<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/NCT02998723</url>
  </required_header>
  <id_info>
    <org_study_id>20150174-01H</org_study_id>
    <nct_id>NCT02998723</nct_id>
  </id_info>
  <brief_title>Early or Late Booster for Basic Life Support?</brief_title>
  <official_title>Does an Early Booster Session Improve Performance and Retention of Skills in Basic Life Support Compared to a Later Booster? A Simulation Based Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ottawa Hospital Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Attrition of skills after basic life support (BLS) training is common. Psychology studies&#xD;
      have established that for basic memory recall tasks, spaced learning strategies improve&#xD;
      retention. Spaced learning is often organized as a refresher or 'booster' course after&#xD;
      initial training. This study aims to investigate if this principle holds true for BLS skills,&#xD;
      which require rapid memory recall and efficient deployment of procedural skills while under&#xD;
      time pressure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Novice laypeople who have not received BLS training in the 6 months leading up to the date of&#xD;
      participation will be recruited from the University of Ottawa and the general public.&#xD;
      Participants will be randomized into one of three groups: early booster, late booster, or no&#xD;
      booster (control). Currently, no booster is the educational standard. The early booster group&#xD;
      will receive a booster at 3 weeks, the late booster at 2 months, and no booster for the&#xD;
      control. All participants will undergo BLS training, an immediate post-test, and a retention&#xD;
      post-test at 4 months. Post-tests involve a simulated cardiac arrest scenario. Raters will be&#xD;
      blinded to the group allocation and simulation test order.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</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>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Basic Life Support performance, as measured by the standardized Heart and Stroke Heartsaver checklist</measure>
    <time_frame>4 months</time_frame>
    <description>BLS performance, as measured by the standardized Heart and Stroke Heartsaver checklist</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to start chest compression;</measure>
    <time_frame>4 months</time_frame>
    <description>Time from entering the scene to initiation of compression (in seconds)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of compression depth</measure>
    <time_frame>4 months</time_frame>
    <description>Percentage of compressions that are deep enough</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compression ratio</measure>
    <time_frame>4 months</time_frame>
    <description>The percentage of time during the scenario that compressions are done</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hand position</measure>
    <time_frame>4 months</time_frame>
    <description>The percentage of time the hand position is correct</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tidal volume</measure>
    <time_frame>4 months</time_frame>
    <description>Mean tidal volume (ml)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilation success rate</measure>
    <time_frame>4 months</time_frame>
    <description>The percentage of time ventilations are done with adequate volume 400-700mls</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to defibrillation using AED.</measure>
    <time_frame>4 months</time_frame>
    <description>Time from start to defibrillation using AED (in seconds)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">95</enrollment>
  <condition>Basic Life Support</condition>
  <arm_group>
    <arm_group_label>Early Booster Teaching</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The early booster group will receive a booster teaching session at 3 weeks post-training followed by feedback.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Late booster Teaching</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The late booster group will receive a booster teaching session at 2 months post-training followed by feedback.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will receive no booster at all.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Early Booster Teaching</intervention_name>
    <description>The early booster group will receive a booster teaching session at 3 weeks post-training followed by feedback.</description>
    <arm_group_label>Early Booster Teaching</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Late Booster Teaching</intervention_name>
    <description>The late booster group will receive a booster teaching session at 2 months post-training followed by feedback</description>
    <arm_group_label>Late booster Teaching</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Laypeople who have not received any BLS training or practice in the 6 months leading&#xD;
             up to the date of their participation will be recruited.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 18 years old;&#xD;
&#xD;
          -  Non layperson and Basic Life Training in less than 6 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sylvain Boet, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Ottawa Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ottawa Hospital</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y4E9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>September 6, 2018</last_update_submitted>
  <last_update_submitted_qc>September 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Basic Life Support</keyword>
  <keyword>Education, Medical</keyword>
  <keyword>Cardiopulmonary Resuscitation</keyword>
  <keyword>Learning</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>October 1, 2022</submitted>
    <returned>August 18, 2023</returned>
  </pending_results>
  <!-- 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/NCT02998723
org study id: 20150174-01H
nct id: NCT02998723
lead sponsor: 
has dmc: No
Attrition of skills after basic life support (BLS) training is common. Psychology studies
      have established that for basic memory recall tasks, spaced learning strategies improve
      retention. Spaced learning is often organized as a refresher or 'booster' course after
      initial training. This study aims to investigate if this principle holds true for BLS skills,
      which require rapid memory recall and efficient deployment of procedural skills while under
      time pressure.
Novice laypeople who have not received BLS training in the 6 months leading up to the date of
      participation will be recruited from the University of Ottawa and the general public.
      Participants will be randomized into one of three groups: early booster, late booster, or no
      booster (control). Currently, no booster is the educational standard. The early booster group
      will receive a booster at 3 weeks, the late booster at 2 months, and no booster for the
      control. All participants will undergo BLS training, an immediate post-test, and a retention
      post-test at 4 months. Post-tests involve a simulated cardiac arrest scenario. Raters will be
      blinded to the group allocation and simulation test order.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Basic Life Support performance, as measured by the standardized Heart and Stroke Heartsaver checklist
time frame: 4 months
description: BLS performance, as measured by the standardized Heart and Stroke Heartsaver checklist
measure: Time to start chest compression;
time frame: 4 months
description: Time from entering the scene to initiation of compression (in seconds)
measure: Accuracy of compression depth
time frame: 4 months
description: Percentage of compressions that are deep enough
measure: Compression ratio
time frame: 4 months
description: The percentage of time during the scenario that compressions are done
measure: Hand position
time frame: 4 months
description: The percentage of time the hand position is correct
measure: Tidal volume
time frame: 4 months
description: Mean tidal volume (ml)
measure: Ventilation success rate
time frame: 4 months
description: The percentage of time ventilations are done with adequate volume 400-700mls
measure: Time to defibrillation using AED.
time frame: 4 months
description: Time from start to defibrillation using AED (in seconds)
arm group label: Early Booster Teaching
arm group type: Experimental
description: The early booster group will receive a booster teaching session at 3 weeks post-training followed by feedback.
arm group label: Late booster Teaching
arm group type: Active Comparator
description: The late booster group will receive a booster teaching session at 2 months post-training followed by feedback.
arm group label: Control group
arm group type: No Intervention
description: The control group will receive no booster at all.
intervention type: Other
intervention name: Early Booster Teaching
description: The early booster group will receive a booster teaching session at 3 weeks post-training followed by feedback.
arm group label: Early Booster Teaching
intervention type: Other
intervention name: Late Booster Teaching
description: The late booster group will receive a booster teaching session at 2 months post-training followed by feedback
arm group label: Late booster Teaching
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sylvain Boet, MD
role: Principal Investigator
affiliation: The Ottawa Hospital
facility: 
country: Canada
responsible party type: Sponsor
sharing ipd: No
submitted: October 1, 2022
returned: August 18, 2023