This document presents the activities related to the Intellectual Property (IP) Management for the CAPABLE project. The report presents the overall process of management of the IP, describes the general rules for background and foreground taken from the Consortium Agreement (CA) and Grant Agreement (GA), and then presents the foreground assets classified in software, data, and knowledge results. Possible strategies for result valorization are presented together with different routes of commercialization of the results. Finally, the document presents the IP procedures that will be taken to monitor, assess and protect the project's results. ; This deliverable is a part of a project receiving funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No. 875052
The document presents the first version of the exploitation plan and business model of the CAPABLE project. At this stage of the project the Consortium proposed to focus on the exploitation of 3 Key Exploitable Results (KERs), they represent a first analysis of joint commercialization of the following services: Overall CAPABLE system: a mobile health solution to monitor cancer patients during the treatment. Technological stack for Digital Health products, to develop a novel solution in the field of digital health leveraging on the methodological approach and software re-adaptability of the project. Digital therapeutics app for cancer self-management. An adaptation of the overall system to provide an app for cancer patient communities. ; This deliverable is a part of a project receiving funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No. 875052
[EN] A Public Health Observatory (PHO) is a platform to provide "health intelligence" as a service for a specific population. The World Health Organization (WHO) identifies the primary purposes of PHOs as "monitoring health situations and trends, including assessing progress toward agreed-upon health-related targets; producing and sharing evidence; and, supporting the use of such evidence for policy and decision making" For the purposes of the PULSE project, create an observatory to function as a unique point of access to the PULSE technology for people both inside and outside the project consortium.Specifically, we create a platform for e-learning and knowledge sharing that it can be easily navigated by lay persons that are interested in learning about or participating in the PULSE project. We targeted specifically policymakers, clinicians, as well as leaders and citizens in other cities. As a concept, it reflects the principles participation, sustainability, and collaboration across sectors and levels of government The Observatory leverages on the Health in All Policies (HiAP) framework. HiAP is a cross-sectoral approach to public policy that systematically takes into account the health implications of decisions, seeks synergies, and avoids harmful health impacts in order to improve population health and health equity. ; PULSE project has been founded by the European Union's Horizon 2020 research and innovation programme, and it is documented in the grant agreement No 727816. Specifically. PULSE has been founded under the call H2020-EU-3.1.5. in the topic SCIPM-18-2016-Big Data supporting Public Health policies. More information on http://www.project-pulse.eu ; Vito, D.; Ottaviano, M.; Cabrera, MF.; Teriús Padrón, JG.; Casella, V.; Bellazzi, R. (2020). Public Health Observatories: a learning community model to foster knowledge transfer for sustainable cities. En 6th International Conference on Higher Education Advances (HEAd'20). Editorial Universitat Politècnica de València. (30-05-2020):1383-1390. ...
The aim of this deliverable is to introduce the CAPABLE evaluation plan, including the activities carried out both during the development of the system and those to be performed once the system is complete. Special attention is devoted to the clinical pilot study that will take place during the last year of the project. For this study, we provide a draft of the study protocols that will have to be presented to the Ethical Committees (EC) of the two hospitals where the studies will be performed. ; This deliverable is a part of a project receiving funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No. 875052
This document presents the results of the second evaluation and validation iteration of the CAPABLE prototypes as defined in previous deliverable D7.1. In this validation process, an updated version of the WP6 prototype has been evaluated applying the two methods presented in D7.1: Interviews with patients and relatives. These interviews aimed to collect feedback from the end-users of the Patient App: melanoma and kidney cancer patients during the treatment phase. Given the broader applicability of the app to any type of cancer patient, this iteration included also other types of oncological patients, cancer survivors (treatment finished since no more than 2 years), and experts in patients' needs, such as caregivers. Overall, 17 patients and 2 caregivers have been interviewed. Interviews with healthcare professionals (HCPs). These interviews aimed to collect overall feedback about both doctors' and patients' solutions, understand if the clinical and patients' needs are covered, and revise the core functionalities that have been proposed in the current prototype. A total of 11 health professionals have been interviewed. We present the results of the 2 executed studies. The protocols of each study are attached in the annex. The document also presents the general conclusions from these validation activities and the next steps to follow in the future developments in order to satisfy the user experience needs found in this process. ; This deliverable is a part of a project receiving funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No. 875052
This document presents the results of the first evaluation and validation of the CAPABLE prototypes as defined in previous deliverable D7.1. In this validation process, the first version of the prototype presented by WP6 has been evaluated applying the three methods presented in D7.1: Heuristic validation of the user experience and usability performed by user Interaction experts. Interviews with patients. Interviews with healthcare professionals (HCPs) and experts in digital health. ; This deliverable is a part of a project receiving funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No. 875052
