Do Cardiac Health Advanced New Generation Ecosystem 2

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 bloodpressure 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 improve self-management and lifestyle
-To increase quality of life
-To improve behavioral habits and flexibility of patients with coronary
disease, heart failure, or hypertension.

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 physiological measures (e.g. ECG, Blood pressure, weight)
improve (in the intervention group)
-To gain more insight in patients* sleep patterns and physical activity (in the
intervention group)

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.

1. 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
(www.dsd.me). 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.

In addition to the core programme a patient may receive up to two Responsive
Do*s (also referred to as ToDo*s) per week. Whether a patient receives one of
these ToDo*s, and which one is selected, is determined by analysis of data
collected from the sensor devices the patient has opted in to use (e.g. the
Fitbit). Patients who tend to have a sedentary lifestyle as indicated by their
Fitbit will receive ToDo*s that will encourage them to break with these
negative habits and increase their physical activity.
There is a theoretical maximum of receiving 16 ToDo*s during a programme, but
the average would be less.

Patients will receive their Do*s trough the care portal and/or via sms,
depending on patients* preferences.

2. CarePortal
All patients who are randomized to the intervention group will also receive a
CarePortal (Docobo Ltd.) which will be installed at their home. The CarePortal
will be used to gather ECG data, address symptomatic data, blood pressure, and
weight on a daily basis. The patient will be able to take the ECG measure at
any time. By touching the screen of the CarePortal the instructions to take the
measure will appear, guiding the patient step by step to take the ECG (which
all will take 2 minutes). The CarePortal 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. Further to that the patients
will receive questions addressing the daily symptoms of their condition.


3. Moves App
Do Something Different programme will providing *Contextual Do*s* /behavioural
prompts at the moment that is most relevant to the patient. In order to reach
this goal getting more insight in patients behavioral patterns is of utmost
importance. 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 and to third
parties as described in the *terms of use* document which will be provided as
supplement file to the patients. 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.


4. Beddit
To log patients* sleep data and evaluate whether their sleep patterns have
improved over time due to the intervention, patients assigned to the
intervention group will all receive the Beddit device (www.beddit.com). Beddit
is a certified medical device to measure sleep, heart rate and breathing during
time spend in bed. The devices has been validated (Paalasmaa, J., 2014 PhD
thesis. University of Helsinki) and is considerd one of the most accurate
devices to monitor sleep. For the current strial the *Beddit 3* will be used.
Beddit 3 is thin device that is hidden under your sheet. The patients are not
required to carry any tools with them. The Beddit transfers information via
Bluetooth to the Beddit app that the patient will have on their phone. This
data is in addition transferred to the Do CHANGE App where the patient will be
able to see their own data. Simultaniously the data is also stored at the
consortium servers (at TU/e, Docobo, and ONMI)

5. Fitbit
Patients* physical functioning will be assessed using a Fitbit. With this
device we will be able to examine whether patients* sedentary lifestyle has
changed due to the intervention. With the Fitbit patients step count, physical
activity, heart rate, calories burned, distanced walked, number of stairs
climbed will be assessed. This information will not only be available for
patients to get more insight in their functioning (and for research purposes),
but will also be used as input to generate ToDo*s from the Do Something
Different programme as mentioned before. For the current trial *Fitbit Alta HR*
will be used.

6. CookIT:
Is a smart spatula that is able to monitor patients cooking behavior (whether
patients are using the spatula) and estimate the sodium concentration of the
food being prepared. The CookiT has been developed by ONMI and Eurecat as part
of the Do CHANGE project. .

7. Vire app
In order for patient not to feel overwhelmed by the apps that they will have to
check everyday (if they are interested in their own progress) the Do CHANGE app
has been developed. The Do CHANGE app has been developed together with end
users and input from health care professionals. This app is able to provide an
overview of all the devices that the patients will be using during the study
(e.g. Beddit, Fitbit, etc.). Through this app patients will also be able to
receive the Do*s from the Do Something Different programme. The app has been
developed to help the patients get an integrated overview of their own data. No
addition data will be collected through the Do CHANGE app, the dData coming in
from the devices that will be integrated in this app (Moves, Beddit, Fitbit, Do
Something Different) will be stored as previously mentioned at the consortium
servers at TU/e, ONMI, and Docobo.
The Do CHANGE app will have an additional function which will enable the
patients to collect (and share with their health care provider) pictures of
their food. By simply taking a picture with this app the pictures will be
uploaded to the health care professional portal and the health care
professional will be able to see what the patient ate.


8. Dependent on the main heart condition, the patient will decide together with
the healthcare professional what additional devices the patient will be using .



- FluIT: FluiT is a tool to assess fluid intake during the day. This device has
previously been developed and is currently being using in another clinical
trial in the Catharina Hospital in Eindhoven.

- Bloodpressure 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. Patients will be asked to measure their blood pressure on a
daily basis and record the values through the care-portal.

-Scale: If needed patients will be provided with a weight scale to monitor
their weight on a daily basis. For the current trial the *Seca Aura 807* model
will be used. Patients will be able to communicate their weight on a daily
basis through the care portal. This information will also be visible in the
health care professional portal which is accessible for the patients*
cardiologist.


All patients in the intervention group will be approached between month 3 and 6
to provide kwalitative data about the satisfaction with the intervention. With
this information we will be able to further personalize the programme.

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 copared to
the comparator group. There is no risk associated with participation in the
trial, as the intervention does not entail invasive medical treatment. The
intervention consists of a behavioural intervention, and the technological
applications used for this purpose are all CE marked or approved by the IGZ.