Do Cardiac Health: Advanced New Generation Ecosystem

Cardiac diseases are the leading cause of death and a major health problem in
Europe accounting for 47% of all deaths annually. Although pharmacological and
medical treatment options for cardiac diseases have improved considerably over
the last decades, there is increasing recognition that this strategy is neither
sufficient nor sustainable to reduce disease burden and associated costs. By
contrast, targeting modifiable risk factors, such as sedentary lifestyle,
unhealthy diet, and psychosocial risk factors, may be a more sustainable
strategy to reduce the disease and economic burden related to cardiac disease.
The conventional medical approach tends to involve multi-disciplinary
health-care professional teams compiling a care package based on the past
history of the patient. This is likely to be determined at the case conference
and it may be some months before the case is reviewed again. This activity is
generally initiated and subsequently delivered by the general practitioner and
who may then propose interaction with the dietician as required. For most
personal e-health applications physiological parameters or symptoms are the
primary * and often the only * means to determine the status and help to
improve or manage the health of patients. The feedback on patient*s
physiological condition is often not comprehensible for patients since the
direct link with their everyday behaviour and experiences is missing. The Do
CHANGE project approach differs from the conventional medical approach in that
it focuses on assisting patients to increase their behavioural flexibility and
subsequently their lifestyle. This is by providing them with specific
information and alternative suggestions based upon their needs. The Do CHANGE
project aims to combine concepts of behavioural change mechanisms with
technical tools that can capture physiological data.
Therefore the advantage of the Do CHANGE approach is that it provides
methodologies for changing human behaviour by gathering physiological and
symptomatic patient data to inform both the patient to enable self-management
of their condition and the clinician to enable him to create a personalized
care package for the patient. The Do CHANGE approach uses innovative technology
that can be persistent, timely, specific, has access to enormous storage space
and data, is multimodal, on the spot and efficient. It can easily be replicated
and distributed (and thus standardized). The intention is that by changing
behavioural habits and flexibility this will help patients to modify unhealthy
habits.
In the Do CHANGE project, we address the needs of patients with coronary artery
disease, heart failure, and hypertension whose condition often requires them to
change their unhealthy lifestyle and decrease the cardiac risk factors.

The primary objective of Do CHANGE is to develop a health ecosystem for
integrated disease management of citizens with high blood pressure and patients
with ischemic heart disease or heart failure. The system will give them access
to a set of personalized health services in a near real-time fashion. This
disruptive system will incorporate the behaviour change methods, such as *Do
Something Different*, in conjunction with new innovative wearable/portable
tools that can monitor behaviour and clinical parameters in normal living
situations.

Primary objectives:
-To enhance behavioural habits and flexibility of patients with coronary
disease, heart failure, or hypertension.
- To improve self-management and lifestyle
-To increase quality of life

Secondary objectives:
-Assess satisfaction, usability, and acceptance of the intervention(tools).
-To assess cost effectiveness of the intervention
-To evaluate changes in health care consumption

Exploratory:
-To assess subgroups who are more likely to benefit from the intervention based
on their psychological, clinical, and demographic profile
-To examine whether the intervention is associated with physiological measures
(e.g. ECG)
-To derive behavioural patterns of patients who participate by using anonymized
GPS data

A randomized controlled trial study design will be used where patients will be
randomized (1:1) to either the intervention group or the control group (usual
care). Assessment will take place at 3 time points: baseline, 3- and 6 months
post inclusion. Figure 1 provides a schematic representation of the trial
design.