The document presents the preliminary results of the exploitation activities of the CAPABLE project. The activities that will be reported in the document are the following: Revision of the challenges for the technologies to improve cancer care Approaches to be used to set up a roadmap for the business development of the CAPABLE project (CEHRES Roadmap) Analysis of the stakeholders that might directly and indirectly benefit from CAPABLE Initial market and competitor analysis First draft of the value proposition Summarize the conclusion of the work drafting a preliminary SWOT analysis Revision of the exploitation opportunities in the project. ; This deliverable is a part of a project receiving funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No. 875052
The aim of this deliverable is to describe the approach that the CAPABLE consortium will have with respect to the ethical issues that might arise during the development and use of the CAPABLE AI-based clinical decision support system. In addition, the document also describes the policy related to incidental findings detection and management. ; This deliverable is a part of a project receiving funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No. 875052
The document shows the activities of market research performed in the second half of the first year of the project. Differently from the initial deliverable (D8.1): the focus of the market research has been to study the specific costs of kidney and melanoma cancer, and the possible barriers and success criteria to market to then continue the CAPABLE roadmap to the adoption following the CEHRES method presented in D8.1. The document also presents an update of the technology vigilance, which also contains a specific selection of solutions that are relevant competitors of CAPABLE and a study of the existing solution in the 2 hospitals of CAPABLE (ICSM and NKI-NVL). The document also presents an updated version of the Consortium IPR strategy and questionnaire interviews to be launched next year to start exploiting interests from key decision makers. ; This deliverable is a part of a project receiving funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No. 875052
BACKGROUND: This study assessed the effectiveness of the NEVERMIND e-health system, consisting of a smart shirt and a mobile application with lifestyle behavioural advice, mindfulness-based therapy, and cognitive behavioural therapy, in reducing depressive symptoms among patients diagnosed with severe somatic conditions. Our hypothesis was that the system would significantly decrease the level of depressive symptoms in the intervention group compared to the control group. METHODS: This pragmatic, randomised controlled trial included 425 patients diagnosed with myocardial infarction, breast cancer, prostate cancer, kidney failure, or lower limb amputation. Participants were recruited from hospitals in Turin and Pisa (Italy), and Lisbon (Portugal), and were randomly assigned to either the NEVERMIND intervention or to the control group. Clinical interviews and structured questionnaires were administered at baseline, 12 weeks, and 24 weeks. The primary outcome was depressive symptoms at 12 weeks measured by the Beck Depression Inventory II (BDI-II). Intention-to-treat analyses included 425 participants, while the per-protocol analyses included 333 participants. This trial is registered in the German Clinical Trials Register, DRKS00013391. FINDINGS: Patients were recruited between Dec 4, 2017, and Dec 31, 2019, with 213 assigned to the intervention and 212 to the control group. The sample had a mean age of 59·41 years (SD=10·70), with 44·24% women. Those who used the NEVERMIND system had statistically significant lower depressive symptoms at the 12-week follow-up (mean difference=-3·03, p<0·001; 95% CI -4·45 to -1·62) compared with controls, with a clinically relevant effect size (Cohen's d=0·39). INTERPRETATION: The results of this study show that the NEVERMIND system is superior to standard care in reducing and preventing depressive symptoms among patients with the studied somatic conditions. FUNDING: The NEVERMIND project received funding from the European Union's Horizon 2020 Research and Innovation Programme ...
Background This study assessed the effectiveness of the NEVERMIND e-health system, consisting of a smart shirt and a mobile application with lifestyle behavioural advice, mindfulness-based therapy, and cognitive behavioural therapy, in reducing depressive symptoms among patients diagnosed with severe somatic conditions. Our hypothesis was that the system would significantly decrease the level of depressive symptoms in the intervention group compared to the control group. Methods This pragmatic, randomised controlled trial included 425 patients diagnosed with myocardial infarction, breast cancer, prostate cancer, kidney failure, or lower limb amputation. Participants were recruited from hospitals in Turin and Pisa (Italy), and Lisbon (Portugal), and were randomly assigned to either the NEVERMIND intervention or to the control group. Clinical interviews and structured questionnaires were administered at baseline, 12 weeks, and 24 weeks. The primary outcome was depressive symptoms at 12 weeks measured by the Beck Depression Inventory II (BDI-II). Intention-to-treat analyses included 425 participants, while the per-protocol analyses included 333 participants. This trial is registered in the German Clinical Trials Register, DRKS00013391. Findings Patients were recruited between Dec 4, 2017, and Dec 31, 2019, with 213 assigned to the intervention and 212 to the control group. The sample had a mean age of 59·41 years (SD=10·70), with 44·24% women. Those who used the NEVERMIND system had statistically significant lower depressive symptoms at the 12-week follow-up (mean difference=-3·03, p<0·001; 95% CI -4·45 to -1·62) compared with controls, with a clinically relevant effect size (Cohen's d=0·39). Interpretation The results of this study show that the NEVERMIND system is superior to standard care in reducing and preventing depressive symptoms among patients with the studied somatic conditions. Funding The NEVERMIND project received funding from the European Union's Horizon 2020 Research and Innovation Programme under ...
The aim of this deliverable is to define the requirements of the CAPABLE system. These requirements include clinical requirements regarding the clinical scope of decision-support and its content (knowledge base), patient and clinician user needs and requirements, and technical system requirements for the different system components. Following our iterative development approach for the CAPABLE system, this document presents the majority of the functional and non-functional requirements. Once we implement the system in iterations and have users try out the system, additional requirements may be refined and reported at the end of Year 2. ; This deliverable is a part of a project receiving funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No. 875052
