NCT05909917

Brief 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 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
658

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
27 days until next milestone

Study Start

First participant enrolled

July 15, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

1.1 years

First QC Date

June 9, 2023

Last Update Submit

December 25, 2025

Conditions

Keywords

Pre-HospitalFirst ResponderFirst AidEducation

Outcome Measures

Primary Outcomes (3)

  • 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).

    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).

    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).

    3 months

Secondary Outcomes (2)

  • Knowledge Retention

    9 months

  • Skill Usage

    6 months

Study Arms (2)

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.

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.

Other: Half-Day First Responder Training

Interventions

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.

In-PersonVirtual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Commercial transportation providers

You may not qualify if:

  • \- Does not possess means of transportation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Masinde Muliro University of Science and Technology

Kakamega, Kakamega County, Kenya

Location

Health Emergency Initiative

Lagos, Lagos, Nigeria

Location

School of Clinical Sciences

Makeni, Northern Province, Sierra Leone

Location

Vision for Trauma Care in Africa

Mukono, Central Region, Uganda

Location

MeSH Terms

Conditions

Wounds and InjuriesAccidental Injuries

Study Officials

  • Zachary Eisner, BS

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes assessors will be blinded to intervention arm randomization of participants.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 9, 2023

First Posted

June 18, 2023

Study Start

July 15, 2023

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

December 31, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations