NCT03618888

Brief Summary

Cardio vascular disease (CVD) including out-of-hospital cardiac arrest (OHCA) is still the leading cause of death in a global perspective. Start of cardiopulmonary resuscitation (CPR) with automated external defibrillator (AED) may double or quadruple survival. Scientific research on education in Basic Life Support (BLS) in the society is active in different part of Europe but low in Sweden. The aim of this study is to investigate the effectiveness and retention after different training interventions in BLS and willingness to act in a real-life cardiac arrest situation in the society of Sweden, based on European Resuscitation Council (ERC) guidelines. This is an experimental cluster randomized trial, including participants from a BLS education project in Sweden.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,623

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 7, 2018

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 27, 2020

Status Verified

March 1, 2020

Enrollment Period

2.8 years

First QC Date

July 21, 2018

Last Update Submit

March 26, 2020

Conditions

Keywords

Out-of-Hospital Cardiac arrestCardiopulmonary ResuscitationAutomated External DefibrillatorSelf-learningBasic Life Support

Outcome Measures

Primary Outcomes (1)

  • Total score from Cardiff Test for retention at 6 months

    Total score from the modified instrument Cardiff Test on the participants individual practical skills and adherence to the Basic Life Support algorithm in retention-test at six months after intervention.

    6 months after intervention

Secondary Outcomes (6)

  • Individual quality variables from PC SkillReporting System at baseline and at retention at 6 months.

    0 days + 6 months later

  • Self-assessed theoretical knowledge from questionnaires at baseline and retention at 6 months

    0 days + 6 months later

  • Self-assessed confidence from questionnaires at baseline and retention at 6 months

    0 days + 6 months later

  • Self-assessed willingness from questionnaires at baseline and retention at 6 months

    0 days + 6 months later

  • Theoretical knowledge on cardio vascular disease, symptoms and first actions from questionnaires at baseline and retention at 6 months

    0 days + 6 months later

  • +1 more secondary outcomes

Study Arms (2)

Instructor-led training

ACTIVE COMPARATOR

Instructor-led training contents a supervised practical training for BLS, facilitated by a certified instructor.

Other: Instructor-led training

Self-learning training

EXPERIMENTAL

Self-learning training is self-directed and contents practical training for BLS

Other: Self-learning training

Interventions

The Instructor-led training contents a supervised practical training with a standard kit for training in BLS

Instructor-led training

The self-learning training contents a standard kit for self-directed training in BLS

Self-learning training

Eligibility Criteria

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

You may qualify if:

  • Adults in society over eighteen years old
  • Working at workplaces outside hospital
  • Without training in BLS or within the past five years
  • A completed and signed consent form.

You may not qualify if:

  • Participants younger than 18 years old
  • Undergone training on BLS within the past five years
  • Working at hospital as health care personnel
  • Do not want to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Borås Sweden

Borås, SE 501 90, Sweden

Location

Related Publications (2)

  • Bylow H, Karlsson T, Lepp M, Claesson A, Lindqvist J, Svensson L, Herlitz J. Learning Outcome After Different Combinations of Seven Learning Activities in Basic Life Support on Laypersons in Workplaces: a Cluster Randomised, Controlled Trial. Med Sci Educ. 2020 Nov 18;31(1):161-173. doi: 10.1007/s40670-020-01160-3. eCollection 2021 Feb.

  • Bylow H, Karlsson T, Claesson A, Lepp M, Lindqvist J, Herlitz J. Self-learning training versus instructor-led training for basic life support: A cluster randomised trial. Resuscitation. 2019 Jun;139:122-132. doi: 10.1016/j.resuscitation.2019.03.026. Epub 2019 Mar 26.

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular Diseases

Study Officials

  • Johan D Herlitz, Professor

    University of Borås Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Parallel Assignments
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RNAN, Master of Pedagogy, PhD Student, University of Gothenburg, University of Boras

Study Record Dates

First Submitted

July 21, 2018

First Posted

August 7, 2018

Study Start

March 1, 2014

Primary Completion

December 31, 2016

Study Completion

December 31, 2019

Last Updated

March 27, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Data will be analysed and published on group level only

Locations