Online Formation in Cardiopulmonary Resuscitation in a Rural Area.

NCT ID: NCT05747495

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Background: Sudden death due to cardiorespiratory arrest has a high mortality and in most cases occurs in out-of-hospital. Cardiopulmonary resuscitation (CPR) initiated immediately by witnesses doubles survival. However, rural areas present different challenges regarding the arrival of emergency services. As a result, the rural population could benefit from basic CPR training programs, in order to improve survival in front of a situation of cardiorespiratory arrest. The aim of this study is to evaluate the effectiveness of the online training in CPR-AED carried out by participants in a rural area of Camp de Tarragona.

Methodology: Quasi-experimental design, consisting of 2 phases: Phase 1) Evaluation of the effectiveness of the online training in CPR-AED knowledge; Phase 2) Evaluation of the effectiveness of the online training in CPR-AED maneuvers in simulation at short- and medium- term.

The main variable is the score difference between the pre- and post-training test (phase 1) and the passing or not (pass/fail) of the simulated test (phase 2). Continuous variables will be compared using the Student's t-test or the U-Man Whitney test (depending on normality). For categorical variables, Pearson's Chi-square test will be used. A multivariate analysis will be performed to determine which factors independently influence the main variable.

Applicability and Relevance: The evaluation of the effectiveness of this course will allow it to be extended to different rural territories of the community, contributing to the expansion of knowledge of CPR-AED maneuvers.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

STUDY OBJECTIVES

The main objective of this study is to determine the effectiveness of an online training in CPR and AED carried out by participants from a rural area of Camp de Tarragona.

Secondary objectives: 1) To determine the improvement of the CPR knowledge of the participants after the course; 2) To assess the CPR skills of the participants of the online course through a face-to-face simulation with mannequins in the short (1 month) and medium term (6 months).

STUDY DESIGN AND SETTING

This study consists of a quasi-experimental comunitary intervention study without a control group.The flowchart of the study is detailed in figure 1. It will be carried out in two phases:

* PHASE 1. Evaluation of the effectiveness of the online training in CPR-AED knowledge.
* PHASE 2. Evaluation of the effectiveness of the online training in CPR-AED maneuvers in simulation.

Participants are being recruited by the primary care centers that encompass the rural area of Tarragona.

PARTICIPANT'S SELECTION AND RECRUITMENT

The reference population is the inhabitants of 15 municipalities in the rural area of the interior of Tarragona, which involve the countries of Priorat and Baix Camp Nord, including a total of 10,256 inhabitants.

These towns refer to the primary care team of Les Borges del Camp and Cornudella de Montsant, according to the followed distribution:

* Basic health area of Les Borges: Alforja, Les Borges del Camp, Riudecols, Aleixar, Maspujols, Vilaplana and Arbolí.
* Basic health area of Cornudella de Montsant: Poboleda, Cornudella de Montsant, Ulldemolins, Prades, Capafonts, La Febró, La Morera de Montsant and Escaladei.

During a 3-month period prior to the courses, online training will be disseminated to different population groups including police, firemen, teaching staff, health workers, shopkeepers, pharmacists among others. In addition, the course will be offered from the primary care centers to everybody but insisting to the relatives of people with heart disease. Moreover, alliances will be sought with the municipal councils, and informative posters will be distributed.

PROCEDURES

PHASE 1. Evaluation of the effectiveness of the online training in CPR-AED knowledge.

People interested in participating must register on a Moodle environment platform. First registration steps will consist of a brief questionnaire with the eligibility criteria and informed consent to participate in the study.

Once registered and during one month they have free access to complete the course, which requires a dedication of 3-4 hours. They can access the platform 7 days a week, 24 hours a day.

Enrolled people will complete two questionnaires, one to assess prior knowledge (Pre-training test) and another, acquired knowledge (Post-training test).

The qualification will be pass or fail. All suitable people will obtain a course certificate and will be invited to be assessed in person by staff accredited by the CCR.

Those who complete the training and are eligible for the assessment will be included in phase II.

PHASE 2. Evaluation of the effectiveness of the online training in CPR-AED maneuvers in simulation.

Volunteers who agree to participate will be invited to face-to-face assessment of CPR skills and use of the AED at short term (1 month) and medium term (6 month) after training. The evaluation will be external to the team that designed the course. The participant will be exposed to an CPA situation and will have to solve according to the acquired competence in CPR and use of the AED, to attend to the affected person (in this case simulated). This evaluation will follow the recommendations described by the ERC. At the end, all competent people will obtain a certified accreditation.

