# <div style="text-align:center"> epromC2 by MedC2 <center> <img src="https://i.imgur.com/0Xd3sQu.png" width="200p"> </center> </div> # 1. User Guide ## A. Introductive Video A brief introductive video can be found [here](https://spark.adobe.com/video/7poBpfzva2YJh). <iframe src="https://spark.adobe.com/video/7poBpfzva2YJh/embed" width="100%" height="540" frameborder="0" allowfullscreen></iframe> ![](https://i.imgur.com/Wsiv7jY.png) ## B. Trial Nurse Interface ### i. Organisational Workflow ![](https://i.imgur.com/OzJ25Rc.png) ### ii. Installation on a Desktop #### Background: PWA `ePROMcp` is progressive web application (PWA). In other words, it is a website that looks and behaves in the same way as a mobile application, which means that it can be added to the main screen of the smartphone, send push notifications, access the hardware of the device, and work offline. In our case, this type of infrastructure has several advantages: - Ability to send push notifications: This hardware feature enables us to send real-time reminders to complete tasks on the application directly on the patient’s phone. - No install needed: Instead of having to go on their app store, patients that want to use the PWA only have to click on the provided URL (or scan the provided QR Code) and store it on their phone. The PWA then gets its own icon on phones and tablets, just like a mobile application. - Improved performances: Progressive Web Apps work significantly faster due to the way the underlying technology caches and serves text, stylesheets, images and other content on the websites. As a result, conversation, user experience and retention rates benefit from the improved performance compared to standard web. - Coherence of design and navigation: Creating a PWA enables to keep consistency in the design and navigation of the app/website between all supported devices. #### How to use`epromC2` as a Web app ? 1. Just visit immunosabr.medc2.com (bordet.medc2.com in a later phase) with Google Chrome browser #### How to use`epromC2` as a Desktop app ? To install any PWA website as a application on Windows 10 or Mac OS via Google Chrome Browser follow below steps. 1. Open immunosabr.medc2.com (bordet.medc2.com in a later phase) in Chrome 70+ on Windows 10. 2. Go to Setting ("3 dots" button on top right corner next to address bar) 3. Choose “Install Immunosabr” options and done! ![](https://i.imgur.com/7KRvwj7.png) These steps will install PWA as a desktop application and create desktop shortcut. To uninstall a PWA application, easy option is click on options (three dots on header) and select uninstall. ### iii. Dashboard: ePROM task overview ![](https://i.imgur.com/GIxXKQv.png) The main features on the Home page are the following: **Overview of the ePROM tasks:** In "ALL" you will be able to see all the ePROM tasks, completed or not, for your set of patients. By using the "COMPLETED", "NOT COMPLETED" and "ARCHIVED" filters you will be able to refine your search. **Schedule new ePROM tasks:** The create a single ePROM task or a complete schedule for the patient, click on the "+" in the green circle. For complete schedules, the baseline or the treatment date (in case of E arm) will have to be filled in. **Obtain the ePROM report made by a patient:** To consult the answers of a patient answers to an ePROM, click on the magnifying glass. ### iv. Participants ![](https://i.imgur.com/kySlYPx.png) On the Partipants page ### v. Preview ePROM questionnaires ![](https://i.imgur.com/uTOu36M.png) ![](https://i.imgur.com/CCVPWTu.png) The Questionnaires Page will enable you to go through the ePROM questionnaires that the patients will have to fill in. The answers you give in these questionnaires preview will not be stored in the database. Questionnaires that are preceded by a "lock" are not used in the ImmunoSABR clinical trial. ### vi. Results ![](https://i.imgur.com/1jQJaS8.png) ![](https://i.imgur.com/8ne9yZx.png) In the Results page, you will have the possibility to search and look at the answer report of a certain patient to a certain ePROM questionnaire. ## D. Patient Interface ### i. Installation ![](https://i.imgur.com/dFLeu6z.png) ### ii. Start answering an ePROM On the Home page, you will see your three upcoming ePROM tasks. These tasks will be unlocked on they that they have to be filled in. To start answering, simply clicking on the unlocked ePROM task. When a ePROM task is finished and validated, the answers cannot be changed. ### iii. About us On the About Us page, a summary of the ImmunoSABR clinical trial description and main objectives are provided. ### iv. Settings/Languages On the Settings page, you will have the possibility to change the language of the app ### v. Notifications Notifications can be enabled/disabled at any time by changing settings directly on your phone. iOS users can access their device “Settings” from the iOS Home Screen. Android users can access their device Settings, typically by dragging down the Notifications Bar. Depending on your phone and the version of iOS or Android that you are using, you may be able to control some settings on an app-by-app basis. You may also change settings directly on your web navigator when using the web version of the App. # 2. Development Status ## Ongoing development * ePROM tasks schedule generator (Multidate picker widget) * Reminders * Automatic push notifications (Android only) * In-app notifications (Android & iOS) * Send mail to participants (Android & iOS) * Multi-language support * CE t1 pending ## Optional Further development * Integration of Reminders into Google Calendar & iCalendar * Ability to add ePROM questionnaires * Connection to OpenClinica * Videoconference tool between trial nurse & patient # 3. Background ### WHO WE ARE The Medical Cloud Company (MedC2, www.medc2.com ) is a software development company dedicated to building digital platforms within the healthcare sector. Our applications aim to enable the collection and personalized analysis of multifactorial patient