Cardiac ArrestNCT03151785
The School Lifesavers Study
A study testing Face-to-face BLS training, Lifesaver training and Lifesaver and Face-to-Face BLS training in people with Cardiac Arrest, run by University of Birmingham.
Trial summary
60,000 people suffer an out of hospital cardiac arrest in the United Kingdom (UK) every year. Bystander cardiopulmonary resuscitation (CPR) rates are dismal (30%) compared with places where CPR education is mandatory for all school children (>50%). Read more about this study
- Who is it for?
- Ages 11 to 14 years
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Face-to-face BLS training, Lifesaver training and Lifesaver and Face-to-Face BLS training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Dec 2016
- 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 11 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All secondary schools in West Midlands
- Year 8 pupils
Who cannot join
- Participation in British Heart Foundation Heartstart programme
- Schools with established CPR training programme for Year 8 and unable to substitute their programme with teaching provided by this study
- Inability to participate in study during allocated timeframe
About this study
Official title: The School Lifesavers Study: A Randomised Controlled Trial Comparing the Impact of Lifesaver Programme Only, Lifesaver With Face-to-face Training and Face-to-face Training Only on CPR Knowledge, Skills and Attitudes in School Children
60,000 people suffer an out of hospital cardiac arrest in the United Kingdom (UK) every year. Bystander cardiopulmonary resuscitation (CPR) rates are dismal (30%) compared with places where CPR education is mandatory for all school children (>50%). Strategies are needed to increase these rates through innovative approaches. Lifesaver (www.life-saver.org.uk) is an immersive interactive programme/application that presents such an opportunity. This study aims to assess the effectiveness of Lifesaver on CPR attitudes, knowledge, skills acquisition and retention in school children. Additionally, it aims to examine whether Lifesaver provides additional benefits in terms of CPR attitudes, knowledge, skills acquisitions and retention in school children when combined with face-to-face BLS training.
Read the detailed description
The UK has one of the highest rates of cardiovascular disease in the world and approximately 60,000 out-of-hospital cardiac arrests occur every year, half of which are attended to by the emergency services. The public health implications of this are significant as the number of out of hospital cardiac arrests will increase with the rising incidence of obesity and other co-morbidities in the UK's ageing population. Basic Life Support (BLS) can improve the outcomes of these people if it is swiftly performed at the scene of the cardiac arrest.
BLS is defined as a set of skills that can be used to 'help keep someone alive in an emergency...before professional help arrives'. One of the main elements of BLS is cardio- pulmonary resuscitation (CPR). Bystander CPR is important because it slows down the rapid decline in a patient's chances of survival while waiting for professional help. If a patient is found to be in a 'shockable rhythm' such as ventricular fibrillation (VF) or ventricular tachycardia (VT) then receiving bystander CPR could treble the chances of survival.
Currently the average bystander CPR rate in the UK is 30%. This figure is very poor when compared to Seattle where the bystander CPR rates are 61% after routinely training school children for the past 32 years. Similar results have also been achieved in Norway.
While educating the lay public in BLS is key to increasing survival from cardiac arrests, it is difficult to reach the entire population. One potential strategy is to educate school children as young as 12 years old. The American Heart Association advocated compulsory resuscitation training in American schools in 2011, and countries in which resuscitation has been integrated into educational programs in schools report significantly higher resuscitation rates. In Denmark, successful training of school children has led to the rate of bystander CPR doubling after 5 years with a threefold improvement in survival following out-of-hospital cardiac arrest over 10 years. A threefold improvement in survival cannot be achieved solely by improvements in professional medical care in this area.
CPR training in school children has many potential benefits. School children at a young age have a less inhibited approach to resuscitation training and both medical professionals and teachers achieve success after appropriate training themselves. The response to instruction is easier and better at a younger age. Research has shown that the strongest factor preventing laypeople to help in real-life cardiac arrest is a fear of making mistakes. This fear can hopefully be prevented when taught during a young age at school. A more favourable attitude to learning is also reflected by the fact that practical training can be communicated in a more positive way. Embedding resuscitation in related school subjects such as biology, sports or health education is possible and it can make it meaningful.
