Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05747495
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2023-02-08
Brief Title:
Online Formation in Cardiopulmonary Resuscitation in a Rural Area
Sponsor:
Fundacio dInvestigacio en Atencio Primaria Jordi Gol i Gurina
Organization:
Fundacio dInvestigacio en Atencio Primaria Jordi Gol i Gurina
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RECADE
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 passfail of the simulated test phase 2 Continuous variables will be compared using the Students t-test or the U-Man Whitney test depending on normality For categorical variables Pearsons 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
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 passfail of the simulated test phase 2 Continuous variables will be compared using the Students t-test or the U-Man Whitney test depending on normality For categorical variables Pearsons 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 groupThe 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
PARTICIPANTS 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 10256 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 studys 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 005 and a beta risk of 02 for a bilateral contrast it is considered that 52 participants are needed to detect a difference equal to or greater than 05 points in the face-to-face evaluation of the online training A common standard deviation of 107 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
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 groupThe 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
PARTICIPANTS 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 10256 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 studys 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 005 and a beta risk of 02 for a bilateral contrast it is considered that 52 participants are needed to detect a difference equal to or greater than 05 points in the face-to-face evaluation of the online training A common standard deviation of 107 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None