TraumaDEBITNCT05909917
Deploying Emergency Bystander Internet Training
A study testing Half-Day First Responder Training in people with Trauma and Trauma Injury, run by University of Michigan at 4 sites in 4 countries.
Trial summary
The primary aim of this study is to evaluate the efficacy of a massive open online course (MOOC) for training lay first responders in sub-Saharan Africa. The research team will assess educational outcomes of first responder training implemented at program locations in Nigeria, Sierra Leone, Uganda, and Kenya, through… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Trauma, Trauma Injury
- What is being tested?
- Half-Day First Responder Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 658 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 15 Jul 2023to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Commercial transportation providers
Who cannot join
- Does not possess means of transportation
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Kenya1 site
Masinde Muliro University of Science and Technology
Kakamega, Kakamega County
About this study
Official title: Deploying Emergency Bystander Internet Training (DEBIT) for Lay First Responders in Resource Limited Settings
The primary aim of this study is to evaluate the efficacy of a massive open online course (MOOC) for training lay first responders in sub-Saharan Africa. The research team will assess educational outcomes of first responder training implemented at program locations in Nigeria, Sierra Leone, Uganda, and Kenya, through previously validated pre- and post-course survey instruments, standardized patient assessments, and incident reporting. The research team will investigate efficacy of MOOC training amongst diverse populations with variable technology literacy and utilize data gathered to develop more efficient means of disseminating basic first aid training information.
Read the detailed description
Low- and middle-income countries (LMIC) bear the brunt of non-intentional traumatic injury. In fact, millions of people die from injury each year, with 90% of the mortality faced by LMICs. An additional 650 million people suffer from disabilities resulting from similar causes worldwide. The expansion of emergency medical services (EMS) in low- and middle-income countries could address 45% of all deaths and 36% of the total disease burden in low-income countries. However, emergency care, let alone prehospital emergency medical services, are often not priorities in LMICs. Though injury is the leading prehospital condition in Africa, 91.3% of the African population has no EMS available and there is no evidence of EMS systems in 61% of African countries. Sub-Saharan Africa is particularly affected, as available data on emergency care demonstrates the current combination of high patient volume and mortality make emergency care an urgent area of focus for future mortality-reducing interventions, especially as 80% of injury deaths occur in the prehospital setting in low-resource settings compared with just 59% in developed settings. Several studies investigating programs training lay first responders to treat the previously unaddressed traumatic injury burden were undertaken beginning in the mid- to late-1990's.
Subsequent to those initial studies, the World Health Organization (WHO) recommended establishing lay first responder systems as the first step toward developing formal emergency medical services in 2004. However, global uptake of the guidelines has been limited, even as injury has become the leading cause of death for young people between ages 15 and 45. Most LMICs lack organized EMS systems, while ambulances have been used primarily for interfacility transport, rather than as emergency care vehicles. Since the 2004 WHO announcement, many programs have attempted to leverage pre-existing networks of first responders, such as commercial drivers, lay persons, and bystanders, who currently already provide a large proportion of prehospital transport and occasionally also provide first aid in LMICs. As such, EMS system development since has been incongruous and varied, though the lay first responders (LFR) Model has demonstrated program success across heterogeneous across regions. Despite the World Health Organization recommendation and studies completed subsequently, the first aid provided by laypeople to victims of trauma requires additional programs and studies investigating first responder training, program scalability, and clinical implications for trauma patients. To meet these needs, the primary objectives of this study are to evaluate the educational efficacy and clinical impact of a Massive Open Online Course (MOOC) for LFR training through international roll-out.
A randomized control trial design with two arms will be identically deployed in four settings: Sierra Leone (Makeni), Nigeria (Lagos), Uganda (Mukono), and Kenya (Kakamega). In the control arm, participants will be assigned to a previously validated half-day first responder course and assessed for knowledge acquisition and clinical skills performance. In the experimental arm, participants will be assigned to a novel half-day MOOC course and similarly assessed for knowledge acquisition and clinical skills performance. Trainees in both arms will be monitored for knowledge retention and skill usage post-training. Outcomes will demonstrate the relative efficacy of the novel MOOC course as compared to traditional in-person training methods, and may inform LFR program scalability in future EMS capacity building efforts.
- Conditions
- Trauma, Trauma Injury
- Being tested
- Half-Day First Responder Training
- Keywords
- Pre-Hospital, First Responder, First Aid, Education
- Medical subject headings
- Wounds and Injuries, Accidental Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Half-Day First Responder TrainingOther
Participants in both study arms will undergo a half-day first responder training course designed for laypeople. The course will consist of five curricular categories: scene management, airway and breathing, hemorrhage control, fracture management, and victim transport. Course material will not differ between in-person and virtual arms, however the method of information dissemination will vary.
| Study group | Role | What they receive |
|---|---|---|
| In-Person | Active comparator | Participants will undergo a previously validated, half-day first responder training course, taught live in-person by local instructors in each study location. Participant knowledge acquisition will be measured via a 23-question pre/post-training assessment, administered in person. Participant skill performance will be measured via direct observation grading of a standardized patient encounter, performed in person. Receives: Other: Half-Day First Responder Training |
| Virtual | Experimental | In a controlled computer laboratory setting, participants will undergo an experimental first responder training course consisting of a half-day of pre-recorded video, lecture notes, and illustrations. Participant knowledge acquisition will be measured via a 23-question pre/post-training assessment, administered in person. Participant skill performance will be measured via direct observation grading of a standardized patient encounter, performed in person. Receives: Other: Half-Day First Responder Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge Acquisition
Acquisition will be measured using a 23-question test administered prior to the intervention and then immediately following training. Scores for the test range from 0 (no knowledge acquired) to 23 (all knowledge acquired).
Measured: 3 months
Clinical Skills Performance Checklist - Airway Management
Performance will be assessed using a direct-observation checklist evaluating first-responder interventions on standardized patients. Participants will be assessed on one of two clinical scenarios: airway management and fracture management. The airway management checklist will have a total of 8 points with higher score indicating better performance (0-8, with 0 meaning failed performance and 8 meaning perfect performance).
Measured: 3 months
Clinical Skills Performance Checklist - Fracture Management
Performance will be assessed using a direct-observation checklist evaluating first-responder interventions on standardized patients. Participants will be assessed on one of two clinical scenarios: airway management and fracture management. The fracture management checklist will have a total of 12 points with higher score indicating better performance (0-12, with 0 meaning failed performance and 12 meaning perfect performance).
Measured: 3 months
Secondary outcomes (2)
Knowledge Retention
Retention will be measured using the same 23-question test used to assess knowledge acquisition but administered at 6 months and then 9 months following the intervention. Scores for the test range from 0 (no retention) to 23 (all knowledge retained).
Measured: 9 months
Skill Usage
Usage will be tracked using incident report forms where participants reported using the skills acquired from the intervention to treat someone. Incident report forms will include de-identified patient information, care rendered by the first responder, location of the treated injury, mechanism of the treated injury, injury severity, and the hospital transportation method employed.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start15 Jul 2023
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 658 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- LFR International
- Responsible party
- Principal investigator, Zachary Eisner, University of Michigan
- Investigators
- Zachary Eisner, BS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909917
- Sponsor's protocol ID
- HUM00228774
- Acronym
- DEBIT
- Status last verified
- Dec 2025
- First submitted
- 9 Jun 2023
- Last updated
- 31 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deploying Emergency Bystander Internet Training (DEBIT) for Lay First Responders in Resource Limited Settings
- ClinicalTrials.gov ID
- NCT05909917
- Acronym / sponsor ID
- DEBIT / HUM00228774
- Conditions
- Trauma, Trauma Injury
- Keywords
- Pre-Hospital, First Responder, First Aid, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 658 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- LFR International
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this study is to evaluate the efficacy of a massive open online course (MOOC) for training lay first responders in sub-Saharan Africa. The research team will assess educational outcomes of first responder training implemented at program locations in Nigeria, Sierra Leone, Uganda, and Kenya, through previously validated pre- and post-course survey instruments, standardized patient assessments, and incident reporting. The research team will investigate efficacy of MOOC training amongst diverse populations with variable technology literacy and utilize data gathered to develop more efficient means of disseminating basic first aid training information.
Detailed description
Low- and middle-income countries (LMIC) bear the brunt of non-intentional traumatic injury. In fact, millions of people die from injury each year, with 90% of the mortality faced by LMICs. An additional 650 million people suffer from disabilities resulting from similar causes worldwide. The expansion of emergency medical services (EMS) in low- and middle-income countries could address 45% of all deaths and 36% of the total disease burden in low-income countries. However, emergency care, let alone prehospital emergency medical services, are often not priorities in LMICs. Though injury is the leading prehospital condition in Africa, 91.3% of the African population has no EMS available and there is no evidence of EMS systems in 61% of African countries. Sub-Saharan Africa is particularly affected, as available data on emergency care demonstrates the current combination of high patient volume and mortality make emergency care an urgent area of focus for future mortality-reducing interventions, especially as 80% of injury deaths occur in the prehospital setting in low-resource settings compared with just 59% in developed settings. Several studies investigating programs training lay first responders to treat the previously unaddressed traumatic injury burden were undertaken beginning in the mid- to late-1990's.
Subsequent to those initial studies, the World Health Organization (WHO) recommended establishing lay first responder systems as the first step toward developing formal emergency medical services in 2004. However, global uptake of the guidelines has been limited, even as injury has become the leading cause of death for young people between ages 15 and 45. Most LMICs lack organized EMS systems, while ambulances have been used primarily for interfacility transport, rather than as emergency care vehicles. Since the 2004 WHO announcement, many programs have attempted to leverage pre-existing networks of first responders, such as commercial drivers, lay persons, and bystanders, who currently already provide a large proportion of prehospital transport and occasionally also provide first aid in LMICs. As such, EMS system development since has been incongruous and varied, though the lay first responders (LFR) Model has demonstrated program success across heterogeneous across regions. Despite the World Health Organization recommendation and studies completed subsequently, the first aid provided by laypeople to victims of trauma requires additional programs and studies investigating first responder training, program scalability, and clinical implications for trauma patients. To meet these needs, the primary objectives of this study are to evaluate the educational efficacy and clinical impact of a Massive Open Online Course (MOOC) for LFR training through international roll-out.
A randomized control trial design with two arms will be identically deployed in four settings: Sierra Leone (Makeni), Nigeria (Lagos), Uganda (Mukono), and Kenya (Kakamega). In the control arm, participants will be assigned to a previously validated half-day first responder course and assessed for knowledge acquisition and clinical skills performance. In the experimental arm, participants will be assigned to a novel half-day MOOC course and similarly assessed for knowledge acquisition and clinical skills performance. Trainees in both arms will be monitored for knowledge retention and skill usage post-training. Outcomes will demonstrate the relative efficacy of the novel MOOC course as compared to traditional in-person training methods, and may inform LFR program scalability in future EMS capacity building efforts.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-Person | Active comparator | Other: Half-Day First Responder TrainingParticipants will undergo a previously validated, half-day first responder training course, taught live in-person by local instructors in each study location. Participant knowledge acquisition will be measured via a 23-question pre/post-training assessment, administered in person. Participant skill performance will be measured via direct observation grading of a standardized patient encounter, performed in person. |
| Virtual | Experimental | Other: Half-Day First Responder TrainingIn a controlled computer laboratory setting, participants will undergo an experimental first responder training course consisting of a half-day of pre-recorded video, lecture notes, and illustrations. Participant knowledge acquisition will be measured via a 23-question pre/post-training assessment, administered in person. Participant skill performance will be measured via direct observation grading of a standardized patient encounter, performed in person. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Commercial transportation providers
Key exclusion criteria (1 listed)
- Does not possess means of transportation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Half-Day First Responder TrainingParticipants in both study arms will undergo a half-day first responder training course designed for laypeople. The course will consist of five curricular categories: scene management, airway and breathing, hemorrhage control, fracture management, and victim transport. Course material will not differ between in-person and virtual arms, however the method of information dissemination will vary. | Other | In-Person, Virtual |
Primary outcome
Knowledge Acquisition
Time frame: 3 months
Acquisition will be measured using a 23-question test administered prior to the intervention and then immediately following training. Scores for the test range from 0 (no knowledge acquired) to 23 (all knowledge acquired).
Clinical Skills Performance Checklist - Airway Management
Time frame: 3 months
Performance will be assessed using a direct-observation checklist evaluating first-responder interventions on standardized patients. Participants will be assessed on one of two clinical scenarios: airway management and fracture management. The airway management checklist will have a total of 8 points with higher score indicating better performance (0-8, with 0 meaning failed performance and 8 meaning perfect performance).
Clinical Skills Performance Checklist - Fracture Management
Time frame: 3 months
Performance will be assessed using a direct-observation checklist evaluating first-responder interventions on standardized patients. Participants will be assessed on one of two clinical scenarios: airway management and fracture management. The fracture management checklist will have a total of 12 points with higher score indicating better performance (0-12, with 0 meaning failed performance and 12 meaning perfect performance).
2 secondary outcomes
Knowledge Retention
Time frame: 9 months
Skill Usage
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zachary Eisner, BS principal investigator
University of Michigan
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Half-Day First Responder Training in people with Trauma and Trauma Injury, run by University of Michigan at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Kenya, Nigeria, Sierra Leone, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge Acquisition (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.