Clinical trial NCT04914871: Readiness for Basic Life Support in Schools
Official title: Readiness for Basic Life Support in Schools: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Health Education
First Aid
Cardiopulmonary Resuscitation
Keywords: Basic Life Support
Student
Teaching
Nursing
Readiness
Lead sponsor: Universidad Nacional de Colombia
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 70
Sex: ALL
Minimum age (years): 7
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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: 1. 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?
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.

Eligibility criteria: Inclusion criteria:

* 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)

Exclusion criteria:

* 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).

Primary outcomes:
measure: Viability
timeFrame: 8 weeks
measure: Acceptability
timeFrame: 8 weeks
Secondary outcomes:
measure: knowledge in Basic Life Support.
timeFrame: 8 weeks
measure: Skills in Basic Life Support.
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Nacional de Colombia
name: Sonia Patricia Carreño Moreno, RN, MSc, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Yasunaga 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.
citation: Semeraro 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.
citation: Oving 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.