Breathe4T - Stage 3
Research type
Research Study
Full title
Breathing REtraining for Asthma Trial of Home Exercises for Teenagers; repurposing, refining and feasibility – Stage 3
IRAS ID
290847
Contact name
Graham Roberts
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
The problem we aim to address is impaired quality of life despite appropriate medicines for young people with asthma. Young people tell us that during an asthma attack they have to calm themselves down to control their breathing. Although physiotherapist-delivered breathing retraining programmes now have a clear evidence base in adults with asthma, improving quality of life, there is a lack of evidence assessing its use in younger patients. We have redesigned an adult training package to make it appropriate for young people and we would now like to assess how effective such an intervention would be in this population. This study will include young people (12-17 years) with physician diagnosed asthma.
The repurposing, optimisation and acceptability of the intervention in the adolescent age group has been undertaken in Stages 1 and 2 of the BREATHE4T project. We have developed a self-guided, breathing retraining digital intervention that is delivered via a mobile friendly, online platform.
The current study is a randomised, controlled feasibility trial and will provide the necessary information for a substantive cost-effectiveness trial. Participants with access to the intervention will be compared to a usual care group. We will compare the asthma and quality of life of both groups at baseline, 2-month and 6-month time points. At the end of the 6 months, the control group will also be given access to the website.
The online nature of this study allows recruitment from across the UK. Recruitment methods would include primary care, hospital clinics, social media and posters. Asthma UK will also provide publicity to assist recruitment.
Summary of Results:
Teenage years can be a challenging time as the body and mind undergo various changes to prepare for adulthood. Teenagers with health conditions such as asthma can sometimes find this affects their daily lives and can therefore find it difficult to take part in the activities that they enjoy doing. A study for adults found that breathing exercises can be effectively self-taught to help patients to manage their asthma and find it easier to take part in daily activities. This has the potential to be a cheaper and quicker way for patients to access support. The current study has repurposed the adult programme to be in a format that will be suitable for teenagers and that they will want to use. Teenagers have been involved throughout the study to make sure the website meets their needs. The study consisted of 3 parts; 1) to develop the website, 2) to enhance the website and 3) to find out if teenagers can be recruited and followed up in a 6-month trial. A total of 42 teenagers were involved in developing and optimising the website. Then, 64 teenagers took part in the 6-month trial and were put into 2 groups in which they either had instant access to the website or had to wait to use it at the end of the 6 months. Both groups were asked to complete questions about their asthma and their daily lives when they signed up to the study, after 2 months and at the end of the study. Teenagers had positive feedback about the website, and around 70% of teenagers completed the questionnaires at the end of the study. The study was found to be acceptable and possible for teenagers with asthma.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
21/YH/0033
Date of REC Opinion
16 Apr 2021
REC opinion
Further Information Favourable Opinion