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
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”.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