Cardiorespiratory ArrestEFORCPNCT06275984
Effectiveness of Online Training in Cardiopulmonary Resuscitation Maneuvers for a Network of Volunteers.
A study testing online CPR-AED training in people with Cardiorespiratory Arrest and Cardiopulmonary Arrest With Successful Resuscitation, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
Background: Cardiorespiratory arrest (CPA) occurs when there is a cessation of cardiac mechanical activity, typically diagnosed by the absence of consciousness, pulse, and breathing. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiorespiratory Arrest, Cardiopulmonary Arrest With Successful Resuscitation
- What is being tested?
- online CPR-AED training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Over 18 years of age
- Residents in the municipalities of Camp de Tarragona
- With internet access
Who cannot join
- Language difficulties
- Disability that prevents the correct completion or performance of a CPR maneuver (exclusion criteria for moving to phase 2)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of Online Training in Cardiopulmonary Resuscitation Maneuvers for a Network of Volunteers to Increase Survival in Cardiac Arrest. EFORCP Study
Background: Cardiorespiratory arrest (CPA) occurs when there is a cessation of cardiac mechanical activity, typically diagnosed by the absence of consciousness, pulse, and breathing. Actions taken in response to CPA include recognizing the condition and promptly notifying emergency medical services, initiating Cardiopulmonary Resuscitation (CPR) maneuvers, and employing an Automated External Defibrillator (AED). Survival rates are directly influenced by the time elapsed between CPA onset and the initiation of CPR maneuvers, as well as the quality of these interventions
Hypotheses: Online education in CPR maneuvers is an effective and efficient tool for training individuals from the general population on how to respond to cardiac arrests
Read more
Objectives: The primary aim of this study is to assess the efficacy of online CPR and AED training within the general population of the province of Tarragona. Specific objectives include: 1) evaluating participants' theoretical and practical CPR skills in the short and medium term following online training, and 2) exploring the experiences of individuals who have completed the online training and simulation sessions using qualitative methodology.
Methodology:This study will unfold in several phases: 1) Online CPR-AED training and assessment of theoretical knowledge acquisition; 2) Evaluation of acquired practical CPR skills (know-how) within a simulation environment, conducted on a subset of the population completing phase 1;3)Analysis of the experiences of a subset of individuals who have participated in the preceding two phases, employing qualitative methodology
Variables and determinations:The primary response variable for phase 1 will be the difference in scores obtained from the online questionnaire between the final (post-training) and initial (pre-training) assessments.
In phase 2, the main variable will be the pass/fail categorization of scores in the simulation. This evaluation will be conducted by two members of the Advanced Clinical Simulation Unit at Joan XXII Hospital using a predefined checklist. Throughout the various phases of the study, socio-demographic data and course performance data will be taken into account
Expected results: The research team for this study aims to ascertain the efficacy and effectiveness of online CPR-AED training within the general population. Furthermore, the study aims to provide evidence regarding the optimal duration and frequency for repeating such training.
Applicability and Relevance: This proposal advocates for a significant and innovative project, given the dearth of literature on this topic. While there are existing indications and studies on CPR-AED training among specific populations such as students and healthcare professionals, the presented proposal seeks to broaden the scope of training to encompass the general population.
Read the detailed description
Study Development:
The recruitment period spans from June 2024 to June 2025. Individuals meeting the selection criteria will have access to the online training. Upon registration, they will be notified of the study's existence, and if they consent, their data may be analyzed in phase 1. Participants will also be informed about phase 2 and asked for their interest in participating. Those interested will need to provide contact information (telephone and/or email).
For phase 2, a random sample will be drawn from individuals expressing interest in the simulation. All participants in this phase will receive an information sheet and will be required to sign an informed consent form.
Phase 1: Online CPR and AED Training and Evaluation of Theoretical Skills
Participants will be administered a questionnaire on CPR-AED knowledge before and after completing the online training. This questionnaire, tailored specifically for the course, adheres to the recommendations of the Spanish Cardiopulmonary Resuscitation Council. It comprises five questions in various formats (e.g., multiple-choice, sequencing actions). To obtain the training certificate, participants must answer all five questions correctly, with unlimited attempts permitted. The primary response variable for this phase will be the difference between the final score (on the first attempt) and the initial score. Additionally, the number of attempts made until achieving the maximum score (5) will be recorded as a variable
Phase 2: Evaluation of Practical Skills Acquired afetr the online training through Simulations
Monthly evaluations will be conducted at the Advanced Clinical Simulation Unit of HJ23 (Hospital Universitari Joan XXIII), with 15 participants per session. This structure ensures that three random samples of 52 individuals each will be evaluated at 3, 6, and 12 months following completion of the online training.
To assess phase 2 (simulation), two evaluators from the Advanced Clinical Simulation Unit of HJ23, who are independent of the research team, will complete a checklist based on their observations of the participants' performance during the evaluation. The evaluation will be considered successful if the participant adequately performs eight out of nine actions on the checklist, with a high agreement between evaluators (Kappa index greater than 0.8). The primary response variable for this practical assessment will be the percentage of participants who pass the test. Additionally, the time elapsed between completion of the online training and the simulation will be recorded.
Statistical Analysis:
A descriptive analysis of the study population will be conducted for both participants in phase one and the subsample undertaking simulations. Continuous variables will be presented as mean (± standard deviation) or median and interquartile range (IQR), while categorical variables will be expressed as absolute and relative frequencies.
To compare scores in the pre- and post-training tests (phase 1), the Student's t-test for related samples or the non-parametric Wilcoxon test will be utilized.
For phase 2, absolute and relative frequencies of individuals passing tests (overall and by period) will be provided, along with 95% confidence intervals. Additionally, the success percentage for each assessed item will be analyzed. These scores will be compared across different periods (3, 6, and 12 months) using the Chi-square or Fisher's exact test if necessary.
Furthermore, multivariate regression models will be explored, with the response variable being the dichotomous pass/fail variable (binary logistic regression) in phase 2, and including other study variables as adjustment variables. Crude and adjusted odds ratios (ORs) will be provided for all variables included in the final models. This analysis aims to identify variables associated with succes obtained in the simulation (phase 2).
The threshold for statistical significance is set at p<0.05. All statistical analyses will be performed using the R Statistics program (R Foundation for Statistical Computing, Vienna, Austria; version 4.1.2 or later).
Phase 3: Evaluation of Participants' Experience
For the qualitative study, interviews will be conducted with focus groups consisting of four to six individuals, selected based on representativeness criteria, from those who have completed both previous phases (online training and simulation). The objective of this phase is to gain insight into participants' experiences and, based on these insights, to adapt and enhance the online training program. Participants will be asked about the strengths and weaknesses of the training and assessments in both phases, and will be encouraged to provide suggestions for improvement.
- Being tested
- online CPR-AED training
- Keywords
- Heart Arrest, Simulation Training, Primary Health Care, Defibrillators
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online CPR-AED trainingOther
The online CPR-AED training consists of successfully completing the online training course. To access the course, interested persons must register on a Moodle environment platform, with free and open access, through the following link: https://register.magnore.com/registre-curs-de-reanimacio -cardiopulmonary-dea/
Online training takes 3-4h and the participant will have access for 1 month (7x24h).
| Study group | Role | What they receive |
|---|---|---|
| Online training | Other | Participants will perform an online training in CPR-AED Receives: Other: online CPR-AED training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between pre and post training scores in ad hoc designed scale
The scale used to measure the acquisition of knowledge through online theoretical training has been designed ad hoc for the present study, following the recommendations of the Spanish Council of Cardiopulmonary Resuscitation. It consists of 5 items. The scoring ranges from 0 to 5, with higher scores indicating greater knowledge.
Measured: 12 months
Percentage of participants that reach or exceed 10 out of 12 on the checklist
Percentage of participants that pass the CPR-AED evaluation in a simulated environment. (phase 2)
Measured: 14 months
Secondary outcomes (2)
Odds ratios (with 95% CI) for adjustment variables
These odds ratios will assess the association between sociodemographic and other study variables and the likelihood of success in the simulation (indicating competence in CPR).
