Smart-SABI: Digital Phenotyping of Stroke Access Barriers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Targeted Stroke Systems of Care Training (SABI-Guided).
- Who it may be relevant to
- Registry conditions: Stroke, Practice, Healthcare Disparities, Thrombectomy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Machine Learning Identification of Modifiable Access Barriers in Acute Ischemic Stroke: A Multimodal "Digital Phenotyping" Approach
Overview
This study aims to identify and quantify the non-clinical barriers (social, transport, and knowledge-based) that delay patient arrival at the hospital during an Acute Ischemic Stroke. By utilizing a multimodal approach that combines a validated patient questionnaire (SABI Tool), Geographic Information Systems (GIS) analysis, and biological markers (infarct volume), the investigators seek to develop a Machine Learning model capable of predicting high-risk phenotypes for pre-hospital delay. The ultimate goal is to validate "Social Determinants of Health" against objective biological outcomes.
Detailed description
Despite advances in stroke reperfusion therapies (thrombectomy and thrombolysis), pre-hospital delays remain the primary cause of preventable disability. Current triage systems rely heavily on clinical severity scales but fail to account for Social Determinants of Health (SDOH) that dictate onset-to-door times.
This is a prospective, observational, single-center cohort study designed to validate the "Stroke Access Barrier Identification" (SABI) tool using a "Triangulation Strategy."
The study employs three distinct data sources:
Subjective: Administration of the SABI questionnaire to assess cognitive, physical, and structural barriers.
Geospatial (Objective): Network-based GIS analysis to calculate precise drive-time isochrones and public transit density, validating patient reports of transport difficulty.
Biological (The "Anchor"): Correlation of barrier scores with Infarct Core Volume (measured via CT-Perfusion/MRI) and 90-day functional outcomes.
Data will be processed using interpretable Machine Learning algorithms (Random Forest / XGBoost) and SHAP (SHapley Additive exPlanations) values to identify the specific social features that most strongly predict delayed presentation and increased brain tissue loss.
Interventions
- Behavioral Targeted Stroke Systems of Care Training (SABI-Guided)
Implementation of targeted barrier-reduction strategies at selected stroke centers based on baseline SABI profiles. The primary intervention consists of EMS Training Programs focused on stroke recognition, triage protocols, and rapid transport to Mechanical Thrombectomy (MT) capable centers. Comparator/Control: Pre-intervention period (historical control) where standard of care was utilized without the targeted SABI-guided training. Post-Intervention: Assessment of MT utilization rates and SAB
Primary outcome measures
- Correlation of SABI Score with Infarct Core Volume (The Biological Anchor) [Time frame: Baseline (Admission Imaging)]
Secondary outcome measures (3)
- Predictive Accuracy of ML Model for "High-Risk" Delay [Time frame: Baseline through Study Completion (12 months)]
- Agreement between Subjective Transport Barriers and GIS Metrics [Time frame: Baseline]
- Functional Outcome (mRS) at 90 Days [Time frame: 90 Days post-discharge]
Eligibility criteria
Inclusion criteria
- Diagnosis of Acute Ischemic Stroke (AIS) confirmed by neuroimaging (CT or MRI). Age $\\geq$ 18 years. Presentation to the Emergency Department within 7 days of symptom onset (to ensure recall accuracy).
Patient or Legally Authorized Representative (LAR) able to provide informed consent.
Verifiable residential address (required for GIS analysis).
Exclusion criteria
- In-hospital stroke onset. Stroke mimics (e.g., seizure, complex migraine, hypoglycemia). Hemorrhagic stroke. Homelessness or lack of fixed address (precludes geospatial analysis). Severe aphasia or cognitive deficit without an available surrogate/caregiver to complete the questionnaire.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Egypt · 1 center
- Alexandria Stroke and Neurointervention Center — Alexandria
Identifiers
NCT: NCT07257146 · MENASINO105 · NALAregistrySABI2026