NCT04914871

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 7, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

October 20, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

September 9, 2021

Status Verified

September 1, 2021

Enrollment Period

1 month

First QC Date

April 30, 2021

Last Update Submit

September 8, 2021

Conditions

Keywords

Basic Life SupportStudentTeachingNursingReadiness

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    8 weeks

Secondary Outcomes (2)

  • knowledge in Basic Life Support.

    8 weeks

  • Skills in Basic Life Support.

    8 weeks

Study Arms (2)

The experimental protocol UN Lifeguard Kids in the Tunja version

EXPERIMENTAL

Group to which the experimental protocol will be offered.

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.

Behavioral: Educational session accident prevention and wound management

Interventions

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.

The experimental protocol UN Lifeguard Kids in the Tunja version

It will be provided to the control group

Educational session, accident prevention and wound management.

Eligibility Criteria

Age7 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 26088639BACKGROUND
  • 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.

    PMID: 21050434BACKGROUND
  • 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.

    PMID: 30098386BACKGROUND
  • 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.

    PMID: 31842928BACKGROUND

MeSH Terms

Conditions

Health Education

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Sonia Patricia Carreño Moreno, RN, MSc, PhD

    Universidad Nacional de Colombia

    STUDY DIRECTOR

Central Study Contacts

Luz D Cano Rodriguez, Nursing

CONTACT

Luz D Cano Rodriguez, Nursing

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The research will be conducted using the double-blinded model since the children, parents, and research assistants who will carry out the pre- and post-test measurements, will not know the assignment of the groups, control, and intervention.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2021

First Posted

June 7, 2021

Study Start

October 20, 2021

Primary Completion

December 1, 2021

Study Completion

April 1, 2022

Last Updated

September 9, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
SAP, ICF, CSR
Time Frame
five years.
Access Criteria
Access Criteria: Health workers and researchers. Nursing students. Health science students. Research teachers. Students in education. Applications will be received by email from the researcher lucanor@unal.edu.co, where an analysis will be carried out to share the information on the intervention.