Cardiopulmonary ResuscitationNCT03469154
Sustainable Solutions for Paediatric Basic Life Support Training in Day Care Centres
A study testing Dyad training method and Instructor led training method in people with Cardiopulmonary Resuscitation and Education, run by Copenhagen Academy for Medical Education and Simulation.
Trial summary
In a randomised non-inferiority trial the investigators examine two training interventions to train paediatric basic life support to laypersons: Dyad training vs Instructor led training. For dyad training two participants are guided by video instructions and perform exercises on children resuscitation manikins. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiopulmonary Resuscitation, Education, Medical Emergencies
- What is being tested?
- Dyad training method and Instructor led training method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 569 participants
- Where
- No sites listed yet
- Study dates
- 7 Dec 2015to 5 Jul 2017
- 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
- Working with children under seven years of age for >20 hours/week
- Physically able to participate in tests
Who cannot join
- Any basic life support training within 1 year from training day
- Trained health professional
About this study
Official title: Sustainable Solutions for Paediatric Basic Life Support Training in Day Care Centres: A Comparative Effectiveness Trial
In a randomised non-inferiority trial the investigators examine two training interventions to train paediatric basic life support to laypersons: Dyad training vs Instructor led training.
For dyad training two participants are guided by video instructions and perform exercises on children resuscitation manikins. The participants take turn to complete the exercises and provide feedback to their peer. The duration is up to 50 minutes Instructor led training of paediatric basic life support in instructor led courses with up to 6 participants per course with hands-on training on children resuscitation manikin. The duration of the courses is up to two hours.
Read more
Instructor led training represents the common gold standard for training Paediatric Basic Life Support, however it is inflexible and uses a lot of resources. Dyad training provides a low cost solution with improved flexibility. Consequently a non-inferiority design is chosen as the benefits of dyad training with the same learning outcomes favours the dyad training method.
Prior to the training both groups are informed about and have access to a website with videos, quizzes, pictures and text information on paediatric basic life support and foreign body airway obstruction management.
Read the detailed description
Introduction Paediatric Basic Life support (PBLS) training is essential for acquisition of resuscitation skills. Trained laypersons are more likely to provide bystander cardiopulmonary resuscitation. The skills are important if life-threatening incidents occur as immediate bystander response is needed to improve survival and neurological outcomes for critically ill children. Previously most training has been conducted by instructor-led training courses of small groups. The courses are fairly good at learning the skills, but the skills acquired still deteriorate in a period as quickly as six months. To increase survival of children there is a need for teaching PBLS skills to large communities. Instructor-led training is not suitable for this task due to the need of very large numbers of instructors, the short retention spans, the inflexibility of the course planning and the economic costs of having small groups training with an expensive instructor thus emphasising needs for alternative training strategies.
Alternative approaches to community based learning of PBLS have not been examined in larger scales and especially not in the lights of feasibility, retention and costs. Improving retention of skills or developing feasible quick retraining methods with relevant intervals for the purpose of maintaining PBLS skills remains a challenge.
This study examines these problems by conducting a study of an alternative approach to PBLS training for the community of employees in day care centres using dyad training. If successful, the training method could provide flexible training, improve retention, reduce costs and be suitable for training large communities.
Dyad training In the Dyad training method learners work together in pairs to acquire skills. The participants take turns in performing the practical skills and the other observes and gives feedback. In other medical settings dyad training has been found effective in skills training especially for novices and in short courses. The dyad training studies have been limited to small numbers of health care professional participants in simulated settings. Possible explanations of these effects include observational processing, psychomotor, cognitive and social factors and the mirror neuron system. The use of dyad partners allows learners to observe, support and feedback each other during practice and thereby reduce cognitive load and support cognitive co-construction. The active role as dyad observer has been suggested to let participants set higher goals for own performance, increase motivation by inducing a competitive component and increase responsibility for training which in all cases may enhance the cognitive processing and increase learning. The learning strategy has not been studied for workplace-based skills learning, in PBLS nor for larger groups of lay persons. Dyad training in this study is assisted and facilitated by computer based video instruction as other studies have found it to be effective for novice training. Consequently the presented learning method does not involve an instructor and presents an alternative to traditional skills training which could prove efficient, feasible, flexible and reduce costs. Secondly the training method has a potential for easy up scaling to larger groups/communities. Some studies have found positive correlations between simulation assessment and patient-related outcomes, linking the PBLS training to real life incidents.
The aim of this study is in a randomised control trial to examine if dyad training and E-learning (dyads guided by computer programme videos) as a learning model is non-inferior to instructor led training regarding acquisition of PBLS practical skills and self-efficacy in lay persons. The investigators want to examine if the dyad training positive effects described in literature can be applied to short training courses in a broader population. Second the investigators want to examine if the learning and retention of PBLS skills is affected by the training methods.
Prior to the training both groups have access to a website with videos, quizzes, pictures and text information on paediatric basic life support and foreign body airway obstruction management.
The investigators hypothesise that dyad training and E learning is non-inferior or equivalent compared to instructor led practical skills training. The hypothesis emerges from data obtained in focus group interviews stating that employees are used to work in teams, find PBLS training very important, want to engage in this form of training and lack PBLS competencies. Incidents in day care centres are handled in teams hence dyad training is similar to real life situations in day care centres and this may increase motivation and learning. If incidents requiring PBLS are to be performed in day care centres it will be in a stressful environment with reduced individual cognitive capacities thus supporting teamwork and sharing resources. This may be strengthened by the dyad training method.
Real transfer studies cannot be performed regarding PBLS but training close to realities (i.e. in groups of well-known colleagues) may facilitate easier transfer to real incidents.
Interviews have indicated that instructor-led training might boost immediate self-confidence and potentially the performance right after a course but may deteriorate fast when course and instructor support stops. It is hypothesized that the possible enhanced cognitive processing after the course suggested in dyad training may improve performance and retention of skills after the course compared to individual instructor-led training.
In addition to the analysis mentioned above elf-efficacy on acquired skills in PBLS will be examined in questionnaires as it is important for bystanders' willingness to act.
The assessment tool to assess video recorded scenario tests has been examined for validity evidence winter 2017/2018. Consequently blinded assessors are rating the videos in January through March 2018 and no analysis of the results has taken place before the clinicaltrials.gov registration.
- Being tested
- Dyad training method, Instructor led training method
- Keywords
- Layperson, Paediatric Basic life Support, education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dyad training methodOther
The training model for paediatric basic life support for laypersons involves a course based on pairs training together guided by instructional videos and with hands-on practice on resuscitation manikins.
Instructor led training methodOther
The training model for paediatric basic life support for laypersons involves a course led by an instructor including hands-on practice on resuscitation manikins.
| Study group | Role | What they receive |
|---|---|---|
| Dyad training | Experimental | The participants in this arm will train in teams of two. Participants will be instructed in paediatric basic life support by instructional videos in a computer programme and train on children resuscitation manikins. Training involves recognition of cardiac arrest, cardio-pulmonary resuscitation and foreign body airway obstruction management. The training involves series of short video clips and following exercises. Each participant performs the exercise and the other gives feedback. Afterwards roles are changed. The procedure is done for all exercises after a video clip. The duration of the training is maximum 50 minutes Receives: Other: Dyad training method |
| Instructor led training | Active comparator | Participants train in courses of up to 6 participants with an instructor. Training content is identical to dyad training content involving: recognition of cardiac arrest, cardio-pulmonary resuscitation and foreign body airway obstruction management.
Skills are instructed by an instructor using af 4 step approach (1. show skills, 2. show with explanation, 3. participants instruct instructor, 4. participants performs the skills on resuscitation manikins). Training is maximum two hours but course duration is adjusted to number of participants two allow for similar hands-on time per participant as in the experimental arm. Receives: Other: Instructor led training method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paediatric basic life support skill level immediately after training
All participants participate in video recorded standardised scenario tests on resuscitation manikins just after the training course for paediatric basic life support. The videos are rated by blinded assessors using a developed assessment tool for laypersons paediatric basic life support (validity evidence study currently under preparation for publication) - The assessment tool is based on internationally identified assessment items from a delphi consensus study (see references).
Measured: Participant performs the tests of approximately 3-5 minutes, up to one hour after the course finalization.
Foreign body airway obstruction management skill level immediately after training
All participants participate in video recorded standardised scenario tests on resuscitation manikins just after the training course for foreign body airway obstruction management. The videos are rated by blinded assessors using a developed assessment tool for laypersons paediatric basic life support (validity evidence study currently under preparation for publication) - The assessment tool is based on internationally identified assessment items from a delphi consensus study (see references).
Measured: Participant performs the tests of approximately 3-5 minutes up to one hour after the course finalization.
Secondary outcomes (10)
Retention test of paediatric basic life support skills assessed by standardised scenario tests
By randomisation one third of the participants in the primary outcome 1 measure participate in a test similar to the primary outcome measure 1.
