<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03233490</url>
  </required_header>
  <id_info>
    <org_study_id>2013/358-31</org_study_id>
    <nct_id>NCT03233490</nct_id>
  </id_info>
  <brief_title>CPR Training in Students to Increase Bystander Intervention in Out-of-hospital Cardiac Arrest.</brief_title>
  <official_title>CPR Training in Students to Increase Bystander Intervention in Out-of-hospital Cardiac Arrest.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall aim of this thesis is to identify the factors that may affect 13 year old&#xD;
      students' acquisition of CPR skills and their willingness to act. The primary hypothesis is&#xD;
      that the training method (intervention) influences the participants' acquisition of practical&#xD;
      CPR skills and willingness to intervene.&#xD;
&#xD;
      The study used a cluster randomized design, based on a randomization list generated by an&#xD;
      independent statistician. The school classes were randomly assigned to different CPR training&#xD;
      interventions.&#xD;
&#xD;
      A strategic sample, where invitation to participate in the study was sent to the headmasters&#xD;
      of all council schools, with seventh grade students, in two Swedish municipalities (140,000).&#xD;
      Thus, the sample consists of participants with different cultural as well as socio-economic&#xD;
      background. Eighteen of 24 schools agreed to participate. Four schools did not respond and&#xD;
      two schools had a routine to offer CPR education only for grade nine (all six schools from&#xD;
      the same municipality). The eighteen schools who agreed to participate consisted of&#xD;
      sixty-eight classes with 1547 students.&#xD;
&#xD;
      Prior to study participation, students and their guardians obtained a letter with study&#xD;
      information. Study participation of the individual students was voluntary and all&#xD;
      participants gave an oral informed consent.&#xD;
&#xD;
      Inclusion criteria: seventh grade student in one of the participating schools. Exclusion&#xD;
      criteria: student does not want to participate, student with a physical handicap that limited&#xD;
      the physical performance, classes of students with development disabilities (these classes&#xD;
      are age-integrated and have fewer students per class).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main interventions were app or DVD-based education. In addition to the main intervention&#xD;
      some classes were randomized to various additional interventions; web-course, visits of elite&#xD;
      athletes, practical test, reflection and AED training. All CPR education was performed in&#xD;
      accordance with the ERC guidelines of 2010. Training was given to the entire class together.&#xD;
      The classes consisted of 14-29 students. All participants in all intervention groups used an&#xD;
      individual training manikin, MiniAnne, during the training. The schools were allowed to keep&#xD;
      the training manikins after the end of study. Ten teachers were previous CPR instructors and&#xD;
      another 19 teachers received a five hours education to become CPR instructor. All teachers&#xD;
      obtained individual oral and written instructions about each class randomized intervention&#xD;
      method and written bullet points about how the course would be implemented, to ensure that&#xD;
      they were up to date with present guidelines and training. The teachers acted as&#xD;
      facilitators; they introduced the lesson, gave advice on the fly, answered questions and&#xD;
      completed the course.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 16, 2013</start_date>
  <completion_date type="Actual">October 22, 2014</completion_date>
  <primary_completion_date type="Actual">October 22, 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The total score of the modified Cardiff test at six months</measure>
    <time_frame>At six months follow-up test</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The total score of the modified Cardiff test directly after training</measure>
    <time_frame>Directly after training (on the day of intervention)</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported willingness to make a lifesaving intervention</measure>
    <time_frame>Both directly after training (on the day of intervention) and at six months</time_frame>
    <description>Self-reported willingness to make a lifesaving intervention was measured by a questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knowledge about stroke, acute myocardial infarction and living habits</measure>
    <time_frame>Both directly after training (on the day of intervention) and at six months</time_frame>
    <description>Theoretical knowledge about acute myocardial infarction and living habits was measured by a questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1547</enrollment>
  <condition>Coping Skills</condition>
  <arm_group>
    <arm_group_label>CPR training and web corse intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The students performed a web course (Help Brain Heart) prior training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CPR training intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CPR training without web course</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>web course</intervention_name>
    <description>Web course Help Brain Heart was conducted Before CPR training.</description>
    <arm_group_label>CPR training intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CPR training</intervention_name>
    <description>No web course was conducted</description>
    <arm_group_label>CPR training and web corse intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  seventh grade student in one of the participating schools&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  student does not want to participate&#xD;
&#xD;
          -  student with a physical handicap that significantly limited the physical performance&#xD;
&#xD;
          -  classes of students with development disabilities (these classes are age integrated&#xD;
             and have fewer students per class).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>L Svensson</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>August 15, 2017</last_update_submitted>
  <last_update_submitted_qc>August 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Leif Svensson</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>CPR training</keyword>
  <keyword>students</keyword>
  <keyword>willingness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Arrest</mesh_term>
    <mesh_term>Out-of-Hospital Cardiac Arrest</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No data shall be analyzed at the individual level.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03233490
org study id: 2013/358-31
nct id: NCT03233490
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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).
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Investigator)
measure: The total score of the modified Cardiff test at six months
time frame: At six months follow-up test
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.
measure: The total score of the modified Cardiff test directly after training
time frame: Directly after training (on the day of intervention)
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.
measure: Self-reported willingness to make a lifesaving intervention
time frame: Both directly after training (on the day of intervention) and at six months
description: Self-reported willingness to make a lifesaving intervention was measured by a questionnaire
measure: Knowledge about stroke, acute myocardial infarction and living habits
time frame: Both directly after training (on the day of intervention) and at six months
description: Theoretical knowledge about acute myocardial infarction and living habits was measured by a questionnaire
arm group label: CPR training and web corse intervention
arm group type: Experimental
description: The students performed a web course (Help Brain Heart) prior training
arm group label: CPR training intervention
arm group type: Experimental
description: CPR training without web course
intervention type: Other
intervention name: web course
description: Web course Help Brain Heart was conducted Before CPR training.
arm group label: CPR training intervention
intervention type: Other
intervention name: CPR training
description: No web course was conducted
arm group label: CPR training and web corse intervention
criteria: 
gender: All
minimum age: 12 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: L Svensson
role: Principal Investigator
affiliation: Karolinska Institutet
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Leif Svensson
investigator title: Professor
mesh term: Heart Arrest
mesh term: Out-of-Hospital Cardiac Arrest
sharing ipd: No
ipd description: No data shall be analyzed at the individual level.