xml: <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/NCT06003504</url>
    </required_header>
    <id_info>
      <org_study_id>FABL-001</org_study_id>
      <nct_id>NCT06003504</nct_id>
    </id_info>
    <brief_title>The Impact of First Aid Blended Learning Training on Learning Outcomes and Helping Behaviour of Adult Laypeople in Rwanda</brief_title>
    <official_title>The Impact of First Aid Training, Delivered Via a Face-to-face or Blended Learning Approach, on Learning Outcomes and Helping Behaviour of Adult Laypeople in Rwanda: a Randomised Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre for Evidence-Based Practice, Belgium</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Rwanda Red Cross</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Belgian Red Cross</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Centre for Evidence-Based Practice, Belgium</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 goal of this study is to assess the impact of a first aid training delivered through a&#xD;
        blended learning approach on learning outcomes and helping behaviour in adult laypeople in&#xD;
        Rwanda.&#xD;
  &#xD;
        Participants will be randomly assigned to either:&#xD;
  &#xD;
          -  a first aid training with blended learning approach;&#xD;
  &#xD;
          -  a first aid training with conventional face-to-face approach;&#xD;
  &#xD;
          -  no first aid training.&#xD;
  &#xD;
        All participants will be asked before, immediately after, and 6 months after the first aid&#xD;
        trainings to complete&#xD;
  &#xD;
          -  a questionnaire on first aid-related knowledge, self-efficacy, and willingness to help;&#xD;
  &#xD;
          -  a practical test on first aid-related skills.&#xD;
  &#xD;
        The helping behaviour of the participants will be surveyed before and 6 months after the&#xD;
        first aid trainings have been completed.&#xD;
  &#xD;
        Researchers will compare the effects in learning outcomes and helping behaviour after 6&#xD;
        months between:&#xD;
  &#xD;
          -  the first aid training with blended learning approach and no first aid training;&#xD;
  &#xD;
          -  the first aid training with blended learning approach and first aid training with&#xD;
             conventional face-to-face approach.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">August 7, 2023</start_date>
    <completion_date type="Anticipated">March 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 31, 2024</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>
      <intervention_model_description>This is a randomised controlled trial in which the allocation is done at the level of the individual participant.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>First aid knowledge</measure>
      <time_frame>Before, immediately after, and 6 months after the first aid trainings</time_frame>
      <description>20-item multiple choice questionnaire about first aid topics using a numerical scale. Possible scores range from 0 to 20, with higher scores meaning a better outcome.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>First aid skills</measure>
      <time_frame>Before, immediately after, and 6 months after the first aid trainings</time_frame>
      <description>22-item observation checklist about first aid practical skills using a numerical scale. Possible scores range from 0 to 30, with higher scores meaning a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>First aid self-efficacy</measure>
      <time_frame>Before, immediately after, and 6 months after the first aid trainings</time_frame>
      <description>10-item scenario-based questionnaire using a 5-point Likert scale assessing self-efficacy concerning first aid topics. Possible scores range from 0 to 40, with higher scores meaning a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>First aid willingness to help</measure>
      <time_frame>Before, immediately after, and 6 months after the first aid trainings</time_frame>
      <description>6-item scenario-based questionnaire using a 5-point Likert scale assessing willingness to help concerning first aid topics. Possible scores range from 0 to 24, with higher scores meaning a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Helping behaviour in the past 6 months</measure>
      <time_frame>Before and 6 months after the first aid trainings</time_frame>
      <description>Structured questionnaire to survey the helping behaviour and to gauge the potential barriers and facilitators.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Costs</measure>
      <time_frame>Before, immediately after, and 6 months after the first aid trainings</time_frame>
