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.
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.
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.
- Conditions
- Basic Life Support
- 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 group | Role | What they receive |
|---|---|---|
| Instructor-led training | Active comparator | Instructor-led training contents a supervised practical training for BLS, facilitated by a certified instructor. Receives: Other: Instructor-led training |
| Self-learning training | Experimental | Self-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.
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)
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
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
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
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
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
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.
- First posted7 Aug 2018
- Study start1 Mar 2014
- Primary completion31 Dec 2016
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Basic Life SupportStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Boras
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Heart Lung Foundation
- Responsible party
- Principal investigator, Helene Bylow, University of Boras
- Investigators
- Johan D Herlitz, Professor, Principal investigator, University of Borås Sweden
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 34457876Bylow 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03618888
- Acronym / sponsor ID
- Johan Herlitz
- Conditions
- Basic Life Support
- Keywords
- Out-of-Hospital Cardiac arrest, Cardiopulmonary Resuscitation, Automated External Defibrillator, Self-learning, Basic Life Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,623 participants (actual)
- Lead sponsor
- University of BorasUniversity, hospital or other
- Collaborators
- Swedish Heart Lung Foundation
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 7 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignments
| Arm | Type | Receives |
|---|---|---|
| Instructor-led training | Active comparator | Other: Instructor-led trainingInstructor-led training contents a supervised practical training for BLS, facilitated by a certified instructor. |
| Self-learning training | Experimental | Other: Self-learning trainingSelf-learning training is self-directed and contents practical training for BLS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Instructor-led trainingThe Instructor-led training contents a supervised practical training with a standard kit for training in BLS | Other | Instructor-led training |
| Self-learning trainingThe self-learning training contents a standard kit for self-directed training in BLS | Other | Self-learning training |
Primary outcome
Total score from Cardiff Test for retention at 6 months
Time frame: 6 months after intervention
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 secondary outcomes
Individual quality variables from PC SkillReporting System at baseline and at retention at 6 months.
Time frame: 0 days + 6 months later
Self-assessed theoretical knowledge from questionnaires at baseline and retention at 6 months
Time frame: 0 days + 6 months later
Self-assessed confidence from questionnaires at baseline and retention at 6 months
Time frame: 0 days + 6 months later
Self-assessed willingness from questionnaires at baseline and retention at 6 months
Time frame: 0 days + 6 months later
Theoretical knowledge on cardio vascular disease, symptoms and first actions from questionnaires at baseline and retention at 6 months
Time frame: 0 days + 6 months later
Self-assessed experience on learning outcome at baseline and retention at 6 months
Time frame: 0 days + 6 months later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Derived from this study: PubMed 34457876Bylow 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.
- Derived from this study: PubMed 30926451Bylow 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.
- Individual participant dataSharing planned: No. Data will be analysed and published on group level only
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan D Herlitz, Professor principal investigator
University of Borås Sweden
1 site in 1 country: see every site and its status.
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.