Our research paper titled “HIV Patients’ Tracer for Clinical Assistance and Research during the COVID-19 Epidemic: A Paradigm for Chronic Conditions” has been published in the Special Issue Reprint titled “Advances in AI for Health and Medical Applications“.

This publication shares insights derived from the INTERFACE study; a collaborative effort conducted by Healthentia that provided support to HIV patients during the 1^st wave of the Covid-19 pandemic.

The INTERFACE study focused on leveraging e-health and remote monitoring to enhance care for people living with HIV/AIDS (PLWHA), especially during the SARS-CoV-2 pandemic period. Using Healthentia, a mobile application with decision-making algorithms, the study collected data on symptoms, treatment adherence, and quality of life, processed through an innovative e-Clinical platform. Machine learning algorithms aimed to create a digital composite biomarker for HIV-related alerts. With over 1500 stable HIV patients in a university hospital, the study aimed to improve patient care beyond the pandemic, showing promising results in monthly data for learning predictive models.

INTERFACE, an interventional research initiative, collected real-world data (RWD) on patient outcomes. Voluntarily enrolled patients provide informed consent through the app or eConsent process. Operating within Gemelli Generator Real-World Data (G2 RWD), the study integrated Healthentia data into a tailored e-Clinical environment provided by Innovation Sprint. Healthentia combined traditional electronic patient-reported outcomes with lifestyle, behavioral, and health-related data, employing AI and machine learning to predict outcomes and generate prevention alarms, supporting clinical decision-making during trials.

This comprehensive approach proved crucial for managing HIV patients during the COVID-19 pandemic, addressing physical and mental health challenges. The e-health system identified health issues, tailored interventions, and served as a pre-screening tool for chronic patients during the epidemic. Preliminary evidence indicated effective prediction of alerts, with ongoing data collection and integration enhancing accuracy. Future development involves SHAP analysis, assessing the machine learning system’s impact on health indicators, and evaluating its application in advanced chronicity management. The study aimed to provide tailored and effective care for individuals living with HIV, especially in challenging times like the COVID-19 pandemic.

Explore the INTERFACE study for detailed insights into how Healthentia offered assistance to individuals with HIV during the Covid-19 pandemic.

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CATEGORY: Advances in AI for Health and Medical Applications

SOURCE: MDPI Open Access Journals, Information, February 2022, 13(2), 76; https://doi.org/10.3390/info13020076

HIV Patients’ Tracer for Clinical Assistance and Research during the COVID-19 Epidemic (INTERFACE): A Paradigm for Chronic Conditions

More Publications

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CATEGORY: Databases, Human behaviour
SOURCE: Scientific Data, 2022, December; DOI Link, Research Article DOI Link

COVID-BEHAVE dataset: measuring human behaviour during the COVID-19 pandemic

Kostas Konsolakis, Oresti Banos, Miriam Cabrita & Hermie Hermens

Abstract

Aiming to illuminate the effects of enforced confinements on people’s lives, this paper presents a novel dataset that measures human behaviour holistically and longitudinally during the COVID-19 outbreak. In particular, we conducted a study during the first wave of the lockdown, where 21 healthy subjects from the Netherlands and Greece participated, collecting multimodal raw and processed data from smartphone sensors, activity trackers, and users’ responses to digital questionnaires. The study lasted more than two months, although the duration of the data collection varies per participant. The data are publicly available and can be used to model human behaviour in a broad sense as the dataset explores physical, social, emotional, and cognitive domains. The dataset offers an exemplary perspective on a given group of people that could be considered to build new models for investigating behaviour changes as a consequence of the lockdown. Importantly, to our knowledge, this is the first dataset combining passive sensing, experience sampling, and virtual assistants to study human behaviour dynamics in a prolonged lockdown situation.

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We are excited that Innovation Sprint is short-listed for the Innovation Radar Award on Disruptive Health, together with 9 other companies.

Since 2015 the European Commission has been awarding the annual Innovation Radar Prize to great EU-funded innovators, putting a spotlight on the high-potential innovations they are trying to get "out of the lab and into the market". Intelligence gathered by the Innovation Radar is used to identify innovators who can then compete for the prize. 

The top innovation finalists are grouped into 3 categories of 10 each, out of a tremendous number of applications for the 2022 Innovation Radar Prize. The 3 categories are: 

• Disruptive Health 
• Purpose-driven & Green 
• Kickstarter 

The Innovation Radar Prize 2022 includes voting from the public, which will assist the jury in their search for the best innovation of 2022.   

Innovation Sprint is one of the 10 candidates for the Innovation Prize of Disruptive Health and we are looking forward to receiving your vote here. 

Why have we been selected as finalists?  

Sofoklis Kyriazakos, CEO of Innovation Sprint, explains the reasons that brought Innovation Sprint to the final of the Innovation Radar Prize 2022.

Innovation is part of our company name, but foremost it is part of our DNA. Our purpose to improve health outcomes and outperform existing therapeutic care-paths using innovative technologies, has been an exciting and long journey from the day we started until where we are now commercializing our novel MedTech product in this highly regulated and challenging domain. Our product Healthentia, is a certified Software as Medical Device that uses best of breed of Internet, IoT, AI, and Big Data technologies together with clinical and regulatory knowledge to support healthcare professionals to monitor their patients, through digital clinical pathways addressing chronic conditions. Healthentia has been used so far in patient cohorts with cancer, heart failure, COPD, Covid-19, HIV, and other conditions. The clinical evidence that has been captured so far demonstrates increased adherence to treatment and Quality of Life, while we are currently running clinical studies, in which we monitor endpoints like mortality and rehospitalization. In Belgium, we are already at level 2 of the mHealthBELGIUM pyramid link, which paves the way towards reimbursement. We have market authorization for Europe and we have finalized the PreSub evaluation from FDA for 510(k) clearance.  This journey was strongly influenced by our research activities, many of them performed under EC R&D projects, which contributed to the inclusion of key innovations in Healthentia and bringing the product to another level; a level that is backed up by science. We are committed to continuously improving Healthentia to disrupt health, by outperforming traditional treatments, thus contributing to Good Health and Wellbeing, one of the key sustainability goals of the UN. In this trajectory, we will continue to improve Healthentia in a way to address demanding market needs, regulatory challenges, while implementing our purpose to use innovative technologies to improve health outcomes and outperform existing therapeutic care paths. 

 

What are the key innovations so far? 

Aristodemos Pnevmatikakis, R&D Director of Innovation Sprint, explains Healthentia smart services and the role of EU co-funded projects in implementing them. 

Healthentia is a secure big data platform for patient data, providing two applications to its two categories of end-users: a) Patients use the mobile app to facilitate the collection of their data and delivery of info and feedback, and b) healthcare professionals use the portal app to setup studies or programs to monitor their patients both as a cohort, or as individuals. Both applications are empowered by smart services: On the one hand, clinicians can handle patients in clusters and get insights from inference on models learnt on patients’ data. On the other hand, patients benefit from feedback on important attributes in their data, as these attributes are highlighted by explainable AI techniques. 

EU co-funded projects have been playing a dual role in Healthentia. Looking back at our origins, the company started as the exploitation output of the eWALL project. Many more recent and ongoing projects have been instrumental in the implementation of our smart services. They allow us to run studies across Europe, increasing our volume and diversity of subjects, thus reducing the bias in the models we can learn from the collected data. They also facilitate early testing of our models in prototypes of our smart services. Last but not least, they facilitate our scientific output, by providing us with collaboration opportunities and funding for publications.

At Innovation Sprint we commit to providing patients and professionals with continuously improved smart services, aiming at helping the former improve the life of the latter. 

 

How do we combine innovation with needs? 

Konstantina Kostopoulou, Chief Product Officer of Innovation Sprint, explains how Healthentia has evolved into the solution it is today by combining innovation with the different stakeholder’s needs from the market.

Healthentia has been developed through participatory design and evaluation from stakeholders. Both the application for the patients and the portal for the clinicians are co-designed with patient focus groups and workshops with clinicians. In this product development journey, we have done user studies and interviewed patient focus groups after asking them to accomplish a set of tasks on the mobile app. They have evaluated the easiness and experience of using Healthentia. For similar tasks their valuable feedback is collected for feature optimizations. Regarding the clinician portal, regular sessions are taking place to collect feedback from clinicians to address their needs and optimize the assessment of a patients’ health state. We work together with clinicians from customizing their dashboards or enhance their patient record with selected clinical date from a hospital’s EMR. The Healthcare market include a great range of Stakeholders including but not limiting to, patients, caregivers, doctors, nurses, patient organizations, government, insurance companies, communities and pharmaceutical firms. Our collaborations within this market influence our product roadmap to meet the needs and expectations in this changing environment of digital Health.

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Study Details

• Type: Interventional
• Disease: HIV/AIDS (PLWHA)
• Primary Site: Fondazione Policlinico Gemelli
• Start: 10th January 2021
• Population: 1500 patients
• Duration: 24 months

Study Description

Interface is a pilot study for People living with HIV/AIDS (PLWHA) with stable chronic disease, designed by the Department of Infectious Diseases at the Fondazione Policlinico Gemelli. Gemelli has partnered with Innovation Sprint to use Healthentia as the Clinical platform to offer clinical assistance through an efficient operating model to “follow” the patient, capture the evolution of his/her disease, provide assistance and care, interact also to establish proximity and relief through a remote collaborative model.

At the same time, a standardized approach to translate the huge amount of data collected on the day-to-day experience, integrated with historical health data, into useful insight and medical practices based on experience and lessons learned has been built up. People living with HIV/AIDS (PLWHA) represent a typology of patients for whom telemedicine could, particularly in pandemic times, represent an extremely useful tool of support and clinical management, quickly identifying potential sources for spreading of SarS-CoV2 diffusion and transmission among potentially high-risk population such as PLWHA.