      <description>Costs associated with a first aid training, relatively to the gain in knowledge.</description>
    </other_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">540</enrollment>
    <condition>Emergencies</condition>
    <condition>Injuries</condition>
    <condition>Illness Physical</condition>
    <arm_group>
      <arm_group_label>First aid training with blended learning approach</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants follow a first aid training delivered through a blended learning approach.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>First aid training with face-to-face approach</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants follow a first aid training delivered through a conventional face-to-face approach.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Waitlist control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants do not receive any training</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>First aid training with blended learning approach</intervention_name>
      <description>The content of the first aid blended learning training is standardised and based on the 2021 edition of the Basic First Aid in Africa manual from the Belgian Red Cross, covering first aid general principles and instructions for:&#xD;
  emergencies (i.e. choking, unconsciousness with and without normal breathing, chest discomfort and stroke, poisoning, and severe external bleeding);&#xD;
  injuries (i.e. skin wounds, burns, and injuries to muscles, joints, limbs, head, neck, and back);&#xD;
  illnesses (i.e. fainting, fever, fits, and diarrhoea).&#xD;
  The training consists of 2 consecutive parts:&#xD;
  First aid theory is learned independently in a mobile application followed by an online test to ob-tain an admission ticket for the subsequent in-class training;&#xD;
  First aid skills are practiced during a 1-day in-class training facilitated by a certified first aid instructor of the Rwanda Red Cross.&#xD;
  Participants get at least 10 days to learn in the mobile application and obtain the admission ticket.</description>
      <arm_group_label>First aid training with blended learning approach</arm_group_label>
      <other_name>First Aid Blended Learning (FABL)</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>First aid training with face-to-face approach</intervention_name>
      <description>The content of the first aid face-to-face training is standardised and based on the 2021 edition of the Basic First Aid in Africa manual from the Belgian Red Cross, covering first aid general principles and instructions for:&#xD;
  emergencies (i.e. choking, unconsciousness with and without normal breathing, chest discomfort and stroke, poisoning, and severe external bleeding);&#xD;
  injuries (i.e. skin wounds, burns, and injuries to muscles, joints, limbs, head, neck, and back);&#xD;
  illnesses (i.e. fainting, fever, fits, and diarrhoea).&#xD;
  The training consists of a 3-days in-class training with lectures and practical exercises on first aid the-ory and skills, facilitated by a certified first aid instructor of the Rwanda Red Cross.</description>
      <arm_group_label>First aid training with face-to-face approach</arm_group_label>
      <other_name>Basic First Aid in Africa (BFA)</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult (≥ 18 years) laypeople&#xD;
  &#xD;
            -  Access to a smartphone or tablet, which is able to install and run a mobile&#xD;
               application&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having attended a first aid training in the past&#xD;
  &#xD;
            -  Having an academic or professional background in the (para)medical field&#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>Emmy De Buck, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Centre for Evidence-Based Practice, Belgium</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Rwanda Red Cross</name>
        <address>
          <city>Kigali</city>
          <country>Rwanda</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Rwanda</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>First aid</keyword>
    <keyword>Blended learning</keyword>
    <keyword>Laypeople</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Emergencies</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06003504
  org study id: FABL-001
  nct id: NCT06003504
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this study is to assess the impact of a first aid training delivered through a
        blended learning approach on learning outcomes and helping behaviour in adult laypeople in
        Rwanda.
  
