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  • Periodic Reporting for period 1 - MyCyFAPP (Innovative approach for self-management and social welfare of Cystic Fibrosis patients in Europe: development, validation and implementation of a telematics tool.)

MyCyFAPP Report Summary

Project ID: 643806
Funded under: H2020-EU.3.1.

Periodic Reporting for period 1 - MyCyFAPP (Innovative approach for self-management and social welfare of Cystic Fibrosis patients in Europe: development, validation and implementation of a telematics tool.)

Reporting period: 2015-01-01 to 2015-12-31

Summary of the context and overall objectives of the project

An accurate pancreatic enzyme replacement arises as an early nutritional intervention able to provide better nutritional status and Cystic Fibrosis (CF) patients’ welfare from early stages, avoiding complications associated to the development of the disease. By means of our innovative and portable ICT tool we aim to improve the socio-economic impact of the disease, promoting healthy lifestyle, intertwining patient empowerment, education and training with self-management and prevention of secondary CF-complications. The multidisciplinary and complementary approach of this co-developed integrative PROJECT tries to guarantee the patient’s adherence to the treatment and the most optimal outcome of the nutritional intervention mainly in childhood. The beneficiaries of the application comprise patients, caregivers, families and health professionals as well as health monitoring authorities. MyCyFAPP is tailored designed and will be validated in clinics for CF self-management and monitoring, becoming a competitive market product in Europe. This APP will have a key role as decision support system, boosting the growth and competitiveness of the participating SMEs in Europe, which will ensure the market uptake and the MyCyFAPP distribution for the benefit of the patient.

It is to get to a scenario in which self-management of enzyme replacement and nutrition in the European Cystic Fibrosis (CF) patients by means of an APP is progressively achieved and successfully implemented. The co-developed APP is aimed at a personalised and accurate control and monitoring of the disease thanks to the interaction between health professionals and patients and thanks to the tailored evidence-based tools and resources specifically developed through the Project.

1. Health and nutritional status improvement through a precise pancreatic enzymes supplements dosage.
2. Improved Quality of life both for patients and their families.
3. Economic savings both for the health system and for the patients’ families.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

During the first 12 months the MyCyFAPP consortium work was focused on setting the grounds for the core WPs (WP5 will work on the development of the software and WP6 will conduct the clinical trial for APP usage’ impact assessment). To this extent, basic and clinical research has been carried out to generate new knowledge and tools that will be included in the software and will bring evidence-based added value to the final product.

Clinical and basic research have been complementing each other in the following way: WP1 (European survey on CF nutritional habits) has had the biggest effort in the first period (%PM). Four tasks have been accomplished along with four deliverables (D1.1-D1.4) and two milestones (MS2, MS3). The most relevant outputs include the characterisation of the nutritional habits among the European CF patients and the identification of dietary patterns. These results were needed for WP2 (Enzyme requirements for different food and dishes) to test the fats digestibility of an initial selection of food products and meals under in vitro simulated standard CF gastrointestinal conditions (first activity of T2.3). The in vitro studies were carried out according to the SOP for the in vitro characterization of lipids digestion in foods and dishes (D2.1). These outputs will be of great interest to be published in the scientific literature. WP3 also started its activity with the design of the study protocol and the definition of a test menu to be used in the pilot study: included food products had been studied in vitro before, and a theoretical optimal dose of enzymes was determined. Overall this is the description of the strong interaction between WP1, WP2 and WP3, including the main outcomes and achieved goals.

In parallel, WP4 had also an intense activity during the first year towards the identification of user needs and requirements. Following a user centred design approach, 32 co-design workshops and 71 interviews with stakeholders were conducted in different countries. They yielded more than 466 requirements, which were categorised and prioritized. D4.1-D4.3 reported the overall methodology for the user centred design process throughout the project, as well as a first game concept and first mock-ups, both for the self-management app and for the health professionals’ web tool.

Besides the above, the Project’s development and innovation stages had also started: During the second semesters (tasks 5.1-5.4) WP5 defined the architectural description framework and development methods and tools, and the requirement categories as described in WP4 were mapped (D5.1).
From a very early stage of the project, preliminary business models identification and requirements have been addressed in WP8. The work during the first year has been limited to establish the overall methodological framework for the exploitation in close co-operation with WP4, by separating the requirements addressed for the project, and for further exploitation of results. Additionally we started analysing the stakeholder’s framework and identifying the relevant laws that could affect the future exploitation of the results.

Additionally, WP6 (Impact assessment through a European Multicentre Clinical Trial) started before the expected deadline, since the preliminary draft for the clinical trial was considered to be addressed necessarily at an early stage.

As for the dissemination activities, Project website and social networks were set-up in M1 and the preliminary dissemination strategy was defined. In M12 more than 1700 new visitors browsed MyCyFAPP website around Europe, and the Project was presented in 10 relevant scientific events.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

In the first year of activity the Project has progressed especially in the exploratory and creative activities, concentrated in WP1 to WP4. These are the Project’s research areas from which the highest amount of newly generated knowledge is expected along the Projects’ course.
MyCyFAPP aims to contribute significantly to the adoption of open access by the participants of the European Research Area (ERA), and to comply with the open access policies and rules of participation set out for Horizon 2020. Concretely the main multidisciplinary disseminable/exploitable achievements, that will be eventually published, from M1-M12, have been the following:
WP1: nutritional habits of paediatric CF have been well established and current nutrients intake, enzymes supplements usage and nutritional status have been determined. No previous studies in the literature report such type of gathered data in a CF population. These outcomes will be published in order to illustrate the current nutritional situation in the European CF population: based on this, we will elaborate on the development of tailored and evidence-based tools for the nutrition self-management.

WP2: in vitro digestion studies are increasingly being used in the field of Food Science and Technology. A specific SOP to conduct in vitro digestion studies under CF gastrointestinal conditions has been set up, and for the first time, a massive number of real food products and complete meals (rather than emulsions or model systems) are being assessed, to study the influence of the food matrix and the lipids’ molecular structure on fat digestion.

WP3: although in a very early stage, this WP has drafted a study protocol for the pilot study. In this study, an evidence-based criterion to establish the optimal dose of enzymes in the pancreatic enzyme replacement therapy will be assessed, and this never existed before. By M30 the definitive calculation method, using a predictive algorithm, is expected as one of the main outcomes of the Project.

WP4: the user research during the first months has given an extensive overview of central needs, concerns, and behaviour patterns of CF patients across age groups and several countries. MyCyFAPP is among the very few development projects which actively include a hard to reach, international, user group in form of co-design in the development process. Based on this research, the apps in the project will be tailor made for the users.

As for the impact the Project will produce within the ERA, the exploitation activities are currently working on an active seeking and exploring of the potential markets and stakeholders that can guarantee the sustainability of the future APP implementation beyond the Project timespan.

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