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Trial record 6 of 1057 for:    scale | Norway

Paramedic - Norwegian Acute Stroke Prehospital Project (ParaNASPP)

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ClinicalTrials.gov Identifier: NCT04137874
Recruitment Status : Recruiting
First Posted : October 24, 2019
Last Update Posted : October 30, 2019
Sponsor:
Collaborator:
Norwegian Air Ambulance Foundation
Information provided by (Responsible Party):
Maren Ranhoff Hov, Oslo University Hospital

Brief Summary:
The main aim of the study is to show that patients with suspected acute stroke met by the emergency medical service and assessed using the eSTROKE model including prehospital NIHSS and a mobile application will identify a higher number of patients with stroke, than those who receive conventional prehospital care.

Condition or disease Intervention/treatment Phase
Stroke Triage Paramedic Mobile Application Diagnostic Test: eSTROKE model Other: Control Not Applicable

Detailed Description:

Primary aims:

In patients with suspected stroke

  1. The proportion of patients hospitalized with a suspected acute stroke and discharged with a stroke diagnose is significantly increased using the ParaNASPP model compared with conventional prehospital care
  2. Time from onset to hospitalization is significantly reduced with the ParaNASPP model
  3. The ParaNASPP model identifies patients eligible for direct transportation for comprehensive stroke center

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1300 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: ParaNASPP is a stepped wedge cluster randomized controlled intervention trial (SW-RCT).
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnostics and Triage of Acute Stroke by the National Institute of Stroke Scale (NIHSS) by Paramedics, the ParaNASPP (Paramedic - Norwegian Acute Stroke Prehospital Project) Study
Actual Study Start Date : June 3, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Experimental: eSTROKE Diagnostic Test: eSTROKE model
The eSTROKE model includes an electronic learning module, a full day course with practical teaching of National Institute of Health Stroke Scale and a mobile application which will be used for communication with in-hospital stroke physician
Other Name: ParaNASPP

Active Comparator: Control
Conventional prehospital care
Other: Control
Conventional prehospital care




Primary Outcome Measures :
  1. Positive predictive value (PPV) of the ParaNASPP model to identify patients suffering acute stroke. [ Time Frame: On discharge from hospital - typically within 7 days. ]

Secondary Outcome Measures :
  1. Number of patients in hospitalized within the first 4 hours after symptom onset [ Time Frame: first 4 hours On admission ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients with suspected acute stroke met by emergency medical services (ambulance and rapid response car)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04137874


Contacts
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Contact: Maren Ranhoff Hov, MD, PhD +4793458492 maren.ranhoff.hov@norskluftambulanse.no
Contact: Else Charlotte Sandset, MD, PhD elsesa@ous-hf.no

Locations
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Norway
Prehospital services - Oslo University Hospital Recruiting
Oslo, Norway, 0424
Contact: Anne-Cathrine Braarud, MD, PhD       ANNNAE@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
Norwegian Air Ambulance Foundation

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Responsible Party: Maren Ranhoff Hov, Principal Investigator, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04137874     History of Changes
Other Study ID Numbers: 2018/2310
First Posted: October 24, 2019    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases