Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Patients in the Arm 2 will:
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:
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:
Quantitative data:
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard secondary prevention + digital twin | Experimental | 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. |
|
| Standard secondary prevention only | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI | Device | STRATIF-AI apps will be used as an integral part of the dialogue with patients during thesecondary prevention phase |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feedback from users | To get initial feedback on the patients' experience regarding the use of the STRATIF-AIplatform in the secondary prevention phase. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| feedback to developers | feedback to development team. This will be used as a starting point for future studiesand for conversations with other clinics, politicians, and policy maker. | 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matilde Leonardi, MD | Contact | +39 02 2394 2511 | 2521 | matilde.leonardi@istituto-besta.it |
| Barbara Maistrello | Contact | +39 02 2394 2521 | 2521 | barbara.maistrello@istituto-besta.it |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Istituto Neurologico Carlo Besta | Recruiting | Milan | Michigan | 20133 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35972776 | Result | Elkefi S, Asan O. Digital Twins for Managing Health Care Systems: Rapid Literature Review. J Med Internet Res. 2022 Aug 16;24(8):e37641. doi: 10.2196/37641. | |
| 34000646 | Result | Herrgardh T, Madai VI, Kelleher JD, Magnusson R, Gustafsson M, Milani L, Gennemark P, Cedersund G. Hybrid modelling for stroke care: Review and suggestions of new approaches for risk assessment and simulation of scenarios. Neuroimage Clin. 2021;31:102694. doi: 10.1016/j.nicl.2021.102694. Epub 2021 May 7. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| healthy dialogue | Other | Patients allocated to arm 2 will receive only standard secondary prevention, which includes typical treatments and monitoring protocols used for patients with stroke, Moyamoya disease, and CAA |
|
| 37620982 | Result | Marwaa MN, Guidetti S, Ytterberg C, Kristensen HK. Using experience-based co-design to develop mobile/tablet applications to support a person-centred and empowering stroke rehabilitation. Res Involv Engagem. 2023 Aug 24;9(1):69. doi: 10.1186/s40900-023-00472-z. |
| 38228908 | Result | Prust ML, Forman R, Ovbiagele B. Addressing disparities in the global epidemiology of stroke. Nat Rev Neurol. 2024 Apr;20(4):207-221. doi: 10.1038/s41582-023-00921-z. Epub 2024 Jan 16. |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D009072 | Moyamoya Disease |
| D016657 | Cerebral Amyloid Angiopathy |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002340 | Carotid Artery Diseases |
| D002539 | Cerebral Arterial Diseases |
| D020765 | Intracranial Arterial Diseases |
| D001157 | Arterial Occlusive Diseases |
| D000686 | Amyloidosis |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided