First period (M1-M18)
we set up 3 task forces: TF1 (technical development), TF2 (demonstrations), and TF3 (user interface), working on:
- functional requirements, involving literature review, AIMAC forum content, and interviews with potential users in order to get feedback on the app mockups
- implementation of the system components: the "case manager" coordinating all the other components; the "Data Platfom", providing a persistent data layer using the OMOP Common Data Model; HL7 FHIR resources as standard for data exchange; user interface mockups; physician decision support system implementing GLs, and the Virtual Coach, implementing the patient guide;
- M12-demo (diarrhea guideline scenario ) and M18-demo (extended with predictive models)
- harmonisation of the clinical pathways related to oncologists, psychologists and nutritionists' visits
- enrollment of control patients for assessing basal values of QoL
- market analysis and survey to detect possible competitors. A workshop was held to discuss the innovation potential of CAPABLE, how to compete and start paving options for business models
- dissemination through website, conferences, scientific journals, local/national press. We also involved two artists with extensive experience in disseminating AI project results to broad audience (capable-project.eu/art-visualizations)
Second period (M19-M36)
Being this period devoted to the final system development, TF2 was no longer used and technical work was coordinated by TF1, which monitored the evolution of all CAPABLE components. A comprehensive testing (involving simulation of a high number of realistic clinical scenarios) and internal deployment strategy has been developed and the technical aspects connected to the different study phases (patient enrollment, clinical study execution, results gathering) have been agreed among the different partners. At the end of the reporting period, the system is in the final test phase before the starting of the pilot study.
TF3 (User Interface) continued the process of collecting and handling the requirements. Those were collected in parallel with different prototypes preparation, carrying out an intensive (weekly) activity to implement and test the required functionalities.
Moreover, since regulatory (ethical and legal) aspects are of paramount importance to finalise any study on human subjects, an additional task force, TF4, has been set up, caring for: preparing the study protocols to be submitted to Ethical Committees; preparing the notifications to the Ministry of Health, needed because CAPABLE is a medical device in risk class IIa; following the bureaucratic processes leading to all the necessary approvals.
Additional progresses have been:
- finalising the enrollment of the control patients cohort and provided a statistical analysis of the data collected;
- continuing the activities devoted to the possible exploitation of the project results: cooperation with the CS_AIW cluster that collects 9 EU-funded projects wieth similar goals. Moreover, with the support of HRB PDES, we also formed a smaller cluster of 4 EU projects. Finally, at National level, CAPABLE entered the TAV (Lombardy Region Cluster for Ambient Assisted Living Technologies) cluster
- enhancing the dissemination strategies. In particular, we posted a lot of contents on social media (Instagram, Facebook) and we promoted the project at local level through brochures and posters in the hospital waiting rooms. The artists' work so far available has been shown at the SMAU exposition in Milan.
- enhancing the educational material accessible through the patient's app.
Third Period (M37-M49)
- finalising the system deployment at ICSM and NKI hospitals
- finalising the legal steps for the notifications of the app as medical devices
- enrolling the patients in the pilot studies (56 in Italy and 31 in the Netherlands)
- monitoring the system status (the correct functioning of each component)
- organising events to maintain the patients' engagement (such as focus groups, workshops, exhibitions, etc)
- evaluation of the results by analysing the collected data (QoL trend over time was improved in Capable cohort with respect to the control cohort)
- continuing the dissemination and exploitation activities (10 dissemination events, 6 journal papers, 6 international workshop papers and 1 book chapter)
