Application of Digital Twins' Technology in Patients With Stroke, Moyamoya Disease, and Cerebral Amyloid Angiopathy During Secondary Prevention: A Proof of Concept Randomized Controlled Trial

What this Trial Is About

This research aims to gather initial feedback on the use of the STRATIF-AI platform and digital twin technology during the secondary prevention phase for adults with stroke, Moyamoya disease, and Cerebral Amyloid Angiopathy. It compares the experiences of patients using the STRATIF-AI app alongside standard care versus those receiving standard care alone. The goal is to understand how patients interact with the app and how usable they find it. Participants are randomly assigned to one of two groups. Arm 1 patients will use the STRATIF-AI app daily to help manage their health and understand their medical situation, in addition to following standard secondary prevention treatments. They may also choose to connect wearable devices to the app. Arm 2 patients will receive only the standard secondary prevention treatments and monitoring usual for these conditions. Both groups will complete cognitive and psychological assessments at the start and after six months. During the study, participants will undergo various assessments including cognitive tests like the Montreal Cognitive Assessment, health and disability surveys, and psychological evaluations. Clinical data and demographic information will also be collected. For Arm 1, interviews at six months will gather qualitative feedback on the app experience. The primary measurement focuses on user feedback after 12 months. The study is expected to end in April 2027 and is sponsored by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta.

Application of Digital Twins' Technology in Patients Who Had a Stroke, With Moyamoya Disease and With Cerebral Amyloid Angiopathy (CAA) During the Secondary Prevention Phase: A Proof of Concept Using a Randomized Control Trial (Clinical Study 6, STRATIF-AI Project)