Health EducationNCT04914871
Readiness for Basic Life Support in Schools
A study testing Protocol UN Lifeguard Kids in the Tunja version and Educational session accident prevention and wound management in people with Health Education and First Aid, run by Universidad Nacional de Colombia.
Trial summary
This research is a response to problems with Cardiovascular Disease in Colombia, where circulatory system diseases are the first cause of mortality in the adult population, making them a critical issue for the country. Read more about this study
- Who is it for?
- Ages 7 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Education, First Aid, Cardiopulmonary Resuscitation
- What is being tested?
- Protocol UN Lifeguard Kids in the Tunja version and Educational session accident prevention and wound management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2021to 1 Apr 2022
- 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 7 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Seven and eight-year-old.
- Children who are in the second grade of elementary school in two schools in the city of Tunja.
- Children's families with an available computer tablet or mobile device and internet connection will be considered for the study.
- Children who have a caregiver 18 years of age or older to accompany them during the intervention.
- Children with adequate learning skills (This data will be obtained from the report of the course teacher)
Who cannot join
- Children who have received a scientific intervention on CPR.
- Children who participate in a rescue force (i.e., police, civil defense, brigade members).
- Children with a diagnosis of physical or mental disability (autism spectrum disorder, trisomy 21, Asperger syndrome, Tourette syndrome, attention deficit hyperactivity disorder (ADHD), severe visual, hearing, or motor problems, and/or similar disabilities).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Readiness for Basic Life Support in Schools: Randomized Controlled Trial
This research is a response to problems with Cardiovascular Disease in Colombia, where circulatory system diseases are the first cause of mortality in the adult population, making them a critical issue for the country. It is known that around 70% of cardiac arrests occur outside health institutions, generally at home or on public roads.
To reduce these high mortality rates, international recommendations were issued to establish strategies to train the general population in cardiopulmonary resuscitation, especially school-age children. This constitutes a key stage for initiating learning. This condition significantly favors learning and preserving the acquired knowledge for the rest of their life.
Based on the reasons above, this pilot project seeks to be the first approach at the national level to train second-grade elementary school children in Basic Life Support. This training will describing the step by step experiences of the participants, focusing on: project viability related to recruitment and follow-up, acceptability, the experience of participation from the educational community, and the effects of implementing the intervention on the knowledge and skills in the child population. A virtual protocol will be implemented (adapted to the current situation generated by the Coronavirus pandemic), and will be developed through didactic methodologies in three 60-minute educational sessions, during regular class hours.
Read the detailed description
- Research question What are the viability, acceptability, and potential effects of implementing the UN Lifeguard Kids in the Tunja version intervention in two schools in the city of Tunja in 2021?
- General objective: To describe the viability, acceptability, participation experience, and potential effects of implementing the UN Lifeguard Kids in the Tunja version intervention, in two schools in the city of Tunja in 2021.
- Specific objectives To carry out the characterization of the child population under study. To describe the viability of the UN Lifeguard Kids in the Tunja version intervention in terms of recruitment and follow through. To describe the acceptability of the UN Lifeguard Kids in the Tunja version intervention for the child population that receives it. To describe the experience of participating in the UN Lifeguard Kids in the Tunja version intervention for the academic community. To describe the effects of the UN Lifeguard Kids in the Tunja version intervention on theoretical knowledge and practical skills in the child population that receives it.
- A sample population of 70 children was determined as appropriate for the study. Two second-graded classes were selected to fulfill this requirement. Children were assigned to a control or test group using simple random sampling. Finally, five additional children were added to reduce sample attrition.
- Biases control
- Selection bias: It will be controlled in this study by strictly complying with the inclusion and exclusion criteria. Likewise, by applying the random blocks methodology for the allocation of the intervention and control group, guaranteeing an equitable distribution of children. Another measure is the application of the double-blind method so that neither the participants nor the research assistants responsible for measuring response variables, know which group they belong to or which intervention they received.
- Detection biases: It will be controlled by including five nursing professionals who are not part of the study to carry out the measurements.
- Attrition biases: There are two steps to control attrition. Firts, children will be motivated in each session through playful methodologies and novel didactic material, encouraging continued participation. Second, sessions will be within the usual class schedule to prevent abandonment.
- Notification bias: It will be controlled through an ethical commitment by the researcher when publishing the complete results of the interventions. Additionally, these results will be publically available through the clinicaltrial.org portal.
- Confusion biases: it will be controlled by randomization; distributing the known and unknown confounding variables equally between the groups and therefore, avoiding possible biases in the analysis. Subsequently, a comparison of the confounding variables will be made between the experimental and control groups before analyzing the response variables to identify the equivalence of the groups.
- Statistical analysis: Descriptive statistics will be used for the analyses of the qualitative variables, through the distribution of frequencies and proportions. For continuous quantitative variables, descriptive statistics will be used with measures of central tendency (i.e. average and SD), dispersion, and 95% confidence intervals. For the intra- and inter-group comparisons of the continuous quantitative response variables, adjustment tests will be performed using the Kolgomorov Smirnov Gaussian model. If the adjustment is satisfactory, the comparisons will be made with paired Student's T-tests for intragroup and unpaired Student's T-tests for the intergroup analyses. Otherwise, Wilcoxon and Man Whitney U signed-rank tests will be performed, respectively.
- Conditions
- Health Education, First Aid, Cardiopulmonary Resuscitation
- Being tested
- Protocol UN Lifeguard Kids in the Tunja version, Educational session accident prevention and wound management
- Keywords
- Basic Life Support, Student, Teaching, Nursing, Readiness
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocol UN Lifeguard Kids in the Tunja versionBehavioural
The experimental protocol UN Lifeguard Kids in the Tunja version done by the researcher following the guidelines of International organizations such as the American Heart association and European Resuscitation Council.
The intervention consists of 3 sessions of 60 minutes of theoretical and practical exercises on BLS, developed within the usual class schedule.
Educational session accident prevention and wound managementBehavioural
It will be provided to the control group
| Study group | Role | What they receive |
|---|---|---|
| The experimental protocol UN Lifeguard Kids in the Tunja version | Experimental | Group to which the experimental protocol will be offered. Receives: Behavioral: Protocol UN Lifeguard Kids in the Tunja version |
| Educational session, accident prevention and wound management. | Placebo comparator | The control group will be offered the Educational session. Receives: Behavioral: Educational session accident prevention and wound management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viability
This variable is defined as the proportion of eligible participants who agree to participate in the study.
Selection and monitoring form: In the first place, the form is filled out to discern if the children meet the inclusion criteria, then the consent form is signed, and finally the children agree to participate in the study.
Then, the children who enter training sessions complete a form, in order to measure the percentage of children who attended all the sessions and to compare it with the children who were initially recruited.
Measured: 8 weeks
Acceptability
Defined as the degree to which the participants were comfortable with their experience with the nursing intervention "UN Salvavidas Kids Tunja version".
Participant's satisfaction questionnaire with the intervention: This approach has two parts, the first one involves three open questions and the second 6 with closed answers using dichotomous nominal variables.
Measured: 8 weeks
Secondary outcomes (2)
knowledge in Basic Life Support.
Defined as the initial measures to recognize, act and ask for help in an emergency. Questionnaire (it will be designed for researchers): evaluation of theoretical knowledge in basic Life support before and after intervention (8 weeks).
It consists of 7 open questions with answers that are evaluated according to criteria (correct/incorrect response or fulfil/fails) that clarify which answers are eligible for scoring.
Measured: 8 weeks
Skills in Basic Life Support.
Defined as the initial measures to recognize, act and ask for help in an emergency situation. Checklist (it will be designed for researchers): practical knowledge assessment in basic life support before and after intervention (8 weeks): It is done in a simulated situation in which children must apply the knowledge acquired during the training.
It consists of 6 questions, each one has a statement and an administration condition that must be followed as described and a scoring criterion that clarifies what behavior is acceptable to receive a score(correct/incorrect action for fulfil/fails).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start20 Oct 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Health EducationStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- According to the stated objectives, this study has a quantitative approach, Randomized Controlled Clinical Trial (RCT), with an experimental and control group and pre- and post-test measures; to explore the response of children to the intervention UN Lifeguard Kids in the Tunja version and approximation can be made its effectiveness.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Colombia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sonia Patricia Carreño Moreno, RN, MSc, PhD, Study director, Universidad Nacional de Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914871
- Sponsor's protocol ID
- 46377995
- Status last verified
- Sep 2021
- First submitted
- 30 Apr 2021
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After data analysis, using the results obtained in this study, and the generation of the final report, the database will be shared shared with the public.
Publications
Bottiger BW, Van Aken H. Training children in cardiopulmonary resuscitation worldwide. Lancet. 2015 Jun 13;385(9985):2353. doi: 10.1016/S0140-6736(15)61099-6. No abstract available.
PubMed 26088639Yasunaga H, Horiguchi H, Tanabe S, Akahane M, Ogawa T, Koike S, Imamura T. Collaborative effects of bystander-initiated cardiopulmonary resuscitation and prehospital advanced cardiac life support by physicians on survival of out-of-hospital cardiac arrest: a nationwide population-based observational study. Crit Care. 2010;14(6):R199. doi: 10.1186/cc9319. Epub 2010 Nov 4.
PubMed 21050434Semeraro F, Wingen S, Schroeder DC, Ecker H, Scapigliati A, Ristagno G, Cimpoesu D, Bottiger BW. KIDS SAVE LIVES-Three years of implementation in Europe. Resuscitation. 2018 Oct;131:e9-e11. doi: 10.1016/j.resuscitation.2018.08.008. Epub 2018 Aug 8. No abstract available.
PubMed 30098386Oving I, Masterson S, Tjelmeland IBM, Jonsson M, Semeraro F, Ringh M, Truhlar A, Cimpoesu D, Folke F, Beesems SG, Koster RW, Tan HL, Blom MT; ESCAPE-NET Investigators. First-response treatment after out-of-hospital cardiac arrest: a survey of current practices across 29 countries in Europe. Scand J Trauma Resusc Emerg Med. 2019 Dec 16;27(1):112. doi: 10.1186/s13049-019-0689-0.
PubMed 31842928
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Readiness for Basic Life Support in Schools: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04914871
- Acronym / sponsor ID
- 46377995
- Conditions
- Health Education, First Aid, Cardiopulmonary Resuscitation
- Keywords
- Basic Life Support, Student, Teaching, Nursing, Readiness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Universidad Nacional de ColombiaUniversity, hospital or other
- Study start
- 20 Oct 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 7 Jun 2021 (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.
This research is a response to problems with Cardiovascular Disease in Colombia, where circulatory system diseases are the first cause of mortality in the adult population, making them a critical issue for the country. It is known that around 70% of cardiac arrests occur outside health institutions, generally at home or on public roads.
To reduce these high mortality rates, international recommendations were issued to establish strategies to train the general population in cardiopulmonary resuscitation, especially school-age children. This constitutes a key stage for initiating learning. This condition significantly favors learning and preserving the acquired knowledge for the rest of their life.
Based on the reasons above, this pilot project seeks to be the first approach at the national level to train second-grade elementary school children in Basic Life Support. This training will describing the step by step experiences of the participants, focusing on: project viability related to recruitment and follow-up, acceptability, the experience of participation from the educational community, and the effects of implementing the intervention on the knowledge and skills in the child population. A virtual protocol will be implemented (adapted to the current situation generated by the Coronavirus pandemic), and will be developed through didactic methodologies in three 60-minute educational sessions, during regular class hours.
Detailed description
- Research question What are the viability, acceptability, and potential effects of implementing the UN Lifeguard Kids in the Tunja version intervention in two schools in the city of Tunja in 2021?
- General objective: To describe the viability, acceptability, participation experience, and potential effects of implementing the UN Lifeguard Kids in the Tunja version intervention, in two schools in the city of Tunja in 2021.
- Specific objectives To carry out the characterization of the child population under study. To describe the viability of the UN Lifeguard Kids in the Tunja version intervention in terms of recruitment and follow through. To describe the acceptability of the UN Lifeguard Kids in the Tunja version intervention for the child population that receives it. To describe the experience of participating in the UN Lifeguard Kids in the Tunja version intervention for the academic community. To describe the effects of the UN Lifeguard Kids in the Tunja version intervention on theoretical knowledge and practical skills in the child population that receives it.
- A sample population of 70 children was determined as appropriate for the study. Two second-graded classes were selected to fulfill this requirement. Children were assigned to a control or test group using simple random sampling. Finally, five additional children were added to reduce sample attrition.
- Biases control
- Selection bias: It will be controlled in this study by strictly complying with the inclusion and exclusion criteria. Likewise, by applying the random blocks methodology for the allocation of the intervention and control group, guaranteeing an equitable distribution of children. Another measure is the application of the double-blind method so that neither the participants nor the research assistants responsible for measuring response variables, know which group they belong to or which intervention they received.
- Detection biases: It will be controlled by including five nursing professionals who are not part of the study to carry out the measurements.
- Attrition biases: There are two steps to control attrition. Firts, children will be motivated in each session through playful methodologies and novel didactic material, encouraging continued participation. Second, sessions will be within the usual class schedule to prevent abandonment.
- Notification bias: It will be controlled through an ethical commitment by the researcher when publishing the complete results of the interventions. Additionally, these results will be publically available through the clinicaltrial.org portal.
- Confusion biases: it will be controlled by randomization; distributing the known and unknown confounding variables equally between the groups and therefore, avoiding possible biases in the analysis. Subsequently, a comparison of the confounding variables will be made between the experimental and control groups before analyzing the response variables to identify the equivalence of the groups.
- Statistical analysis: Descriptive statistics will be used for the analyses of the qualitative variables, through the distribution of frequencies and proportions. For continuous quantitative variables, descriptive statistics will be used with measures of central tendency (i.e. average and SD), dispersion, and 95% confidence intervals. For the intra- and inter-group comparisons of the continuous quantitative response variables, adjustment tests will be performed using the Kolgomorov Smirnov Gaussian model. If the adjustment is satisfactory, the comparisons will be made with paired Student's T-tests for intragroup and unpaired Student's T-tests for the intergroup analyses. Otherwise, Wilcoxon and Man Whitney U signed-rank tests will be performed, respectively.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- According to the stated objectives, this study has a quantitative approach, Randomized Controlled Clinical Trial (RCT), with an experimental and control group and pre- and post-test measures; to explore the response of children to the intervention UN Lifeguard Kids in the Tunja version and approximation can be made its effectiveness.
| Arm | Type | Receives |
|---|---|---|
| The experimental protocol UN Lifeguard Kids in the Tunja version | Experimental | Behavioral: Protocol UN Lifeguard Kids in the Tunja versionGroup to which the experimental protocol will be offered. |
| Educational session, accident prevention and wound management. | Placebo comparator | Behavioral: Educational session accident prevention and wound managementThe control group will be offered the Educational session. |
Who may qualify
- Ages
- 7 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Seven and eight-year-old.
- Children who are in the second grade of elementary school in two schools in the city of Tunja.
- Children's families with an available computer tablet or mobile device and internet connection will be considered for the study.
- Children who have a caregiver 18 years of age or older to accompany them during the intervention.
- Children with adequate learning skills (This data will be obtained from the report of the course teacher)
Key exclusion criteria (3 listed)
- Children who have received a scientific intervention on CPR.
- Children who participate in a rescue force (i.e., police, civil defense, brigade members).
- Children with a diagnosis of physical or mental disability (autism spectrum disorder, trisomy 21, Asperger syndrome, Tourette syndrome, attention deficit hyperactivity disorder (ADHD), severe visual, hearing, or motor problems, and/or similar disabilities).
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 |
|---|---|---|
| Protocol UN Lifeguard Kids in the Tunja versionThe experimental protocol UN Lifeguard Kids in the Tunja version done by the researcher following the guidelines of International organizations such as the American Heart association and European Resuscitation Council. The intervention consists of 3 sessions of 60 minutes of theoretical and practical exercises on BLS, developed within the usual class schedule. | Behavioural | The experimental protocol UN Lifeguard Kids in the Tunja version |
| Educational session accident prevention and wound managementIt will be provided to the control group | Behavioural | Educational session, accident prevention and wound management. |
Primary outcome
Viability
Time frame: 8 weeks
This variable is defined as the proportion of eligible participants who agree to participate in the study. Selection and monitoring form: In the first place, the form is filled out to discern if the children meet the inclusion criteria, then the consent form is signed, and finally the children agree to participate in the study. Then, the children who enter training sessions complete a form, in order to measure the percentage of children who attended all the sessions and to compare it with the children who were initially recruited.
Acceptability
Time frame: 8 weeks
Defined as the degree to which the participants were comfortable with their experience with the nursing intervention "UN Salvavidas Kids Tunja version". Participant's satisfaction questionnaire with the intervention: This approach has two parts, the first one involves three open questions and the second 6 with closed answers using dichotomous nominal variables.
2 secondary outcomes
knowledge in Basic Life Support.
Time frame: 8 weeks
Skills in Basic Life Support.
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Background: PubMed 26088639Bottiger BW, Van Aken H. Training children in cardiopulmonary resuscitation worldwide. Lancet. 2015 Jun 13;385(9985):2353. doi: 10.1016/S0140-6736(15)61099-6. No abstract available.
- Background: PubMed 21050434Yasunaga H, Horiguchi H, Tanabe S, Akahane M, Ogawa T, Koike S, Imamura T. Collaborative effects of bystander-initiated cardiopulmonary resuscitation and prehospital advanced cardiac life support by physicians on survival of out-of-hospital cardiac arrest: a nationwide population-based observational study. Crit Care. 2010;14(6):R199. doi: 10.1186/cc9319. Epub 2010 Nov 4.
- Background: PubMed 30098386Semeraro F, Wingen S, Schroeder DC, Ecker H, Scapigliati A, Ristagno G, Cimpoesu D, Bottiger BW. KIDS SAVE LIVES-Three years of implementation in Europe. Resuscitation. 2018 Oct;131:e9-e11. doi: 10.1016/j.resuscitation.2018.08.008. Epub 2018 Aug 8. No abstract available.
- Background: PubMed 31842928Oving I, Masterson S, Tjelmeland IBM, Jonsson M, Semeraro F, Ringh M, Truhlar A, Cimpoesu D, Folke F, Beesems SG, Koster RW, Tan HL, Blom MT; ESCAPE-NET Investigators. First-response treatment after out-of-hospital cardiac arrest: a survey of current practices across 29 countries in Europe. Scand J Trauma Resusc Emerg Med. 2019 Dec 16;27(1):112. doi: 10.1186/s13049-019-0689-0.
- Individual participant dataSharing planned: Yes. After data analysis, using the results obtained in this study, and the generation of the final report, the database will be shared shared with the public.
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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.
Sonia Patricia Carreño Moreno, RN, MSc, PhD study director
Universidad Nacional de Colombia
Questions about this trial
What is this clinical trial studying?
A study testing Protocol UN Lifeguard Kids in the Tunja version and Educational session accident prevention and wound management in people with Health Education and First Aid, run by Universidad Nacional de Colombia.
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 5 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: status not confirmed, as of the sponsor's last update on 9 Sep 2021. 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?
Contact Luz D Cano Rodriguez, Nursing (313 871 9480, lucanor@unal.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viability (time frame: 8 weeks). 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 NCT04914871, which also lists 4 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 9 Sep 2021.