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Although Living Labs have emerged as resilient research and innovation infrastructures and have proved to be a “key” to the integration of research and innovation processes in real-life settings, they still fail to provide and function according to unified and harmonized processes that are easily accessible and exploitable by academic and industry researchers. Towards this end, VITALISE aims to create the first Harmonization guidelines for Living Labs that will facilitate the access of researchers to the provided infrastructures. This document presents the work performed for the Harmonization of the way Living Labs work for the second semester of VITALISE. Taking as a starting point the Standard v0.1, VITALISE performed Harmonization activities with consortium partners and external stakeholders in order to create the Standard v0.2 presented in this document. Standard v0.1 included the state of the art information about Living Labs in the VITALISE consortium and was the first deliverable that set up the structure of the VITALISE Standards. The performed activities for this deliverable included the production and dissemination of a wiki page that included the Standard v0.1 and gives the ability to readers to make comments and suggest adjustments. The Harmonization Board was established and met throughout this second semester. The Harmonization Board consists of experts from the consortium and beyond and is the main Board taking decisions about the Standard Versions. A meeting with the Harmonization Body took place as well, in which participants discussed mainly the Harmonization methodology, the Living Lab management system and the wiki page. The consortium worked also towards updating the parts of the Standard that describe the data and technologies used in living labs, using a Delphi study method and collected the first set of terms for the living lab lexicon. The final Section of this document presents the Standard v0.2 that will be also published in the living lab harmonization wiki page.

Background Living labs in the health and well-being domain have become increasingly common over the past decade but vary in available infrastructure, implemented study designs, and outcome measures. The Horizon 2020 Project Virtual Health and Wellbeing Living Lab Infrastructure aims to harmonize living lab procedures and open living lab infrastructures to facilitate and promote research activities in the health and well-being domain in Europe and beyond. This protocol will describe the design of a joint research activity, focusing on the use of innovative technology for both rehabilitation interventions and data collection in a rehabilitation context. Objective With this joint research activity, this study primarily aims to gain insight into each living lab’s infrastructure and procedures to harmonize health and well-being living lab procedures and infrastructures in Europe and beyond, particularly in the context of rehabilitation. Secondarily, this study aims to investigate the potential of innovative technologies for rehabilitation through living lab methodologies. Methods This study has a mixed methods design comprising multiple phases. There are two main phases of data collection: cocreation (phase 1) and small-scale pilot studies (phase 2), which are preceded by a preliminary harmonization of procedures among the different international living labs. An intermediate phase further allows the implementation of minor adjustments to the intervention or protocol depending on the input that was obtained in the cocreation phase. A total of 6 small-scale pilot studies using innovative technologies for intervention or data collection will be performed across 4 countries. The target study sample comprises patients with stroke and older adults with mild cognitive impairment. The third and final phases involve Delphi procedures to reach a consensus on harmonized procedures and protocols. Results Phase 1 data collection will begin in March 2022, and phase 2 data collection will begin in June 2022. Results will include the output of the cocreation sessions, small-scale pilot studies, and advice on harmonizing procedures and protocols for health and well-being living labs focusing on rehabilitation. Conclusions The knowledge gained by the execution of this research will lead to harmonized procedures and protocols in a rehabilitation context for health and well-being living labs in Europe and beyond. In addition to the harmonized procedures and protocols in rehabilitation, we will also be able to provide new insights for improving the implementation of innovative technologies in rehabilitation. International Registered Report Identifier (IRRID) PRR1-10.2196/34537

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

Although Living Labs have emerged as resilient research and innovation infrastructures and have proved to be a “key” to the integration of research and innovation processes in real-life settings, they still fail to provide and function according to unified and harmonized processes that are easily accessible and exploitable by academic and industry researchers. Towards this end, VITALISE aims to create the first Harmonization guidelines for Living Labs that will facilitate the access of researchers to the provided infrastructures. This document presents the work performed for the Harmonization of the way Living Labs work for the first semester of VITALISE. The initial work of Harmonization aims to establish the state-of-the-art for the Living Lab services, methods and tools that will be used. This is also used as a baseline upon which the Standard versions will continue evolving throughout VITALISE and beyond. Another important aspect presented in this deliverable is the methodological framework that will be followed in the Harmonization process.

The goal of this deliverable is to illustrate the project management framework of the VITALISE project along with all project quality control and operational procedures and associated roles required by the different managerial and operational activities planned for the whole project duration. This document is designed as a set of practical guidelines to help clearly define workflows and rules that the partners will have to follow throughout the project’s activities, to ensure the highest quality standards are met and to strengthen project management (e.g., partner responsibilities, quality control mechanisms, documentation control, documentation formats and exchange rules). The document lists the procedures required for a well-organised execution of the project, aiming to maximise cooperation of partners and to clearly define responsibilities among the beneficiaries of the project. Furthermore, the document clearly specifies the quality, administrative and communication procedures to be followed by the partners during the implementation of the project, to ensure full control of its development, from both a financial and a technical standpoint. This report complements the provisions of the Grant Agreement and its annexes as well as the Consortium Agreement, which has been already signed by all the beneficiaries, in that it clearly defines several practical guidelines and rules essential for the day-to-day management of the project.

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

In this study, the Minimum Viable Product (MVP) model was applied with regards to “Measure-developlearn” circle along with its impact on the decision for the development tools and technologies. An example of designing exergames for Parkinson’s disease (PD) patients by considering their valuable feedback [1] and how this influenced low-level technical decisions (changing game engine from 2D Exergames to 3D) are thoroughly discussed.

Our work exhibits how previous projects on the Active and Healthy Ageing field have advanced to the conception of CAPTAIN, a radically new approach towards increased enduser acceptance. The goal is to create intuitive technology that does not require specific skills for interaction and blends in with real life. CAPTAIN will be co-designed by all types of stakeholders, including older adults, involved in all stages, from the initial design to delivery of the final system