Introduction – about the RETENTION project

The primary goal of the RETENTION project is to develop an integrated platform that gathers and analyses health-related data flows, with further analysis of the day-by-day activities of Heart Failure study participants in their home environment. Such continuous data collection and processing will later provide the input for personalized interventions that support the healthy and independent lives of the study participants.

This collection will be performed by:

• Continuously monitoring and collecting medical, clinical, physiological, behavioural, psychosocial, and real-world data of patients.
• Analysing this data using innovative model-driven big data analytics, statistical, artificial intelligence and machine learning techniques.
• Detecting patterns in the HF disease progress and the quality of life of patients.
• Cross checking and validating them against clinical literature.
• Offering transparent, explainable and verifiable decision-making capabilities that leverage the evidence produced by the underlying data analysis.

This document is a user manual of the RETENTION application. The application's main goal is to monitor (collect and present) a Cardiology patient's measurements while outside hospital care using standard, easily acquired equipment. It should also be noted that RETENTION will abide by all principles of GDPR including the principles of lawfulness, fairness and transparency, purpose limitation and data minimization.

Study pre-specified subgroup analyses include

• The three patient categories:
  • Heart Failure [HF],
  • Left Ventricular Assist Device [LVAD]
  • and Heart Transplant [HT]
• Males and Females
• Patients with a hospitalization less than three months from the enrolment
• Patients older than 60 years old

Data points used by the study

• Smartwatch (Heart rate, Steps counter, Sleep analysis)
• Oximeter (Oxygen saturation)
• Pressure gauge (Blood pressure) - excluding patients with LVAD
• Weight scales (Body weight)
• Temperature (Manual entry)
• VAD (Manual entry)

As an additional feature, a questionnaire is embedded, giving doctors the ability to easily access patient symptoms. This action should be completed at least once a week, on demand.

Extra Measurements -VAD

The following data will be additionally collected for patients with VAD device installed:

• Controller parameters
• Alarms
• RPMs
• Power consumption
• Flow
• Pulsatility index
• Driveline exit site evaluation (photographic evidence) as early signs of infection

Devices – Equipment used

• Application edge (mobile device)
  • Samsung A13
• Watch – Garmin
  • Garmin Venue SQ
• Oximeter – OMRON
  • Omron P300 Intelli IT pulse oximeter
• Pressure gauge
  • Omron M7 Intelli IT
• Weight scales -OMRON
  • Omron HN 300T2 Intelli IT

Alternative devices

• Application edge (mobile device)
  • Samsung A02s or A03s
• Watch – Garmin
  • Garmin Venue SQ 2
• Pressure gauge
  • Omron M4 Intelli IT

Daily Measurement intervals for the application

Data collected by the application from smart sensors and devices on a daily basis should be:

• Weight (once per day)
• Blood pressure (morning)– excluding patients with LVAD
• Heart Rate (continuous by wearing the Smartwatch) (sync once per day)
• Peripheral capillary oxygen saturation (morning, evening)
• Sleep: deep and light sleep phases, sleep interruptions (via the watch)
• Steps, distance, floors climbed, calories consumed (via the watch)

Timeframes

Installing and updating the application

Installation

The application is available on the Google App Store and can be accessed by using the following link: https://play.google.com/store/apps/details?id=com.datamed.retention&pli=1

Users need to simply:

1. Navigate to the app's page.
2. Tap the "Install" button.
3. Tap the "Open" button when the installation finishes to open the application.

Updating

The application will not function if it's not updated to the latest version. A pop-up will inform the user accordingly if they try to open an outdated version of the app and will help them easily navigate to the app's page on the Google Play Store.

Sign in, Pair with devices and Measurements

• In order to set up the application, the first sign in should be as an admin. To access the admin login screen, tap the retention icon 7 times. The app will respond, counting down the number of times for entry.
• Please keep in mind that in order to use the application, you must keep Wi-Fi and Bluetooth on. It is also important to have a stable Wi-Fi connection.

• Use the following credentials to sign into the appropriate hospital Database or test environment:

Patient ID	XXX {ex. 106, this will be provided by the CSB}
URL	{ex. https://retention-csb-test.biomed.ntua.gr}
Language	Choose desired language
Admin Password	{add a Password}

• Tapping "Submit" will return the user to the login screen and will allow them to log in either as a carer or as a patient.
• Adding an admin password is a must (will be given by the IT support teams of the Hospitals).
• Tapping "Patient" or "Carer" and using their biometrics will allow the user to log in.
• Users will have to accept the privacy policy by tapping "OK", then allow the application to use the required parts of the device.
• Please accept all user policies. The system does NOT keep or transmit any personal information.

Smartwatch

Watch pairing

• Tap the Watch icon. The application will automatically scan for nearby pairable devices.
• On the Watch, press the upper button until the menu appears, then tap the Phone-Bluetooth button.

• Select the device from the list of the available devices.

• Fill in the requested basic user data. "Start sleep time" should be the earliest hour that the patient might go to sleep and "End sleep time" should be the latest hour that the patient might wake up. This is information that will be stored as part of the user profile on the watch and is not transmitted. The information can be changed later via the system settings of the watch.

• Tap on save.
• A pin number will appear on the watch screen while the "enter pin" screen will appear on the phone. Enter the pin number on the application screen. If the pin was entered correctly, the device will now be paired, and the application will return to the "measures" screen.
• A prompt asking for permission to use the watch will appear. Tap on "allow".

