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:
Condition or disease | Intervention/treatment | Phase |
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First Aid Education for Road Traffic Crashes | Other: first aid education | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention 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 (Participant) |
Primary Purpose: | Supportive Care |
Official Title: | Effectiveness of Road Traffic Crashes First-aid Education on Knowledge, Attitude, and Practice Among Commercial Motorcyclists in Kigali-City, Rwanda |
Estimated Study Start Date : | July 15, 2021 |
Estimated Primary Completion Date : | December 15, 2021 |
Estimated Study Completion Date : | July 15, 2022 |
Arm | Intervention/treatment |
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Experimental: Road traffic crashes first aid education module
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.
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Other: first aid education
To teach commercial motorcyclists first aid for post-crash while waiting for medical team to reach the scene
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Placebo Comparator: Tuberculosis prevention education module
This education module covers the definition of the disease, types ways of prevention in working place, and its management
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Other: first aid education
To teach commercial motorcyclists first aid for post-crash while waiting for medical team to reach the scene
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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.
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
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: UFASHINGABIRE MINANI CHRISTINE, PhD student | 01169687293 | ufachristine@gmail.com | |
Contact: SOH KIM LAM, Prof. | +60199369893 | sklam@upm.edu.my |
Rwanda | |
University of Rwanda | |
Kigali, Kigali -City, Rwanda, +250 | |
Contact: TWAGIRUMUGABE THEOGENE, Assoc.Prof. +250788539904 twagirumugabe@gmail.com | |
Contact: UFASHINGABIRE MINANI CHRISTINE +250788593416 ufachristine@gmail.com |
Study Chair: | SOH KIM LAM, Prof. | Universiti Putra Malaysia | |
Study Director: | KULANTHAYAN KC MANI, Prof. | Universiti Putra Malaysia | |
Study Director: | TWAGIRUMUGABE THEOGENE, Assoc. Prof. | Butare university Teaching Hospital | |
Study Director: | Rosliza Abdul Manaf, Assoc. Prof. | Universiti Putra Malaysia |
Tracking Information | |||||||||||||
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First Submitted Date ICMJE | May 28, 2021 | ||||||||||||
First Posted Date ICMJE | June 21, 2021 | ||||||||||||
Last Update Posted Date | June 21, 2021 | ||||||||||||
Estimated Study Start Date ICMJE | July 15, 2021 | ||||||||||||
Estimated Primary Completion Date | December 15, 2021 (Final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
Change History | No Changes Posted | ||||||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
Descriptive Information | |||||||||||||
Brief Title ICMJE | Effectiveness of Road Traffic Crashes First-aid Education Among Commercial Motorcyclists in Kigali-City, Rwanda | ||||||||||||
Official Title ICMJE | Effectiveness of Road Traffic Crashes First-aid Education on Knowledge, Attitude, and Practice Among Commercial Motorcyclists in Kigali-City, Rwanda | ||||||||||||
Brief 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. 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:
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Detailed Description |
Specific objectives are:
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 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.
Variables:
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Study Type ICMJE | Interventional | ||||||||||||
Study Phase ICMJE | Early Phase 1 | ||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention 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 (Participant)Primary Purpose: Supportive Care |
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Condition ICMJE | First Aid Education for Road Traffic Crashes | ||||||||||||
Intervention ICMJE | Other: first aid education
To teach commercial motorcyclists first aid for post-crash while waiting for medical team to reach the scene
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||||||||
Estimated Enrollment ICMJE |
200 | ||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||
Estimated Study Completion Date ICMJE | July 15, 2022 | ||||||||||||
Estimated Primary Completion Date | December 15, 2021 (Final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Rwanda | ||||||||||||
Removed Location Countries | |||||||||||||
Administrative Information | |||||||||||||
NCT Number ICMJE | NCT04932239 | ||||||||||||
Other Study ID Numbers ICMJE | JKEUPM-2021-173 | ||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||||||
Responsible Party | Christine UFASHINGABIRE MINANI, Universiti Putra Malaysia | ||||||||||||
Study Sponsor ICMJE | Universiti Putra Malaysia | ||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||
Investigators ICMJE |
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PRS Account | Universiti Putra Malaysia | ||||||||||||
Verification Date | June 2021 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |