数字孪生技术在二级预防阶段中风、烟雾病和脑淀粉样血管病 (CAA) 患者中的应用：使用随机对照试验的概念验证（临床研究 6，STRATIF-AI 项目） (SMART)

AIMS

Patients in secondary prevention with Moyamoya, CAA and stroke admitted to the Cerebrovascular Disease Unit of Carlo Besta Neurological Institute will be enrolled and randomized 1:1 in the following two arms:

• Arm 1 is the intervention group: patients allocated to this arm will receive the standard secondary prevention and will also use the STRATIF-AI app, which will integrate digital twin (DT) technology to improve patient management during the secondary prevention phase and to assist patients in understanding key concepts, such as: "Why should I care about a certain risk factor (e.g. blood pressure), and how can my lifestyle impact that risk factor? In other words, they will use the app to understand their medical situation, and to set personal goals.
• Arm 2 is the control group: patients allocated to this arm will receive only standard seconda prevention, which includes typical treatments and monitoring protocols used for patients with stroke, Moyamoya disease, and CAA.

Patients will be screened and enrolled upon admission to the Cerebrovascular Disease Unit. They will complete a set of clinical, cognitive, and psychological evaluation, performed at the time point of enrolment (T0) and at a 6-months follow-up (T1).

Only for the Arm 1, a brief explanation about the use of the app will add about 30 minutes to the initial visit. Afterward, patients can use the app at their discretion to assist in self-care. The app also offers the option to connect to wearable devices.

This study involves the collection of quantitative and qualitative data as follows:

1. Quantitative data:

   • Cognitive status will be evaluated with Montreal Cognitive Assessment (MOCA) test
   • General health and disability status will be evaluated with Patient Reported Outcome Measures: Short Form Health Survey 36 (SF-36), WHO Disability Assessment Schedule (WHO DAS 2.0),
   • Psychological status will be evaluated with Center for Epidemiologic Studies Depression Scales (CES-D), General Anxiety Disorder 7-Item (GAD-7), Fatigue Severity Scale, Impact of Event Scale Revised (IES-R).
   • Clinical functioning will be evaluated using the modified Rankin scale (mRS) and the Clinical Functioning Information Tool (ClinFIT).

   Moreover, we will collect clinical variables such as: TFNE (Transient Focal Neurological Episodes), headache, seizures, hypertension, diabetes mellitus, dyslipidemia, obstructive sleep apnea (OSA), ischemic heart disease, atrial fibrillation, smoke, weight, height, body Mass Index (BMI), sedentariness, current use of estrogens and progestins, hyperhomocysteinemia, previous head injury, previous neurosurgery, previous blood transfusion, comorbidities, current medical therapy.

   • Data related to the index event will be collected: symptomatic or asymptomatic patient; type of index event, date of index event, age of onset, mRS for symptomatic patients.
   • Socio-demographic data will be also collected (age, gender, birth date, age at the first visit, date of the visit, race, level of education).

2. Qualitative data Semi-structured interviews will be developed and perform at T1 to obtain feedback from the end users (patients and/or caregivers) of the DT to understand their user experience.

Qualitative analysis of user experiences will be the main focus. The NVivo software will be used to identify topics and perform advanced queries.