Improvement of BLS/AED Training ProgrammesNCT00932906
Comparison of Different Automated External Defibrillation (AED) Training Methods
A study testing Different self-training methods and Standard training in people with Improvement of BLS/AED Training Programmes, run by Doczero.
Trial summary
This study is a prospective, randomized trial that compares the effectiveness and retention of four different training methods for the use of an AED: A. Traditional instructor based learning; B. The use of a personal manikin with a DVD training to practice the necessary AED skills; C. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Improvement of BLS/AED Training Programmes
- What is being tested?
- Different self-training methods and Standard training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 396 participants
- Where
- No sites listed yet
- Study dates
- Jul 2008to Dec 2009
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- willing to follow a BLS/AED course up to 2h
Who cannot join
- CPR training within the last five years
- professional health care provider
About this study
Official title: Comparison of Four Different AED Training Methods in Three Different Age Groups
This study is a prospective, randomized trial that compares the effectiveness and retention of four different training methods for the use of an AED:
- Traditional instructor based learning;
- The use of a personal manikin with a DVD training to practice the necessary AED skills;
- The use of a personal manikin with a DVD training to practice the necessary AED skills and additional scenario training;
- Watching a 2.5 minutes DVD which shows the use of an AED.
Read more
It is hypnotised that there are no differences between these training methods, in which case method D is most efficient to reach large number of people to learn BLS/AED skills.
There are two interesting target groups to reach:
- Younger people, as they might give the highest interest after training, as they normally live longer.
- Older people as they are member of the most important group in risk and have therefore a higher change of being a witness of cardiac arrest.
As there might be differences in the results between different training methods than can be related to age, each training group is distinguished to three different groups:
- 21 years of younger;
- between 21 and 50 years;
- older than 50 years.
It is hypnotised that there are no differences between younger and older students within each of the four training methods.
- Being tested
- Different self-training methods, Standard training
- Keywords
- Education, Retention, Retrieval, Self training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different self-training methodsOther
Self training with MiniAnne Training Kit
Standard trainingOther
Instructor-based training meeting ERC directions
| Study group | Role | What they receive |
|---|---|---|
| Instructor based training; <21 years | Placebo comparator | The instructor based training is a 1.25 hour training as described by the ERC in their standard training program [ref; navragen bij Koen] and using the ERC PowerPoint presentation. There is one manikin and one AED trainer per six students. The group consists out of 12 students maximal, with one instructor per six students. Receives: Other: Standard training |
| Instructor based training; 21-50 years | Placebo comparator | The instructor based training is a 1.25 hour training as described by the ERC in their standard training program [ref; navragen bij Koen] and using the ERC PowerPoint presentation. There is one manikin and one AED trainer per six students. The group consists out of 12 students maximal, with one instructor per six students. Receives: Other: Standard training |
| Instructor based training; >50 years | Placebo comparator | The instructor based training is a 1.25 hour training as described by the ERC in their standard training program [ref; navragen bij Koen] and using the ERC PowerPoint presentation. There is one manikin and one AED trainer per six students. The group consists out of 12 students maximal, with one instructor per six students. Receives: Other: Standard training |
| Video Skill Training; <21 years | Experimental | Participants practise AED skills, watching a 4.5-min video in a single uninterrupted session. There is no instructor available. The video demonstrates the use of an AED; when to use it, how to turn it on, how to attach the electrodes, keeping distance and delivering a shock. Receives: Other: Different self-training methods |
| Video Skill Training; 21-50 years | Experimental | Participants practise AED skills, watching a 4.5-min video in a single uninterrupted session. There is no instructor available. The video demonstrates the use of an AED; when to use it, how to turn it on, how to attach the electrodes, keeping distance and delivering a shock. Receives: Other: Different self-training methods |
| Video Skill Training; >50 years | Experimental | Participants practise AED skills, watching a 4.5-min video in a single uninterrupted session. There is no instructor available. The video demonstrates the use of an AED; when to use it, how to turn it on, how to attach the electrodes, keeping distance and delivering a shock. Receives: Other: Different self-training methods |