Watch sync (measurements sync)

• Tap the 'Measures' icon

• Select "Activity"
• Tap "Sync"
• The Watch will automatically synchronize with the application and the measurements will appear on the respective fields.
• You should see a "Request was successful" pop-up at the bottom of the screen. If you get a "Request was unsuccessful" pop-up or no pop-up at all, try to close the application, turn Wi-Fi off and then on again, then start the application and attempt to sync again. If the issue persists, try again a few hours later or contact the hospital IT department.

Warnings

Oximeter

Oximeter Pairing

• Tap the 'Measures' icon

• Tap the 'Oxygen level' icon

• A pop-up will appear. Follow the instructions on it to pair with the device and then tap the "I did it" button.
• An android OS message will appear, requesting permission to pair with the device. Press "Pair".

Oximeter measurement

• Tap the "Oxygen" icon.
• Place the device on your finger so that it fits properly in its opening.
• When the measurement results appear in the oximeter screen, tap the "Sync" button on the app.
• Once the results appear in the phone screen, tap "Upload" to upload them to the database. If you made a mistake during the measurement, then you can instead press "Cancel" and retake the measurement.
• You should see a "Request was successful" pop-up at the bottom of the screen. If you get a "Request was unsuccessful" pop-up or no pop-up at all, try to close the application, turn Wi-Fi off and then on again, then start the application and attempt to sync again. If the issue persists, try again a few hours later or contact the hospital IT department.

Warnings

Pressure gauge

Pressure gauge pairing

• Tap the 'Measures' icon

• Tap the 'Blood Pressure' icon

• A pop-up will appear. Follow the instructions on it to pair with the device and then tap the "I did it" button.
• An android OS message will appear, requesting permission to pair with the device. Press "Pair".

Blood pressure measurement

• Place and fix the cuff on your arm.
• Press the ON / OFF button to start inflating the cuff.
• Once the measurement appears on the device screen, press the "Sync" button on the application.
• Once the results appear on the phone screen, tap "Upload" to upload them to the database. If you made a mistake during the measurement, then you can instead press "Cancel" and retake the measurement.
• You should see a "Request was successful" pop-up at the bottom of the screen. If you get a "Request was unsuccessful" pop-up or no pop-up at all, try to close the application, turn Wi-Fi off and then on again, then start the application and attempt to sync again. If the issue persists, try again a few hours later or contact the hospital IT department.

Warnings

Scale

Scale Pairing

• Tap the 'Measures' icon

• Tap the 'Weight' icon

• A pop-up will appear. Follow the instructions on it to pair with the device and then tap the "I did it" button.
• An android OS message will appear, requesting permission to pair with the device. Press "Pair".

Weight measurement

• Tap the "Weight" icon.
• Step on the scale.
• Wait until the result appears.
• Tap the "Sync" button.
• Once the results appear on the phone screen, tap "Upload" to upload them to the database. If you made a mistake during the measurement, then you can instead press "Cancel" and retake the measurement.
• You should see a "Request was successful" pop-up at the bottom of the screen. If you get a "Request was unsuccessful" pop-up or no pop-up at all, try to close the application, turn Wi-Fi off and then on again, then start the application and attempt to sync again. If the issue persists, try again a few hours later or contact the hospital IT department.

Warnings

Thermometer

Temperature measurement

• Take the temperature measurement.
• Tap the 'Measures' icon

• Tap the "Temperature" icon

• Enter the measurement.
• Press "Sync"
• You should see a "Request was successful" pop-up at the bottom of the screen. If you get a "Request was unsuccessful" pop-up or no pop-up at all, try to close the application, turn Wi-Fi off and then on again, then start the application and attempt to sync again. If the issue persists, try again a few hours later or contact the hospital IT department.

Warnings

Other functions

Adherence to Medication

• Tap the Medication icon

• A list of medication the patient is currently taking will appear on the screen.

• Tap the checkmark next to the names of the medication you want to mark as taken and then press the "Submit" button.
• You should see a "Request was successful" pop-up at the bottom of the screen. If you get a "Request was unsuccessful" pop-up or no pop-up at all, try to close the application, turn Wi-Fi off and then on again, then start the application and attempt to sync again. If the issue persists, try again a few hours later or contact the hospital IT department.

Questionnaire

• Tap the 'Others' icon

• Tap the 'Questionnaire' icon

• A list of questions will follow

• After answering the questionnaire, tap on 'Submit'.
• You should see a "Request was successful" pop-up at the bottom of the screen. If you get a "Request was unsuccessful" pop-up or no pop-up at all, try to close the application, turn Wi-Fi off and then on again, then start the application and attempt to sync again. If the issue persists, try again a few hours later or contact the hospital IT department.

Database

The patient or carer can check previous uploaded measurements via the database screen.

• Tap the 'Measures' icon

• Tap 'Database'

• This screen will display a history of the user's past measurements, broken down into the following categories:

1. Diastolic blood pressure
2. Systolic blood pressure
3. Pulse
4. Oxygen levels
5. Temperature levels
6. Weight
7. Calories

• Tapping the purple frame at the top will cause a dropdown to appear, allowing the user to change the measurement displayed.

• To change the number of measurements displayed, tap the number next to the "Items per page" text at the bottom. Users can choose to display up to 100 items per page.
• Tap the "Previous" and "Next" buttons to move between pages.