D1.4 Definition of assessment study including test scenarios & metrics, and study initiation package

The AIDAVA prototype will be delivered in 2 generations: Generation 1 in Q3 2024 and Generation 2 in Q2 2026. It will be tested in 4 hospitals and 2 Health Data Intermediaries, with 45 patients respectively per therapeutic area across all sites (90 patients for the 2 therapeutic areas in scope).

This deliverable includes the description of the 4 documents developed to support the execution of this assessment study of the two generations of the AIDAVA prototype in an ELSI compliant way, with a minimum burden for the patients and the sites.

The first document - and the most important one - is the study protocol (Annexe 1); it starts with a synopsis of the study and includes a description of the objectives of the study, the specification of the primary and secondary endpoints, the study schedule with the different activities to take place during the evaluation of the prototype across the 2 generations (including the washout period between the 2 generations), the study population with eligibility criteria, the data points to be collected with associated data collection forms (in RedCap) and the statistical analysis.

Another important document, related to the protocol is the English version of the Study Information Package and Informed Consent Form (Annexe 2) to be translated by each site and provided to patients during the recruitment process.

The third document includes a training plan (Annexe 3) for the patients participating in the evaluation and for the study team. It includes a specification of the different modules and a training program for the participants of the study, based on their role.

The final document is a template Data Sharing agreement (Annexe 4), to be adapted and finalised by each site, including guidance for technical and legal provisions.

The deliverable also includes description of work that was conducted with the help of Health Data Intermediaries (HDI) who helped to identify vendors who would provide a patient app application (to collect Quality of Life information) and a blood pressure medical device to be used during the study; the collected data will be managed by the HDI and provided to AIDAVA for integration in the patient record.

We also provide an overview on the feedback provided by the patients´consultants for the different materials mentioned above, and specify the study design with the schedule of activities as well as the Study Information Package and the Informed Consent Form.