Clinical trial NCT04932239: Effectiveness of Road Traffic Crashes First-aid Education Among Commercial Motorcyclists in Kigali-City, Rwanda
Official title: Effectiveness of Road Traffic Crashes First-aid Education on Knowledge, Attitude, and Practice Among Commercial Motorcyclists in Kigali-City, Rwanda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: First Aid Education for Road Traffic Crashes
Keywords: Road traffic crashes
First aid education
knowledge,attitude and practice
motorcyclists
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: SUPPORTIVE_CARE

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

Eligibility 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

Primary outcomes:
measure: Change of knowledge on road traffic crashes first aid
timeFrame: immediate post intervention and after 4 months
measure: Change in attitudes on road traffic crashes first aid
timeFrame: immediate post interventions and after 4 months
measure: Change in reported practice toward first aid provision
timeFrame: immediate post interventions and after 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kigali
country: Rwanda
facility: University of Rwanda
state: Kigali -City
Study officials:
affiliation: Universiti Putra Malaysia
name: SOH KIM LAM, Prof.
role: STUDY_CHAIR
affiliation: Universiti Putra Malaysia
name: KULANTHAYAN KC MANI, Prof.
role: STUDY_DIRECTOR
affiliation: Butare university Teaching Hospital
name: TWAGIRUMUGABE THEOGENE, Assoc. Prof.
role: STUDY_DIRECTOR
affiliation: Universiti Putra Malaysia
name: Rosliza Abdul Manaf, Assoc. Prof.
role: STUDY_DIRECTOR
References: