The COMFORTage project addresses the complex challenge of developing personalized and technologically advanced interventions for the prevention and management of frailty and cognitive decline in older adults. At the heart of this initiative lies a collaborative co-design approach, essential for coordinating the work of thirteen distinct yet interconnected clinical pilot studies, distributed across different levels of healthcare (primary, secondary, and tertiary).

Harmonisation of Pilots and Protocols

The co-design process has been a crucial element in ensuring that all involved partners—clinicians, researchers, and technical experts—speak a common language and work synergistically. This involved the shared definition of inclusion and exclusion criteria, the selection of evaluation scales, neuropsychological questionnaires, and standardized clinical variables, as well as the harmonization of data collection methods. Such uniformity was essential for enabling robust and comparable statistical analyses across the different pilots, thereby increasing the validity and generalizability of the results.

Key Project Workshops and Meetings

The first pilot meeting, held in Rome in April 2024, marked a key milestone in the co-design journey. Over a two-day event featuring interactive workshops and in-depth discussions, partners shared experiences, challenges, and project ideas, working together to define a common project “architecture.” Special attention was given to refining diagnostic and clinical criteria relevant to the frail population and those with cognitive disorders, creating a coherent and clinically meaningful framework.

Integration of Digital Technologies

During this phase, common variables to be used across all studies were identified, along with pilot-specific assessments tailored to the particularities of each scenario, thus ensuring both the homogeneity and flexibility needed to meet specific needs. Additionally, a co-creation workshop model was introduced to guide partners in gathering input from users and stakeholders—an essential step for developing effective, truly needs-centered interventions.

Co-design efforts also extended to the integration of advanced digital technologies: mobile platforms, wearable devices, the Internet of Things (IoT), artificial intelligence, and machine learning are being used to stratify patients by risk, personalize interventions, and monitor therapy effects in real time. Ongoing collaboration between clinical experts and technology developers enables agile adaptation of these solutions to emerging needs during the course of the studies.

Ethical Protocols and Data Governance

Operationally, the definition of shared clinical protocols and ethical frameworks has been an integral part of the co-design process, ensuring compliance with strict regulations and the protection of sensitive data. This posed a significant challenge, overcome through close collaboration among partners and alignment in governance practices.

Multidisciplinary Collaboration for Innovation in Health

The co-design model adopted by COMFORTage has not only facilitated technical and methodological harmonization but also promoted a broader, multidisciplinary vision for managing frailty and dementia—engaging neurologists, AI experts, social scientists, caregivers, and policymakers. The goal is to build an integrated healthcare system capable of delivering personalized, effective, and sustainable care while empowering older adults and their families.

In conclusion, the co-design experience in COMFORTage’s pilot scenarios stands as an innovative and replicable model for designing complex clinical studies in the geriatric and neurological fields. Synergistic collaboration among partners, protocol standardization, and contextual adaptability are key elements in overcoming technical, clinical, and ethical challenges—laying the groundwork for a real and lasting transformation in care models for frailty and cognitive decline.