at the correct flow rate (not too deep or too soft) a quiet whistle sound will be made, the exact frequency of which will be detect by the App. The app then gives real time on-screen feedback to the patient as to whether they have breathed deep enough, and for long enough. It will also feedback about the timing of the inhaler actuation in relation to the breath. There are visual cues on the screen to encourage best use during the inhalation and feedback at the end as to what went right and what went wrong.
The aim of our study was to find out if the Clip-Tone system (CTS), would lead to better and maintained pMDI technique compared with using the inhaler in the usual way (Usual Care, UC).
Methods. Asthmatic patients (>16 years old), on daily treatment via a pMDI inhaler, were recruited from primary care. Inhaler technique was scored using validated UK inhaler technique checklist (score 0-10; 0 being worst and 10 best) and then patients were randomised to either start using the CTS (CTS group) or carry on as usual (UC group) for the next 6 months. Repeated inhaler technique assessment was carried out at 1-, 3- and 6-months post randomisation. The inhaler assessment was videoed at baseline and at the 6 month follow up visit to allow duration of inhalation to be measured accurately and also so the technique could be scored again by another individual who was blind to the group that the patient had been assigned to.
Results. 126 participants (mean age 44.2years; 29 male) consented to the study and were randomised (65 CTS, 61 UC). The baseline inhaler score was very similar in both groups (mean inhaler score [95%CI]; CTS: 5.06[4.60,5.52]; UC: 5.10[4.64,5.56]; p=0.82). However, in the group using the CTS inhaler scores improved significantly from 1 month and were maintained to month 6. At 6 months, in the CTS group the mean (95%CI) inhaler score was 7.68 (7.33, 8.02) compared with UC group score 5.59(5.17, 6.00); p<0.001). Also, the duration of inhalation increased significantly in the CTS group by a median of 1.84 seconds, compared with a median of 0.0s in the UC group (p<0.001).
Conclusion. Using the CTS with a pMDI improved inhaler score and the length of time patients were inhaling significantly. The use of CTS may be a useful approach not only for initial training of pMDI users, but for ongoing daily medication use, to maintain improved inhaler technique.REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
22/NW/0137
Date of REC Opinion
20 May 2022
REC opinion
Further Information Favourable Opinion