Measured: 14 days after training
Retention test of paediatric basic life support skills assessed by standardised scenario tests
By randomisation one third of the participants in the primary outcome measure 1 participate in a test similar to the primary outcome measure 1.
Measured: 1 month after training
Retention test of paediatric basic life support skills assessed by standardised scenario tests
By randomisation one third of the participants in the primary outcome measure 1 participate in a test similar to the primary outcome measure 1.
Measured: 3 months after training
Retention test of foreign body airway obstruction management skills assessed by standardised scenario tests
The secondary outcome 1 participants participate in a test similar to the primary outcome measure (outcome 2).
Measured: 14 days after training
Retention test of foreign body airway obstruction management skills assessed by standardised scenario tests
The secondary outcome 2 participants participate in a test similar to the primary outcome measure (outcome 2).
Measured: 1 month after training
Retention test of foreign body airway obstruction management skills assessed by standardised scenario tests
The secondary outcome 3 participants participate in a test similar to the primary outcome measure (outcome 2).
Measured: 3 months after training
Self-efficacy by questionaires
All participants examined for self-efficacy on foreign body airway obstruction and paediatric basic life support skills. Immediately after the training course.
Measured: Up to 10 minutes after training
Self-efficacy by questionaires
Secondary outcome 1 participants examined by questionaires on self-efficacy on foreign body airway obstruction and paediatric basic life support skills. Immediately before the retention tests.
Measured: 14 days after training
Self-efficacy by questionaires
Secondary outcome 2 participants examined by questionaires on self-efficacy on foreign body airway obstruction and paediatric basic life support skills. Immediately before the retention tests.
Measured: 1 month after training
Self-efficacy by questionaires
Secondary outcome 3 participants examined by questionaires on self-efficacy on foreign body airway obstruction and paediatric basic life support skills. Immediately before the retention tests.
Measured: 3 months after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start7 Dec 2015
- Primary completion5 Apr 2017
- Study completion5 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary ResuscitationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel groups. Participants randomised to either dyad training or instructor led training. Dyad training in pairs guided by instructional videos Instructor led training with maximum 6 participants per instructor.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 569 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen Academy for Medical Education and Simulation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asbjørn Hasselager,MD, Copenhagen Academy for Medical Education and Simulation
- Investigators
- Asbjørn Hasselager, MD, Principal investigator, Copenhagen Academy for Medical Education and Simulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469154
- Sponsor's protocol ID
- 1
- Status last verified
- Mar 2018
- First submitted
- 22 Feb 2018
- Last updated
- 22 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hasselager AB, Lauritsen T, Kristensen T, Bohnstedt C, Sonderskov C, Ostergaard D, Tolsgaard MG. What should be included in the assessment of laypersons' paediatric basic life support skills? Results from a Delphi consensus study. Scand J Trauma Resusc Emerg Med. 2018 Jan 18;26(1):9. doi: 10.1186/s13049-018-0474-5.
PubMed 29347956
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustainable Solutions for Paediatric Basic Life Support Training in Day Care Centres: A Comparative Effectiveness Trial
- ClinicalTrials.gov ID
- NCT03469154
- Acronym / sponsor ID
- 1
- Keywords
- Layperson, Paediatric Basic life Support, education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 569 participants (actual)
- Lead sponsor
- Copenhagen Academy for Medical Education and SimulationUniversity, hospital or other
- Study start
- 7 Dec 2015 (actual)
- Primary completion
- 5 Apr 2017 (actual)
- Study completion
- 5 Jul 2017 (actual)
- First posted
- 19 Mar 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.
In a randomised non-inferiority trial the investigators examine two training interventions to train paediatric basic life support to laypersons: Dyad training vs Instructor led training.
For dyad training two participants are guided by video instructions and perform exercises on children resuscitation manikins. The participants take turn to complete the exercises and provide feedback to their peer. The duration is up to 50 minutes Instructor led training of paediatric basic life support in instructor led courses with up to 6 participants per course with hands-on training on children resuscitation manikin. The duration of the courses is up to two hours.
Instructor led training represents the common gold standard for training Paediatric Basic Life Support, however it is inflexible and uses a lot of resources. Dyad training provides a low cost solution with improved flexibility. Consequently a non-inferiority design is chosen as the benefits of dyad training with the same learning outcomes favours the dyad training method.
Prior to the training both groups are informed about and have access to a website with videos, quizzes, pictures and text information on paediatric basic life support and foreign body airway obstruction management.