Measured: 24 months
Scores on the standard satisfaction questionnaire commonly used by the Catalan Health Institute to evaluate training activities
The questionnaire used to measure satisfaction is a standard questionnaire commonly employed by the Catalan Health Institute to evaluate the satisfaction of students participating in training activities. It assesses organizational aspects, methodology, applicability, overall assessment (expectations and whether the course is recommendable to others), and the instructors. Each item is rated from 1 to 5. The scoring ranges from 6 to 30. Higher scores indicate a higher degree of satisfaction
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start1 Oct 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiorespiratory ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitari Joan XXIII de Tarragona.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275984
- Sponsor's protocol ID
- PI23/00288
- Other IDs
- 4R23/440
- Acronym
- EFORCP
- Status last verified
- Feb 2025
- First submitted
- 9 Feb 2024
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Online Training in Cardiopulmonary Resuscitation Maneuvers for a Network of Volunteers to Increase Survival in Cardiac Arrest. EFORCP Study
- ClinicalTrials.gov ID
- NCT06275984
- Acronym / sponsor ID
- EFORCP / PI23/00288
- Keywords
- Heart Arrest, Simulation Training, Primary Health Care, Defibrillators
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Hospital Universitari Joan XXIII de Tarragona.
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Cardiorespiratory arrest (CPA) occurs when there is a cessation of cardiac mechanical activity, typically diagnosed by the absence of consciousness, pulse, and breathing. Actions taken in response to CPA include recognizing the condition and promptly notifying emergency medical services, initiating Cardiopulmonary Resuscitation (CPR) maneuvers, and employing an Automated External Defibrillator (AED). Survival rates are directly influenced by the time elapsed between CPA onset and the initiation of CPR maneuvers, as well as the quality of these interventions
Hypotheses: Online education in CPR maneuvers is an effective and efficient tool for training individuals from the general population on how to respond to cardiac arrests
Objectives: The primary aim of this study is to assess the efficacy of online CPR and AED training within the general population of the province of Tarragona. Specific objectives include: 1) evaluating participants' theoretical and practical CPR skills in the short and medium term following online training, and 2) exploring the experiences of individuals who have completed the online training and simulation sessions using qualitative methodology.
Methodology:This study will unfold in several phases: 1) Online CPR-AED training and assessment of theoretical knowledge acquisition; 2) Evaluation of acquired practical CPR skills (know-how) within a simulation environment, conducted on a subset of the population completing phase 1;3)Analysis of the experiences of a subset of individuals who have participated in the preceding two phases, employing qualitative methodology
Variables and determinations:The primary response variable for phase 1 will be the difference in scores obtained from the online questionnaire between the final (post-training) and initial (pre-training) assessments.
In phase 2, the main variable will be the pass/fail categorization of scores in the simulation. This evaluation will be conducted by two members of the Advanced Clinical Simulation Unit at Joan XXII Hospital using a predefined checklist. Throughout the various phases of the study, socio-demographic data and course performance data will be taken into account
Expected results: The research team for this study aims to ascertain the efficacy and effectiveness of online CPR-AED training within the general population. Furthermore, the study aims to provide evidence regarding the optimal duration and frequency for repeating such training.
Applicability and Relevance: This proposal advocates for a significant and innovative project, given the dearth of literature on this topic. While there are existing indications and studies on CPR-AED training among specific populations such as students and healthcare professionals, the presented proposal seeks to broaden the scope of training to encompass the general population.
Detailed description
Study Development:
The recruitment period spans from June 2024 to June 2025. Individuals meeting the selection criteria will have access to the online training. Upon registration, they will be notified of the study's existence, and if they consent, their data may be analyzed in phase 1. Participants will also be informed about phase 2 and asked for their interest in participating. Those interested will need to provide contact information (telephone and/or email).
For phase 2, a random sample will be drawn from individuals expressing interest in the simulation. All participants in this phase will receive an information sheet and will be required to sign an informed consent form.
Phase 1: Online CPR and AED Training and Evaluation of Theoretical Skills
Participants will be administered a questionnaire on CPR-AED knowledge before and after completing the online training. This questionnaire, tailored specifically for the course, adheres to the recommendations of the Spanish Cardiopulmonary Resuscitation Council. It comprises five questions in various formats (e.g., multiple-choice, sequencing actions). To obtain the training certificate, participants must answer all five questions correctly, with unlimited attempts permitted. The primary response variable for this phase will be the difference between the final score (on the first attempt) and the initial score. Additionally, the number of attempts made until achieving the maximum score (5) will be recorded as a variable
Phase 2: Evaluation of Practical Skills Acquired afetr the online training through Simulations
Monthly evaluations will be conducted at the Advanced Clinical Simulation Unit of HJ23 (Hospital Universitari Joan XXIII), with 15 participants per session. This structure ensures that three random samples of 52 individuals each will be evaluated at 3, 6, and 12 months following completion of the online training.