If school children receive such training, they are also likely to teach this to their family at home. Not only will there be an increase in the number of cardiac arrest survivors worldwide, but also the social benefits of enthusiastic and positive young people. They learn to help others and a sense of responsibility can be instilled in children from a young age. School children and teachers are important "multipliers" in both private and public settings and thus, in the longer term, the proportion of trained individuals in society will markedly increase, leading to an increase in the overall rate of lay resuscitation. By teaching school children, CPR training can reach all groups of society including those in lower social groups. To achieve a statistically significant increase in the resuscitation results, it has been estimated that at least 15% of a population need to be trained and such numbers cannot be achieved by offering voluntary courses.
In their systematic review Plant and Taylor found that training school children in CPR from the age of 10 years old is effective. Young children can learn about certain elements of first aid such as the recovery position and making a 999 call which they are able to retain. It has also been shown that early training helps reduces anxieties about making mistakes in an emergency situation and also markedly increases participants willingness to help. Individuals who have received CPR training are more likely to perform bystander CPR than people without training.
In March 2013, the Department of Health published a Cardiovascular Disease Outcomes Strategy. One of their targeted outcomes is "to consider ways of increasing the numbers trained in CPR and using automated external defibrillators (AED)". Delivering BLS training to every school child would achieve this outcome. Using secondary schools to teach first aid would capture a large proportion of the population as it is compulsory to attend secondary education up until 16 years of age. There is a growing level of support for this approach from Health Care Professionals such as Cardiologists. A joint statement was released by the European Patient Safety Foundation (EuPSF), the European Resuscitation Council (ERC), the International Liaison Committee on Resuscitation (ILCOR) and the World Federation of Societies of Anesthesiologists (WFSA) to call for all children across the world to be trained in the performance of CPR. This initiative supports the training of children at the age of 12 for 2 hours per year in emergency life support and has received strong backing from the World Health Organisation.
The investigators literature review revealed learning technology such as computer or multi-media based resuscitation training programs has been previously evaluated. Studies have found that computer- based simulation provided a learning environment with realistic scenarios when compared to traditional classroom-based teaching. Students who participated in computer or multi-media CPR training had equivalent or superior knowledge and skill acquisition when compared with traditional training. Studies that examined the use of new learning technology merely as a vehicle of delivering the same learning content have failed to improve learning. The systematic review by Plant and Taylor concluded that CPR training in school children could be successful using a variety of approaches. In order to engage and capture the attention the current generation of school children, innovative interactive games could be used in CPR training. To date there has been no studies that investigated the use of immersive interactive scenario training as a standalone education tool or in combination with face-to-face instructor-led training.
The investigators believe that Lifesaver Programme can provide age-appropriate training to schoolchildren. The novel 'game-in-film' format of Lifesaver is an immersive interactive website or application which provides an engaging learning experience and real life scenarios whereby the user helps a victim of cardiac arrest of choking. It is free to use and has currently been downloaded over 46,800 times and the website has been visited over 423,000 times. There is already anecdotal evidence of two lives saved as a result. Furthermore, Lifesaver has won a Webby award, five e-Learning Age awards, and was shortlisted for a British Academy of Film and Television Arts (BAFTA) award.
This study aims to assess the effectiveness of Lifesaver on CPR attitudes, knowledge, skills acquisition and retention in school children. Additionally, it aims to examine whether Lifesaver provides additional benefits in terms of CPR attitudes, knowledge, skills acquisitions and retention in school children when combined with face-to-face BLS training.
Three secondary schools in the West Midlands will participate. Parents of the participating school pupils will be provided with detailed and sufficient information to allow them to consent on behalf of their child for participation in the study. After the initial intervention, 2 and 4 month follow up visits will be conducted to assess the retention of the pupils CPR knowledge, skills and attitudes.
- Conditions
- Cardiac Arrest
- Being tested
- Face-to-face BLS training, Lifesaver training, Lifesaver and Face-to-Face BLS training
- Keywords
- CPR, Schools, Education, Lifesaver
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-face BLS trainingOther
Pupils will receive CPR training by standardised face-to-face BLS training only
Lifesaver trainingOther
Pupils will receive CPR training by Lifesaver programme only
Lifesaver and Face-to-Face BLS trainingOther
Pupils will receive CPR training by Lifesaver and standardised face-to-face BLS training
| Study group | Role | What they receive |
|---|---|---|
| Face-to-face BLS training | Active comparator | Pupils will receive CPR training by standardised face-to-face BLS training only Receives: Other: Face-to-face BLS training |
| Lifesaver training | Active comparator | Pupils will receive CPR training by Lifesaver programme only Receives: Other: Lifesaver training |
| Lifesaver and Face-to-Face BLS training | Active comparator | Pupils will receive CPR training by Lifesaver and standardised face-to-face BLS training Receives: Other: Lifesaver and Face-to-Face BLS training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Chest compression depth (mm) from day of intervention and at 2 month and 4 month follow up visits.
Measured: Day 0, 2 month, 4 month
Change in Chest compression rate from day of intervention and at 2 month and 4 month follow up visits
Measured: Day 0, 2 month, 4 month
Secondary outcomes (2)
Change in CPR attitude measured using an attitudes table questionnaire from baseline to post teaching and testing on Day 0 of intervention and at follow up
Measured: Baseline on Day 0, Post intervention on Day 0 of testing, 2 month, 4 month
CPR knowledge test using a questionnaire
Measured: Post intervention on Day 0 of testing, 2 month, 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study startJan 2016
- Primary completionNov 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Heart of England NHS Trust, Resuscitation Council UK, Calderdale and Huddersfield NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Joyce Yeung, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151785
- Sponsor's protocol ID
- UoB
- Status last verified
- May 2017
- First submitted
- 29 Jun 2016
- Last updated
- 12 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The School Lifesavers Study: A Randomised Controlled Trial Comparing the Impact of Lifesaver Programme Only, Lifesaver With Face-to-face Training and Face-to-face Training Only on CPR Knowledge, Skills and Attitudes in School Children
- ClinicalTrials.gov ID
- NCT03151785
- Acronym / sponsor ID
- UoB
- Conditions
- Cardiac Arrest
- Keywords
- CPR, Schools, Education, Lifesaver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Heart of England NHS Trust, Resuscitation Council UK, Calderdale and Huddersfield NHS Foundation Trust
- Study start
- Jan 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 12 May 2017 (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.
60,000 people suffer an out of hospital cardiac arrest in the United Kingdom (UK) every year. Bystander cardiopulmonary resuscitation (CPR) rates are dismal (30%) compared with places where CPR education is mandatory for all school children (>50%). Strategies are needed to increase these rates through innovative approaches. Lifesaver (www.life-saver.org.uk) is an immersive interactive programme/application that presents such an opportunity. This study aims to assess the effectiveness of Lifesaver on CPR attitudes, knowledge, skills acquisition and retention in school children. Additionally, it aims to examine whether Lifesaver provides additional benefits in terms of CPR attitudes, knowledge, skills acquisitions and retention in school children when combined with face-to-face BLS training.
Detailed description
The UK has one of the highest rates of cardiovascular disease in the world and approximately 60,000 out-of-hospital cardiac arrests occur every year, half of which are attended to by the emergency services. The public health implications of this are significant as the number of out of hospital cardiac arrests will increase with the rising incidence of obesity and other co-morbidities in the UK's ageing population. Basic Life Support (BLS) can improve the outcomes of these people if it is swiftly performed at the scene of the cardiac arrest.
