Asthma Clinical Trial
Official title:
An Open Feasibility Study to Investigate the Impact of A Digitally Delivered Asthma Service for Patients in Primary Care (IDEAL-001: Integrated Digitally EnhAnced Care for Long-term Conditions-001
Asthma is a common lung condition that causes long term breathing difficulties. There is
currently no cure for asthma but the use of simple inhaler treatments can keep the symptoms
under control. If asthma symptoms get worse this can lead to an asthma attack which can be
life-threatening. It has been shown that most of the deaths related to asthma are preventable
if asthma is managed using the correct treatment plan however a significant proportion of
patients are not using the right inhalers or not using them properly and do not know how to
manage their asthma if it gets worse.
There is currently an unmet need to develop tools that can help improve asthma care, identify
high risk patients, closely monitor their asthma control in 'real time' and intervene to
optimise treatment to prevent asthma attacks. Both patients and indeed, the current British
Thoracic Society (BTS) asthma guidelines recognise that technology has the potential to be
used to improve asthma care and could lead to reductions in National Health Service (NHS)
services use and improvements in symptoms.
Patients with better controlled asthma are less likely to be admitted to hospital and more
likely to have an improved quality of life. This study aims to evaluate the delivery of an
asthma service using an online doctor providing remote consultations paired with a
self-management asthma app. The patients will use the app to input and track their symptoms,
which will be monitored by a doctor remotely who can provide advice, optimise medications and
intervene in a timely manner to prevent an asthma attack. The service is interactive, so the
patient and doctor can communicate with one another 7 days a week by completing a
consultation or sending messages via the online doctor portal or speaking on the telephone.
The app will relay information about environmental triggers to the patient to help prevent
the patient's asthma getting worse. The service will provide a new and potentially more
convenient way of delivering routine appointments to reduce the numbers that do not attend.
The patients will be able to watch educational videos stored on the app about asthma to
potentially improve understanding of their condition. Digital training in inhaler technique
will be supported with face to face support from pharmacists.
The goals are to increase adherence to and correct use of medication, help patients
self-manage dynamically to reduce their risk of an asthma attack (with solutions personalised
to an individual's triggers) and equip healthcare professionals with the data to identify
those people at higher risk of an attack.
This is a before-and-after open interventional study, which means participants' asthma
control will be compared before and after using the digital asthma management service. It is
not a randomised study and participants will be given the choice of using a digital service.
It is a single-centre study which will take place within one Clinical Commissioning Group
(CCG) in Hampshire (UK), across at least two GP surgeries. It is anticipated that
approximately 80 patients will be recruited.
Patients will be provided with this digital asthma service for a period of 6 months of 2018
and outcomes will be measured using a combination of questionnaires (quality of life, patient
satisfaction, level of activation) and quantitative measures such as Forced Expired Volume
over 1 second (FEV1)(measure of airway obstruction), Fractional Exhaled Nitric Oxide (FENO)
(measure of airway inflammation) and Asthma Control Test Scores (measure of symptom control).
Feedback from NHS professionals hosting the study and online doctors will also be sought. A
Health economic model will be generated comparing the digitally enhanced model versus usual
care. The main outcome of this study is looking at whether this new model of service delivery
can provide an improvement in asthma control test scores.
Asthma is a 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. 4.3 million adults (1 in 12) in the UK are
currently receiving treatment for asthma. Treatment usually involves a combination of
reliever and preventative inhaler therapy. On average 3 people a day die from asthma. The
National Review of Asthma Deaths (NRAD) has shown that much of the morbidity relates to poor
management particularly around the use of preventative treatment concluding that two-thirds
of asthma deaths were preventable.
We have a well-established evidence base of how to help control asthma and prevent attacks
using interventions that focus on maintaining control and reducing risk of an attack.