SAMPLE SIZE

For phase 1, the online training course is open access, so anyone who meets the study's selection criteria will be able to take part. For phase 2, of all the people who have completed the course in phase 1 of the study, a representative selection will be made of the reference population covering different age and gender ranges. In addition, the population of participants will be selected proportionally to population density.

In order to evaluate the effectiveness of the training in the simulation, the necessary sample has been calculated with the statistical software GRANMO (IMIM, 2012) using the option of averages observed with respect to a reference sample.

Accepting an alpha risk of 0.05 and a beta risk of 0.2 for a bilateral contrast, it is considered that 52 participants are needed to detect a difference equal to or greater than 0.5 points in the face-to-face evaluation of the online training. A common standard deviation of 1.07\* is assumed.

The number of subjects is increased by 30% assuming a forecast of losses to follow-up.

DATA COLLECTION

For phase 1, data will be collected through the online training platform and stored in an electronic format on a personal device, under the supervision of the principal investigator. Access is controlled with credentials. The data obtained will be used only for this study for the purpose of the same.

For phase 2, data is collected through the CCR questionnaire (Annex 5) by the health professional with CCR accreditation.

STATISTICAL ANALYSES

Quantitative variables will be expressed as mean (± standard deviation), if they follow a normal distribution, or in median and interquartile range if they do not follow a normal distribution. The normality of the variables will be described using the Kolmogorov test.

Qualitative variables will be described with percentages and 95% confidence intervals. The usual statistical tests will be used in this type of study.

Initially, a descriptive analysis of the study population and a bivariate analysis will be carried out, separating the cohort between the participants who were PASS or NOT PASS the simulation. Finally, a multivariate analysis will be performed to determine which factors independently influence the main variable, adjusting all the variables of interest described above. It will be performed with a linear regression.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Arrest

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Participants registered in the online training in CPR-AED

The online training has been designed according to the Catalan Resuscitation Council (CCR) and the European Resuscitation Council (ERC) guidelines. The aim of this training is to provide theoretical and practical knowledge to respond to aid situations (from unconscious people to drowning, both adults and children), as well as the use of the AED.

The contents are available at the link \[https://register.magnore.com/registre-curs-de-reanimacio-cardiopulmonar-dea/\].

Group Type EXPERIMENTAL

Online training in CPR-AED

Intervention Type OTHER

The online training has been designed according to the Catalan Resuscitation Council (CCR) and the European Resuscitation Council (ERC) guidelines. The aim of this training is to provide theoretical and practical knowledge to respond to aid situations (from unconscious people to drowning, both adults and children), as well as the use of the AED.

The contents are available at the link \[https://register.magnore.com/registre-curs-de-reanimacio-cardiopulmonar-dea/\].

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Online training in CPR-AED

The online training has been designed according to the Catalan Resuscitation Council (CCR) and the European Resuscitation Council (ERC) guidelines. The aim of this training is to provide theoretical and practical knowledge to respond to aid situations (from unconscious people to drowning, both adults and children), as well as the use of the AED.

The contents are available at the link \[https://register.magnore.com/registre-curs-de-reanimacio-cardiopulmonar-dea/\].

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Residing in the rural area of Priorat and Baix Camp Nord.
* \>18 years old
* Having a device with internet connection
* Be interested in taking part in the virtual course as a participants

Exclusion Criteria

* Language troubles
* Disability that prevents from carrying out the CPR and AED course and measures
* Difficulty attending practical sessions.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Cristina Rey-Reñones, PhD

Role: PRINCIPAL_INVESTIGATOR

IDIAP JORDI GOL

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

IDIAP Jordi Gol

Barcelona, , Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Cristina Rey-Reñones, PhD

Role: CONTACT

977778515 ext. +34

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Cristina Rey-Reñones, PhD

Role: primary

977778515 ext. 405

References

Explore related publications, articles, or registry entries linked to this study.

Taverna-Llaurado E, Martinez-Torres S, Granado-Font E, Palleja-Millan M, Del Pozo A, Roca-Biosca A, Martin-Lujan F, Rey-Renones C. Online platform for cardiopulmonary resuscitation and automated external defibrillator training in a rural area: a community clinical trial protocol. BMJ Open. 2024 Feb 7;14(2):e079467. doi: 10.1136/bmjopen-2023-079467.

Reference Type DERIVED
PMID: 38326271 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SLT008/18/00039

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Automated Real-time Feedback on CPR Study
NCT00539539 COMPLETED PHASE2
SNPeCPR In Cardiac Arrest REsuscitation
NCT02225561 TERMINATED PHASE3
CPR Prescription Program
NCT00570947 COMPLETED NA
CPR Training in 7th Grade Students
NCT00570609 COMPLETED NA