CATEGORY: Digital Health

SOURCE: European Heart Journal – Digital Health, April 2025, https://doi.org/10.1093/ehjdh/ztaf040

Study design and rationale of the AZIMUTH trial: a smartphone, app-based, E-health-integrated model of care for heart failure patients

Domenico D’Amario¹, Attilio Restivo^2,3, Renzo Laborante^2,3, Donato Antonio Paglianiti^2,3, Alfredo Cesario^2,3,4,5, Stefano Patarnello², Sofoklis Kyriazakos⁶, Alice Luraschi², Konstantina Kostopoulou⁶, Antonio Iaconelli^2,3, Enrico Incaminato¹, Gaetano Rizzo¹, Marco Gorini⁷, Stefania Marcoli⁷, Vincenzo Bartoli⁷, Thomas Griffiths⁸, Peter Fenici^3,7,9, Simona Giubilato¹⁰, Maurizio Volterrani¹¹, Giuseppe Patti¹, Vincenzo Valentini^2,3, Giovanni Scambia^2,3, Filippo Crea^3,12

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Managing chronic obstructive pulmonary disease (COPD) alongside other chronic conditions (CCs) like depression requires a comprehensive and innovative approach. As part of the RE-SAMPLE research project, Healthentia, our advanced SaMD solution, addresses this challenge by integrating real-world data (RWD) to enhance disease management and improve daily life for patients. For more information about the intended use of the device and the medical modules, please consult: https://healthentia.com/medical-device/

This research-driven initiative bridges the gap between clinical research and real-world healthcare, supporting two phases of COPD and CCs management:

• Phase 1: Healthentia collects RWD to track disease progression, uncover patterns, and predict exacerbations. These insights enable proactive care, empowering healthcare providers to anticipate and address patient needs more effectively.
• Phase 2: Through its Virtual Companionship Program (VCP), the platform delivers tailored self-management tools, including lifestyle coaching, goal-setting, and real-time medical suggestions. Patients gain the confidence to manage their health actively, while healthcare providers benefit from actionable insights via a clinical dashboard. This enables personalized, adaptive care strategies, ensuring better outcomes.

Healthentia redefines the standard of COPD care in hospitals across Europe by seamlessly integrating real-world insights with technology-driven solutions. By prioritizing both patients and providers, it transforms the approach to managing not only COPD but also co-existing chronic conditions, helping patients regain control over their health and well-being.

This World COPD Day, Healthentia reaffirms its commitment to innovation, providing hope and support for millions living with COPD.

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World Diabetes Day is an essential reminder of the global impact of diabetes. Especially type 2 diabetes affects millions of lives and continues to grow at an alarming rate. Currently, type 2 diabetes makes up more than 90% of the over 450 million adults worldwide that are living with diabetes. By 2030, this number is expected to reach 578 million. This increase not only strains healthcare systems but places a significant burden on individuals who must learn to live with and manage this chronic condition.

At Innovation Sprint, we believe in empowering patients by providing Healthentia, the patient companion app they need to effectively manage their condition at home. Healthentia is designed for chronic disease management, offering a personalized approach to each patient. By collecting data on daily habits, physical activity, and health metrics, Healthentia offers customized support and advice that aligns with the patient’s health goals and current state. For more information about the intended use of the device and the medical modules, please consult: https://healthentia.com/medical-device/.

For type 2 diabetes patients, effective management is key to preventing serious complications like heart disease and nerve damage. While healthcare professionals are essential, most daily care happens at home, requiring regular monitoring, a balanced diet, physical activity, and adherence to treatments. Many patients find this challenging, especially without personalized guidance.

In our ongoing research study with type 2 diabetes patients, we are taking this a step further. By gathering detailed data, we can provide personalized recommendations that evolve alongside the patient. For instance, if a patient’s activity level drops or they struggle with diet management, Healthentia can recognize these patterns and suggest targeted interventions that encourage gradual improvements. This constant, personalized feedback loop helps patients feel supported and more capable of taking control of their health.

On this World Diabetes Day, let’s acknowledge not only the challenges but also the strides being made in digital health to enhance self-management for millions of people worldwide. With solutions like Healthentia, we’re creating a future where living with diabetes doesn’t have to be so daunting.

