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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feedback from users
研究概览
简要总结
The goal of this clinical trial is to obtain initial feedback on the implementation of the STRATIF-AI platform and digital twin in the secondary prevention phase in patients with stroke, Moyamoya disease and Cerebral amyloid angiopathy, including adults of both sexes.
The main questions it aims to answer is: how is the patients' experience regarding the use of the STRATIF-AI platform? Researchers will compare Arm 1, who use the STRATIF-AI app in addition to standard secondary prevention, against Arm 2, who receive standard secondary prevention only, to collect feedback regarding the platform usability.
Participants in the Arm 1 will:
- Complete cognitive and psychological assessments at the time of the first visit and after six months
- Follow the indications received from the clinician for standard secondary prevention
- Use the STRATIF-AI app daily for health management
- Optionally, purchase wearable devices that connect to the app.
- Participate in interviews at the six-month mark to share their experiences with the app.
Patients in the Arm 2 will:
- Complete cognitive and psychological assessments at the time of the first visit and after six months
- Follow the indications received from the clinician for standard secondary prevention
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People aged ≥ 18
- •Clinical and neuroradiological diagnosis of stroke (TAC or MR); diagnosis of CAA based on Boston 2.0 criteria; diagnosis of Moyamoya disease based on diagnostic criteria
- •MOCA total score ≥ 23
- •modified Rankin Scale (mRS) ≤ 2
- •First-time patients at the Besta Institute
- •Ability to sign informed consent
- •Possibility of performing a brain MRI
排除标准
- •Patients with transient neurological deficits that resolve within an hour and normal brain imaging
- •Patient under legal protection or deprived of liberty by judicial or administrative decision
- •Patient whose follow-up will be impossible
- •Contraindication to magnetic resonance imaging and/or Digital subtraction angiography (DSA)
- •Pregnant patients
- •Known or suspected drug or alcohol abuse
研究组 & 干预措施
Standard secondary prevention + digital twin
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.
干预措施: AI (Device)
Standard secondary prevention only
Patients allocated to this arm will receive only standard secondary prevention, which includes typical treatments and monitoring protocols used for patients with stroke, Moyamoya disease, and CAA.
干预措施: healthy dialogue (Other)
结局指标
主要结局
Feedback from users
时间窗: 12 months
To get initial feedback on the patients' experience regarding the use of the STRATIF-AIplatform in the secondary prevention phase.
次要结局
- feedback to developers(12 months)