Background: Living Labs are user-centered, open innovation ecosystems based on a systematic user cocreation approach, which integrates research and innovation processes in real-life communities and settings. The Horizon 2020 Project VITALISE (Virtual Health and Wellbeing Living Lab Infrastructure) unites 19 partners across 11 countries. The project aims to harmonize Living Lab procedures and enable effective and convenient transnational and virtual access to key European health and well-being research infrastructures, which are governed by Living Labs. The VITALISE consortium will conduct joint research activities in the fields included in the care pathway of patients: rehabilitation, transitional care, and everyday living environments for older adults. This protocol focuses on health and well-being research in everyday living environments. Objective: The main aim of this study is to cocreate and test a harmonized research protocol for developing big data–driven hybrid persona, which are hypothetical user archetypes created to represent a user community. In addition, the use and applicability of innovative technologies will be investigated in the context of various everyday living and Living Lab environments. Methods: In phase 1, surveys and structured interviews will be used to identify the most suitable Living Lab methods, tools, and instruments for health-related research among VITALISE project Living Labs (N=10). A series of web-based cocreation workshops and iterative cowriting processes will be applied to define the initial protocols. In phase 2, five small-scale case studies will be conducted to test the cocreated research protocols in various real-life everyday living settings and Living Lab infrastructures. In phase 3, a cross-case analysis grounded on semistructured interviews will be conducted to identify the challenges and benefits of using the proposed research protocols. Furthermore, a series of cocreation workshops and the consensus seeking Delphi study process will be conducted in parallel to cocreate and validate the acceptance of the defined harmonized research protocols among wider Living Lab communities. Results: As of September 30, 2021, project deliverables Ethics and safety manual and Living lab standard version 1 have been submitted to the European Commission review process. The study will be finished by March 2024. Conclusions: The outcome of this research will lead to harmonized procedures and protocols in the context of big data–driven hybrid persona development among health and well-being Living Labs in Europe and beyond. Harmonized protocols enable Living Labs to exploit similar research protocols, devices, hardware, and software for interventions and complex data collection purposes. Economies of scale and improved use of resources will speed up and improve research quality and offer novel possibilities for open data sharing, multidisciplinary research, and comparative studies beyond current practices. Case studies will also provide novel insights for implementing innovative technologies in the context of everyday Living Lab research. International Registered Report Identifier (IRRID): DERR1-10.2196/34567

Background: Attention deficit hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders during childhood; however, the diagnosis procedure remains challenging, as it is nonstandardized, multiparametric, and highly dependent on subjective evaluation of the perceived behavior. Objective: To address the challenges of existing procedures for ADHD diagnosis, the ADHD360 project aims to develop a platform for (1) early detection of ADHD by assessing the user’s likelihood of having ADHD characteristics and (2) providing complementary training for ADHD management. Methods: A 2-phase nonrandomized controlled pilot study was designed to evaluate the ADHD360 platform, including ADHD and non-ADHD participants aged 7 to 16 years. At the first stage, an initial neuropsychological evaluation along with an interaction with the serious game developed (“Pizza on Time”) for approximately 30-45 minutes is performed. Subsequently, a 2-week behavior monitoring of the participants through the mADHD360 app is planned after a telephone conversation between the participants’ parents and the psychologist, where the existence of any behaviors characteristic of ADHD that affect daily functioning is assessed. Once behavior monitoring is complete, the research team invites the participants to the second stage, where they play the game for a mean duration of 10 weeks (2 times per week). Once the serious game is finished, a second round of behavior monitoring is performed following the same procedures as the initial one. During the study, gameplay data were collected and preprocessed. The protocol of the pilot trials was initially designed for in-person participation, but after the COVID-19 outbreak, it was adjusted for remote participation. State-of-the-art machine learning (ML) algorithms were used to analyze labeled gameplay data aiming to detect discriminative gameplay patterns among the 2 groups (ADHD and non-ADHD) and estimate a player’s likelihood of having ADHD characteristics. A schema including a train-test splitting with a 75:25 split ratio, k-fold cross-validation with k=3, an ML pipeline, and data evaluation were designed. Results: A total of 43 participants were recruited for this study, where 18 were diagnosed with ADHD and the remaining 25 were controls. Initial neuropsychological assessment confirmed that the participants in the ADHD group showed a deviation from the participants without ADHD characteristics. A preliminary analysis of collected data consisting of 30 gameplay sessions showed that the trained ML models achieve high performance (ie, accuracy up to 0.85) in correctly predicting the users’ labels (ADHD or non-ADHD) from their gameplay session on the ADHD360 platform. Conclusions: ADHD360 is characterized by its notable capacity to discriminate player gameplay behavior as either ADHD or non-ADHD. Therefore, the ADHD360 platform could be a valuable complementary tool for early ADHD detection. Trial Registration: ClinicalTrials.gov NCT04362982; https://clinicaltrials.gov/ct2/show/NCT04362982 International Registered Report Identifier (IRRID): RR1-10.2196/40189

