- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03233490
CPR Training in Students to Increase Bystander Intervention in Out-of-hospital Cardiac Arrest.
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).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CPR training and web corse intervention
The students performed a web course (Help Brain Heart) prior training
|
No web course was conducted
|
|
Experimental: CPR training intervention
CPR training without web course
|
Web course Help Brain Heart was conducted Before CPR training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The total score of the modified Cardiff test at six months
Time Frame: At six months follow-up test
|
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.
|
At six months follow-up test
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The total score of the modified Cardiff test directly after training
Time Frame: Directly after training (on the day of intervention)
|
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.
|
Directly after training (on the day of intervention)
|
|
Self-reported willingness to make a lifesaving intervention
Time Frame: Both directly after training (on the day of intervention) and at six months
|
Self-reported willingness to make a lifesaving intervention was measured by a questionnaire
|
Both directly after training (on the day of intervention) and at six months
|
|
Knowledge about stroke, acute myocardial infarction and living habits
Time Frame: Both directly after training (on the day of intervention) and at six months
|
Theoretical knowledge about acute myocardial infarction and living habits was measured by a questionnaire
|
Both directly after training (on the day of intervention) and at six months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: L Svensson, Karolinska Institutet
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013/358-31
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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