Pan African Clinical Trials Registry

South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202308560830554 Date of Approval: 28/08/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The impact of first aid blended learning training on learning outcomes and helping behaviour of adult laypeople in Rwanda
Official scientific 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
Brief summary describing the background and objectives of the trial Estimates suggest that out of approximately 45 million deaths in low- and middle-income countries (LMICs) each year, 24.3 million, or 54 percent, are attributable to conditions that are potentially addressable by prehospital care. Unfortunately, prehospital emergency medical services (EMS) are not readily available in many LMICs. Hence, victims of injury or illness are mainly dependent on the basic care provided by members of the community or bystanders. Training laypeople in first aid techniques is considered a low-cost opportunity to decrease the burden of injury and illness. Therefore, a great emphasis is placed on strengthening the capacity of laypeople in providing first aid in order to manage acute health problems where EMS are limited. Several first aid training initiatives in the sub-Saharan African context have been developed, such as the evidence-based Basic First Aid in Africa training materials by the Belgian Red Cross (BRC) in collaboration with African experts in the field. Usually, these first aid trainings are given over multiple days in a conventional face-to-face approach by a certified first aid instructor. However, this mode of delivery is often hindered due to context-specific barriers, such as available time, location, and limited financial and/or human resources of the organising party. In an effort to increase the access to high quality first aid trainings for a broader audience, the BRC developed the innovative First Aid Blended Learning (FABL) training based on the BFA content. This FABL training consists of 2 consecutive parts in which trainees first inde-pendently learn first aid theory in a mobile application (FABL app) followed by a 1-day in-class training on first aid practical skills given by a certified first aid instructor. The objective of this study is to assess the impact of first aid blended learning training on learning outcomes and helping behaviour, compared to face-to-face and no training, in adult laypeople in Rwanda
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Emergency, injury, illness
Sub-Disease(s) or condition(s) being studied
Purpose of the trial First aid training
Anticipated trial start date 07/08/2023
Actual trial start date 07/08/2023
Anticipated date of last follow up 31/03/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 540
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
G 2022 11 2124 SMEC review board
NCST 482 377 2022 National Council for Science and Technology
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group First aid training with blended learning approach 1 session The individual mobile learning is estimated to take about 6 hours, and the in-class practical skills training about 9 hours on 1 day. Participants follow a first aid training delivered through a blended learning approach. 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: 1. First aid theory is learned independently in a mobile application followed by an online test to obtain an admission ticket for the subsequent in-class training; 2. 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. 180
Control Group First aid training with face to face approach 1 session The face-to-face in-class first aid training is covered over 3 days of each 9 hours. Participants follow a first aid training delivered through a face-to-face approach. 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 theory and skills, facilitated by a certified first aid instructor of the Rwanda Red Cross. 180 Active-Treatment of Control Group
Control Group No training None None Participants are placed on a waiting list and do not receive any training during the study. 180 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult (≥ 18 years) laypeople Access to a smartphone or tablet, which is able to install and run a mobile application Having attended a first aid training in the past Having an academic or professional background in the (para)medical field 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 999 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/11/2022 SMEC Review Board
Ethics Committee Address
Street address City Postal code Country
Dekenstraat 2 Leuven 3000 Belgium
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/10/2022 University of Rwanda Directorate of Research and Innovation
Ethics Committee Address
Street address City Postal code Country
KK738 Street Gikondo Kigali 4285 Rwanda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome First aid knowledge measured by a 20-item multiple choice questionnaire about first aid topics. Possible scores range from 0 to 20. Before, immediately after, and 6 months after the first aid trainings
Secondary Outcome First aid skills measured by a 22-item observation checklist about first aid practical skills. Possible scores range from 0 to 30. Before, immediately after, and 6 months after the first aid trainings
Secondary Outcome First aid self-efficacy measured by a 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. Before, immediately after, and 6 months after the first aid trainings
Secondary Outcome First aid willingness to help measured by a 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. Before, immediately after, and 6 months after the first aid trainings
Secondary Outcome Helping behaviour measured by a structured questionnaire to survey the helping behaviour in the past 6 months and to gauge the potential barriers and facilitators. Before and 6 months after the first aid trainings
Secondary Outcome Costs associated with a first aid training, relatively to the gain in knowledge. Before, immediately after, and 6 months after the first aid trainings
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Rwanda Red Cross KG 15 Ave Kigali Rwanda
FUNDING SOURCES
Name of source Street address City Postal code Country
Belgian Red Cross Flanders International Motstraat 40 Mechelen 2800 Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Centre for Evidence Based Practice Motstraat 42 Mechelen 2800 Belgium Research center
COLLABORATORS
Name Street address City Postal code Country
Rwanda Red Cross KG 15 Ave Kigali Rwanda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Emmy De Buck emmy.debuck@rodekruis.be +3215443514 Motstraat 42
City Postal code Country Position/Affiliation
Mechelen 2800 Belgium Director of Centre for Evidence Based Practice
Role Name Email Phone Street address
Public Enquiries Irvin Kendall irvin.kendall@rodekruis.be +3215443573 Motstraat 42
City Postal code Country Position/Affiliation
Mechelen 2800 Belgium Junior Researcher at Centre for Evidence Based Practice
Role Name Email Phone Street address
Scientific Enquiries Irvin Kendall irvin.kendall@rodekruis.be +3215443573 Motstraat 42
City Postal code Country Position/Affiliation
Mechelen 2800 Belgium Junior Researcher at Centre for Evidence Based Practice
Role Name Email Phone Street address
Public Enquiries Saskia Beerts saskia.beerts@rodekruis.be +250792988992 KG 15 Ave
City Postal code Country Position/Affiliation
Kigali Rwanda Project Manager Rwanda of Belgian Red Cross Flanders
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes No plan to share individual participant data, but we shall share data on a case-by-case basis. By sharing our data upon reasonable request gives us the advantage to be aware of who is doing something with our data, and of course to assist where needed. Clinical Study Report Not applicable Not applicable
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 24/08/2023 Correction of typos Estimates suggest that out of approximately 45 million deaths in low- and middle-income countries (LMICs) each year, 24.3 million, or 54 percent, are attributable to conditions that are potentially addressable by prehospi-tal care. Unfortunately, prehospital emergency medical services (EMS) are not readily available in many LMICs. Hence, victims of injury or illness are mainly dependent on the basic care provided by members of the commu-nity or bystanders. Training laypeople in first aid techniques is considered a low-cost oppor-tunity to decrease the burden of injury and illness. Therefore, a great em-phasis is placed on strengthening the capacity of laypeople in providing first aid in order to manage acute health problems where EMS are limited. Several first aid training initiatives in the sub-Saharan African context have been developed, such as the evidence-based Basic First Aid in Africa training materials by the Belgian Red Cross (BRC) in collaboration with African experts in the field. Usually, these first aid trainings are given over multiple days in a conven-tional face-to-face approach by a certified first aid instructor. However, this mode of delivery is often hindered due to context-specific barriers, such as available time, location, and limited financial and/or human resources of the organising party. In an effort to increase the access to high quality first aid trainings for a broader audience, the BRC developed the innovative First Aid Blended Learning (FABL) training based on the BFA content. This FABL training consists of 2 consecutive parts in which trainees first inde-pendently learn first aid theory in a mobile application (FABL app) followed by a 1-day in-class training on first aid practical skills given by a certified first aid instructor. The objective of this study is to assess the impact of first aid blended learning training on learning outcomes and helping behaviour, compared to face-to-face and no training, in adult laypeople in Rwand Estimates suggest that out of approximately 45 million deaths in low- and middle-income countries (LMICs) each year, 24.3 million, or 54 percent, are attributable to conditions that are potentially addressable by prehospital care. Unfortunately, prehospital emergency medical services (EMS) are not readily available in many LMICs. Hence, victims of injury or illness are mainly dependent on the basic care provided by members of the community or bystanders. Training laypeople in first aid techniques is considered a low-cost opportunity to decrease the burden of injury and illness. Therefore, a great emphasis is placed on strengthening the capacity of laypeople in providing first aid in order to manage acute health problems where EMS are limited. Several first aid training initiatives in the sub-Saharan African context have been developed, such as the evidence-based Basic First Aid in Africa training materials by the Belgian Red Cross (BRC) in collaboration with African experts in the field. Usually, these first aid trainings are given over multiple days in a conventional face-to-face approach by a certified first aid instructor. However, this mode of delivery is often hindered due to context-specific barriers, such as available time, location, and limited financial and/or human resources of the organising party. In an effort to increase the access to high quality first aid trainings for a broader audience, the BRC developed the innovative First Aid Blended Learning (FABL) training based on the BFA content. This FABL training consists of 2 consecutive parts in which trainees first inde-pendently learn first aid theory in a mobile application (FABL app) followed by a 1-day in-class training on first aid practical skills given by a certified first aid instructor. The objective of this study is to assess the impact of first aid blended learning training on learning outcomes and helping behaviour, compared to face-to-face and no training, in adult laypeople in Rwand
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 28/08/2023 PACTR Admin Estimates suggest that out of approximately 45 million deaths in low- and middle-income countries (LMICs) each year, 24.3 million, or 54 percent, are attributable to conditions that are potentially addressable by prehospital care. Unfortunately, prehospital emergency medical services (EMS) are not readily available in many LMICs. Hence, victims of injury or illness are mainly dependent on the basic care provided by members of the community or bystanders. Training laypeople in first aid techniques is considered a low-cost opportunity to decrease the burden of injury and illness. Therefore, a great emphasis is placed on strengthening the capacity of laypeople in providing first aid in order to manage acute health problems where EMS are limited. Several first aid training initiatives in the sub-Saharan African context have been developed, such as the evidence-based Basic First Aid in Africa training materials by the Belgian Red Cross (BRC) in collaboration with African experts in the field. Usually, these first aid trainings are given over multiple days in a conventional face-to-face approach by a certified first aid instructor. However, this mode of delivery is often hindered due to context-specific barriers, such as available time, location, and limited financial and/or human resources of the organising party. In an effort to increase the access to high quality first aid trainings for a broader audience, the BRC developed the innovative First Aid Blended Learning (FABL) training based on the BFA content. This FABL training consists of 2 consecutive parts in which trainees first inde-pendently learn first aid theory in a mobile application (FABL app) followed by a 1-day in-class training on first aid practical skills given by a certified first aid instructor. The objective of this study is to assess the impact of first aid blended learning training on learning outcomes and helping behaviour, compared to face-to-face and no training, in adult laypeople in Rwand Estimates suggest that out of approximately 45 million deaths in low- and middle-income countries (LMICs) each year, 24.3 million, or 54 percent, are attributable to conditions that are potentially addressable by prehospital care. Unfortunately, prehospital emergency medical services (EMS) are not readily available in many LMICs. Hence, victims of injury or illness are mainly dependent on the basic care provided by members of the community or bystanders. Training laypeople in first aid techniques is considered a low-cost opportunity to decrease the burden of injury and illness. Therefore, a great emphasis is placed on strengthening the capacity of laypeople in providing first aid in order to manage acute health problems where EMS are limited. Several first aid training initiatives in the sub-Saharan African context have been developed, such as the evidence-based Basic First Aid in Africa training materials by the Belgian Red Cross (BRC) in collaboration with African experts in the field. Usually, these first aid trainings are given over multiple days in a conventional face-to-face approach by a certified first aid instructor. However, this mode of delivery is often hindered due to context-specific barriers, such as available time, location, and limited financial and/or human resources of the organising party. In an effort to increase the access to high quality first aid trainings for a broader audience, the BRC developed the innovative First Aid Blended Learning (FABL) training based on the BFA content. This FABL training consists of 2 consecutive parts in which trainees first inde-pendently learn first aid theory in a mobile application (FABL app) followed by a 1-day in-class training on first aid practical skills given by a certified first aid instructor. The objective of this study is to assess the impact of first aid blended learning training on learning outcomes and helping behaviour, compared to face-to-face and no training, in adult laypeople in Rwanda
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 28/08/2023 PACTR Admin 07 Aug 2023
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 21/08/2023 Extended the intervention description with more information Control Group, First aid training with face to face approach, 1 session, The face-to-face in-class first aid training is covered over 3 days of each 9 hours., Participants follow a first aid training delivered through a face-to-face approach. 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 theory and skills, facilitated by a certified first aid instructor of the Rwanda Red Cross., 180, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 17/08/2023 Attachment added to the ethics letter from SMEC Review Board TRUE, SMEC Review Board, Dekenstraat 2, Leuven, 3000, Belgium, , 28 Nov 2022, +3216324010, smec@kuleuven.be, 25776_24692_4737.pdf TRUE, SMEC Review Board, Dekenstraat 2, Leuven, 3000, Belgium, , 28 Nov 2022, +3216324010, smec@kuleuven.be, 25776_24692_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 24/08/2023 Even though it is done in 2022, this ethics application has been approved by the Directorate of Research and Innovation of the University of Rwanda in Rwanda and remains valid up to this date. The same applies for the ethics approval from the SMEC review board of the KU Leuven in Belgium, which was approved in 2022 and remains valid for 4 years. TRUE, University of Rwanda Directorate of Research and Innovation, KK738 Street Gikondo, Kigali, 4285, Rwanda, , 27 Oct 2022, +250788716140, info@ur.ac.rw, 25776_24693_4737.pdf TRUE, University of Rwanda Directorate of Research and Innovation, KK738 Street Gikondo, Kigali, 4285, Rwanda, , 27 Oct 2022, +250788716140, info@ur.ac.rw, 25776_24693_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 24/08/2023 Country has to be Belgium and not Rwanda. Scientific Enquiries, Irvin, Kendall, Mr., irvin.kendall@rodekruis.be, , +3215443573, Motstraat 42, Mechelen, 2800, Rwanda, Junior Researcher at Centre for Evidence Based Practice Scientific Enquiries, Irvin, Kendall, Mr., irvin.kendall@rodekruis.be, , +3215443573, Motstraat 42, Mechelen, 2800, Belgium, Junior Researcher at Centre for Evidence Based Practice
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 25/08/2023 Contact person in country of recruiting center Public Enquiries, Saskia, Beerts, Ms., saskia.beerts@rodekruis.be, , +250792988992, KG 15 Ave, Kigali, , Rwanda, Project Manager Rwanda of Belgian Red Cross Flanders
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 17/08/2023 Added individual participant data sharing statement or plan Undecided No
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 22/08/2023 Provide reason. No No plan to share individual participant data, but we shall share data on a case-by-case basis. By sharing our data upon reasonable request gives us the advantage to be aware of who is doing something with our data, and of course to assist where needed.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 17/08/2023 Added individual participant data sharing statement or plan Undecided Not applicable
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 17/08/2023 Added individual participant data sharing statement or plan Undecided Not applicable