Study Design & Method

People living with HIV today are people who have a life expectancy very similar to that of the general population, due to the extraordinary effect that antiretroviral therapies have produced on survival and on the reduction of HIV-related morbidity. Nowadays PLWHA patients face a chronic condition with all the consequences that this situation entails (symptoms, side effects of the drugs, management of adherence and quality of life, periodic supply of drugs, blood samples to check the tolerability of the drugs, any new clinical events that may occur, need advice from other specialists, etc.). With the persisting of pandemic restrictions, it is essential to find ways of managing these patients remotely to allow continuity of care that will inevitably not reflect what happened in pre-epidemic periods.

Capture the evolution of the disease and establish proximity and relief through a remote collaborative model

The daily patient experience, integrated with the historical patient health data, is translated into useful insights and experience for medical practices

Testimonial

"It will be a sort of 'virtual clinic', which will allow us to demedicalize the life of the chronic patient with HIV as much as possible, maintaining close contact even when face-to-face visits are impossible, with an 'on demand' web meetings in case of the appearance of physical symptoms or psychological problems, which in this phase of the pandemic can have a significant impact on the quality of life of people with HIV.", Dr. Antonella Cingolani, Department of Infectious Diseases of the Gemelli Polyclinic

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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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Study Details

• Type: Interventional
• Disease: Covid19 Surveillance on Hospital personnel
• Primary Site: Fondazione Policlinico Gemelli
• Start: January 2021
• Population: Personnel
• Duration: Ongoing

Study Description

VACCINE APP is a study to record and monitor the personnel of the Agostino Gemelli IRCCS University Hospital Foundation after the administration of the first dose of vaccine. After downloading the application on the smartphone and registering, the user is asked to report any side effects that occurred on the day of vaccination and the next seven days, through a questionnaire. Healthentia collects real-world data (RWD) from each user and any reactions experienced on the day of vaccination and in the following days, through an agile questionnaire.

Study Design & Method

The application will be used by the personnel of the Agostino Gemelli IRCCS University Hospital Foundation to monitor their health status after the first dose of the COVID-19 vaccine. There is a composite questionnaire in the Healthentia application with a series of tags and alerts, which will be activated in case of any vaccine reaction.

Monitoring possible adverse events, through a series of real self-reported data

Hospital personnel surveillance for post-vaccination symptoms of COVID-19

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Study Details

• Type: Interventional
• Disease: Covid 19 Surveillance of positive tests
• Primary Site: Fondazione Policlinico Gemelli
• Start: February 2021
• Population: Outpatient pulmonary adults with documented positive SARS-CoV-2 test
• Duration: Ongoing

Study Description

MONET study is a Phase 3, open-label, individually randomized study in patients with documented positive SARS-CoV-2 test and mild symptoms of COVID-19, not hospitalized and recruited in Italy. This study will assess the efficacy of multiple MoAbs cocktails compared to SoC for Treatment of COVID-19 in Outpatient Adults. The study will be conducted in 42 clinical centers across Italy.

Study Design & Method

The procedure to be followed is the randomized administration of 2 different MoAbs cocktails, all intravenously over one-hour infusion. Then there will be control and monitoring of the differences that will occur in the participants of the study. The adaptive design of the study is aimed to meet the most topical needs of translational medical research programs implemented during a massive epidemic emergency due to newly emergent pathogens, such as SARS-CoV-2.

All participants will use the Healthentia app to answer simple and composite questionnaires about their health status. Each organisation will monitor any symptoms that any user/participant may appear.

42 Centers involved in the study and is planned to be executed on 750 to 2350 subjects

Estimation of the efficacy of any MoAbs in the prevention of the composite endpoint of either severe COVID-19 or hospitalization or access in an emergency department or death

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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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@Sofoklis Kyriazakos (CEO): The obvious benefit of #workingfromhome is #businessContinuity. People think that tech businesses are privileged; indeed they are, but the company should be able to ensure security for teleworking, especially when dealing with access to servers, source code, etc.

@Aristodemos Pnevmatikakis (R&D Director): #workingfromhome in IT is perfect for managing situations like #Covid_19. But is it good in normal situations? Yes, it is easier, cheaper, and environmentally friendlier, but face-to-face leads to better #teamwork in almost all cases. So we should adapt it with caution.

@Konstantina Kostopoulou (CPO): Well I do like to see your face across from mine so I will argue that a mixed model suits me best. I have missed the interactions between the whole team though and designing UX features for #healthentia through #slack can be daunting

@Alfredo Cesario (CSO-Medical): As an MD I can not say the obvious, that #workingathome can pose serious challenges to the delivery of care to citizens. However, #Healthentia is proving super-useful as a tool to implement safe healthcare operations, by smartly monitoring patients and operators.

@George Matikas (Software Engineer): From a Software Engineer’s point of view #workingathome doesn’t change much on your daily working routine; all you need is a laptop and your brain. The biggest challenge is keeping contact with your team since brainstorming during a meeting is how ideas come in life

@Akis Idrizi (Software Engineer): Adapting to #workingfromhome was a very easy transition and most of the time created a focus mindset for the daily challenges. Although, it has a social drawback for teams; where sharing thoughts and ideas are limited to scheduled calls.

Would you like to share your view on this topic? Follow Innovation Sprint’s page on Twitter and continue the thread with your opinion.

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