NCT03141528

Brief Summary

This study investigates whether there is a difference in the BLS skills in first year medical students directly after training and three months later, when randomly assigned to self-learning versus instructor-led training courses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

February 9, 2017

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 5, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2017

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

January 13, 2020

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

21 days

First QC Date

February 9, 2017

Results QC Date

November 19, 2018

Last Update Submit

January 7, 2020

Conditions

Keywords

Self-learningInstructor-led learningLong-term retention

Outcome Measures

Primary Outcomes (1)

  • Percentage of Correct Compressions

    The percentage of correct compressions obtained from the printed report from the Laerdal Skill Reporter.

    after first BLS course and 3 months later

Secondary Outcomes (17)

  • Assessment of the Participants BLS Competences After Test

    after first BLS course and 3 months later

  • Self-assessment of the Participants BLS Competences Before Test

    before first BLS course and 3 months later

  • Assessment of the Teaching Method

    after first BLS course

  • Average Ventilation Volume

    after first BLS course and 3 months later

  • Number of Ventilations Per Minute

    after first BLS course and 3 months later

  • +12 more secondary outcomes

Study Arms (2)

Instructor-led learning

ACTIVE COMPARATOR

This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)

Other: Instructor-led learning

Self-learning

EXPERIMENTAL

This group will Train alone without supervision and without communicating with the other participants.

Other: Self-learning

Interventions

Training without supervision

Self-learning

Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)

Instructor-led learning

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • First year medical students at the University of Bern participating in the course "Erweiterte Erste Hilfe für Studierende der Humanmedizin" with written informed consent.

You may not qualify if:

  • Students with professional BLS-experience, unable to perform BLS, or missing informed consent will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Inselspital

Bern, 3010, Switzerland

Location

Results Point of Contact

Title
Dr. Tina Pedersen
Organization
Inselspital

Study Officials

  • Robert Greif, MD

    University Hospital Bern Inselspital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2017

First Posted

May 5, 2017

Study Start

February 9, 2017

Primary Completion

March 2, 2017

Study Completion

July 7, 2017

Last Updated

January 13, 2020

Results First Posted

January 13, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations