Periodic Reporting for period 2 - RE-SAMPLE (RE-SAMPLE)
Reporting period: 2022-09-01 to 2024-02-29
Patients with Chronic Obstructive Pulmonary Disease (COPD) often also have other Complex Chronic Conditions (CCCs), like diabetes, depression or chronic heart failure. As these conditions have common risk factors and overlapping symptoms, this easily leads to delay of appropriate treatment. Flare ups (called ‘exacerbations’) of COPD and CCCs are detrimental to patient, health and social outcomes. Therefore it is important that patients receive timely care, which can prevent worsening of their disease(s), and that fits their personal needs and characteristics.
RE-SAMPLE will answer upon the challenge of the increasing number of patients with COPD and CCCs who are in need of such integrated, personalised, and holistic approach to manage care. We do this by monitoring disease progression and other parameters in daily life (called real-world data; RWD) and combine these with other relevant information like clinical data from the hospital, research data and data from the environment. With this data, we use artificial intelligence to predict upcoming CCC exacerbations and to coach patients in their self-management in an adaptive and tailored manner. These are integrated in an eHealth programme called the Virtual Companionship Programme. This programme is offered to patients (i.e. virtual companion) and healthcare providers (i.e. active support programme) and supported by shared-care facilities for additional monitoring. These together serve shared-decision making and cross care paths towards daily life. RE-SAMPLE’s architecture strictly follows privacy and security-by-design principles and uses highly-innovative techniques (i.e. secure multiparty computation). The integrated disease management fits values and needs by continuous involvement of stakeholders, and our Pan-European service model will ensure deployment in different systems throughout Europe.
RE-SAMPLE will answer upon the challenge of the increasing number of patients with COPD and CCCs who are in need of such integrated, personalised, and holistic approach to manage care. We do this by monitoring disease progression and other parameters in daily life (called real-world data; RWD) and combine these with other relevant information like clinical data from the hospital, research data and data from the environment. With this data, we use artificial intelligence to predict upcoming CCC exacerbations and to coach patients in their self-management in an adaptive and tailored manner. These are integrated in an eHealth programme called the Virtual Companionship Programme. This programme is offered to patients (i.e. virtual companion) and healthcare providers (i.e. active support programme) and supported by shared-care facilities for additional monitoring. These together serve shared-decision making and cross care paths towards daily life. RE-SAMPLE’s architecture strictly follows privacy and security-by-design principles and uses highly-innovative techniques (i.e. secure multiparty computation). The integrated disease management fits values and needs by continuous involvement of stakeholders, and our Pan-European service model will ensure deployment in different systems throughout Europe.
In the first 18 months of the project, we focused on building a strong foundation for the RE-SAMPLE platform and services in terms of a collective knowledge base and active end-user involvement, leading to definition of our functional specifications, platform architecture, release of our first functional prototype and the start of an observational cohort study for RWD gathering.
In months 19-36, we focused on implementing the RE-SAMPLE features and models, defining our privacy and security measures and building our final prototype. Furthermore, we focused on defining the contents of our Virtual Companionship programme (VCP) by defining the intervention and coaching strategies, as well as on the integration of the VCP as part of daily care and daily life by defining the integrated care protocols. Next, we started with the dissemination of project results to our stakeholders, by numerous scientific publications, workshops and social media activities. Lastly, we shaped our business strategy using market analysis and are advancing our exploitation strategy.
More specifically, we have accomplished the following main achievements in the second reporting period:
Clinical perspective: Knowledge-base, specifications and treatment guidelines
Knowledge and parameters that could be important for predicting exacerbations of COPD or comorbid CCCs are currently unknown or distributed among different (heterogenous and multimodal) data sources and representations. We provided an update of the possible predictors identified by literature research for AECOPD and published a review which focused on the identification of diagnostic tools to differentiate acute heart failure from AECOPD in acutely dyspnoeic patients with COPD. Furthermore, we defined the intervention and coaching strategies for the VCP. These include suggestions provided of pharmacological and non-pharmacological RE-SAMPLE self-management interventions for different patient profiles; development of a coaching framework to guide tailored coaching; and the outline for the shared decision making (SDM) strategy. We have created and published the pan-European service model for the three different pilot sites.
Technical perspective: Model platform, personalised prediction and VCP development
Taking into account the sensitive type of (health) data to be handled, the RE-SAMPLE platform needs to have a secure and privacy-securing data management in all its components and communications. We have completed the distributed privacy-preserving platform prototype to train ML models on the distributed data in the pilot sites and their use on current patients to predict the exacerbation risks including explanations and simulations. Moreover, the platform has been deployed in production in the secured premises of the three pilot hospital sites. Several machine learning algorithms are trained and the best models are selected for predictions. With regard to the VCP, the prototypes have been developed. These are the virtual companion, a patient companion app that is offering personalised and timely advice; the clinical dashboard where the healthcare professionals can check progress and can follow-up on the advice provided; and shared care facilities.
