First Aid Education for Road Traffic CrashesNCT04932239
Effectiveness of Road Traffic Crashes First-aid Education Among Commercial Motorcyclists in Kigali-City, Rwanda
A study testing first aid education in people with First Aid Education for Road Traffic Crashes, run by Universiti Putra Malaysia at 1 site in Rwanda.
Trial summary
Prehospital management after road traffic crashes(RTC) is a predicting factor to patient outcomes especially in Low-Income Countries where emergency medical services are lacking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- First Aid Education for Road Traffic Crashes
- What is being tested?
- first aid education
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteRwanda
- Study dates
- 19 Jun 2021to 22 Oct 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be a citizen of Rwanda and a commercial motorcyclist working in one of the Districts, Gasabo, Nyarugenge, and Kicukiro.
- Participant must have the age of 18 years and above.
- Participant must be able to read, write and speak Kinyarwanda (mother tongue)
- Participant must have at least a primary school level of education.
- Participant must have a motorcycle driving license.
Who cannot join
- Commercial motorcyclists with physical disabilities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Road Traffic Crashes First-aid Education on Knowledge, Attitude, and Practice Among Commercial Motorcyclists in Kigali-City, Rwanda
Prehospital management after road traffic crashes(RTC) is a predicting factor to patient outcomes especially in Low-Income Countries where emergency medical services are lacking. This may explain the high mortality related to RTC in Rwanda for instance, where the delay to reach the hospital of these victims was found as an independent factor to death . For that reason, this study hypothesizes that the training of non -professionals as commercial motorcyclists could help to reduce trauma-related mortality and morbidity in Rwanda.
The protocol general objective is to evaluate the effectiveness of road traffic crashes first -aid education on knowledge, attitudes, and practice among commercial motorcyclists in Kigali-City, Rwanda.
Read more
Hypotheses are:
- There is a difference in the baseline level of knowledge, attitudes, and practice on road crashes' first aid between the intervention and control groups of commercial motorcyclists.
- There is a relationship between socio-demographic characteristics and knowledge, attitudes, and practice' levels on first aid among commercial motorcyclists.
- There is a relationship between the education intervention and Knowledge, attitudes, and practice' level on first aid among commercial motorcyclists
Read the detailed description
Specific objectives are:
- To differentiate the baseline level of knowledge, attitudes, and practice on road crashes' first aid on the intervention and control groups of commercial motorcyclists.
- To determine the relationship between socio-demographic characteristics of commercial motorcyclists and their level of knowledge, attitudes, and practice on first-aid.
- To evaluate the effect of road traffic crashes' first-aid education on knowledge, attitudes, and practice of commercial motorcyclists after the intervention, within and between the intervention and control group.
- Population: is the total number of commercial motorcyclists working in Kigali- City.
- Sample size: The sample of 100 participants per group, i.e. intervention and control was estimated based on similar studies and using the following formula: n = {[z(1-α/2) *√2 P̄ (1- P̄)] + [z(1-β)*√P1(1-P1) + P2 (1-P2)]}2 (P1-P2)2 The total number of participants is 200.
- Study instrument:self-administered questionnaire
- Intervention group will receive road traffic crashes' first aid education module
- Control group will get the Tuberculosis prevention in working place as an education module
Study procedure:
For the questionnaire, a pre-test on first aid will be done to the intervention and control groups before education intervention to measure the baseline level of knowledge attitudes and reported practice. In addition, a post-test immediately after education intervention will follow to assess the effectiveness of the educational intervention provided. The same evaluation will be conducted after four months of this training.
-Data analysis: SPSS version 25 will be used to analyze data. The first objective will be analyzed using descriptive statistics and chi-square. For the second objective, multiple logistic regression will be used to determine the relationship between socio-demographic characteristics and level of knowledge, attitude, and practice among commercial motorcyclists. Lastly, One way repeated ANOVA will be used to evaluate the relationship between first aid education intervention and level of knowledge, attitudes, and practice of commercial motorcyclists between pre and post-test scores. A P-value less than 0.05 will be considered statistically significant.
-Sensitivity analysis: Intention -to- treat( ITT) and per-protocol (PP) analyses will be used to determine the effect of dropout and non-response. The differences between the coefficients found from these two analyses will then calculated and stated as percentages.
- Ethical considerations:
- I got ethical approval from JKEUPM from Malaysia and IRB from Rwanda
- All study participants will provide informed consent prior to enrollment in the study. Data will be kept confidential and access will be restricted to the research team only. No participants' names will be required during data collection, only codes will be used.
Variables:
- Age
- Years of driving experience
- Level of education
- Previous training on first aid: will be measured by answering yes or no
- First aid education: refers to recognize the emergency, call for help, scene safety, airway, and breathing, hemorrhage control, first aid kit, immobilization of fractures, and transport of injured people.
