CPR Training in Students to Increase Bystander Intervention in Out-of-hospital Cardiac Arrest.
Primary Purpose
Coping Skills
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
web course
CPR training
Sponsored by
About this trial
This is an interventional basic science trial for Coping Skills focused on measuring CPR training, students, willingness
Eligibility Criteria
Inclusion Criteria:
- seventh grade student in one of the participating schools
Exclusion Criteria:
- student does not want to participate
- student with a physical handicap that significantly limited the physical performance
- classes of students with development disabilities (these classes are age integrated and have fewer students per class).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
CPR training and web corse intervention
CPR training intervention
Arm Description
The students performed a web course (Help Brain Heart) prior training
CPR training without web course
Outcomes
Primary Outcome Measures
The total score of the modified Cardiff test at six months
The total score was calculated by adding the individual scores of the 12 different categories (check responsiveness by talking, check responsiveness by shaking, open the airway, checks respiration, dials 112, compression/ventilation ratio, hand-position during compression, average compression depth, total compression counted, average ventilation volume, total ventilation counted, total hands-off time) assessed by the practical test.
Secondary Outcome Measures
The total score of the modified Cardiff test directly after training
The total score was calculated by adding the individual scores of the 12 different categories (check responsiveness by talking, check responsiveness by shaking, open the airway, checks respiration, dials 112, compression/ventilation ratio, hand-position during compression, average compression depth, total compression counted, average ventilation volume, total ventilation counted, total hands-off time) assessed by the practical test.
Self-reported willingness to make a lifesaving intervention
Self-reported willingness to make a lifesaving intervention was measured by a questionnaire
Knowledge about stroke, acute myocardial infarction and living habits
Theoretical knowledge about acute myocardial infarction and living habits was measured by a questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03233490
Brief Title
CPR Training in Students to Increase Bystander Intervention in Out-of-hospital Cardiac Arrest.
Official Title
CPR Training in Students to Increase Bystander Intervention in Out-of-hospital Cardiac Arrest.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
December 16, 2013 (Actual)
Primary Completion Date
October 22, 2014 (Actual)
Study Completion Date
October 22, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The overall aim of this thesis is to identify the factors that may affect 13 year old students' acquisition of CPR skills and their willingness to act. The primary hypothesis is that the training method (intervention) influences the participants' acquisition of practical CPR skills and willingness to intervene.
The study used a cluster randomized design, based on a randomization list generated by an independent statistician. The school classes were randomly assigned to different CPR training interventions.
A strategic sample, where invitation to participate in the study was sent to the headmasters of all council schools, with seventh grade students, in two Swedish municipalities (140,000). Thus, the sample consists of participants with different cultural as well as socio-economic background. Eighteen of 24 schools agreed to participate. Four schools did not respond and two schools had a routine to offer CPR education only for grade nine (all six schools from the same municipality). The eighteen schools who agreed to participate consisted of sixty-eight classes with 1547 students.
Prior to study participation, students and their guardians obtained a letter with study information. Study participation of the individual students was voluntary and all participants gave an oral informed consent.
Inclusion criteria: seventh grade student in one of the participating schools. Exclusion criteria: student does not want to participate, student with a physical handicap that limited the physical performance, classes of students with development disabilities (these classes are age-integrated and have fewer students per class).
Detailed Description
The main interventions were app or DVD-based education. In addition to the main intervention some classes were randomized to various additional interventions; web-course, visits of elite athletes, practical test, reflection and AED training. All CPR education was performed in accordance with the ERC guidelines of 2010. Training was given to the entire class together. The classes consisted of 14-29 students. All participants in all intervention groups used an individual training manikin, MiniAnne, during the training. The schools were allowed to keep the training manikins after the end of study. Ten teachers were previous CPR instructors and another 19 teachers received a five hours education to become CPR instructor. All teachers obtained individual oral and written instructions about each class randomized intervention method and written bullet points about how the course would be implemented, to ensure that they were up to date with present guidelines and training. The teachers acted as facilitators; they introduced the lesson, gave advice on the fly, answered questions and completed the course.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coping Skills
Keywords
CPR training, students, willingness
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
1547 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CPR training and web corse intervention
Arm Type
Experimental
Arm Description
The students performed a web course (Help Brain Heart) prior training
Arm Title
CPR training intervention
Arm Type
Experimental
Arm Description
CPR training without web course
Intervention Type
Other
Intervention Name(s)
web course
Intervention Description
Web course Help Brain Heart was conducted Before CPR training.
Intervention Type
Other
Intervention Name(s)
CPR training
Intervention Description
No web course was conducted
Primary Outcome Measure Information:
Title
The total score of the modified Cardiff test at six months
Description
The total score was calculated by adding the individual scores of the 12 different categories (check responsiveness by talking, check responsiveness by shaking, open the airway, checks respiration, dials 112, compression/ventilation ratio, hand-position during compression, average compression depth, total compression counted, average ventilation volume, total ventilation counted, total hands-off time) assessed by the practical test.
Time Frame
At six months follow-up test
Secondary Outcome Measure Information:
Title
The total score of the modified Cardiff test directly after training
Description
The total score was calculated by adding the individual scores of the 12 different categories (check responsiveness by talking, check responsiveness by shaking, open the airway, checks respiration, dials 112, compression/ventilation ratio, hand-position during compression, average compression depth, total compression counted, average ventilation volume, total ventilation counted, total hands-off time) assessed by the practical test.
Time Frame
Directly after training (on the day of intervention)
Title
Self-reported willingness to make a lifesaving intervention
Description
Self-reported willingness to make a lifesaving intervention was measured by a questionnaire
Time Frame
Both directly after training (on the day of intervention) and at six months
Title
Knowledge about stroke, acute myocardial infarction and living habits
Description
Theoretical knowledge about acute myocardial infarction and living habits was measured by a questionnaire
Time Frame
Both directly after training (on the day of intervention) and at six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
seventh grade student in one of the participating schools
Exclusion Criteria:
student does not want to participate
student with a physical handicap that significantly limited the physical performance
classes of students with development disabilities (these classes are age integrated and have fewer students per class).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
L Svensson
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No data shall be analyzed at the individual level.
Citations:
PubMed Identifier
31061026
Citation
Hollenberg J, Claesson A, Ringh M, Nordberg P, Hasselqvist-Ax I, Nord A. Effects of native language on CPR skills and willingness to intervene in out-of-hospital cardiac arrest after film-based basic life support training: a subgroup analysis of a randomised trial. BMJ Open. 2019 May 5;9(5):e025531. doi: 10.1136/bmjopen-2018-025531.
Results Reference
derived
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CPR Training in Students to Increase Bystander Intervention in Out-of-hospital Cardiac Arrest.
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