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出境医 / 临床实验 / Effectiveness of Road Traffic Crashes First-aid Education Among Commercial Motorcyclists in Kigali-City, Rwanda

Effectiveness of Road Traffic Crashes First-aid Education Among Commercial Motorcyclists in Kigali-City, Rwanda

Study Description
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:

  1. 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.
  2. There is a relationship between socio-demographic characteristics and knowledge, attitudes, and practice' levels on first aid among commercial motorcyclists.
  3. There is a relationship between the education intervention and Knowledge, attitudes, and practice' level on first aid among commercial motorcyclists

Condition or disease Intervention/treatment Phase
First Aid Education for Road Traffic Crashes Other: first aid education Early Phase 1

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Study Design
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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
Arms and Interventions
Arm Intervention/treatment
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.
Other: first aid education
To teach commercial motorcyclists first aid for post-crash while waiting for medical team to reach the scene

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
Other: first aid education
To teach commercial motorcyclists first aid for post-crash while waiting for medical team to reach the scene

Outcome Measures
Primary Outcome Measures :
  1. 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.


  2. 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


  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Commercial motorcyclists with physical disabilities
Contacts and Locations

Contacts
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Contact: UFASHINGABIRE MINANI CHRISTINE, PhD student 01169687293 ufachristine@gmail.com
Contact: SOH KIM LAM, Prof. +60199369893 sklam@upm.edu.my

Locations
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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   
Sponsors and Collaborators
Universiti Putra Malaysia
Investigators
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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
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
 (submitted: June 17, 2021)
  • 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.
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:

  1. 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.
  2. There is a relationship between socio-demographic characteristics and knowledge, attitudes, and practice' levels on first aid among commercial motorcyclists.
  3. 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:

  1. To differentiate the baseline level of knowledge, attitudes, and practice on road crashes' first aid on the intervention and control groups of commercial motorcyclists.
  2. To determine the relationship between socio-demographic characteristics of commercial motorcyclists and their level of knowledge, attitudes, and practice on first-aid.
  3. 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 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
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
Study Arms  ICMJE
  • 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.
    Intervention: Other: first aid education
  • 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
    Intervention: Other: first aid education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 17, 2021)
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:

  • 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.

Exclusion Criteria:

  • Commercial motorcyclists with physical disabilities
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: UFASHINGABIRE MINANI CHRISTINE, PhD student 01169687293 ufachristine@gmail.com
Contact: SOH KIM LAM, Prof. +60199369893 sklam@upm.edu.my
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
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
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