BLS is defined as a set of skills that can be used to 'help keep someone alive in an emergency...before professional help arrives'. One of the main elements of BLS is cardio- pulmonary resuscitation (CPR). Bystander CPR is important because it slows down the rapid decline in a patient's chances of survival while waiting for professional help. If a patient is found to be in a 'shockable rhythm' such as ventricular fibrillation (VF) or ventricular tachycardia (VT) then receiving bystander CPR could treble the chances of survival.
Currently the average bystander CPR rate in the UK is 30%. This figure is very poor when compared to Seattle where the bystander CPR rates are 61% after routinely training school children for the past 32 years. Similar results have also been achieved in Norway.
While educating the lay public in BLS is key to increasing survival from cardiac arrests, it is difficult to reach the entire population. One potential strategy is to educate school children as young as 12 years old. The American Heart Association advocated compulsory resuscitation training in American schools in 2011, and countries in which resuscitation has been integrated into educational programs in schools report significantly higher resuscitation rates. In Denmark, successful training of school children has led to the rate of bystander CPR doubling after 5 years with a threefold improvement in survival following out-of-hospital cardiac arrest over 10 years. A threefold improvement in survival cannot be achieved solely by improvements in professional medical care in this area.
CPR training in school children has many potential benefits. School children at a young age have a less inhibited approach to resuscitation training and both medical professionals and teachers achieve success after appropriate training themselves. The response to instruction is easier and better at a younger age. Research has shown that the strongest factor preventing laypeople to help in real-life cardiac arrest is a fear of making mistakes. This fear can hopefully be prevented when taught during a young age at school. A more favourable attitude to learning is also reflected by the fact that practical training can be communicated in a more positive way. Embedding resuscitation in related school subjects such as biology, sports or health education is possible and it can make it meaningful.
If school children receive such training, they are also likely to teach this to their family at home. Not only will there be an increase in the number of cardiac arrest survivors worldwide, but also the social benefits of enthusiastic and positive young people. They learn to help others and a sense of responsibility can be instilled in children from a young age. School children and teachers are important "multipliers" in both private and public settings and thus, in the longer term, the proportion of trained individuals in society will markedly increase, leading to an increase in the overall rate of lay resuscitation. By teaching school children, CPR training can reach all groups of society including those in lower social groups. To achieve a statistically significant increase in the resuscitation results, it has been estimated that at least 15% of a population need to be trained and such numbers cannot be achieved by offering voluntary courses.
In their systematic review Plant and Taylor found that training school children in CPR from the age of 10 years old is effective. Young children can learn about certain elements of first aid such as the recovery position and making a 999 call which they are able to retain. It has also been shown that early training helps reduces anxieties about making mistakes in an emergency situation and also markedly increases participants willingness to help. Individuals who have received CPR training are more likely to perform bystander CPR than people without training.
In March 2013, the Department of Health published a Cardiovascular Disease Outcomes Strategy. One of their targeted outcomes is "to consider ways of increasing the numbers trained in CPR and using automated external defibrillators (AED)". Delivering BLS training to every school child would achieve this outcome. Using secondary schools to teach first aid would capture a large proportion of the population as it is compulsory to attend secondary education up until 16 years of age. There is a growing level of support for this approach from Health Care Professionals such as Cardiologists. A joint statement was released by the European Patient Safety Foundation (EuPSF), the European Resuscitation Council (ERC), the International Liaison Committee on Resuscitation (ILCOR) and the World Federation of Societies of Anesthesiologists (WFSA) to call for all children across the world to be trained in the performance of CPR. This initiative supports the training of children at the age of 12 for 2 hours per year in emergency life support and has received strong backing from the World Health Organisation.
