Study Details

• Type: Interventional
• Disease: Covid19 Surveillance of Oncology patients and Hospital personnel
• Primary Site: Fondazione Policlinico Gemelli
• Start: March 2020
• Population: Incoming patients and personnel
• Duration: Ongoing

Study Description

TRACER RT is an interventional study introducing a new operational model for the monitoring and early diagnosis of COVID-19 infection in healthcare professionals and patients during multimodal therapies and the follow-up period through the use of Healthentia as a dedicated App and wearable technologies. The primary aim is to introduce Oncology patients with the use of portable monitoring systems such as Patient Reported Experience Measures (PREMs) and Patient-Reported Outcome Measures (PROMs) by means of a dedicated app and even a tracking device as Electronic Health Record data harvesting devices, during their multimodal therapies and follow-up period.

Study Design & Method

The application will be used by patients during radiotherapy (RT) or in the first phase of follow-up and healthcare workers of the RT division, with the aim of monitoring the earlier symptoms of SARS-COV-2 infection. After the SARS-COV-2 emergency, the app will be used to monitor patients during and after radiotherapy with a special focus on supportive care and oncological rehabilitation.
Daily, weekly and monthly questionnaires are collecting data to be assessed by Healthentia and alert low or high risk of a Covid-19 infection.

Reduce risk of Infection in the Radiotherapy Department

Oncology patients and Hospital personnel surveillance for COVID-19 Symptom appearance

Testimonial

“Monitoring patients during multimodal therapies or during special situations such as SARS-COV-2 infection may represent a significant step towards a comprehensive and reliable therapy approach, quality of life assessment, prevention of complications before its clinical onset, and clinical outcomes prediction.”
Dr. Luca Tagliaferri, Department of Radiotherapy and Oncology

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The COVID-X Programme aims to accelerate companies with Medical Devices that have a track record with Covid-X applications and support them to introduce solutions of strong impact to the market.

Since March 2020, Innovation Sprint helps Hospitals and other Healthcare Organizations to improve their Covid-19 resilience and response by managing Covid-19 related symptoms of patients and health workers from remote and providing targeted support and care guidelines to them.

The Care4Covid solution is a remote care and remote support solution, yet it directly boosts the business continuity and operational efficiency of healthcare organizations as well. The solution was initially developed in March 2020, following the pandemic outbreak. It was developed as pivot of the Healthentia eClinical platform, which already provided symptom-tracking functionalities and used by Top5 Pharma for clinical studies. Innovation Sprint adapted its Healthentia Symptom tracker towards tracking Covid-19 symptoms and managing patients-provided Covid-19 information.

During the past months, the solution has evolved to provide remote management and support for healthcare workers, in terms of their Covid-19 related status and symptoms. As of today, Healthentia is used in several Covid-19 related clinical studies and recently it has launched its Vax version to support tracking of the vaccination programme.

Therefore, the problems that are solved by the use of Healthentia are related to:

• Preventive actions by clustering patients & healthy individuals into risk categories
• Remote monitoring and supporting of patients
• Execute workflows and clinical pathways to Covid-19 positive cases
• Business Continuity in large organizations
• Follow-up of vaccination programme

Care4Covid is leveraging the existing infrastructure of Healthentia for reporting, tracking, and analysing the symptoms of the patients, Innovation Sprint has developed a data-driven infrastructure that provides targeted care recommendations to healthcare workers and Covid-19 patients using the Healthentia Covid-19 app.

The novelty of the solution, therefore, lies in the Covid-19 profiling of different patients’ phenotypes and the provision of personalized care support and recommendations to them. Through the participation of Innovation Sprint in the COVID-X Programme, it will be feasible to extend the functionalities of the solution through the COVID-X sandbox and the accumulated knowledge of the clinical partners available, thus creating a new version of the solution, namely Healthentia Care4Covid.

*Healthentia application is a certified Class I Medical Device.

