- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07318376
Effect of E-learning Training on National Institutes of Health Stroke Scale (NIHSS) and Modified Rankin Scale (mRS) Assessment
Effect of E-learning Training on National Institutes of Health Stroke Scale (NIHSS) and Modified Rankin Scale (mRS) Assessment Performance: a Web-based Randomized Controlled Trial
The goal of this web-based randomized clinical trial is to evaluate whether an e-learning training program improves the accuracy of National Institutes of Health Stroke Scale (NIHSS) and modified Rankin Scale (mRS) assessments among practicing paramedics in French-speaking Switzerland who have not previously received formal training in these scales.
The main questions it aims to answer are:
- Does e-learning training improve performance on a standardized NIHSS assessment quiz compared with no prior training?
- Does e-learning training improve the accuracy of mRS assessment using case-based clinical vignettes compared with no prior training?
Researchers will compare paramedics who complete the NIHSS and mRS e-learning modules before assessment (intervention group) with paramedics who complete the assessments without prior training (control group) to determine whether e-learning training leads to higher assessment performance scores.
Participants will:
- Provide electronic informed consent via a secure web-based platform
- Be randomly assigned to either the intervention group or the control group
- Complete either the e-learning modules before assessment or the assessments before training, depending on group allocation
- Complete an online NIHSS quiz and mRS case-based vignettes
- Receive access to the NIHSS and mRS e-learning modules by the end of the study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Loric Stuby
- Phone Number: +41228001212
- Email: l.stuby@gt-ambulances.ch
Study Contact Backup
- Name: Laurent Suppan
- Email: laurent.suppan@hug.ch
Study Locations
-
-
Canton of Geneva
-
Geneva, Canton of Geneva, Switzerland, 1201
- Genève TEAM Ambulances
-
Contact:
- Loric Stuby
- Phone Number: +41228001212
- Email: l.stuby@gt-ambulances.ch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Holding a paramedic title (recognized in Switzerland)
- Currently actively practicing in Switzerland
- Fluent in French (all study material will be provided in French)
Exclusion Criteria:
- Previously completed formal training on either the NIHSS or the mRS.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
Control group: Participants will first complete the NIHSS quiz and mRS case vignettes without prior training.
|
|
|
Experimental: Intervention group
Participants will follow the e-learning modules (NIHSS and mRS).
|
Educational intervention by the mean of an e-learning modules (NIHSS and mRS).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Performance on a NIHSS 50-item quiz
Time Frame: From enrollment to the end of the study path in a timeframe of maximum 4 weeks.
|
The primary outcome will be the performance on a NIHSS 50-item quiz consisting in 3 full assessments of a patient (3x15 items) plus 5 general questions (each question scores 1 point if correct, maximum total of 50 points).
|
From enrollment to the end of the study path in a timeframe of maximum 4 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Performance of mRS assessment
Time Frame: From enrollment to the end of the study path in a timeframe of maximum 4 weeks.
|
The secondary outcome will be the performance of mRS assessment of about 10 newly developed case-based vignettes (each question scores 1 point if correct, maximum total of 10 points).
|
From enrollment to the end of the study path in a timeframe of maximum 4 weeks.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Loric Stuby, Genève TEAM Ambulances
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Randomized controlled trial
- Emergency Medical Services
- Educational intervention
- Paramedics
- Prehospital care
- E-learning
- Distance education
- Web-based training
- Modified Rankin Scale (mRS)
- Clinical competence
- Stroke assessment
- National Institutes of Health Stroke Scale (NIHSS)
- Performance assessment
- Continuing professional education
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIHSS-6
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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