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Cerebrovascular DisordersNCT05737420

Video-call Assisted Assessment of Acute Stroke in Addition to Stroke Severity Scales in a Prehospital Setting

A study testing Video call in people with Cerebrovascular Disorders and Brain Diseases, run by University of Southern Denmark at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to investigate whether a live stream video between the on-call neurologist and the emergency medical services is feasible. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Video call
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteDenmark
Study dates
6 Jul 2023to 30 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Suspected stroke within 24 hours from onset (confirmed with Pre-hospital stroke score 1 ≥1)
  • Catchment area of Hospital Sønderjylland
  • Deferred informed consent obtained from patient or patient surrogate

Who cannot join

  • In-hospital stroke or private transport to hospital
  • Unconsciousness defined as Glascow Coma Score (GCS) ≤ 8 (as they cannot be rated)

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Sygehus Soenderjylland

    Aabenraa, 6200

Other trials in Denmark

About this study

Official title: Video-call Assisted Assessment of Acute Stroke in Addition to Stroke Severity Scales in a Prehospital Setting: A Cluster Randomised Pilot Trial

This study aims to investigate whether a live stream video between the on-call neurologist and the emergency medical services is feasible.

Read the detailed description

Multiple stroke severity scales have been coined in order to examine patients suspected of stroke in a prehospital setting in order to identify and transfer patients eligible for thrombectomy directly to a comprehensive stroke centre (CSC). However, performance and feasibility vary greatly in different validation studies suggesting that those outcomes are greatly dependent on other factors i.e. acceptance amongst stakeholders, implementation process, patient segment etc. Some recent studies have shown promising results using telemedicine i.e. video solutions between emergency medical services (EMS) personnel and on-call neurologist in examining patients suspected of stroke in the prehospital phase. The investigators will perform this trial to examine whether a cluster randomised trial with video call assisted assessment of patients suspected of stroke in a prehospital setting is an appropriate trial design and feasible with regard to recruitment and retention, acceptability among stakeholders (EMS and neurologists) as well as patients and lastly with regard to stakeholders' adherence to protocol.

Being tested
Video call
Medical subject headings
Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Stroke, Nervous System Diseases, Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Video callDiagnostic test

    The on-call neurologist can see and communicate with the patient via live stream video-call.

Study groups in NCT05737420
Study groupRoleWhat they receive
Interventional video callExperimentalAll patients suspected of stroke in a prehospital setting are examined according to a prehospital stroke score. The emergency services personnel then contact the on-call neurologist and a live video stream is initiated. The on-call neurologist then examines the patient via the video-call.
Receives: Diagnostic Test: Video call
Control with standard careNo interventionAll patients suspected of stroke in a prehospital setting are examined according to a prehospital stroke score. The emergency services personnel then contact the on-call neurologist by telephone. .

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment Rate

    Rate of patients included in the trial amongst all patients screened

    Measured: Through study completion, approximately 2 months

  2. Exclusion rate

    rate of patients excluded from participation amongst all patients screened

    Measured: Through study completion, approximately 2 months

  3. Attrition rate

    rate of patients and data lost

    Measured: Through study completion, approximately 5 months

  4. Adherence to protocol by the Emergency Medical Services

    Evaluation of missing data in the clinical examination prehospital in Pre-hospital patient journal

    Measured: Baseline (Prehospital examination of patient conducted by Emergency Medical Services)

  5. Adherence to protocol by the neurologist prehospital

    Evaluation of missing data in the clinical examination conducted with video

    Measured: Baseline (Prehospital examination of patient conducted on video by neurologists)

  6. Adherence to protocol by the neurologist intrahospital

    Evaluation of missing data in the National Institute of Health Stroke Scale conducted intrahospital by neurologist

    Measured: At admission

  7. Stakeholder Feedback Survey

    Mixed open-ended and closed (Likert type response) questions to assess trial and intervention acceptability