“In our new study with Diabetes Mellitus Type 2 patients in the University of Thessaly we are integrating Healthentia, a digital health solution, to evaluate how digital health tools can enhance traditional healthcare. The patients thus far responded positively, embracing the mobile app for their support at home, while the healthcare professionals benefit from the web portal, which provides real-time data monitoring and insight into the tailored advice each patient receives.” 

Tamouridis Stefanos MD, MSc
Clinic of Endocrinology and Metabolic Diseases, General University Hospital of Larissa
University of Thessaly

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Software as a Medical Devices (SaMD) and mobile health (mHealth) applications have revolutionized the healthcare landscape in the areas of Remote Patient Monitoring (RPM) and Digital Therapeutics (DTx). These technological advancements offer a range of benefits, from improved patient engagement and real-time monitoring to personalized treatment plans and enhanced clinical outcomes. During the continuous design, development, and validation of our medical device Healthentia, we have conducted a comprehensive systematic literature review to assess the current status and efficacy of these digital health interventions and benchmark the results with our finding from the clinical evidence we have collected from various studies. The results are rather positive, demonstrating how SaMDs like Healthentia can support the management of chronic diseases, satisfying patient safety and performance requirements.

The current landscape of SaMD and mHealth apps is characterized by rapid innovation and widespread adoption, especially after the Covid pandemic, which might have worked as a catalyst for digital transformation in digital health. SaMD refers to software intended to be used for medical purposes that perform these purposes without being part of a hardware medical device. mHealth applications, on the other hand, encompass a wide range of digital tools designed to support health and wellness through mobile devices. mHealth applications are not necessarily medical devices and therefore, they often don’t comply with the regulatory framework. Both SaMD and mHealth apps have seen significant advancements, driven by the increasing need for accessible, efficient, and patient-centric healthcare solutions. Regulatory frameworks have also evolved to keep pace with these innovations, ensuring that these technologies meet rigorous safety and efficacy standards. While the potential of SaMD and mHealth apps are immense, there are several challenges that need to be addressed to fully realize their benefits, such as data privacy concerns, integration with existing healthcare systems, and user adoption barriers.

The review involved a scientific process of identifying, selecting, and analyzing relevant studies that evaluate the effectiveness of SaMD and mHealth apps in managing chronic diseases, using the PICO (Population, Intervention, Comparison, Outcomes and Study) framework. The selected studies provide a robust evidence base, highlighting the positive impact of these technologies on patient outcomes.

This post aims to provide a comprehensive overview of the current status of SaMD and mHealth apps, highlight promising results, and discuss the potential these technologies hold for improving health outcomes and provides only an overview of a peer reviewed paper that we expect to publish in the coming months.

The safety and performances of such solutions for chronic disease patients is thoroughly discussed in various meta-analyses that have been retrieved and analyzed and include 14 meta-analyses for diabetes Type II, cardiovascular diseases, COPD and cancer. Those meta-analyses allow to identify the main clinical performances that could be expected for Healthentia to define the acceptance criteria for the risks/benefits acceptability. In addition, clinical studies originating from the selected systematic reviews were analyzed to check which features were put in place in the eHealth solutions under evaluation, allowing a comparison with those of Healthentia, resulting in prospective controlled studies on several chronic diseases:

• Diabetes Type II: 24 studies, about 1.200 patients in the intervention group
• COPD: 1 study, 36 patients
• Cancer: 3 studies, about 150 patients
• Heart diseases: 7 studies, 560 patients

Summarizing the results from these studies we provide some data both biomarkers and other clinical endpoints that demonstrate the potential:

• HbA1c level: Decreased in several of the studies.
• Physical activity & performance: Significant improvements in exercise capacity.
• Body fat: Significant improvements.
• Sleep: Significant improvements in sleep time.
• Self-care/management: Self-reported improved the self-monitoring of patients’ blood glucose levels, diet, exercise, other self-management skills, and knowledge of the disease.
• Depression & anxiety: Self-reported improved effect on their psychological status.
• 6MWD: Significant improvement.
• (HR)QoL: Difference between the DQoL–Social/Vocational Concerns subscale scores was statistically significant.
• Hospital readmissions: The 30-day hospital readmission rate was much lower, compared with the national readmission rates.
• Adherence: Significant improved medication adherence.