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Lifesciences and Healthcare are considered to be slow-moving industries in terms of their digital transformation; however, this has been changing rapidly in the aftermath of the Covid-19 outbreak. In Innovation Sprint we believe that the surrounding environment of these industries pinning to strict regulatory requirements, should not influence the level of technology adoption. Given our tech-DNA, we opt for edge technologies and practices. These cover the best of the breed of architectural approaches, hosting environments, mobile apps, IoT devices, security infrastructures, continuous integration processes, AI and ML mechanics, and all other pieces of the puzzle for a state-of-the-art solution.

Let’s make a dive into the technologies we use in Healthentia and let’s see how we achieve high performance and compliance. Below, you can find an overall description of the system architecture, as well as a presentation of the infrastructure that maintains and facilitates Healthentia System performance.

System Architecture

Healthentia SaaS is a three-tiered application. The datastore tier contains one hosted Azure SQL database for structures study data and an Azure Blob storage for media and any other files. The application tier contains our services, the Web API, and the Web Platform. Finally, the client tier contains the Web Platform client (out portal app targeting the healthcare professionals) and the Mobile client (our Android and iOS app targeting the patients or study participants).
Additionally, a rest API developed in Python Django framework is responsible for Machine Learning Operations and communicates with Healthentia Platform, using Healthentia Web API exposed endpoints.

Hosting environment

Our Infrastructure is hosted on Microsoft Azure, in Western Europe and is based on a Kubernetes cluster on Azure Kubernetes service, which has the following benefits:

• Accelerates containerised application development
• Increases operational efficiency
• Builds on an enterprise-grade, more secure foundation
• Runs any workload in the cloud, at the edge, or as a hybrid

Kubernetes provides a way to schedule and deploy containers, scale them to the desired state and manage their lifecycles. In this way, Healthentia is a container-based application, thus portable, scalable and extensible. More information on Kubernetes: https://azure.microsoft.com/en-in/services/kubernetes-service/

Mobile apps

Our mobile app is built using React Native, a framework for building native apps for Android and iOS using React. It offers a unique user experience in the Bring Your Own Device approach we follow. The user interface is an outcome of co-development with patients, which is a process that is renewed for several therapeutic areas.

IoT devices

Healthentia supports a large number of IoT devices, through API or SDK integration. Prominent among them are all Fitbit and Garmin devices. Furthermore, it supports iOS Health Kit integration, which extends the spectrum of devices that can be used. Further to the above, Healthentia can capture activity information directly from the smartphones’ sensors, utilizing their hardware sensors (like the accelerometer and barometer) as well as their software ones (like the step sensor). This direct access to raw sensor data facilitates composite activity measurements, like the frailty test and the 6-minute walk test.

Security & Privacy

The high information security performance of the Healthentia is aspired to stand as one of its competitive advantages. Our Information Security Policy aims to:

• Εnsure the confidentiality, availability and integrity of the information it processes
• Protect the data subjects’ rights within the scope of its business operations
• Comply with the applicable legislative and regulatory requirements

Security is ensured at 3 levels: 1) infrastructure, 2) processes, 3) continuous security posture assessment and update.

CI-CD Infrastructure

Azure Build Pipelines are responsible to build our code from source control and create artefacts to be used from the release pipelines and the deployments. Build Pipelines exist in Azure DevOps to be triggered automatically by committing the branch they are linked to, or manually from Azure DevOps.
The release pipelines are responsible for publishing apps to the production and test environments. These pipelines deploy the newest application images (Web and API) from the docker repository to the Kubernetes cluster.

AI mechanics

The AI module of Healthentia offers three services: biomarker discovery, patient phenotyping and in-silico trials. The biomarker discovery and patient phenotyping services are carried out off-line and their results are available on-line: The discovered biomarkers are used in risk assessment, virtual coaching and DTx. The estimated phenotypes are used in the in-silico trials to modify the behaviors of the simulated patients based on data models.

For more information, you can contact us at info@innovationsprint.eu.

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