data. ### WHAT WE BELIEVE MedC2’s first product is an electronic Patient Reported Outcome Measurements (ePROM) collection platform that is highly customizable to our clients’ needs and focused on user-friendliness. We believe that while obtaining patient centered information can deliver highly valuable information on the patient’s health status and specific needs. The main hurdle is that gathering this data comes with a cost of time for the patient and should be done on a very regular basis to be effective. As a solution, we use ICT to facilitate the collection of data, anywhere, anytime with minimum effort required by the patient. ### OUR PLATFORM The platform we propose is entirely customized to Bordet’s needs and identity. This ensures minimum disturbances for the user and a user-friendly tool for both the trial patients and nurses. The platform is accessible through a web application on a computer and through a Progressive Web Application (PWA) directly downloadable on the patient’s smartphone. We developed the PWA and recommend it to our client because it enables to send push notifications directly to the trial participants to remind him/her of specific tasks to be performed directly on their mobile phone which ensures the highest compliance rate to the trial’s protocol. ### BASIC FEATURES & DESIGN - Multi-language support: Our Proof of Concept is being developed in English, Dutch and French and other translations can very easily be added. - Ability to easily add questionnaires (A user-friendly tool allowing the nurse to add customized questionnaires can be developed in a further stage if needed. Estimated time: 5 WDs. Otherwise the developer can add a new ePROM) - Questionnaires pre-view: Trial nurses are able to check the questionnaires without interfering with the database. - Help information & FAQ: Information about the trial, the ePROM collection platform and contact information of the trial nurses will be easily accessible on the platform. Additionally, a user-friendly design has been implemented for both the patients and trial nurses which will be able to easily search for specific information. The design also matches the one used in Bordet website in order to create minimal disturbances for the patients that have already been presented with the trial’s design. ### AUTOMATED SERVICES The trial nurse will have the ability to create an automated schedule of notifications for each patient based on his/her treatment start date. This option will highly ease the trial nurse work and is flexible in the sense that it will be possible to deviate from the schedule if necessary. Push notifications are being developed and will be sent directly to the patients’ mobile phone and a deadline will be provided. The trial nurse will have access to a dashboard with filters to identify the patients that have passed the deadline and can then personally contact patients (NB: No contact with the patient is allowed on the platform, to ensure anonymity. The nurse needs to contact the patient personally based on ePROMs overview) to understand the motives of these delays. This service will participate in obtaining a high compliance rate to the trial protocol. ### PROGRESSIVE WEB APPLICATION A progressive web application (PWA) is a website that looks and behaves in the same way as a mobile application, which means that it can be added to the main screen of the smartphone, send push notifications, access the hardware of the device, and work offline. This type of infrastructure has several advantages: - Ability to send push notifications: This hardware feature enables us to send real-time reminders to complete tasks on the application directly on the patient’s phone. - No install needed: Instead of having to go on their app store, patients that want to use the PWA only have to click on the provided URL (or scan the provided QR Code) and store it on their phone. The PWA then gets its own icon on phones and tablets, just like a mobile application. - Improved performances: Progressive Web Apps work significantly faster due to the way the underlying technology caches and serves text, stylesheets, images and other content on the websites. As a result, conversation, user experience and retention rates benefit from the improved performance compared to standard web. - Coherence of design and navigation: Creating a PWA enables to keep consistency in the design and navigation of the app/website between all supported devices. ### SECURITY & CERTIFICATIONS Our database is hosted by Firebase of which all services have successfully completed the ISO 27001 and SOC 1, SOC 2, and SOC 3 evaluation process, and some have also completed the ISO 27017 and ISO 27018 certification process. As a backup, PDFs of each filled ePROMs can be stored on Cloud Storage, which is a powerful, simple, secure and cost-effective object storage. Additionally, we can set up a backup database in Maastricht where PDFs of each filled ePROMs will automatically be stored. Firebase is also GDPR ready and we have taken all the necessary measures to protect patients’ personal data. Aditionnaly, we will only store patient IDs, making it impossible to track the users. ### GAMIFICATION In order to keep the patients engaged throughout the trial, we have developed a simple gamification system that unlocks motivational quotes for the patient after completion of his/her tasks. This is optional and can easily be switched off if necessary. ### FUTURE DEVELOPMENTS & COLLABORATIONS The platform is highly customizable to specific trials’ needs and add-ons are currently being developed such as the integration of a Patient Heath Record that has the ability to connect clinical and lifestyle data (e.g. physical activity, sleep). We are also working on the integration of trial Patient Decision Aids being developed by Health Innovation Ventures. The aim is to screen potential trial participants based on acceptance criteria and to further inform about the pros and cons of the trial compared to “usual care”.