Clinical trial NCT05747495: Online Formation in Cardiopulmonary Resuscitation in a Rural Area.
Official title: Formation of a Network of Volunteers in Maneuverd of Cardiopulmonary Resuscitation and the Use of the Automated External Defibrillator (AED) in the Rural Area Through a Virtual Platform.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Arrest
Keywords: Out-of-hospital cardiac arrest
Cardiopulmonary resuscitation
Automated external defibrillators
Emergency medical system services
Primary healthcare
Rural Health services
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effectiveness of the online training in CPR-AED knowledge
timeFrame: 1 month
measure: Effectiveness of the online training in CPR-AED maneuvers in simulation
timeFrame: 6 months
Secondary outcomes:
measure: Socio-demographic data
timeFrame: 1 month
measure: ACP data
timeFrame: 1 month
measure: Time taken to complete the course
timeFrame: 1 month
measure: The number of entries to complete the course
timeFrame: 1 month
measure: Data on the satisfaction questionnaire
timeFrame: 1 month
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: IDIAP Jordi Gol
Study officials:
affiliation: IDIAP JORDI GOL
name: Cristina Rey-Reñones, PhD
role: PRINCIPAL_INVESTIGATOR
References: