NCT05959746RecruitingNot Applicable
Clinical Development of a Tool for Optimized Self- and Hetero-diagnosis of Stroke Using Artificial Intelligence: Stage1- Collection of Video-clinical Data in a Pragmatic Situation.
Centre Hospitalier Universitaire de Nīmes2 sites in 1 country300 target enrollmentStarted: August 28, 2023Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 300
- Locations
- 2
- Primary Endpoint
- Usable video recording made by the patient
Study Overview
Brief Summary
The study authors aim to form a collection of video-clinical data in a pragmatic situation to enable the development of relevant AI algorithms (for both hetero- and self-diagnosis modes). The aim is to optimize management through early diagnosis (self- and hetero-diagnosis) and thus to reduce sequelae disability.
The study authors hypothesize that some stroke patients will be able to successfully perform a self-test consisting of a few exercises dictated by an application on a smartphone or tablet and recorded on video.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients treated in the emergency department or hospitalized in the NICU at the CHU de Nîmes for suspected stroke or transient ischemic attack in the acute phase (<72h), with or without motor deficit
- •Patient to be seen again in consultation within 4 months
- •Patient has given free and informed consent and signed the consent form. If the patient is not in a position to give consent, it must be obtained, prior to filming the first video, from the designated trusted support person or relatives present. In this case, data will not be used until the patient is able to sign the consent (CNIL).
- •Patient affiliated or beneficiary of a health insurance scheme
Exclusion Criteria
- •Patients who do not speak or read French.
- •Patient in a period of exclusion determined by another study.
- •Patient under court protection, guardianship or curatorship.
- •Pregnant, parturient or breast-feeding patients.
Arms & Interventions
Patients with suspected acute stroke
Experimental
Intervention: AI-STROKE application (Other)
Outcomes
Primary Outcomes
Usable video recording made by the patient
Time Frame: Day 0
Recording using AI-STROKE application
Usable video recording made by the hospital worker
Time Frame: Day 0
Recording using AI-STROKE application
Secondary Outcomes
- Acceptability of self-recording by patients(Month 3)
- Patient-reported ease of self-recording(Month 3)
- Feasibility of patient self-recording(Month 3)
- Degree of disability following stroke(Month 3)
- Usable video recording made by the patient(Month 3)
- Usable video recording made by the hospital worker(Month 3)
- Stroke severity(Month 3)
Investigators
Study Sites (2)
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