The investigators literature review revealed learning technology such as computer or multi-media based resuscitation training programs has been previously evaluated. Studies have found that computer- based simulation provided a learning environment with realistic scenarios when compared to traditional classroom-based teaching. Students who participated in computer or multi-media CPR training had equivalent or superior knowledge and skill acquisition when compared with traditional training. Studies that examined the use of new learning technology merely as a vehicle of delivering the same learning content have failed to improve learning. The systematic review by Plant and Taylor concluded that CPR training in school children could be successful using a variety of approaches. In order to engage and capture the attention the current generation of school children, innovative interactive games could be used in CPR training. To date there has been no studies that investigated the use of immersive interactive scenario training as a standalone education tool or in combination with face-to-face instructor-led training.
The investigators believe that Lifesaver Programme can provide age-appropriate training to schoolchildren. The novel 'game-in-film' format of Lifesaver is an immersive interactive website or application which provides an engaging learning experience and real life scenarios whereby the user helps a victim of cardiac arrest of choking. It is free to use and has currently been downloaded over 46,800 times and the website has been visited over 423,000 times. There is already anecdotal evidence of two lives saved as a result. Furthermore, Lifesaver has won a Webby award, five e-Learning Age awards, and was shortlisted for a British Academy of Film and Television Arts (BAFTA) award.
This study aims to assess the effectiveness of Lifesaver on CPR attitudes, knowledge, skills acquisition and retention in school children. Additionally, it aims to examine whether Lifesaver provides additional benefits in terms of CPR attitudes, knowledge, skills acquisitions and retention in school children when combined with face-to-face BLS training.
Three secondary schools in the West Midlands will participate. Parents of the participating school pupils will be provided with detailed and sufficient information to allow them to consent on behalf of their child for participation in the study. After the initial intervention, 2 and 4 month follow up visits will be conducted to assess the retention of the pupils CPR knowledge, skills and attitudes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Face-to-face BLS training | Active comparator | Other: Face-to-face BLS trainingPupils will receive CPR training by standardised face-to-face BLS training only |
| Lifesaver training | Active comparator | Other: Lifesaver trainingPupils will receive CPR training by Lifesaver programme only |
| Lifesaver and Face-to-Face BLS training | Active comparator | Other: Lifesaver and Face-to-Face BLS trainingPupils will receive CPR training by Lifesaver and standardised face-to-face BLS training |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- All secondary schools in West Midlands
- Year 8 pupils
Key exclusion criteria (3 listed)
- Participation in British Heart Foundation Heartstart programme
- Schools with established CPR training programme for Year 8 and unable to substitute their programme with teaching provided by this study
- Inability to participate in study during allocated timeframe
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 |
|---|---|---|
| Face-to-face BLS trainingPupils will receive CPR training by standardised face-to-face BLS training only | Other | Face-to-face BLS training |
| Lifesaver trainingPupils will receive CPR training by Lifesaver programme only | Other | Lifesaver training |
| Lifesaver and Face-to-Face BLS trainingPupils will receive CPR training by Lifesaver and standardised face-to-face BLS training | Other | Lifesaver and Face-to-Face BLS training |
Primary outcome
Change in Chest compression depth (mm) from day of intervention and at 2 month and 4 month follow up visits.
Time frame: Day 0, 2 month, 4 month
Change in Chest compression rate from day of intervention and at 2 month and 4 month follow up visits
Time frame: Day 0, 2 month, 4 month
2 secondary outcomes
Change in CPR attitude measured using an attitudes table questionnaire from baseline to post teaching and testing on Day 0 of intervention and at follow up
Time frame: Baseline on Day 0, Post intervention on Day 0 of testing, 2 month, 4 month
CPR knowledge test using a questionnaire
Time frame: Post intervention on Day 0 of testing, 2 month, 4 month
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 12 May 2017.
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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.
Joyce Yeung principal investigator
University of Birmingham
Questions about this trial
What is this clinical trial studying?
A study testing Face-to-face BLS training, Lifesaver training and Lifesaver and Face-to-Face BLS training in people with Cardiac Arrest, run by University of Birmingham.
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 2 inclusion and 3 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 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in Chest compression depth (mm) from day of intervention and at 2 month and 4 month follow up visits. (time frame: Day 0, 2 month, 4 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2017.