Evaluation of myAirCoach self-management support compared with usual care in asthma: a pragmatic randomized controlled trial

With the advances in technology, mHealth systems can now integrate
physiological, behavioural and environmental information which is relevant for
patients to improve self-management behaviour in order to achieve and maintain
good asthma control and quality of life. To this purpose the myAirCoach project
was started. Preceding the current study, we assessed the patients view on the
use and necessity of mHealth and which components it should consist of, through
focusgroups and a subsequently developed questionnaire (Simpson et al. ERJ
2016).In the quantification campaign a wide range of physiological, behavioural
and environmental data was collected using current mHealth and home-monitoring
systems, environmental databases and patient characteristics, to determine to
what extent asthma control and the occurrence of asthma exacerbations can be
predicted (Honkoop et al. BMJ open 2016). Simultaneously, technicians developed
an add-on to respiratory inhaler devices. For the current study we have
developed a system that is capable of supporting patients in important
self-management aspects and tasks. Good self-management means that patients
need to understand the purpose of asthma medications and be able to use
medication and devices correctly, appreciate the importance of environmental
influences, including lifestyle, need to recognise factors that make the
condition worse and understand the value of self-monitoring and be able to
recognise and treat worsening symptoms or function and know when to seek urgent
medical attention (Reddel et al. Int J Tuberc Lung Dis 2014).
The myAirCoach system provides patients better insight into their condition and
how it is affected by their environment and behaviour. In addition, myAirCoach
supports asthma patients and their health care professionals in setting
self-management goals and facilitates more personalised recommendations on
asthma management based on a patients* medical history and continuous/regular
monitoring of environmental, physiological and behavioural factors that are
known to affect asthma control and to cause asthma exacerbations.
The myAirCoach system provides feedback on the concentration of pollen and dust
particles in the outside environment. However, indoor pollen and dust might
prove to be just as important, especially concentrations in the bed-room where
patients spend many hours. With the advent of air purifiers, this provides with
another target for improvement of asthma outcomes of our patients. However, for
the current study, if the air purifier would be added from the start, it would
be impossible to determine the separate effect on outcomes of the myAirCoach
system and of the air purifier. Therefore we added a second randomisation
procedure, with an additional one month follow-up, to assess the (additional)
effect of the Philips air purifier in both the intervention and control group.

Primary objective
To assess whether self-management support by the myAirCoach system as an
adjunct to usual care improves asthma control in patients with asthma, compared
to usual care.

Secondary objectives
* To determine whether the myAirCoach system improves quality of life, asthma
exacerbations and FeNO and lung function level
* To determine whether the myAirCoach system improves adherence to medications
and asthma self-management
* To determine users* acceptance of the myAirCoach system and identify
potential issues to the implementation of the system
* To assess cost-effectiveness and organisational impact of the myAirCoach
system, compared to usual care
* To determine whether the Philips Air Purifier improves asthma control,
quality of life and exacerbation rate

Type of study: Multi-centre, pragmatic randomized controlled trial, in which
participants will be randomized in a 1:1 ratio to myAirCoach self-management
support as an adjunct to usual care (myAirCoach group) or to usual care alone
(usual care group).
Duration: 3-9 months (variable follow-up length; see figure below) plus 1 month
of environmental monitoring; A sequential phased study so that patients will
therefore be involved for a minimum 4 months, up to a maximum 10 months.
Number and type of subjects: 90 asthmatic patients
Study Outcomes: Primary: Asthma Control (assessed through the ACQ)
Secondary: Asthma exacerbations, lung function, quality of
life, costs
Start date: 01.09.2017
End date: 30.06.2018
The follow-up will end on the same calendar date for all participants in order
to observe sufficient occurrences of asthma exacerbations during the study
period. This results in a variable follow-up duration.
UK Centre: Royal Brompton Hospital
Netherlands: Leiden University Medical Center

Staggered enrolment
To prevent that major technical issues with the myAirCoach system inflicts too
many participants and thereby possibly leading to quitting the study,
participants will be enrolled in cohorts corresponding to myAirCoach version
releases (minor updates).

Usual care vs myAirCoach intervention

myAirCoach intervention
In addition to usual care patients in the myAirCoach group will be provided
with self-management support via the myAirCoach system. This system consists of
the several devices and mHealth and web-applications for patients as well as a
web-application for health care professionals.

Additional 1 month Philips Internal environmental monitoring
We will provide participants with two Philips Air Purifier devices. This system
measures and displays the indoor air quality (particulate matter). We will ask
participants to place one in the bedroom and one in the living room. The
purifier operates quietly, the sound of a gentle breeze, and dims its light at
night, so it won*t disturb sleep. We will supply devices to half in each group
(Intervention vs. Control) who will use the Philips home air purifier machine
and half will not (see Figure 1). Participants receiving these devices will
receive an additional £15 to cover the cost of electricity consumption. The
internal environment Philips monitoring device tells patients about indoor
pollutants, which empowers them to act upon that.

Potential risks and burdens for research participants
We do not consider this study to have any significant risk to the participants.
The skin prick test/peripheral blood test for allergies and the bronchial
challenge are potentially performed at baseline, if participants did not
undergo a recent allergy test, or if they did not have a confirmed diagnosis of
asthma. Although these tests are invasive and might cause discomfort, they will
also be of aid to the individual patient, since it will improve understanding
of potential allergies and/or increase certainty about whether or not the
patient is suffering from asthma. We do not anticipate that our research will
cause any upset to the participants, since all sensors and devices are
non-invasive. There are no known serious adverse effects when using any of the
sensors or devices. However, these sensors and devices will provide
participants with several results of continuous monitoring, such as pulse,
activity, breathing rate, FeNO measurements and exhaled breath temperature and
will give patients feedback on inhalation technique and medication adherence.
These results may be experienced as uncomfortable by some patients, or even
cause anxiety, especially if the scores are out of the ordinary.
To manage this concern we have taken several steps:
* Patients will be informed upon the purpose of the research at several stages
of the process, including* the study advert, the participant information sheet,
during the consent process and at the start of the study.
* Patients will be reassured that they have the right to withdraw anytime, that
the data obtained will remain anonymous and will be handled in adherence with
the data protection act.
* We have assigned an independent pulmonary physician who is available for
questions
This research does constitute a significant burden on the time of participants.


Potential for benefit to research participants
As a result of participation in the research, patients are assisted in their
self-management of asthma and improve their inhalation technique, adherence,
knowledge about potential triggers for loss of asthma control or asthma attacks
and potentially improve their asthma control and quality of life. In the long
term, the results may assist the development/design of the next generation of
'user centred' mHealth systems, that may improve the way asthma is managed and
thus be of help to the participants as well.