The list of results above is indicative and is only provided to showcase the potential and is not to be considered as a scientific outcome itself. Scientific results will be presented and analyzed in the Systematic Literature Review paper in the coming months, which will also include evidence and findings from studies that used Healthentia. By sharing our findings and experiences, we hope to contribute to the ongoing dialogue on digital health innovations and their role in transforming chronic disease management. Furthermore, the insights gained from the literature review and our benchmarking analysis may offer valuable guidance for healthcare providers, patients, and policymakers as they navigate the evolving landscape of digital health.

Looking ahead, the future of SaMD and mHealth applications appears promising, with the potential to significantly enhance the quality of care for patients with chronic diseases.

Sofoklis Kyriazakos, CEO

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Among the many transformative solutions emerging in Healthcare, Virtual Wards have garnered considerable attention for their potential to revolutionize patient care. By leveraging digital tools and remote monitoring technologies, virtual wards offer a paradigm shift in how hospitals deliver services and how patients experience healthcare. In this blog post, we will highlight some benefits of virtual wards, exploring their impact on hospitals, patients, and the broader healthcare landscape and give details of our implementation of our recent use cases.

The biggest benefit of these wards are to facilitate continuous monitoring of patients’ health post discharge, reducing readmissions by providing post-discharge support and guidance. Access to care improves, especially for those in remote areas. Cost savings accrue through optimized resource utilization and reduced hospital stays. Patients feel empowered to manage their health with remote tools and education, enhancing their overall experience. Flexibility and convenience are paramount, allowing patients to receive care from home. Moreover, virtual wards support population health management by enabling effective monitoring and intervention based on collected data. Overall, they promise improved outcomes, cost-effectiveness, and patient satisfaction.

Healthentia has been used in two scenarios in Oncology. We will explore here the one from the Gynecology Oncology Unit that offers a direct line between surgeons and patients who will be able to report any symptoms or complications during convalescence.
The continuous observation and assistance to patients, monitoring their health condition outside the hospital, make management and interaction with the clinical team increasingly effective during the post-operative period, help research towards increasingly personalized care models. These are in summary the objectives of the Virtual Ward, a new App dedicated to gynecological patients undergoing surgery at the Gynecology Oncology Unit of the A. Gemelli IRCCS University Hospital, directed by Professor Giovanni Scambia.

The patient who decides to enter the Virtual Ward can download the Healthentia App for free on her mobile phone and thus begin to share numerous information that will help the clinical team to have a complete and updated picture of her health status. The Care Managers present the care path during the interview with the patient admitted to the ward and inform the doctor about the state of health and promptly notify him in case of need and urgency. The process begins at the time of discharge from the hospital and lasts approximately 30 days during which the patient receives a series of questionnaires which aim to evaluate the progress of the patient’s health condition with particular attention to signs and post-operative symptoms, state of the surgical wound and monitoring of any devices, such as catheters or drainage.
The patient also has the possibility of sharing numerous optional data such as vital parameters and multimedia content (photos, videos, screenshots of reports external to the facility), as well as being able to interact with healthcare professionals immediately and continuously.

“Virtual Ward is an integral part of our clinical practice – explains Professor Anna Fagotti , Director of the Ovarian Carcinoma Unit of the Agostino Gemelli IRCCS University Polyclinic Foundation. – This App is useful for patients to share, understand and resolve any health problems that arise while they are at home, accompanying them in the days following discharge from hospital. The home convalescence phase – continues Professor Fagotti – is a difficult emotional moment for patients, there are many uncertainties and many questions about the treatment path. Furthermore, patients may have little knowledge of the disease and difficulty recognizing signs and symptoms of clinical importance.”

The App can be an extremely useful tool, in fact it includes a Virtual Assistant who conveys useful information and advice, for example, relating to the lifestyle to follow in the post-operative period, thus covering an important educational role.
“This tool – concludes Professor Fagotti – is also very useful for us doctors. The data sent by the App allows us to immediately detect the onset of symptoms to correlate with possible complications related to the surgery which otherwise could emerge late. Through the App we can interact with the patient immediately and continuously and intervene in a timely and punctual manner.”