This study aims to present the development of a wearable prototype device consisting of soft robotic gloves (SRGs), its integration into a wearable robotics platform for sensorimotor rehabilitation, and the device’s validation experiments with individuals suffering from impaired hand motor function due to neurological lesions. The SRG is tested and evaluated by users with spinal cord injury (SCI) and stroke. The proposed system combines multiple-sensor arrays with pneumatic actuation to assist finger movement during grasping tasks. Evaluations on SCI and stroke patients revealed that the gloves consistently improved finger and grip performance. Detailed analyses indicated observable differences in sensor-derived features during actuation versus non-actuation, with statistically significant modifications appearing in both time-domain and frequency-domain metrics. Although the stroke participants exhibited greater variability, all participants were able to use the system reporting low discomfort and effort. The findings underscore the potential for personalized calibration to further optimize therapeutic outcomes. In summary, the study validates the utility of these gloves as assistive and rehabilitative modalities, and future research will focus on refining the device in the context of multimodal wearable robotics and individualized neurorehabilitation strategies.

Prior studies have argued that the value that living labs are providing is blurry. Grounded on the living lab experts’ opinions, the study defines the key value proposition elements for living Labs. An online workshop was arranged in which 22 experts provided a total of 208 value proposition suggestions for the researcher, policy maker and public authority, and SME/company customer segments and for the different Technology Readiness Level (TRL) phases. As a result, the following seven main value categories including a total of 31 different value items were identified: 1) Enhanced collaboration and networking possibilities, 2) Validity and reliability, 3) Improved innovation, 4) Financial and process benefits, 5) Benefits for the users and society, 6) Safe environment for RDI and 7) Increased skills and capabilities. The results also suggest that living lab value argumentation is partially context-dependent. Value proposition suggestions are proposed for companies, researchers, policymakers, and public authorities.

Background: Virtual Health and Wellbeing Living Lab Infrastructure is a Horizon 2020 project that aims to harmonize Living Lab procedures and facilitate access to European health and well-being research infrastructures. In this context, this study presents a joint research activity that will be conducted within Virtual Health and Wellbeing Living Lab Infrastructure in the transitional care domain to test and validate the harmonized Living Lab procedures and infrastructures. The collection of data from various sources (information and communications technology and clinical and patient-reported outcome measures) demonstrated the capacity to assess risk and support decisions during care transitions, but there is no harmonized way of combining this information. Objective: This study primarily aims to evaluate the feasibility and benefit of collecting multichannel data across Living Labs on the topic of transitional care and to harmonize data processes and collection. In addition, the authors aim to investigate the collection and use of digital biomarkers and explore initial patterns in the data that demonstrate the potential to predict transition outcomes, such as readmissions and adverse events. Methods: The current research protocol presents a multicenter, prospective, observational cohort study that will consist of three phases, running consecutively in multiple sites: a cocreation phase, a testing and simulation phase, and a transnational pilot phase. The cocreation phase aims to build a common understanding among different sites, investigate the differences in hospitalization discharge management among countries, and the willingness of different stakeholders to use technological solutions in the transitional care process. The testing and simulation phase aims to explore ways of integrating observation of a patient’s clinical condition, patient involvement, and discharge education in transitional care. The objective of the simulation phase is to evaluate the feasibility and the barriers faced by health care professionals in assessing transition readiness. Results: The cocreation phase will be completed by April 2022. The testing and simulation phase will begin in September 2022 and will partially overlap with the deployment of the transnational pilot phase that will start in the same month. The data collection of the transnational pilots will be finalized by the end of June 2023. Data processing is expected to be completed by March 2024. The results will consist of guidelines and implementation pathways for large-scale studies and an analysis for identifying initial patterns in the acquired data. Conclusions: The knowledge acquired through this research will lead to harmonized procedures and data collection for Living Labs that support transitions in care. International Registered Report Identifier (IRRID): PRR1-10.2196/34573

Objectives: This study aimed to explore healthcare professionals’ views on the use of technology in adult transitional care, identifying challenges, critical procedures, and enabling factors for adoption. Methods: This was a prospective, multisite qualitative study. Data were collected through semi-structured co-creation sessions that explored two main themes, clinical decision-making and technology use in transitional care, through the lenses of current practices, challenges, and future directions. Data were analysed using constant comparison analysis by three independent researchers through iterative open, axial, and selective coding, followed by an impact relationship analysis to explore interconnections between themes. Results: Eleven co-creation sessions were held involving 115 participants. Findings highlight five key transitional care processes, beginning with patient assessment and evaluation, continuing through discharge planning and adherence to protocols, and extending to post-discharge support and follow-up care. The results show how technology can enhance each of these steps by improving digital literacy, user-friendliness, interoperability, and the flow of information. Cross-cutting barriers such as limited resources, privacy concerns, and lack of trust in technology were also identified. Conclusions: Technological tools can support various aspects and processes of transitional care, but their effective adoption requires a distinct set of strategies to address the multiple and complex factors involved.