- Knowledge: will be categorized into correct incorrect responses
- Attitudes: will be stratified into two groups: Strongly agree and agree will represent positive attitudes whereas unsure, disagree, and strongly disagree will stand for negative attitudes
- Practice: will refer to two clusters for correct and incorrect reported practices
- Intervention group: refers to a group of commercial motorcyclists that will receive road traffic crashes first aid education program
- Control group: is a group of commercial motorcyclists that will receive a placebo program concerning tuberculosis prevention in the working place
- Being tested
- first aid education
- Keywords
- Road traffic crashes, First aid education, knowledge,attitude and practice, motorcyclists
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
first aid educationOther
To teach commercial motorcyclists first aid for post-crash while waiting for medical team to reach the scene
| Study group | Role | What they receive |
|---|---|---|
| Road traffic crashes first aid education module | Experimental | It is an education module aiming to address the topics related to first aid: Recognizing emergency, Call for help, Scene safety, Airway and breathing, Haemorrhage control, First aid kit, Immobilization of fractures and transport of injured people. Receives: Other: first aid education |
| Tuberculosis prevention education module | Placebo comparator | This education module covers the definition of the disease, types ways of prevention in working place, and its management Receives: Other: first aid education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of knowledge on road traffic crashes first aid
Knowledge outcome has ten close-ended questions assessing knowledge on first aid for road traffic crashes and each correct question will score one while the incorrect will score zero. Knowledge will be categorized into 3 categories:
Good knowledge: refers to eight to ten correct answers out of ten. Fair knowledge: five to seven score out of ten whereas four and less out of ten is considered as low knowledge.
Measured: immediate post intervention and after 4 months
Change in attitudes on road traffic crashes first aid
To assess attitudes, a five point likert scale on 7 questions will be done .( Strongly agree, agree , unsure, disagree ,and strongly disagree).
Attitudes answers will be stratified into two groups: Strongly agree and agree will represent positive attitudes whereas disagree, unsure and strongly disagree will stand for negative attitudes
Measured: immediate post interventions and after 4 months
Change in reported practice toward first aid provision
Regarding reported practice, four open questions will be given. The reported practice will refer to two clusters for correct and incorrect reported practices.
Measured: immediate post interventions and after 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start19 Jun 2021
- Primary completion22 Oct 2021
- Study completion22 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for First Aid Education for Road Traffic CrashesStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be study will be a two-arms pre-post intervention study with a follow-up survey after 4 months
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine UFASHINGABIRE MINANI, Universiti Putra Malaysia
- Investigators
- SOH KIM LAM, Prof., Study chair, Universiti Putra MalaysiaKULANTHAYAN KC MANI, Prof., Study director, Universiti Putra MalaysiaTWAGIRUMUGABE THEOGENE, Assoc. Prof., Study director, Butare university Teaching HospitalRosliza Abdul Manaf, Assoc. Prof., Study director, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932239
- Sponsor's protocol ID
- JKEUPM-2021-173
- Status last verified
- Nov 2022
- First submitted
- 28 May 2021
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Road Traffic Crashes First-aid Education on Knowledge, Attitude, and Practice Among Commercial Motorcyclists in Kigali-City, Rwanda
- ClinicalTrials.gov ID
- NCT04932239
- Acronym / sponsor ID
- JKEUPM-2021-173
- Keywords
- Road traffic crashes, First aid education, knowledge,attitude and practice, motorcyclists
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 19 Jun 2021 (actual)
- Primary completion
- 22 Oct 2021 (actual)
- Study completion
- 22 Oct 2021 (actual)
- First posted
- 21 Jun 2021 (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.
Prehospital management after road traffic crashes(RTC) is a predicting factor to patient outcomes especially in Low-Income Countries where emergency medical services are lacking. This may explain the high mortality related to RTC in Rwanda for instance, where the delay to reach the hospital of these victims was found as an independent factor to death . For that reason, this study hypothesizes that the training of non -professionals as commercial motorcyclists could help to reduce trauma-related mortality and morbidity in Rwanda.
The protocol general objective is to evaluate the effectiveness of road traffic crashes first -aid education on knowledge, attitudes, and practice among commercial motorcyclists in Kigali-City, Rwanda.
Hypotheses are:
- There is a difference in the baseline level of knowledge, attitudes, and practice on road crashes' first aid between the intervention and control groups of commercial motorcyclists.
- There is a relationship between socio-demographic characteristics and knowledge, attitudes, and practice' levels on first aid among commercial motorcyclists.
- There is a relationship between the education intervention and Knowledge, attitudes, and practice' level on first aid among commercial motorcyclists
Detailed description
Specific objectives are:
- To differentiate the baseline level of knowledge, attitudes, and practice on road crashes' first aid on the intervention and control groups of commercial motorcyclists.
- To determine the relationship between socio-demographic characteristics of commercial motorcyclists and their level of knowledge, attitudes, and practice on first-aid.
- To evaluate the effect of road traffic crashes' first-aid education on knowledge, attitudes, and practice of commercial motorcyclists after the intervention, within and between the intervention and control group.
- Population: is the total number of commercial motorcyclists working in Kigali- City.
- Sample size: The sample of 100 participants per group, i.e. intervention and control was estimated based on similar studies and using the following formula: n = {[z(1-α/2) *√2 P̄ (1- P̄)] + [z(1-β)*√P1(1-P1) + P2 (1-P2)]}2 (P1-P2)2 The total number of participants is 200.
