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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
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Coping Skills focused on measuring CPR training, students, willingness

Eligibility Criteria

12 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    July 26, 2017
    Last Updated
    August 15, 2017
    Sponsor
    Karolinska Institutet
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    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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