NCT04137874

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,300

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 24, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

September 24, 2021

Status Verified

September 1, 2021

Enrollment Period

2.1 years

First QC Date

October 11, 2019

Last Update Submit

September 23, 2021

Conditions

StrokeTriageParamedicMobile Application

Outcome Measures

Primary Outcomes (1)

  • Positive predictive value (PPV) of the ParaNASPP model to identify patients suffering acute stroke.

    On discharge from hospital - typically within 7 days.

Secondary Outcomes (1)

  • Number of patients in hospitalized within the first 4 hours after symptom onset

    first 4 hours On admission

Study Arms (2)

eSTROKE

EXPERIMENTAL
Diagnostic Test: eSTROKE model

Control

ACTIVE COMPARATOR

Conventional prehospital care

Other: Control

Interventions

eSTROKE modelDIAGNOSTIC_TEST

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

Also known as: ParaNASPP
eSTROKE
ControlOTHER

Conventional prehospital care

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prehospital services - Oslo University Hospital

Oslo, 0424, Norway

Location

Related Publications (4)

  • Fagerheim Bugge H, Guterud M, Larsen K, Toft M, Hov MR, Sandset EC. Presenting symptoms and diagnostic accuracy of prehospital stroke scales for patients with suspected mild minor stroke. Eur Stroke J. 2026 Jan 1;11(1):23969873251360592. doi: 10.1093/esj/23969873251360592.

    PMID: 41614523DERIVED

  • Fagerheim Bugge H, Guterud M, Larsen K, Toft M, Hov MR, Sandset EC. Presenting symptoms and diagnostic accuracy of prehospital stroke scales for patients with suspected mild minor stroke. Eur Stroke J. 2025 Aug 11:23969873251360592. doi: 10.1177/23969873251360592. Online ahead of print.

    PMID: 40785620DERIVED

  • Guterud M, Fagerheim Bugge H, Roislien J, Kramer-Johansen J, Toft M, Ihle-Hansen H, Bache KG, Larsen K, Braarud AC, Sandset EC, Ranhoff Hov M. Prehospital screening of acute stroke with the National Institutes of Health Stroke Scale (ParaNASPP): a stepped-wedge, cluster-randomised controlled trial. Lancet Neurol. 2023 Sep;22(9):800-811. doi: 10.1016/S1474-4422(23)00237-5.

    PMID: 37596006DERIVED

  • Bugge HF, Guterud M, Bache KCG, Braarud AC, Eriksen E, Fremstad KO, Ihle-Hansen H, Ingebretsen SH, Kramer-Johansen J, Larsen K, Roislien J, Thorsen K, Toft M, Sandset EC, Hov MR. Paramedic Norwegian Acute Stroke Prehospital Project (ParaNASPP) study protocol: a stepped wedge randomised trial of stroke screening using the National Institutes of Health Stroke Scale in the ambulance. Trials. 2022 Feb 4;23(1):113. doi: 10.1186/s13063-022-06006-4.

    PMID: 35120559DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: ParaNASPP is a stepped wedge cluster randomized controlled intervention trial (SW-RCT).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 11, 2019

First Posted

October 24, 2019

Study Start

June 3, 2019

Primary Completion

July 1, 2021

Study Completion

October 1, 2021

Last Updated

September 24, 2021

Record last verified: 2021-09

Locations

NO(1)