New Information and Communication Technologies (ICT´s) in Basic Life Support Training for Non-medical Students: Educational Trial

May 7, 2024 updated by: Universidad de Antioquia

New Information and Communication Technologies (ICT´s) in Basic Life Support Training for Non-medical Students: Educational Trial.

With the increase in life expectancy of the general population and advances in medicine, there is now a population with a higher amount of cardiovascular diseases that lead to an increased risk of sudden cardiac arrest. In most cases, this occurs in extra-hospital settings such as family homes, shopping centres, public transport and before people without any knowledge or training in basic life support. On the other hand, for every minute that passes without adequate attention of the victim, the probability of surviving or continuing to live with neurological severe sequelae decreases by 10%.

In developed countries, public policies have been created to encourage basic life support education to the general population. In Colombia, because of the high prevalence of these diseases and the need for public health strategies, a law was issued to provide access to automatic external defibrillators (AEDs) in public places. However, it has not been developed strategies for education on this subject.

For that reason, the investigators created an educational strategy of self-learning, which consists of a complete basic life support course based in new Information and Communication technologies with tools to manufacture a mannequin and a homemade DEA, which will allow continuous training, with a very low cost compared to traditional life support training.

The clinical trial will compare that two educational strategies, evaluating as primary aid, which approach has higher knowledge retention of life support chain at 6 months in students after the workshop. As secondary objectives, the investigators would evaluate the efficient in terms of response times, costs and student satisfaction.

This study will be carried out in high school students from two different high schools, without prior training in Life support. Both strategies will be distributed randomly. The experimental group will carry out the self-learning strategy based on ICT (Information and Communication Technologies), with which they will be retrained every month, and the control group will carry out the conventional training only once as usual. Subsequently, each of the objectives will be evaluated at six months.

It is proposed that the self-learning strategy is superior compared to conventional training, requiring fewer resources to perform it and allows constant retraining, which improves retention and quality in a resuscitation process.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia
        • Universidad de Antioquia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Senior students over 14 years in high school.

Exclusion Criteria:

  • Cognitive disorders.
  • Cardiovascular o pulmonary diseases.
  • Any condition that prevents physical activities.
  • To have any previous training in basic life support.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Basic Life Support Training based on ICTs
It will be conformed with students from one highschool random selected. They will receive a basic life support training based on Information and communication technologies.
Other: Basic Life Support training based on ICTs
This intervention is defined as a self-training course consisting of a 5-minute educational video in basic life support and a Kit with the elements to build the home dummy and the home DEA allowing integrally students to develop the steps as the video. The Kit will be delivered at the beginning of the study and every month the necessary materials will be complemented. The strategy will be carried out by the students every month and supervised by their teachers. Students will have constant access to an educational platform based on ICTs.
Active Comparator: Classic Basic Life Support Training
It will be conformed with students from another highschool random selected. They will receive a full and conventional basic life support training based on American and Hear Association recommendations.
Other: Classic Basic Life Support training
It is defined as a module carried out by trained personnel in basic resuscitation (pre-hospital care program staff of the UdeA medical school), which includes two subcomponents of the conventional BLS course that are basic resuscitation and DEA in adults. The duration of the subcomponents is a theoretical part of 30 minutes and a practical part in a low fidelity simulator with 1.5 hours duration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality in survival chain in basic life support
Time Frame: 6 months

It will be a composed outcome of 6 aspects in a check list and the student must comply ALL item to consider as a positive result in good quality in basic life support, the items are:

I. Recognition of a person in cardiorespiratory arrest II. Activate the survival chain to survive III. Start chest compressions during or after activating the chain. IV. Chest compressions between 100-120 V. Proper use of AED VI. No interruptions should made during the thoracic compressions cycle. The result will be presented in proportion of students who completed ALL previous items.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of survival chain activation
Time Frame: 6 months

Time in seconds that takes the student to perform the following components of the survival chain:

  • Identification of the victim
  • Emergency system activation.
  • Start of chest compressions.
  • Implementation of the AED strategy.
6 months
Student Satisfaction
Time Frame: 6 months

The satisfaction scale will be applied to all students. We will use a satisfaction scale developed and validated in Oviedo´s University, Asturias, Spain. It is a seven items scale. Each item is evaluated in 4 points Likert scale. The minimum value is 1, and the maximum value is 4 for each item.

We will evaluate these scale independently and present results in number and percentage en each item.
6 months
Costs
Time Frame: 6 months
We will evaluate the cost in US dolar of each intervention in the different activities related to executions of the interventions in each arm.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Antioquia

Investigators

  • Principal Investigator: Juan Villa-Velasquez, Dr, Univeridad de Antioquia's Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Estimated)

August 31, 2022

Study Completion (Estimated)

December 1, 2022

Study Registration Dates

First Submitted

December 13, 2019

First Submitted That Met QC Criteria

February 24, 2020

First Posted (Actual)

February 26, 2020

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIIU 2019-28530

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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