        Participants will be randomly assigned to either:
  
          -  a first aid training with blended learning approach;
  
          -  a first aid training with conventional face-to-face approach;
  
          -  no first aid training.
  
        All participants will be asked before, immediately after, and 6 months after the first aid
        trainings to complete
  
          -  a questionnaire on first aid-related knowledge, self-efficacy, and willingness to help;
  
          -  a practical test on first aid-related skills.
  
        The helping behaviour of the participants will be surveyed before and 6 months after the
        first aid trainings have been completed.
  
        Researchers will compare the effects in learning outcomes and helping behaviour after 6
        months between:
  
          -  the first aid training with blended learning approach and no first aid training;
  
          -  the first aid training with blended learning approach and first aid training with
             conventional face-to-face approach.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This is a randomised controlled trial in which the allocation is done at the level of the individual participant.
  primary purpose: Other
  masking: Double (Investigator, Outcomes Assessor)
  measure: First aid knowledge
  time frame: Before, immediately after, and 6 months after the first aid trainings
  description: 20-item multiple choice questionnaire about first aid topics using a numerical scale. Possible scores range from 0 to 20, with higher scores meaning a better outcome.
  measure: First aid skills
  time frame: Before, immediately after, and 6 months after the first aid trainings
  description: 22-item observation checklist about first aid practical skills using a numerical scale. Possible scores range from 0 to 30, with higher scores meaning a better outcome.
  measure: First aid self-efficacy
  time frame: Before, immediately after, and 6 months after the first aid trainings
  description: 10-item scenario-based questionnaire using a 5-point Likert scale assessing self-efficacy concerning first aid topics. Possible scores range from 0 to 40, with higher scores meaning a better outcome.
  measure: First aid willingness to help
  time frame: Before, immediately after, and 6 months after the first aid trainings
  description: 6-item scenario-based questionnaire using a 5-point Likert scale assessing willingness to help concerning first aid topics. Possible scores range from 0 to 24, with higher scores meaning a better outcome.
  measure: Helping behaviour in the past 6 months
  time frame: Before and 6 months after the first aid trainings
  description: Structured questionnaire to survey the helping behaviour and to gauge the potential barriers and facilitators.
  measure: Costs
  time frame: Before, immediately after, and 6 months after the first aid trainings
  description: Costs associated with a first aid training, relatively to the gain in knowledge.
  arm group label: First aid training with blended learning approach
  arm group type: Experimental
  description: Participants follow a first aid training delivered through a blended learning approach.
  arm group label: First aid training with face-to-face approach
  arm group type: Active Comparator
  description: Participants follow a first aid training delivered through a conventional face-to-face approach.
  arm group label: Waitlist control
  arm group type: No Intervention
  description: Participants do not receive any training
  intervention type: Other
  intervention name: First aid training with blended learning approach
  description: The content of the first aid blended learning training is standardised and based on the 2021 edition of the Basic First Aid in Africa manual from the Belgian Red Cross, covering first aid general principles and instructions for:
  emergencies (i.e. choking, unconsciousness with and without normal breathing, chest discomfort and stroke, poisoning, and severe external bleeding);
  injuries (i.e. skin wounds, burns, and injuries to muscles, joints, limbs, head, neck, and back);
  illnesses (i.e. fainting, fever, fits, and diarrhoea).
  The training consists of 2 consecutive parts:
  First aid theory is learned independently in a mobile application followed by an online test to ob-tain an admission ticket for the subsequent in-class training;
  First aid skills are practiced during a 1-day in-class training facilitated by a certified first aid instructor of the Rwanda Red Cross.
  Participants get at least 10 days to learn in the mobile application and obtain the admission ticket.
  arm group label: First aid training with blended learning approach
  other name: First Aid Blended Learning (FABL)
  intervention type: Other
  intervention name: First aid training with face-to-face approach
  description: The content of the first aid face-to-face training is standardised and based on the 2021 edition of the Basic First Aid in Africa manual from the Belgian Red Cross, covering first aid general principles and instructions for:
  emergencies (i.e. choking, unconsciousness with and without normal breathing, chest discomfort and stroke, poisoning, and severe external bleeding);
  injuries (i.e. skin wounds, burns, and injuries to muscles, joints, limbs, head, neck, and back);
  illnesses (i.e. fainting, fever, fits, and diarrhoea).
  The training consists of a 3-days in-class training with lectures and practical exercises on first aid the-ory and skills, facilitated by a certified first aid instructor of the Rwanda Red Cross.
  arm group label: First aid training with face-to-face approach
  other name: Basic First Aid in Africa (BFA)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Emmy De Buck, PhD
  role: Principal Investigator
  affiliation: Centre for Evidence-Based Practice, Belgium
  facility: 
  country: Rwanda
  responsible party type: Sponsor
  mesh term: Emergencies
  sharing ipd: Undecided