To assess phase 2 (simulation), two evaluators from the Advanced Clinical Simulation Unit of HJ23, who are independent of the research team, will complete a checklist based on their observations of the participants' performance during the evaluation. The evaluation will be considered successful if the participant adequately performs eight out of nine actions on the checklist, with a high agreement between evaluators (Kappa index greater than 0.8). The primary response variable for this practical assessment will be the percentage of participants who pass the test. Additionally, the time elapsed between completion of the online training and the simulation will be recorded.
Statistical Analysis:
A descriptive analysis of the study population will be conducted for both participants in phase one and the subsample undertaking simulations. Continuous variables will be presented as mean (± standard deviation) or median and interquartile range (IQR), while categorical variables will be expressed as absolute and relative frequencies.
To compare scores in the pre- and post-training tests (phase 1), the Student's t-test for related samples or the non-parametric Wilcoxon test will be utilized.
For phase 2, absolute and relative frequencies of individuals passing tests (overall and by period) will be provided, along with 95% confidence intervals. Additionally, the success percentage for each assessed item will be analyzed. These scores will be compared across different periods (3, 6, and 12 months) using the Chi-square or Fisher's exact test if necessary.
Furthermore, multivariate regression models will be explored, with the response variable being the dichotomous pass/fail variable (binary logistic regression) in phase 2, and including other study variables as adjustment variables. Crude and adjusted odds ratios (ORs) will be provided for all variables included in the final models. This analysis aims to identify variables associated with succes obtained in the simulation (phase 2).
The threshold for statistical significance is set at p<0.05. All statistical analyses will be performed using the R Statistics program (R Foundation for Statistical Computing, Vienna, Austria; version 4.1.2 or later).
Phase 3: Evaluation of Participants' Experience
For the qualitative study, interviews will be conducted with focus groups consisting of four to six individuals, selected based on representativeness criteria, from those who have completed both previous phases (online training and simulation). The objective of this phase is to gain insight into participants' experiences and, based on these insights, to adapt and enhance the online training program. Participants will be asked about the strengths and weaknesses of the training and assessments in both phases, and will be encouraged to provide suggestions for improvement.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Online training | Other | Other: online CPR-AED trainingParticipants will perform an online training in CPR-AED |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years of age
- Residents in the municipalities of Camp de Tarragona
- With internet access
Key exclusion criteria (2 listed)
- Language difficulties
- Disability that prevents the correct completion or performance of a CPR maneuver (exclusion criteria for moving to phase 2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| online CPR-AED trainingThe online CPR-AED training consists of successfully completing the online training course. To access the course, interested persons must register on a Moodle environment platform, with free and open access, through the following link: https://register.magnore.com/registre-curs-de-reanimacio -cardiopulmonary-dea/ Online training takes 3-4h and the participant will have access for 1 month (7x24h). | Other | Online training |
Primary outcome
Difference between pre and post training scores in ad hoc designed scale
Time frame: 12 months
The scale used to measure the acquisition of knowledge through online theoretical training has been designed ad hoc for the present study, following the recommendations of the Spanish Council of Cardiopulmonary Resuscitation. It consists of 5 items. The scoring ranges from 0 to 5, with higher scores indicating greater knowledge.
Percentage of participants that reach or exceed 10 out of 12 on the checklist
Time frame: 14 months
Percentage of participants that pass the CPR-AED evaluation in a simulated environment. (phase 2)
2 secondary outcomes
Odds ratios (with 95% CI) for adjustment variables
Time frame: 24 months
Scores on the standard satisfaction questionnaire commonly used by the Catalan Health Institute to evaluate training activities
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing online CPR-AED training in people with Cardiorespiratory Arrest and Cardiopulmonary Arrest With Successful Resuscitation, 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 3 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 6 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between pre and post training scores in ad hoc designed scale (time frame: 12 months). 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?
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 6 Mar 2025.