Usability Evaluation of an Offline Electronic Data Capture App in a Prospective Multicentre Dementia Registry – digiDEM Bayern: a Mixed Method Study (Preprint)

BACKGROUND Digital registries have shown to provide an efficient way better to understand the clinical complexity and long-term progression of diseases. The paperless way of electronic data collection during a patient interview saves both: time and resources. In the prospective multicenter 'Digital Dementia Registry Bavaria - digiDEM Bayern', interviews are also conducted on-site in rural areas with unreliable internet connectivity. It must be ensured that electronic data collection can still be performed there, and it is no need to fall back on paper-based questionnaires. Therefore, the EDC system REDCap offers, in addition to a web-based data collection solution, the option to collect data offline via an app and synchronize it afterward. OBJECTIVE This study evaluates the usability of the REDCap app as an offline electronic data collection option for a lay user group and examines the necessary technology acceptance using mobile devices for data collection. Thereby, the feasibility of the app-based offline data collection in the dementia registry project was evaluated before going live. METHODS The study was conducted with an exploratory mixed-method in the form of an on-site usability test with the 'Thinking Aloud' method combined with a tailored semi-standardized online questionnaire including System Usability Score (SUS). The acceptance of mobile devices for the data collection was surveyed based on the technology acceptance model (TAM) with five categories. RESULTS Using the Thinking Aloud method, usability problems were identified and solutions were derived therefore. The evaluation of the REDCap app resulted in a SUS score of 74, which represents 'good' usability. After evaluating the technology acceptance questionnaire, it can be stated that the lay user group is open to mobile devices as interview tools. CONCLUSIONS The usability evaluation results show that a lay user group like the data collecting partners in the digiDEM project can handle the REDCap app well overall. The usability test provided statements about positive aspects and was able to identify usability problems of the REDCap app. In addition, the current technology acceptance in the sample showed that heterogeneous groups of different ages with different experiences in handling mobile devices are also ready for the use of app-based EDC systems. Based on the results, it can be assumed that the offline use of an app-based EDC system on mobile devices is a viable solution to collect data in a registry-based research project.