- Study instrument:self-administered questionnaire
- Intervention group will receive road traffic crashes' first aid education module
- Control group will get the Tuberculosis prevention in working place as an education module
Study procedure:
For the questionnaire, a pre-test on first aid will be done to the intervention and control groups before education intervention to measure the baseline level of knowledge attitudes and reported practice. In addition, a post-test immediately after education intervention will follow to assess the effectiveness of the educational intervention provided. The same evaluation will be conducted after four months of this training.
-Data analysis: SPSS version 25 will be used to analyze data. The first objective will be analyzed using descriptive statistics and chi-square. For the second objective, multiple logistic regression will be used to determine the relationship between socio-demographic characteristics and level of knowledge, attitude, and practice among commercial motorcyclists. Lastly, One way repeated ANOVA will be used to evaluate the relationship between first aid education intervention and level of knowledge, attitudes, and practice of commercial motorcyclists between pre and post-test scores. A P-value less than 0.05 will be considered statistically significant.
-Sensitivity analysis: Intention -to- treat( ITT) and per-protocol (PP) analyses will be used to determine the effect of dropout and non-response. The differences between the coefficients found from these two analyses will then calculated and stated as percentages.
- Ethical considerations:
- I got ethical approval from JKEUPM from Malaysia and IRB from Rwanda
- All study participants will provide informed consent prior to enrollment in the study. Data will be kept confidential and access will be restricted to the research team only. No participants' names will be required during data collection, only codes will be used.
Variables:
- Age
- Years of driving experience
- Level of education
- Previous training on first aid: will be measured by answering yes or no
- First aid education: refers to recognize the emergency, call for help, scene safety, airway, and breathing, hemorrhage control, first aid kit, immobilization of fractures, and transport of injured people.
- Knowledge: will be categorized into correct incorrect responses
- Attitudes: will be stratified into two groups: Strongly agree and agree will represent positive attitudes whereas unsure, disagree, and strongly disagree will stand for negative attitudes
- Practice: will refer to two clusters for correct and incorrect reported practices
- Intervention group: refers to a group of commercial motorcyclists that will receive road traffic crashes first aid education program
- Control group: is a group of commercial motorcyclists that will receive a placebo program concerning tuberculosis prevention in the working place
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study will be study will be a two-arms pre-post intervention study with a follow-up survey after 4 months
| Arm | Type | Receives |
|---|---|---|
| Road traffic crashes first aid education module | Experimental | Other: first aid educationIt is an education module aiming to address the topics related to first aid: Recognizing emergency, Call for help, Scene safety, Airway and breathing, Haemorrhage control, First aid kit, Immobilization of fractures and transport of injured people. |
| Tuberculosis prevention education module | Placebo comparator | Other: first aid educationThis education module covers the definition of the disease, types ways of prevention in working place, and its management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant must be a citizen of Rwanda and a commercial motorcyclist working in one of the Districts, Gasabo, Nyarugenge, and Kicukiro.
- Participant must have the age of 18 years and above.
- Participant must be able to read, write and speak Kinyarwanda (mother tongue)
- Participant must have at least a primary school level of education.
- Participant must have a motorcycle driving license.
Key exclusion criteria (1 listed)
- Commercial motorcyclists with physical disabilities
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 |
|---|---|---|
| first aid educationTo teach commercial motorcyclists first aid for post-crash while waiting for medical team to reach the scene | Other | Road traffic crashes first aid education module, Tuberculosis prevention education module |
Primary outcome
Change of knowledge on road traffic crashes first aid
Time frame: immediate post intervention and after 4 months
Knowledge outcome has ten close-ended questions assessing knowledge on first aid for road traffic crashes and each correct question will score one while the incorrect will score zero. Knowledge will be categorized into 3 categories: Good knowledge: refers to eight to ten correct answers out of ten. Fair knowledge: five to seven score out of ten whereas four and less out of ten is considered as low knowledge.
Change in attitudes on road traffic crashes first aid
Time frame: immediate post interventions and after 4 months
To assess attitudes, a five point likert scale on 7 questions will be done .( Strongly agree, agree , unsure, disagree ,and strongly disagree). Attitudes answers will be stratified into two groups: Strongly agree and agree will represent positive attitudes whereas disagree, unsure and strongly disagree will stand for negative attitudes
Change in reported practice toward first aid provision
Time frame: immediate post interventions and after 4 months
Regarding reported practice, four open questions will be given. The reported practice will refer to two clusters for correct and incorrect reported practices.
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 16 Nov 2022.
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.
SOH KIM LAM, Prof. study chair
Universiti Putra Malaysia
KULANTHAYAN KC MANI, Prof. study director
Universiti Putra Malaysia
TWAGIRUMUGABE THEOGENE, Assoc. Prof. study director
Butare university Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing first aid education in people with First Aid Education for Road Traffic Crashes, run by Universiti Putra Malaysia at 1 site in Rwanda.
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 5 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 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Rwanda. 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. Some participants in this study may receive a placebo. 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?
Change of knowledge on road traffic crashes first aid (time frame: immediate post intervention and after 4 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 16 Nov 2022.