Detailed description
Introduction Paediatric Basic Life support (PBLS) training is essential for acquisition of resuscitation skills. Trained laypersons are more likely to provide bystander cardiopulmonary resuscitation. The skills are important if life-threatening incidents occur as immediate bystander response is needed to improve survival and neurological outcomes for critically ill children. Previously most training has been conducted by instructor-led training courses of small groups. The courses are fairly good at learning the skills, but the skills acquired still deteriorate in a period as quickly as six months. To increase survival of children there is a need for teaching PBLS skills to large communities. Instructor-led training is not suitable for this task due to the need of very large numbers of instructors, the short retention spans, the inflexibility of the course planning and the economic costs of having small groups training with an expensive instructor thus emphasising needs for alternative training strategies.
Alternative approaches to community based learning of PBLS have not been examined in larger scales and especially not in the lights of feasibility, retention and costs. Improving retention of skills or developing feasible quick retraining methods with relevant intervals for the purpose of maintaining PBLS skills remains a challenge.
This study examines these problems by conducting a study of an alternative approach to PBLS training for the community of employees in day care centres using dyad training. If successful, the training method could provide flexible training, improve retention, reduce costs and be suitable for training large communities.
Dyad training In the Dyad training method learners work together in pairs to acquire skills. The participants take turns in performing the practical skills and the other observes and gives feedback. In other medical settings dyad training has been found effective in skills training especially for novices and in short courses. The dyad training studies have been limited to small numbers of health care professional participants in simulated settings. Possible explanations of these effects include observational processing, psychomotor, cognitive and social factors and the mirror neuron system. The use of dyad partners allows learners to observe, support and feedback each other during practice and thereby reduce cognitive load and support cognitive co-construction. The active role as dyad observer has been suggested to let participants set higher goals for own performance, increase motivation by inducing a competitive component and increase responsibility for training which in all cases may enhance the cognitive processing and increase learning. The learning strategy has not been studied for workplace-based skills learning, in PBLS nor for larger groups of lay persons. Dyad training in this study is assisted and facilitated by computer based video instruction as other studies have found it to be effective for novice training. Consequently the presented learning method does not involve an instructor and presents an alternative to traditional skills training which could prove efficient, feasible, flexible and reduce costs. Secondly the training method has a potential for easy up scaling to larger groups/communities. Some studies have found positive correlations between simulation assessment and patient-related outcomes, linking the PBLS training to real life incidents.
The aim of this study is in a randomised control trial to examine if dyad training and E-learning (dyads guided by computer programme videos) as a learning model is non-inferior to instructor led training regarding acquisition of PBLS practical skills and self-efficacy in lay persons. The investigators want to examine if the dyad training positive effects described in literature can be applied to short training courses in a broader population. Second the investigators want to examine if the learning and retention of PBLS skills is affected by the training methods.
Prior to the training both groups have access to a website with videos, quizzes, pictures and text information on paediatric basic life support and foreign body airway obstruction management.
The investigators hypothesise that dyad training and E learning is non-inferior or equivalent compared to instructor led practical skills training. The hypothesis emerges from data obtained in focus group interviews stating that employees are used to work in teams, find PBLS training very important, want to engage in this form of training and lack PBLS competencies. Incidents in day care centres are handled in teams hence dyad training is similar to real life situations in day care centres and this may increase motivation and learning. If incidents requiring PBLS are to be performed in day care centres it will be in a stressful environment with reduced individual cognitive capacities thus supporting teamwork and sharing resources. This may be strengthened by the dyad training method.
Real transfer studies cannot be performed regarding PBLS but training close to realities (i.e. in groups of well-known colleagues) may facilitate easier transfer to real incidents.
Interviews have indicated that instructor-led training might boost immediate self-confidence and potentially the performance right after a course but may deteriorate fast when course and instructor support stops. It is hypothesized that the possible enhanced cognitive processing after the course suggested in dyad training may improve performance and retention of skills after the course compared to individual instructor-led training.
In addition to the analysis mentioned above elf-efficacy on acquired skills in PBLS will be examined in questionnaires as it is important for bystanders' willingness to act.
The assessment tool to assess video recorded scenario tests has been examined for validity evidence winter 2017/2018. Consequently blinded assessors are rating the videos in January through March 2018 and no analysis of the results has taken place before the clinicaltrials.gov registration.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel groups. Participants randomised to either dyad training or instructor led training. Dyad training in pairs guided by instructional videos Instructor led training with maximum 6 participants per instructor.
| Arm | Type | Receives |
|---|---|---|
| Dyad training | Experimental | Other: Dyad training methodThe participants in this arm will train in teams of two. Participants will be instructed in paediatric basic life support by instructional videos in a computer programme and train on children resuscitation manikins. Training involves recognition of cardiac arrest, cardio-pulmonary resuscitation and foreign body airway obstruction management. The training involves series of short video clips and following exercises. Each participant performs the exercise and the other gives feedback. Afterwards roles are changed. The procedure is done for all exercises after a video clip. The duration of the training is maximum 50 minutes |
| Instructor led training | Active comparator | Other: Instructor led training methodParticipants train in courses of up to 6 participants with an instructor. Training content is identical to dyad training content involving: recognition of cardiac arrest, cardio-pulmonary resuscitation and foreign body airway obstruction management. Skills are instructed by an instructor using af 4 step approach (1. show skills, 2. show with explanation, 3. participants instruct instructor, 4. participants performs the skills on resuscitation manikins). Training is maximum two hours but course duration is adjusted to number of participants two allow for similar hands-on time per participant as in the experimental arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Working with children under seven years of age for >20 hours/week
- Physically able to participate in tests
Key exclusion criteria (2 listed)
- Any basic life support training within 1 year from training day
- Trained health professional
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 |
|---|---|---|
| Dyad training methodThe training model for paediatric basic life support for laypersons involves a course based on pairs training together guided by instructional videos and with hands-on practice on resuscitation manikins. | Other | Dyad training |
| Instructor led training methodThe training model for paediatric basic life support for laypersons involves a course led by an instructor including hands-on practice on resuscitation manikins. | Other | Instructor led training |
Primary outcome
Paediatric basic life support skill level immediately after training
Time frame: Participant performs the tests of approximately 3-5 minutes, up to one hour after the course finalization.
All participants participate in video recorded standardised scenario tests on resuscitation manikins just after the training course for paediatric basic life support. The videos are rated by blinded assessors using a developed assessment tool for laypersons paediatric basic life support (validity evidence study currently under preparation for publication) - The assessment tool is based on internationally identified assessment items from a delphi consensus study (see references).
Foreign body airway obstruction management skill level immediately after training
Time frame: Participant performs the tests of approximately 3-5 minutes up to one hour after the course finalization.
All participants participate in video recorded standardised scenario tests on resuscitation manikins just after the training course for foreign body airway obstruction management. The videos are rated by blinded assessors using a developed assessment tool for laypersons paediatric basic life support (validity evidence study currently under preparation for publication) - The assessment tool is based on internationally identified assessment items from a delphi consensus study (see references).
10 secondary outcomes
Retention test of paediatric basic life support skills assessed by standardised scenario tests
Time frame: 14 days after training
Retention test of paediatric basic life support skills assessed by standardised scenario tests
Time frame: 1 month after training
Retention test of paediatric basic life support skills assessed by standardised scenario tests
Time frame: 3 months after training
Retention test of foreign body airway obstruction management skills assessed by standardised scenario tests
Time frame: 14 days after training
Retention test of foreign body airway obstruction management skills assessed by standardised scenario tests
Time frame: 1 month after training
Retention test of foreign body airway obstruction management skills assessed by standardised scenario tests
Time frame: 3 months after training
Self-efficacy by questionaires
Time frame: Up to 10 minutes after training
Self-efficacy by questionaires
Time frame: 14 days after training
Self-efficacy by questionaires
Time frame: 1 month after training
Self-efficacy by questionaires
Time frame: 3 months after training
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 22 Mar 2018.
- Background: PubMed 29347956Hasselager AB, Lauritsen T, Kristensen T, Bohnstedt C, Sonderskov C, Ostergaard D, Tolsgaard MG. What should be included in the assessment of laypersons' paediatric basic life support skills? Results from a Delphi consensus study. Scand J Trauma Resusc Emerg Med. 2018 Jan 18;26(1):9. doi: 10.1186/s13049-018-0474-5.
- Individual participant dataSharing planned: No
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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.
Asbjørn Hasselager, MD principal investigator
Copenhagen Academy for Medical Education and Simulation
Questions about this trial
What is this clinical trial studying?
A study testing Dyad training method and Instructor led training method in people with Cardiopulmonary Resuscitation and Education, run by Copenhagen Academy for Medical Education and Simulation.
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 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: finished, as of the sponsor's last update on 22 Mar 2018. 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?
Paediatric basic life support skill level immediately after training (time frame: Participant performs the tests of approximately 3-5 minutes, up to one hour after the course finalization.). 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?
On the ClinicalTrials.gov record for NCT03469154, which also lists 1 linked publication.
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 22 Mar 2018.