| Video scenario training; <21 years | Experimental | Participants practises AED skills, watching a 9-min video in a single uninterrupted session. There is no instructor available. The video demonstrates the use of an AED; when to use it, how to turn it on, how to attach the electrodes, keeping distance and delivering a shock, and additional two scenarios, in each of which they practice the BLS/AED procedure. Receives: Other: Different self-training methods |
| Video scenario training; 21-50 years | Experimental | Participants practises AED skills, watching a 9-min video in a single uninterrupted session. There is no instructor available. The video demonstrates the use of an AED; when to use it, how to turn it on, how to attach the electrodes, keeping distance and delivering a shock, and additional two scenarios, in each of which they practice the BLS/AED procedure. Receives: Other: Different self-training methods |
| Video scenario training; >50 years | Experimental | Participants practises AED skills, watching a 9-min video in a single uninterrupted session. There is no instructor available. The video demonstrates the use of an AED; when to use it, how to turn it on, how to attach the electrodes, keeping distance and delivering a shock, and additional two scenarios, in each of which they practice the BLS/AED procedure. Receives: Other: Different self-training methods |
| Video demonstration training; <21 years | Experimental | Participants watch a 2.5 minutes video demonstration of the use of an AED, in a single uninterrupted session, without hands-on practice. Receives: Other: Different self-training methods |
| Video demonstration training; 21-50 years | Experimental | Participants watch a 2.5 minutes video demonstration of the use of an AED, in a single uninterrupted session, without hands-on practice. Receives: Other: Different self-training methods |
| Video demonstration training; >50 years | Experimental | Participants watch a 2.5 minutes video demonstration of the use of an AED, in a single uninterrupted session, without hands-on practice. Receives: Other: Different self-training methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kruskal-Wallis test
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2009 (estimated)
- Study startJul 2008
- Primary completionJun 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Improvement of BLS/AED Training ProgrammesStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 396 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Doczero
- Sponsor type
- University, hospital or other
- Collaborators
- Laerdal Medical
- Investigators
- Wiebe de Vries, MSc, Principal investigator, DoczeroKoenraad Monsieurs, Professor, Study director, University Hospital, GhentJoost Bierens, Professor, Study chair, VU Medical CentreRudolph Koster, PhD MD, Study chair, Academical Medical Centre AmsterdamNigel M Turner, PhD MD, Study chair, Medicine, Wilhelmina Children Hospital - University Medical Centre Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932906
- Sponsor's protocol ID
- Ed-2008-06
- Status last verified
- Jul 2009
- First submitted
- 3 Jul 2009
- Last updated
- 7 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Four Different AED Training Methods in Three Different Age Groups
- ClinicalTrials.gov ID
- NCT00932906
- Acronym / sponsor ID
- Ed-2008-06
- Keywords
- Education, Retention, Retrieval, Self training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 396 participants (estimated)
- Lead sponsor
- DoczeroUniversity, hospital or other
- Collaborators
- Laerdal Medical
- Study start
- Jul 2008
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 7 Jul 2009 (estimated)
- 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.
This study is a prospective, randomized trial that compares the effectiveness and retention of four different training methods for the use of an AED:
- Traditional instructor based learning;
- The use of a personal manikin with a DVD training to practice the necessary AED skills;
- The use of a personal manikin with a DVD training to practice the necessary AED skills and additional scenario training;
- Watching a 2.5 minutes DVD which shows the use of an AED.
It is hypnotised that there are no differences between these training methods, in which case method D is most efficient to reach large number of people to learn BLS/AED skills.
There are two interesting target groups to reach:
- Younger people, as they might give the highest interest after training, as they normally live longer.
- Older people as they are member of the most important group in risk and have therefore a higher change of being a witness of cardiac arrest.
As there might be differences in the results between different training methods than can be related to age, each training group is distinguished to three different groups:
- 21 years of younger;
- between 21 and 50 years;
- older than 50 years.
