Unleashing a CoMprehensive, Holistic and Patient Centric Stroke Management for a Better, Rapid, AdvancEd and PersonaLised Stroke Diagnosis, TreAtment and Outcome Prediction

Project Information

UMBRELLA

Grant agreement ID: 101172825

DOI

10.3030/101172825

EC signature date 31 July 2024

Start date 1 October 2024

End date 30 September 2029

Funded under

• Health

Total cost

€ 22 955 943,75

EU contribution

€ 14 791 678,93

Coordinated by

FUNDACIO HOSPITAL UNIVERSITARI VALL D'HEBRON - INSTITUT DE RECERCA
Spain

Periodic Reporting for period 1 - UMBRELLA (Unleashing a CoMprehensive, Holistic and Patient Centric Stroke Management for a Better, Rapid, AdvancEd and PersonaLised Stroke Diagnosis, TreAtment and Outcome Prediction)

Reporting period: 2024-10-01 to 2025-09-30

Summary of the context and overall objectives of the project

UMBRELLA aims to revolutionize stroke management by implementing a comprehensive, holistic, multi-centre approach that addresses gaps along the whole continuum of the stroke care pathway.
By focusing on fast, precise, and patient-centered care, Umbrella is set to improve outcomes for millions of stroke patients across Europe. Umbrella aims for a future where every stroke patient in Europe receives timely, accurate and personalised care.

The key paradigm in the project is the multicentric, synergistic "umbrella" strategy for local data collection, harmonization, and standardization along the entire pre-, in-, and post-hospital pathway.
To achieve this, we have defined six specific objectives (OBs): 4 technical and operational (OB1 to OB4) and 2 strategic (OB5 and OB6).The project objectives are:
• OB1: To integrate, harmonize and standardize in a federated manner local retrospective and prospective data collection, as well as stroke protocols and procedures across the whole stroke care pathway.
• OB2: To build and enhance a multi-country federated Real World Data platform (U-platform) that allows the local creation and validation of trustworthy artificial intelligence (AI) models to advance personalized stroke diagnosis, risk prediction, and decision-making.
• OB3: To implement and exploit a Federated Learning framework (FL-platform) that allows the training of the U-platform-AI models across various centres while preserving data security and privacy.
• OB4: To improve stroke patients’ outcomes and interoperable silos' communication with novel digital technologies for patients' engagement, real-time monitoring, data visualization, and decision-making.
• OB5: To develop a roadmap to regulatory compliance and future certification for the selected improved stroke cases' management and the UMBRELLA FL-platform.
• OB6: To develop a roadmap for the long-term sustainability and exploitation of UMBRELLA advancements in stroke care and a plan for dissemination.

UMBRELLA's ambitious goal for 2030 is to establish itself as a leading model in stroke management, setting new paradigms for data standards, harmonised practices, AI development, personalized patient care and healthcare efficiency overall stroke care continuum, facilitating coordinated decision-making among healthcare professionals.

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

At M12, UMBRELLA has demonstrated solid progress across its multiple objectives, and has laid the foundation for subsequent evaluation of its established key performance indicators.
OB1 has advanced notably through the collaborative development and ethics approval of retrospective clinical protocols at all clinical sites, with a joint clinical protocol for the prospective phase finalized and under submission. Initial work on data harmonization has also been carried out, providing a solid basis for prospective studies.
While AI-related objectives in OB2 and OB3 remain in preparatory stages, the project has established the necessary technical requirements and engaged stakeholders to enable upcoming implementation.
OB4 continues to refine its deployment strategy in line with clinical needs and regulatory frameworks.
OB5 has made significant progress in engaging clinical partners to shape a tailored regulatory roadmap, essential for future certification and compliance.
OB6 is advancing sustainability and dissemination plans, with clear timelines and governance structures to ensure the long-term impact of UMBRELLA’s innovations.

Collectively, these advances demonstrate that UMBRELLA is progressing as planned and is well-positioned to achieve its ambitious objectives in the next phases.

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)

Too early to describe. It will be updated in the next reporting periods.

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