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.: PACTR202001815716773 Date of Approval: 14/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The use of mHealth to enhance the adherence to Road Safety Regulations among Commercial Motorcyclists in Douala
Official scientific title The use of mHealth to enhance the adherence to Road Safety Regulations among Commercial Motorcyclists in Douala
Brief summary describing the background and objectives of the trial The increase of motorcycles especially in the LMICs has been a significant factor in the increase of RTAs. In motorcycle trauma, the factors contributing to road crashes can be divided into: the motorcycle, the motorcyclist and the environment in which the rider rides ( eg the traffic, road type and weather condition). The two most important characteristics of the rider are the rider’s behavior and attitude. This study seeks to study the motorcyclist behavior and his attitude towards use of personal protective equipment and respect of traffic signs. With this, the intervention with the use of mHealth will be adapted to address the loopholes. This can serve as a foundation for policy formation directed at reducing motorcycle crashes and injuries. Therefore, specific objective will be to determine 1) the impact ofmHealth on the use of personal protective equipment 2) the impact of mHealth on knowledge of road safety rules 3) the impact of mHealth on compliance with road safety rules
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/01/2020
Actual trial start date
Anticipated date of last follow up 31/05/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Use of mHealth Sending sms twice a day twice a week in one subgroup Sending sms once day once a week in another subgroup six months SMS will be sent to participants in the first subgroup twice a day (6:30am and 5pm) twice a week (Mondays and Fridays) SMS will be sent to participants in the second subgroup once a day (6:30am) once a week( Mondays) 100
Control Group None None Six months No SMS will be sent to participants of the control group 100 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• A commercial motorcyclist with a functional motorcycle and belonging to a bike riders association and own a mobile phone. • A commercial motorcyclist who can either read or write in either the English or French languages. • Commercial motorcyclists who are ill during data collection • Commercial motorcyclists who will not give their consent. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 16 Year(s) 65 Year(s) Male
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 30/08/2019 Faculty Of Health Sciences Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Buea, Cameroon Buea 00237 Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome increase in knowledge, a positive change in attitude towards Road Safety Regulation and an increase in the adherence to Road Safety Regulation. six months
Primary Outcome Increase in Knowledge on Road Safety Regulations Immediately after training
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bonaberi Ancien Route- Bonaberi Douala 00237 Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
Ginyu Innocentia Kwalar University of Buea, Faculty of Health Science, Department of Public Health, PO Box 63 Buea 00237 Cameroon
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ginyu Innocentia Kwalar Faculty Of Health Sciences, University Of Buea PO BOX 63 Buea 00237 Cameroon Individual
COLLABORATORS
Name Street address City Postal code Country
Nsagha Shey Dickson University of Buea, Faculty of Health Science, Department of Public Health PO Box 63 Buea 00237 Cameroon
Elvis Asangbeng Tanue University of Buea, Faculty of Health Science, Department of Public Health, PO Box 63 Buea 00237 Cameroon
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ginyu Innocentia Kwalar ginyu_kwalar@yahoo.fr 00237677924162 Faculty of Health Sciences, University of Buea
City Postal code Country Position/Affiliation
Buea 00237 Cameroon PhD candidate
Role Name Email Phone Street address
Scientific Enquiries Nsagha Dickson Shey dsnsagha@gmail.com 00237 Faculty of Health Sciences, University of Buea
City Postal code Country Position/Affiliation
Buea 00237 Cameroon Supervisor
Role Name Email Phone Street address
Public Enquiries Ginyu Innocentia Kwalar ginyu_kwalar@yahoo.fr 00237677924162 Faculty of Health Sciences, University of Buea
City Postal code Country Position/Affiliation
Buea 00237 Cameroon PhD candidate
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes During the project, tools will be used to collect the IPD. These tools will used will be made available. Especially those that underlie the results presented in article presented Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol The IPD will be shared latest six months after the publication of the article and will be available for two years The Editor in chief and the Statistician can access and review the raw data if they think there is violation of ethical issues. Also, if they have evidence that the data has not been rightly represented or analysed.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
None 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