Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Asthma
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Other

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Asthma is a chronic highly prevalent condition, which results from inflammation and hyper-responsiveness of the airways resulting in variable airway limitation and symptoms of wheeze, cough, breathlessness and chest tightness. There is no cure for asthma, but the use of simple inhaler treatments can...

Asthma is a chronic highly prevalent condition, which results from inflammation and hyper-responsiveness of the airways resulting in variable airway limitation and symptoms of wheeze, cough, breathlessness and chest tightness. There is no cure for asthma, but the use of simple inhaler treatments can keep the symptoms under control. However, if uncontrolled, asthma can be life-threatening. Most deaths related to asthma are preventable if the condition is managed using the right treatment plan and inhaler technique. In the UK, an estimated 4.3 million adults (1 in 12) receive treatment for asthma costing the NHS around £3 billion annually in direct and indirect care. Asthma accounts for approximately 60,000 hospital admissions per year. The NRAD states that a high proportion of patient morbidity is directly related to poor management. The annual 2016 asthma survey reported that 82% of asthma suffers said their asthma was poorly controlled. Those with uncontrolled asthma were almost twice as likely to be admitted to hospital. In the UK seven out of ten people with asthma received care that failed to meet basic quality standards with 30-70% reported as not taking their asthma medication as prescribed. Additionally, a significant proportion of patients do not use their inhalers as prescribed and demonstrate poor inhaler technique. Since the arrival of COVID-19, it has never been more important for asthma suffers to ensure they are following their prescribed treatment plan. COVID-19 is a highly infectious virus that primarily affects the respiratory system, meaning those with asthma are at greater risk of severe complications. Maintaining consistent infection prevention practices and social distancing are key to minimising the risk of contracting the virus. However, social distancing and required 'lockdown' has impacted on routine clinic appointments, highlighting a lack of an alternative remote self-management system to support patients during this pandemic. Systematic reviews have shown that despite the heterogenous interventions, technology enabled healthcare can improve process outcomes such as patient knowledge, self-management skills, improvement in inhaler technique and increased use of preventer medication. However, to date studies have shown an inconsistent effect on clinical outcomes such as symptoms, lung function, SABA use and quality of life. The use of technology enabled healthcare in asthma care has not identified significant harms or instances in which it was less effective than conventional care and results were encouraging enough to suggest further analysis of digital models of care. Prior to COVID-19, the NHS model of care included a once annual asthma review. This has raised concerns that the full picture of asthma control may not be captured and is generally limited to the period around that review which is a fraction of the time people are living with asthma. Healthcare professionals aim to deliver best care and promote good asthma self-management, but this can be complex and time-consuming and so often not possible in the given time for primary care appointments, leading to adverse outcomes and variations in care. Opportunities to address variations in care were identified in the NRAD. These included improving risk stratification to distinguish between those with asthma requiring minimal support through an annual review, and those who require closer monitoring throughout the year. Addressing safer prescribing to highlight those who have been prescribed excessive quantities of SABA inhalers, improving systems to arrange follow up, raising the quality of medical records and enabling systems to support asthma self-management. In 2015, Asthma UK conducted a large survey to explore both asthma patients and healthcare professionals' views on mobile health (mHealth) requirements. They found that two-thirds of adult asthma sufferers had a smartphone suggesting that with the increasing presence of technology in homes, remote monitoring is becoming an alternative health service delivery option. The reported showed that almost three-quarters of patients would value an mHealth device to support asthma monitoring, and almost half would consider a system for use as part of an asthma action plan, to offer advice on medication and when to seek medical attention. Additionally, three-quarters of healthcare professionals stated an mHealth system which monitored asthma symptoms and provide asthma action plans would be beneficial. Digital healthcare interventions are now more important than ever. They are able to support healthcare services to remotely deliver patient-centered care, facilitate timely access to health advice and medications, promote self-monitoring and medication compliance, and educate patients on trigger avoidance. Evidence has shown that self-managed education, incorporating personalised asthma action plans improves health outcomes for people with asthma and reduces the use of healthcare resources particularly emergency department visits and hospital admissions. Furthermore, it can improve markers of asthma control, including reduced symptoms and has a positive effect on quality of life.

Tracking Information

NCT #
NCT04744272
Collaborators
Bradford Teaching Hospitals NHS Foundation Trust
Investigators
Study Director: Tom Wilkinson my mhealth Ltd