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Basic Life SupportNCT03618888

Pedagogical Aspects on Training in Basic Life Support

A study testing Instructor-led training and Self-learning training in people with Basic Life Support, run by University of Boras at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Basic Life Support
What is being tested?
Instructor-led training and Self-learning training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,623 participants
Where
1 siteSweden
Study dates
1 Mar 2014to 31 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • University of Borås Sweden

    Borås, SE 501 90

Other trials in Sweden

About this study

Official title: Pedagogical Aspects on Education in Basic Life Support: A Cluster Randomized Trial on Effectiveness, Comparing Different Educational Methods for Adults in the Society of Sweden.

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.

Read the detailed description

Introduction: The single most important factor for survival from sudden cardiac arrest (SCA) is to minimize the time from cardiac arrest to cardiopulmonary resuscitation (CPR) and to provide an electric chock through the heart with an automated external defibrillator (AED). Early start with CPR-AED increases the chance of survival two to four times. It is therefore important that as many people as possible have knowledge to quickly identify SCA and to start CPR-AED.

In this research, education efforts are directed for the adult public at workplaces in Sweden. The Investigator have designed an intervention in accordance to guidelines from European Resuscitation Council (ERC) and the Swedish national education for Basic Life Support (BLS).

This is a cluster randomized trial primarily comparing in the first study, instructor-led training as the control group and self-learning training as the experimental group. In the second study the Investigator plan to compare a preparatory web-education on CVD before the BLS training versus no web-education before the BLS. The Investigator have conducted quality tests on practical skills on BLS, administered questionnaires to the participants about theoretical knowledge, self-assessed confidence and willingness to act in a real-life SCA situation. It is crucial to be able to identify factors that affect knowledge and retention after BLS training and the willingness to intervene in an acute situation.

Background: With modern IT technology, several different options and learning strategies are available. At the same time pedagogical thoughts have emerged on learning. Education can be instructor-led or self-directed and with preparatory courses for theoretical knowledge. The quality of BLS skills and theoretical knowledge can be measured through validated instruments. Against this background, the research goal is to identify how the study can improve retention and which training methods for BLS that should be recommended for the public in the future.

Objectives: The overall objective is to increase survival from OHCA. The aim is to identify factors that affect retention and contributes to intended practical skills, theoretical knowledge and willingness to act after BLS training and whether these goals are affected by the type of training intervention.

Hypothesis: The main hypothesis is that retention of practical skills after BLS training is affected by the type of educational intervention. The hypothesis in the first study is that an instructor present at the time of training have a positive impact on retention six months after the intervention compared to self-directed training. In the second study the hypothesis is that a preparatory web-education on CVD before the BLS has a positive impact on retention six months after intervention compared to no web-education.

Questions: The Primary question is which intervention is most effective for the total score and contributes to intended practical skills and adherence to protocol, the BLS algorithm, six months after the intervention. Secondary questions deal with if other variables such as practical skills, theoretical knowledge, self-assessed confidence and willingness to intervene in a SCA situation are affected when comparing each intervention both direct after and six months after training.

Method: Voluntary, participants from a BLS project at workplaces in Sweden have been included. The participants have been randomized from a randomization list and organized for the study, from an independent coordinator. After training and at six months, a quantitative approach and data collection measured the quality of practical skills in a simulated SCA scenario, on a Laerdal Resusci Anne manikin, connected to the PCSkillReporting system. The assessor was blinded for the type of training intervention. At data collection, the variables were structured according to a modified international quality test, Cardiff Test of basic life support and automated external defibrillation (Cardiff Test) that scored adherence to the treatment algorithm and practical skills. The modified Cardiff Test included 19 variables with a total score of 70 points. A questionnaire scored theoretical knowledge, self-assessed confidence and willingness to act in a real-life situation. At the practical quality tests, the total score was the primary endpoint with other individual variables as the secondary endpoint.

Study population: Strategic sampling was used to include participants from different workplaces in a number of counties in Sweden.

Planned Studies: 1) Self-learning training versus Instructor-led training. 2) A preparatory web-education on CVD before the BLS training versus no web-education before the BLS training. 3) A register study on bystander activity 4) Instructor-led training versus subgroups of training from the BLS intervention project.

Statistics: All statistical analyses will be analysed in SASforwindows and calculated on a cluster level with an alpha level of five percent.

Ethical considerations: Ethical principles for research are carefully considered in the research process. Ethical vetting from Ethical Review of Research, involving Humans is approved (Regional Ethical Review Board in Gothenburg, diaries number 134-14) and Guidelines from the Swedish Research Council, Good Research Practice is actively used. Information has been given both individually to all participants and to the working places. All participant had to read and sign a personal consent form before participating. The result will be published according to the Declaration of Helsinki.

Being tested
Instructor-led training, Self-learning training
Keywords
Out-of-Hospital Cardiac arrest, Cardiopulmonary Resuscitation, Automated External Defibrillator, Self-learning, Basic Life Support
Medical subject headings
Out-of-Hospital Cardiac Arrest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Instructor-led trainingOther

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

  • Self-learning trainingOther

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

Study groups in NCT03618888
Study groupRoleWhat they receive
Instructor-led trainingActive comparatorInstructor-led training contents a supervised practical training for BLS, facilitated by a certified instructor.
Receives: Other: Instructor-led training
Self-learning trainingExperimentalSelf-learning training is self-directed and contents practical training for BLS
Receives: Other: Self-learning training

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months after intervention

Secondary outcomes (6)
  1. Individual quality variables from PC SkillReporting System at baseline and at retention at 6 months.

    Individual quality variables from the instrument and data program PC SkillReporting system on the participants quality on practical skills for Basic Life Support at baseline as post-test direct after intervention, as retention-test at six months later and as a change in quality of Basic Life Support

    Measured: 0 days + 6 months later

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

    Self-assessed theoretical knowledge with data collected from the participants individual questionnaires at baseline as post-test direct after intervention and as retention-test at six months later.

    Measured: 0 days + 6 months later

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

    Self-assessed confidence after the intervention with data collected from the participants individual questionnaires at baseline and retention at six months later.

    Measured: 0 days + 6 months later

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

    Self-assessed willingness to act in a real-life sudden cardiac arrest situation with data collected from the participants individual questionnaires at baseline and retention at six months later.

    Measured: 0 days + 6 months later

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

    Theoretical knowledge on cardio vascular disease, first actions and healthy life style factors with data collected from the participants individual questionnaires at baseline and retention at six months later. Secondary Outcome for study 2) A preparatory web-education on CVD before the BLS training versus no web-education before the BLS training.

    Measured: 0 days + 6 months later

  6. Self-assessed experience on learning outcome at baseline and retention at 6 months

    Self-assessed experience on the participants individual learning outcome at baseline and retention at six months with data collected from the participants individual questionnaires at baseline and retention at six months later. Secondary Outcome for study 4) Instructor-led training versus subgroups of training from the BLS intervention project.

    Measured: 0 days + 6 months later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2018
  2. Study start1 Mar 2014
  3. Primary completion31 Dec 2016
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignments
Masking
None (open label)
Enrolment
2,623 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03618888
Sponsor's protocol ID
Johan Herlitz
Status last verified
Mar 2020
First submitted
21 Jul 2018
Last updated
27 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data will be analysed and published on group level only

Publications

  • 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.

    PubMed 34457876
  • 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.

    PubMed 30926451

Questions about this trial

What is this clinical trial studying?

A study testing Instructor-led training and Self-learning training in people with Basic Life Support, run by University of Boras at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total score from Cardiff Test for retention at 6 months (time frame: 6 months after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03618888, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2020.

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