It is hypnotised that there are no differences between younger and older students within each of the four training methods.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Instructor based training; <21 years | Placebo comparator | Other: Standard trainingThe instructor based training is a 1.25 hour training as described by the ERC in their standard training program [ref; navragen bij Koen] and using the ERC PowerPoint presentation. There is one manikin and one AED trainer per six students. The group consists out of 12 students maximal, with one instructor per six students. |
| Instructor based training; 21-50 years | Placebo comparator | Other: Standard trainingThe instructor based training is a 1.25 hour training as described by the ERC in their standard training program [ref; navragen bij Koen] and using the ERC PowerPoint presentation. There is one manikin and one AED trainer per six students. The group consists out of 12 students maximal, with one instructor per six students. |
| Instructor based training; >50 years | Placebo comparator | Other: Standard trainingThe instructor based training is a 1.25 hour training as described by the ERC in their standard training program [ref; navragen bij Koen] and using the ERC PowerPoint presentation. There is one manikin and one AED trainer per six students. The group consists out of 12 students maximal, with one instructor per six students. |
| Video Skill Training; <21 years | Experimental | Other: Different self-training methodsParticipants practise AED skills, watching a 4.5-min video in a single uninterrupted session. There is no instructor available. The video demonstrates the use of an AED; when to use it, how to turn it on, how to attach the electrodes, keeping distance and delivering a shock. |
| Video Skill Training; 21-50 years | Experimental | Other: Different self-training methodsParticipants practise AED skills, watching a 4.5-min video in a single uninterrupted session. There is no instructor available. The video demonstrates the use of an AED; when to use it, how to turn it on, how to attach the electrodes, keeping distance and delivering a shock. |
| Video Skill Training; >50 years | Experimental | Other: Different self-training methodsParticipants practise AED skills, watching a 4.5-min video in a single uninterrupted session. There is no instructor available. The video demonstrates the use of an AED; when to use it, how to turn it on, how to attach the electrodes, keeping distance and delivering a shock. |
| Video scenario training; <21 years | Experimental | Other: Different self-training methodsParticipants practises AED skills, watching a 9-min video in a single uninterrupted session. There is no instructor available. The video demonstrates the use of an AED; when to use it, how to turn it on, how to attach the electrodes, keeping distance and delivering a shock, and additional two scenarios, in each of which they practice the BLS/AED procedure. |
| Video scenario training; 21-50 years | Experimental | Other: Different self-training methodsParticipants practises AED skills, watching a 9-min video in a single uninterrupted session. There is no instructor available. The video demonstrates the use of an AED; when to use it, how to turn it on, how to attach the electrodes, keeping distance and delivering a shock, and additional two scenarios, in each of which they practice the BLS/AED procedure. |
| Video scenario training; >50 years | Experimental | Other: Different self-training methodsParticipants practises AED skills, watching a 9-min video in a single uninterrupted session. There is no instructor available. The video demonstrates the use of an AED; when to use it, how to turn it on, how to attach the electrodes, keeping distance and delivering a shock, and additional two scenarios, in each of which they practice the BLS/AED procedure. |
| Video demonstration training; <21 years | Experimental | Other: Different self-training methodsParticipants watch a 2.5 minutes video demonstration of the use of an AED, in a single uninterrupted session, without hands-on practice. |
| Video demonstration training; 21-50 years | Experimental | Other: Different self-training methodsParticipants watch a 2.5 minutes video demonstration of the use of an AED, in a single uninterrupted session, without hands-on practice. |
| Video demonstration training; >50 years | Experimental | Other: Different self-training methodsParticipants watch a 2.5 minutes video demonstration of the use of an AED, in a single uninterrupted session, without hands-on practice. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- willing to follow a BLS/AED course up to 2h
Key exclusion criteria (2 listed)
- CPR training within the last five years
- professional health care provider
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 |
|---|---|---|
| Different self-training methodsSelf training with MiniAnne Training Kit | Other | Video Skill Training; 21-50 years, Video Skill Training; <21 years, Video Skill Training; >50 years, Video demonstration training; 21-50 years, Video demonstration training; <21 years, Video demonstration training; >50 years, Video scenario training; 21-50 years, Video scenario training; <21 years, Video scenario training; >50 years |
| Standard trainingInstructor-based training meeting ERC directions | Other | Instructor based training; 21-50 years, Instructor based training; <21 years, Instructor based training; >50 years |
Primary outcome
Kruskal-Wallis test
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2009.
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.
Wiebe de Vries, MSc principal investigator
Doczero
Koenraad Monsieurs, Professor study director
University Hospital, Ghent
Joost Bierens, Professor study chair
VU Medical Centre
Questions about this trial
What is this clinical trial studying?
A study testing Different self-training methods and Standard training in people with Improvement of BLS/AED Training Programmes, run by Doczero.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Jul 2009. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Kruskal-Wallis test (time frame: 6 months). 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 7 Jul 2009.