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Cardiac ArrestRECADENCT05747495

Online Formation in Cardiopulmonary Resuscitation in a Rural Area.

A study testing Online training in CPR-AED in people with Cardiac Arrest, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Cardiac Arrest
What is being tested?
Online training in CPR-AED
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteSpain
Study dates
1 Nov 2023to 31 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Language troubles
  • Disability that prevents from carrying out the CPR and AED course and measures
  • Difficulty attending practical sessions.

Trial locations and contacts

1 site in 1 country.

Cristina Rey-Reñones, PhD contact

977778515 ext. +34

crey.tgn.ics@gencat.cat

Spain1 site, 1 recruiting
  • IDIAP Jordi Gol

    Barcelona, 08007

    Cristina Rey-Reñones, PhD, 977778515 ext. 405, crey.tgn.ics@gencat.cat

    Recruiting

Other trials in Spain

About this study

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.

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.

Read more

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.

Read the 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.

Conditions
Cardiac Arrest
Being tested
Online training in CPR-AED
Keywords
Out-of-hospital cardiac arrest, Cardiopulmonary resuscitation, Automated external defibrillators, Emergency medical system services, Primary healthcare, Rural Health services
Medical subject headings
Heart Arrest, Out-of-Hospital Cardiac Arrest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online training in CPR-AEDOther

    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/].

Study groups in NCT05747495
Study groupRoleWhat they receive
Participants registered in the online training in CPR-AEDExperimentalThe 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/].
Receives: Other: Online training in CPR-AED

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effectiveness of the online training in CPR-AED knowledge

    The score difference obtained between the pre-training test and the post-training test.

    Measured: 1 month

  2. Effectiveness of the online training in CPR-AED maneuvers in simulation

    The CCR checklist will be used to evaluate the maneuvers in simulation. This variable will be defined as dichotomous. If the participant's result is APPROVED, he will be considered PASSED and if the result is FAILED, he will be NOT APPROVED.

    Measured: 6 months

Secondary outcomes (5)
  1. Socio-demographic data

    Age, gender, population of residence, education level, socioeconomic level.

    Measured: 1 month

  2. ACP data

    Previous training in CPR, family or personal history of heart disease or other risk factors, having previously witnessed an ACP, previous performance before ACP assessed through a questionnaire

    Measured: 1 month

  3. Time taken to complete the course

    Once registered and during one month participants have free access to complete the course, which requires a dedication of 3-4 hours.

    Measured: 1 month

  4. The number of entries to complete the course

    Participants can access the platform 7 days a week, 24 hours a day.

    Measured: 1 month

  5. Data on the satisfaction questionnaire

    Final score (1-5) and by dimensions (organization, methodology, applicability, general assessment, teacher assessment) .

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2023
  2. Study start1 Nov 2023
  3. Primary completion30 Sep 2024 (estimated)
  4. Study completion31 Jan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05747495
Sponsor's protocol ID
SLT008/18/00039
Acronym
RECADE
Status last verified
Jan 2024
First submitted
8 Feb 2023
Last updated
8 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No individual participant data will be shared. Results obtained in the simulation environment will be delivered to the participant himself through email. Results will be published by the investigators in academic journals, newapapers and social media.

Publications

  • Taverna-Llaurado E, Martinez-Torres S, Roca-Biosca A, Palleja-Millan M, Martin-Lujan F, Rey-Renones C. Effectiveness of Online Training on Cardiopulmonary Resuscitation and Automated External Defibrillator Use in Simulations With Rural Populations: Quasi-Experimental Community Intervention Study. JMIR Public Health Surveill. 2026 May 22;12:e80359. doi: 10.2196/80359.

    PubMed 42172642
  • 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.

    PubMed 38326271

Questions about this trial

What is this clinical trial studying?

A study testing Online training in CPR-AED in people with Cardiac Arrest, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Cristina Rey-Reñones, PhD (977778515 ext. +34, crey.tgn.ics@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness of the online training in CPR-AED knowledge (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05747495, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.

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