The main objectives of FrailSafe is to better understand frailty and be able to recognize common patterns through data collection that would explain when a person tips from the non-frail to the frail category.
The technical and clinical partners worked together to set up an Electronic Case Report Form (eCRF) that would enable the clinical partners to gather data of volunteers in a digital form. Indeed, along the project, volunteers from three different locations (Patras in Greece, Nicosia in Cyprus and Nancy in France) have accepted to take part in the FrailSafe study. They will have at their disposal technological devices, such as a smart vest, beacons, and a tablet with augmented reality games to test their cognitive abilities. They will also undergo a series of tests to measure for example their strength, blood pressure and gait and fill in some questionnaires about their well-being and social interaction for example. Through these devices, tests and questionnaires, data will be collected through the eCRF in a digital format (see figure). It will enable technicians and clinicians to extract the relevant information to better understand where lies the limit between non-frail and frail.
A digital format prevailed over a paper version for various reasons, such as eliminate unnecessary duplication of data; avoid data entry errors; facilitate the collection of data and remote monitoring of data; and promote real-time access for data review. The eCRF is built so as to allow clinicians staffs that are in charge of gathering the data, to access the eCRF whenever and where ever there are, as long as they have a web browser (e.g. Chrome, Firefox, Internet Explorer, Safari, Opera).
The eCRF is completely secured as the clinicians will need to authenticate themselves in order to access it. Moreover, the data will be encrypted before being stored on the database to protect the privacy and the integrity of the exchanged data. Finally, the eCRF system has been created in order to support the different work languages used in FrailSafe, namely French, English and Greek. This will help avoid translation errors or misunderstandings during the trials execution.
The eCRF is a technological tool that was produced thanks to a close interdisciplinary collaboration of the technological and medical teams. The tool will allow a proper assessment of the objectives of the project by organising in a simple way the collection of the data. It will also help reach a common goal, namely the implementation of the clinical trial protocol by the mean of an ICT instrument.