Do Something Different programme
All patients randomized to the intervention group will receive the Do Something
Different online programme which has been developed to change behavioural
habits and flexibility of cardiac patients.
The Do Something Different Program has previously been developed and evaluated
(ref). For the current study, the programme has been adapted to the population
of interest (CAD, HF, and HT patients) together with behavioural experts and
cardiologists. The program aims to change behavioural habits and increase
flexibility and subsequently change habits associated with an unhealthy
lifestyle and distress, which are both found to be associated with hypertension
and cardiovascular risks. The program has been developed with input from
cardiologists , psychologists, and patients. *Typical* other behavioural risks
besides hypertension have been identified and are addressed within the program.
To further adapt the program to patient* needs, all patient, prior to starting
the program, will be assessed regarding their own functioning, distress, and
personality such that the Do*s will match their personal habits and challenge
them to change.
After assessing patients personality profile the intervention will be provided
for 11 weeks. Patients will receive a total of 32 Do*s / messages during this
period. The Do*s will be matched to their personal profile.
Patients will receive their Do*s trough the care portal and/or via sms,
depending on patients* preferences.
The Do Something Different programme is being used for behavior change purposes
by various UK regions (for such things as diabetes, people who self-harm, as
well as healthy living generally). In additon, it has been recognized by the UK
Royal Society for Public Health by being given the RSPH award for Health &
Wellbeing.
*The award for Do Something Different is due to its innovative and creative
approach in supporting behaviour change of individuals in Hertfordshire. Its
digital platform is accessible and scalable with the potential for reaching
large groups of people. Its interventions are underpinned by research and good
practice in technology.* RSPH 2015.

Moves app
For the future study within the Do CHANGE project, the Do Something Different
programme wants to focus on providing *Contextual Do*s* where patients will
receive behavioural prompts at the moment that the behaviour takes place. In
order to reach this goal getting more insight in patients behavioral patters is
of utmost importance. Hence, that data will be gathered within this current
study as one of the exploratory objectives using GPS data. This will give us
more insight and will be used as input for our future study. All patients
participating in the intervention will be provided with the *Moves* app that
will log their activities anonymously. This information will automatically be
available for research purposes only. Patients will not receive any push
messages from that app or any feedback.
*Moves* is an automatic diary of your life. Your daily storyline and maps show
where, when, and how much you move. The application automatically records any
walking, cycling, and running you do. The app is always active in the
background, so there*s no need to start and stop it. Just keep your phone in
your pocket or your bag. The app consumes battery power, so nightly charging is
recommended. With typical phone use, a smartphone running Moves should have
enough battery power to last all day. The optional Battery Saving Mode in Moves
for iPhone saves up to 40% of battery.

The Moves API can be used to build new apps, integrate with an existing service
and visualise data. The API is designed for apps and services that have a
server component. Individual users need to give permission to access data.
However, providing any kind of personal information is optional, data
collection can be done anonymously as well. Moves uses OAuth 2.0 for
authentication and authorization and the actual authorization happens in the
Moves app.

During this study the API can be used to collect location based data from
participants. This data will be used to develop the location based responsive
Do program. During the study participants will not receive feedback from the
application. In the settings all notifications can be turned off. Besides, the
app can be used without setting goals and accounts. The only thing a
participant is asked is to install the app and fill in a unique code for data
collection. Participants who do not use a smartphone or are not able to install
the app do not have to use it.

N.B.! All collected location data will be anonymously collected without being
able to trace the patients who are using the app.

Care-Portal
All patients who are randomized to the intervention group will also receive a
Care-Portal (Docobo Ltd.) which will be installed at their home. The
Care-Portal will be used to gather ECG data and blood pressure on a daily
basis. The Care-Portal will send the physiological data directly to the
cardiologist who will be able to access those via an online platform and
contact the patient if necessary.
In addition, patients will receive their Do*s trough the care-portal.
The Care-Portal is a CE-marked device that has previously been successfully
used and implemented to support patients with chronic conditions.

Blood pressure monitor
All patients in the intervention group will receive the digital blood pressure
monitor *UA -767 Plus* which is a CE-marked device for clinical use (Appendix
1: product specification). Patients will be asked to measure their blood
pressure on a daily basis and record the values through the care-portal.

Cardiac patients may benefit from this programme as it may enhance their skills
to change their cardiotoxic lifestyle. The intervention is designed to support
patients in their lifestyle change, hence we expect that patient randomized to
the intervention arm will show an improvement in their lifestyle as compared to
the comparator group. There is no risk associated with participation in the
trial, as the intervention contains no invasive medical treatment.
All the devices that will be used within the study are CE-marked for this
purpose.