Home Asthma Monitoring Study (HAMS), Version 1.0
Research type
Research Study
Full title
A prospective observational study using home monitoring devices for patients with asthma
IRAS ID
243208
Contact name
Mona Bafadhel
Contact email
Sponsor organisation
University of Oxford, Clinical Trials and Research Governance
Duration of Study in the UK
1 years, 5 months, 0 days
Research summary
Summary of Research
Asthma is the most common chronic lung disease in the UK and affects around 1 in 12 of the UK adult population, the equivalent of 5.4 million people. Despite being a relatively treatable condition, it is responsible for a considerable amount of healthcare spending, morbidity and mortality, with 1216 asthma deaths recorded in 2014.
The purpose of this study is to better understand this condition, in particular, to understand how the patient’s condition changes when they are at home, and how home monitoring devices may be used to remotely assess clinical changes. The data and insights gathered from this study will allow us to design and develop better monitoring and self-management tools that patients can use at home. For this, we would also like to explore the experiences of the patient of using these tools.
We would like to use monitoring devices to understand a patient’s asthma condition when they are well, but also when they are getting worse, going through an attack, and when they are recovering. This can help us understand why and when patients have asthma attacks, and what could be done in future to help prevent them or reduce the negative impact they have on patients.
This study is a prospective observational study, which is designed to gather insights about participants' conditions rather than studying the effect of an intervention. Participants with a clinical diagnosis or clinical suspicion of asthma will be eligible for the study, and their participation will last approximately 12 months. This study will be a single-site study led by the Respiratory Medicine Unit at the Nuffield Department of Medicine, University of Oxford.
Summary of Results
We are grateful for all the study participants who kindly volunteered their time and efforts to contribute to this research study, titled Home Asthma Monitoring Study. The study was sponsored by and carried out at Oxford University, and funded by a grant from the National Institute of Health Research Research Capability Fund and through in-kind contributions from BreatheOx Limited, a spin-out company from Oxford University, for whom the study investigators are founding members.
The study sought to recruit adult asthmatic patients who were at risk of having asthma attacks, and the goal was to explore the use of home monitoring devices in monitoring changes in patients’ conditions before, during and after the attack. The research was planned as there is a lack of effective tools that can empower patients to monitor and manage their asthma in the home environment. In the study, participants concurrently used home monitoring technologies in parallel to filling out regular diary questions about their asthma control and attacks.
The study recruited the first participant in December 2018, and continued through 2019. However, it was found that recruitment was more challenging than expected (22 participants recruited), and in the 2nd half of 2019, an amendment was submitted to broaden the recruitment criteria. All the required approvals were granted in early 2020, but unfortunately at this point the Coronavirus pandemic emerged and all non-Covid studies were halted, including this one. During the pandemic, the study continued to be paused whilst exploring options and putting in further amendments to extend the end date for possible resumption of the study. Ultimately, the impact of Covid-19 continued far longer and more severely than expected. In particular, this study involved home visits, which were deemed more challenging in light of social distancing guidelines. Thus, eventually it was decided that the study would stop at the end date rather than further extensions. As the study completed without reaching near the original target number of 100 recruited participants (and thus insufficient asthma attacks captured), it was not deemed scientifically sound to draw conclusions on this small subset of data. Therefore, the study did not proceed to formal analysis and publication of its originally intended research goals.
As the study halted due to covid, participants were explained that it was possible that the study may not be able to resume and complete to publication of the results. Regardless, the participants were thanked for their contributions which were still invaluable. The monitoring data captured important asthma symptoms, such as nocturnal coughs, which were valuable as preliminary data in the development of automated cough monitoring systems. Moreover, the deploying of novel monitoring devices embedded into the homes of asthma patients provided experience and feedback that were helpful for updating the device, now deployed in ongoing studies in asthma both in adults and children.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
18/NW/0704
Date of REC Opinion
1 Nov 2018
REC opinion
Further Information Favourable Opinion