The close collaboration between the healthcare team and the Gemelli Generator – Real World Data Facility, coordinated by Dr. Stefano Patarnello , has made it possible to create a care model capable of integrating and supporting traditional post-operative monitoring means.
The experience of the clinical team made it possible to define an innovative assistance path: the questionnaires were defined to allow the patient an effective and pragmatic interaction; all the information collected allows a holistic view of the state of health; finally, the team of Care Managers dedicated to the development and management of the new care path is the focal point for guaranteeing the provision of the service on a daily basis.
The Gemelli Generator – Real World Data project team, coordinated by Dr. Alice Luraschi , worked together with Innovation Sprint company, manufacturer of the Healthentia medical device, to offer an intuitive service and tool of immediate benefit in clinical practice and in the patient’s daily life .

Source: https://www.policlinicogemelli.it/en/news-events/al-via-virtual-ward-app-per-monitorare-a[…]io-le-pazienti-ginecologiche-post-intervento-chirurgico/

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Managing insulin therapy for type 2 diabetes can be challenging due to the need for frequent dose adjustments. This study examined whether a voice-based AI assistant could help patients achieve better blood sugar control by adjusting their insulin dosages more effectively.

In an RCT presented by Ashwin Nayak et al in JAMA Netw Open. 2023;6(12): e2340232, titled Use of Voice-Based Conversational Artificial Intelligence for Basal Insulin Prescription Management Among Patients With Type 2 Diabetes, is presented the effectiveness of voice-based conversational AI applications in facilitating swift optimization of basal insulin dosage for individuals with type 2 diabetes.

The study involved 32 adults with type 2 diabetes who either used the AI assistant or received standard care. Those who used the AI assistant reached the optimal insulin dose significantly faster (median of 15 days vs. over 56 days for standard care). Additionally, AI users had better insulin adherence (83% vs. 50% for standard care), improved glycemic control, and reduced diabetes-related emotional distress.

These findings suggest that voice-based AI assistants can be a valuable tool for type 2 diabetes patients, helping them achieve better blood sugar control and improve their overall well-being. By providing personalized and adaptive insulin dosing recommendations, voice-based AI assistants can empower patients to take control of their condition and achieve better health outcomes.

The ability to quickly reach the optimal insulin dose, enhance adherence, and reduce emotional distress highlights the transformative impact of this technology in improving the lives of individuals with type 2 diabetes.

As AI continues to advance, its role in healthcare is expected to expand significantly. Voice-based AI assistants like the one used in this study offer a promising approach to medication titration and personalized treatment guidance, holding the potential to revolutionize chronic disease management and improve patient outcomes.

Explore the VirT2D study for detailed insights into how Healthentia provides personalized coaching for individuals with type 2 diabetes, aiming to enhance patient care in diabetes management.

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The “AI state-of-play around clinical research” is a white paper recently published by the AI joint Task Force from the European CRO Federation (EUCROF) and the eClinical Forum (eCF). This is a position paper that provides information about AI and ML in clinical research around the globe, with emphasis in US and Europe.

The use cases presented include: AI to enhance clinical trial operations, feasibility exploration according to inclusion/exclusion criteria for recruitment, patient and site recruitment, applications to improve trial operations, risk-based monitoring and data management, task automation, applications for Real World Evidence (RWE), medical coding, and more.

The paper also presents clinical evaluation challenges for the development and validation of AI and concludes with the positions of the AI Task Force, including the promise for improving treatments and clinical research, the risks, and the challenge for using AI given the current state of evolving regulations.

Sofoklis Kyriazakos, leader of the AI joint Task Force, says “This white paper is an important milestone for the industry that sees the benefits of AI and puts efforts to understand the environment and how to transform the challenges into opportunities. This has been a very nice team work that underlines the importance of joining forces to make a step forward and adopt AI technologies”.

See publication: https://www.eucrof.eu/images/23_11_06_AI_State-of-Play_Around_Clinical_Research_15Sep23__vPR1_Approved_by_eCF_SC_for_Release.pdf

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