    Measured: immediately after the intervention

  8. Patient Feedback Survey

    Semistructured interview with open-ended and closed (Likert type response) questions to assess intervention acceptability

    Measured: Between the day after admission and 5 days after admission

Secondary outcomes (8)

  1. Acute ischemic stroke with Large Vessel Occlusion on neuroimaging

    Acute ischemic stroke with Large Vessel Occlusion (LVO) on neuroimaging (computer tomography (CT), CT angiography, magnetic resonance imaging (MRi), MR angiography or catheter-based angiography). LVO is defined as an occlusion or sub-occlusion of the intracranial internal carotid artery, middle cerebral artery M1 or M2, basilar artery. Sign of a dense cerebral artery on CT is also considered LVO positive.

    Measured: At admission

  2. Other large vessel Acute ischemic stroke

    Neuroimaging (computer tomography (CT), CT angiography, magnetic resonance imaging (MRi), MR angiography or catheter-based angiography) with AIS with occlusion or sub-occlusion of either anterior cerebral artery A1 or A2, posterior cortical artery P1 or intracranial vertebral artery

    Measured: at admission

  3. Other Acute ischemic stroke

    Neuroimaging (computer tomography (CT), CT angiography, magnetic resonance imaging (MRi), MR angiography or catheter-based angiography) with Acute ischemic stroke

    Measured: at admission

  4. Haemorrhagic stroke

    Neuroimaging (computer tomography (CT), CT angiography, magnetic resonance imaging (MRi), MR angiography or catheter-based angiography) with intra cranial haemorrhage (ICH)

    Measured: at admission

  5. Duration of examination on video-call

    Duration of examination on video-call measured in minutes

    Measured: up to 60 minutes (prior to admission, prehospital phase)

  6. Mimic mistaken for stroke

    Mimic mistaken for stroke evaluated as discrepancy between stroke as tentative diagnoses at primary contact from EMS and final diagnosis at discharge

    Measured: Through study completion, approximately 2 months

  7. Prehospital time on scene

    Time on scene from arrival of Emergency Medical Services to departure of Emergency Medical Services measured in minutes

    Measured: up to 60 minutes (at prehospital contact)

  8. 90 days modified Rankin Scale

    Modified Rankin Scale score in stroke patients as evaluated through a structured telephone-based interview performed by a central assessor who is blinded to group assignment

    Measured: 90 days post admission date

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2023
  2. Study start6 Jul 2023
  3. Primary completion6 Oct 2023
  4. Study completion30 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05737420
Sponsor's protocol ID
SHS-Neuro-1-2023
Status last verified
May 2024
First submitted
6 Feb 2023
Last updated
31 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nguyen TTM, van den Wijngaard IR, Bosch J, van Belle E, van Zwet EW, Dofferhoff-Vermeulen T, Duijndam D, Koster GT, de Schryver ELLM, Kloos LMH, de Laat KF, Aerden LAM, Zylicz SA, Wermer MJH, Kruyt ND. Comparison of Prehospital Scales for Predicting Large Anterior Vessel Occlusion in the Ambulance Setting. JAMA Neurol. 2021 Feb 1;78(2):157-164. doi: 10.1001/jamaneurol.2020.4418.

    PubMed 33252631

  • Mazya MV, Berglund A, Ahmed N, von Euler M, Holmin S, Laska AC, Mathe JM, Sjostrand C, Eriksson EE. Implementation of a Prehospital Stroke Triage System Using Symptom Severity and Teleconsultation in the Stockholm Stroke Triage Study. JAMA Neurol. 2020 Jun 1;77(6):691-699. doi: 10.1001/jamaneurol.2020.0319.

    PubMed 32250423

Questions about this trial

What is this clinical trial studying?

A study testing Video call in people with Cerebrovascular Disorders and Brain Diseases, run by University of Southern Denmark at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment Rate (time frame: Through study completion, approximately 2 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05737420, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.

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