However, there are concerns that the current National health Service (NHS) model of care: a
once annual asthma review may not capture the full picture of asthma control 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 the best care and motivate good asthma
self-management, but this can be complex and time-consuming and so often is not possible in
the allotted time for primary care appointments, leading to adverse outcomes and to variation
in care.
Opportunities to address this variation 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,
ensuring safer prescribing to highlight where people with asthma have been prescribed
excessive quantities of Short Acting Beta Agonist (SABA) inhalers, improving systems to
arrange follow up, raising the quality of medical records and enabling systems to support
asthma self-management.
The NHS spends around 1 billion a year treating and caring for people with asthma. Asthma
accounts for about 60,000 hospital admissions per year. The annual 2016 asthma survey
reported an overwhelming majority of patients, 82%, said their asthma was poorly controlled.
Almost half of respondents said their asthma interfered with their day to day life and 46%
said they had difficulty sleeping due to their asthma symptoms. Those with uncontrolled
asthma were almost twice as likely to be admitted to hospital as those whose asthma symptoms
were under control. The majority of patients admitted to hospital did not receive follow up
putting them at higher risk of future attacks and re-admission to hospital. In the United
Kingdom (UK) seven out of ten people with asthma receive care that fails to meet basic
quality standards with 30-70% reported as not taking their asthma medication as prescribed.
With 85% of asthma patients being managed exclusively in primary care, asthma is estimated to
account for around 2-3% of General Practitioners (GP) consultations19, costing an estimated
£108 million annually. As highlighted by the recent General Practice Five Year Forward View,
with an ever-increasing burden on services, conventional models of care are constantly being
challenged and alternative, cost-effective ways of delivering healthcare to a larger cohort
of patients are being sought.
Digital healthcare interventions may help to address some of these challenges by enabling
remote delivery of patient-centred care, facilitating timely access to health advice and
medications, prompting self-monitoring and medication compliance, and educating patients on
trigger avoidance.
Telemonitoring, the transmission of monitoring data from a patient to an electronic health
record which is shared with and monitored by healthcare professionals has the potential to
improve outcomes. The impact of telemonitoring is likely to be strongly influenced by the
level of professional support provided and personalisation of feedback. Studies have shown
that people with poorly-controlled asthma have the potential to gain more by engaging with
telemonitoring, helping people recognise worsening control and take preventative action to
reduce their risk of an attack early. There is a substantial body of evidence to show that
self-management education incorporating written personalised asthma action plans improves
health outcomes for people with asthma. Self-management education reduces emergency use of
healthcare resources including Accident and Emergency department visits and hospital
admissions and improves markers of asthma control, including reduced symptoms and days off
work and improved quality of life. Internet technology might offer an attractive means for
encouraging patients to use self-management strategies within a day-to-day context.
In 2015, two thirds of patients with asthma had a smartphone, and with this ever-increasing
presence of technology in homes, online prescribing and remote monitoring is beginning to
emerge as an alternative way of delivering services. Nearly three-quarters of patients wanted
to see an mHealth device that would help them monitor their asthma and nearly half would
value a system which could be used as part of their asthma action plan and advise them if
changes to medication have improved their asthma and when to seek medical attention.
Three-quarters of healthcare professionals said they would value an mHealth system that would
monitor patients' asthma symptoms over time and provide patients with an asthma action plan.
Systematic review has shown that despite the heterogenous interventions, technology enabled
healthcare can improve process outcomes such as knowledge adherence to monitoring,
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 computerised decision
support systems need to align better with professional workflows so that pertinent and timely
advice is easily accessible within the consultation. Evidence to support asynchronous remote
consulting suggests that it leads to reductions in healthcare usage and disease status
although evidence is very limited and of low quality in this patient group.
Systematic review of 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 the studies in asthma patients gave results encouraging enough to suggest further
analysis of digital models of care. To the best of our knowledge, this is the first study
looking at an integrated approach of using a self-management app, telemonitoring and
asynchronous remote consulting in asthma patients.
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