Evaluation and integration in daily care: Stakeholder perspective, evaluation and integration
In RE-SAMPLE we followed an human-centred approach where stakeholders are engaged throughout the project. A total of 5 iterations with end-users were conducted in this reporting period for the development and evaluation of the VCP. We also changed the set-up of our end-user panel, which is now inclusive for people with COPD, healthcare professionals, caregivers and other stakeholders interested in RE-SAMPLE. We continued sharing summaries of results of the end-user studies.
Current CCC disease management relies heavily on information acquired during scheduled visits when patients are usually stable, whereas actual symptoms and changes during daily life are not quantified. Therefore, in the early phase of the project we started our observational cohort study. A second iteration of the RWD collection was performed in the 2nd Reporting Period. In parallel, we created a common basis and a strategy for the introduction of the VCP in the clinical practice in the Integrated Care Protocol. Finally, we have developed the VCP evaluation study set up.
In months 19-36, we focused on implementing the RE-SAMPLE features and models, defining our privacy and security measures and building our final prototype. Furthermore, we focused on defining the contents of our Virtual Companionship programme (VCP) by defining the intervention and coaching strategies, as well as on the integration of the VCP as part of daily care and daily life by defining the integrated care protocols. Next, we started with the dissemination of project results to our stakeholders, by numerous scientific publications, workshops and social media activities. Lastly, we shaped our business strategy using market analysis and are advancing our exploitation strategy.
More specifically, we have accomplished the following main achievements in the second reporting period:
Clinical perspective: Knowledge-base, specifications and treatment guidelines
Knowledge and parameters that could be important for predicting exacerbations of COPD or comorbid CCCs are currently unknown or distributed among different (heterogenous and multimodal) data sources and representations. We provided an update of the possible predictors identified by literature research for AECOPD and published a review which focused on the identification of diagnostic tools to differentiate acute heart failure from AECOPD in acutely dyspnoeic patients with COPD. Furthermore, we defined the intervention and coaching strategies for the VCP. These include suggestions provided of pharmacological and non-pharmacological RE-SAMPLE self-management interventions for different patient profiles; development of a coaching framework to guide tailored coaching; and the outline for the shared decision making (SDM) strategy. We have created and published the pan-European service model for the three different pilot sites.
Technical perspective: Model platform, personalised prediction and VCP development
Taking into account the sensitive type of (health) data to be handled, the RE-SAMPLE platform needs to have a secure and privacy-securing data management in all its components and communications. We have completed the distributed privacy-preserving platform prototype to train ML models on the distributed data in the pilot sites and their use on current patients to predict the exacerbation risks including explanations and simulations. Moreover, the platform has been deployed in production in the secured premises of the three pilot hospital sites. Several machine learning algorithms are trained and the best models are selected for predictions. With regard to the VCP, the prototypes have been developed. These are the virtual companion, a patient companion app that is offering personalised and timely advice; the clinical dashboard where the healthcare professionals can check progress and can follow-up on the advice provided; and shared care facilities.
Evaluation and integration in daily care: Stakeholder perspective, evaluation and integration
In RE-SAMPLE we followed an human-centred approach where stakeholders are engaged throughout the project. A total of 5 iterations with end-users were conducted in this reporting period for the development and evaluation of the VCP. We also changed the set-up of our end-user panel, which is now inclusive for people with COPD, healthcare professionals, caregivers and other stakeholders interested in RE-SAMPLE. We continued sharing summaries of results of the end-user studies.
Current CCC disease management relies heavily on information acquired during scheduled visits when patients are usually stable, whereas actual symptoms and changes during daily life are not quantified. Therefore, in the early phase of the project we started our observational cohort study. A second iteration of the RWD collection was performed in the 2nd Reporting Period. In parallel, we created a common basis and a strategy for the introduction of the VCP in the clinical practice in the Integrated Care Protocol. Finally, we have developed the VCP evaluation study set up.
With RE-SAMPLE we aim to progress beyond the state of the art by delivering 1) new, unique insights in the course and interrelationships between (bio)markers, lifestyle characteristics, and clinical and well-being parameters, creating holistic models for the onset and progression of CCC exacerbations; 2) a breakthrough in knowledge in timely detecting exacerbations to start preventive treatment effectively; 3) a definition of clinical endpoints to identify and monitor individual patients with CCCs that can be used in a personalised eHealth application in daily care; 4) a highly-innovative secure and trustworthy handing of data and machine learning methodology using multiparty computation.
RE-SAMPLE will disrupt guidelines on how to tailor and implement adaptive predictive CCC care in which individuals benefit optimally by tailored CCC disease management. RE-SAMPLE significantly impacts towards this direction not only through the development of the platform and companionship programme, but also through its uptake in the privacy-sensitive domain of healthcare, by healthcare organizations throughout Europe, to alleviate the overall societal and economic burden of CCCs.
RE-SAMPLE will disrupt guidelines on how to tailor and implement adaptive predictive CCC care in which individuals benefit optimally by tailored CCC disease management. RE-SAMPLE significantly impacts towards this direction not only through the development of the platform and companionship programme, but also through its uptake in the privacy-sensitive domain of healthcare, by healthcare organizations throughout Europe, to alleviate the overall societal and economic burden of CCCs.