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

Primary Purpose

Cardiac Arrest, Out-Of-Hospital

Status
Unknown status
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Basic Life Support training based on ICTs
Classic Basic Life Support training
Sponsored by
Universidad de Antioquia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cardiac Arrest, Out-Of-Hospital focused on measuring Cardiac Arrest, Basic Life Support, New Information and Communication Technologies

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Universidad de AntioquiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Basic Life Support Training based on ICTs

Classic Basic Life Support Training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Quality in survival chain in basic life support
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.

Secondary Outcome Measures

Time of survival chain activation
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.
Student Satisfaction
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.
Costs
We will evaluate the cost in US dolar of each intervention in the different activities related to executions of the interventions in each arm.

Full Information

First Posted
December 13, 2019
Last Updated
March 26, 2020
Sponsor
Universidad de Antioquia
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1. Study Identification

Unique Protocol Identification Number
NCT04286204
Brief Title
New Information and Communication Technologies (ICT´s) in Basic Life Support Training for Non-medical Students: Educational Trial
Official Title
New Information and Communication Technologies (ICT´s) in Basic Life Support Training for Non-medical Students: Educational Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
August 31, 2020 (Anticipated)
Study Completion Date
October 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad de Antioquia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Out-Of-Hospital
Keywords
Cardiac Arrest, Basic Life Support, New Information and Communication Technologies

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Basic Life Support Training based on ICTs
Arm Type
Experimental
Arm Description
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.
Arm Title
Classic Basic Life Support Training
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Basic Life Support training based on ICTs
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Classic Basic Life Support training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality in survival chain in basic life support
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Time of survival chain activation
Description
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.
Time Frame
6 months
Title
Student Satisfaction
Description
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.
Time Frame
6 months
Title
Costs
Description
We will evaluate the cost in US dolar of each intervention in the different activities related to executions of the interventions in each arm.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabian Casas, Dr
Phone
057-3005746882
Email
fabian.casas@udea.edu.co
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Villa-Velasquez, Dr
Phone
057-3002990041
Email
juan.villa@udea.edu.co
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Villa-Velasquez, Dr
Organizational Affiliation
Univeridad de Antioquia's Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad de Antioquia
City
Medellín
State/Province
Antioquia
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabian Casas, MD
Phone
0344441333
Ext
2510
Email
fabian.casas@udea.edu.co
First Name & Middle Initial & Last Name & Degree
Olga Giraldo, MD
Phone
0344441333
Ext
2510
Email
lucia.giraldo@udea.edu.co

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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29386200
Citation
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Results Reference
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Citation
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Results Reference
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Citation
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New Information and Communication Technologies (ICT´s) in Basic Life Support Training for Non-medical Students: Educational Trial

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