Traffic AccidentNCT04243291
The Prevalence of Road Crash Involvement and Its Associated Factors Among Medical Doctors in Malaysia
An observational study of Traffic Accident, run by Universiti Putra Malaysia at 1 site in Malaysia.
Trial summary
This study mainly to investigate the prevalence of road crash involvement and its associated factors (fatigue, demographic factors, sleep quality, and mental health status, number of working hours) among medical doctors in Malaysia. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Traffic Accident
- How many people
- 375 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Apr 2020to 30 Mar 2022
- Phase
- Observational
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Malaysian Medical Association (MMA) members who are fully or partially registered with the Malaysian Medical Council (MMC) and their contacts. MMA is the main representative body for all registered medical practitioners in Malaysia. MMA members include senior and junior doctors, private and public, specialists and general practioners, medical officer and house officer.
Who may be able to join
- Malaysian citizen
- Full or partial registration with MMC
- Work a minimum of six (6) months in public healthcare sector in Malaysia. Doctors who have just been working for less than six months are still adapting to the duties and atmosphere of the hospital, and the responsibilities they hold are also different from those of a senior doctor making them not suitable to include in this study.
Who cannot join
- Medical doctors currently on a long leave. As we only have a short period of data collection, so we will exclude this group of subject.
- Does not self-commute to work
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prevalence of Road Crash Involvement and Its Associated Factors Among Medical Doctors in Malaysia : A Cross Sectional Study
This study mainly to investigate the prevalence of road crash involvement and its associated factors (fatigue, demographic factors, sleep quality, and mental health status, number of working hours) among medical doctors in Malaysia.
Read the detailed description
The incidence reports of road crash involvement among medical doctors in Malaysia have steadily increased in frequency by 28%. Despite the gravity of the situation, there is an obvious absence of further information regarding the causes of such occurrence. A deeper look into literature regarding the phenomenon worldwide indicates that the prevalence of road crash involvement among doctors are less reported on, much less the factors associated with it.
hence, investigators constructed a research to investigate the prevalence of road crash involvement and its associated factors (fatigue, demographic factors, sleep quality, and mental health status, number of working hours) among medical doctors in Malaysia.
It is a cross sectional study where the study population consists of Malaysian Medical Association (MMA) members who are fully or partially registered with the Malaysian Medical Council (MMC) and their contacts.
Respondents will be selected via non probability random sampling among MMA registered member list and their network. The sample will be doctors who are partially or fully registered with the Malaysian Medical Council and following the inclusion and exclusion criteria. The participants who are eligible will need to answer via an online survey link.
Inclusion criteria
- Malaysian citizen
- Full or partial registration with MMC
- Work a minimum of six (6) months in public healthcare sector in Malaysia. Doctors who have just been working for less than six months are still adapting to the duties and atmosphere of the hospital, and the responsibilities they hold are also different from those of a senior doctor making them not suitable to include in this study.
Exclusion criteria
- Medical doctors currently on a long leave. As investigators only have a short period of data collection, so investigators will exclude this group of subject.
- Does not self-commute to work
CALCULATED SAMPLE SIZE = 288.
This study will be in collaboration with Malaysian Medical Associations (MMA) on recruiting sample for this research along with other medical NGOs. MMA will help in dissemination of information throughout their website as well as distribute/email the questionnaires to all MMA members and their contacts.
The questionnaire will be created by using Google Form and then saved on Google Drive. Then MMA will share the form to all their members through email. All responses will be saved in the file stored in Google Drive. Once enough sample acquired, the form will be closed and results will be download for data analysis.
Data entry and analysis will be undertaken by using the 'Statistical Package for Social Sciences' (SPSS) programme, Version 22.0. The statistical significance level is taken at the p value <0.05 with 95% of confidence intervals (CI). The continuous variables will be summarised by using means and standard deviation (SD) and predominantly categorised as required and presented as the number (n) and percentage (%). The statistics analysis will utilise the Pearson Chi-square test for obtaining the statistical difference of the categorical variables.
Lastly, logistic regression analysis will be used to describe the strength of association between the outcome and factors of interest, adjusting for covariates or confounders. It also allows one to determine the important factors affecting the outcome and generate the final model for the factors being studied as the predictor for the outcomes.
Study Instrument: Questionnaire/scoring \& Pilot study
This study's approval for ethical clearance will be obtained from Medical Research Ethics Committee (MREC), "University Putra Malaysia" (UPM). Informed consent will be obtained from each study participant and it will be stated at the beginning of the questionnaire.
- Conditions
- Traffic Accident
- Keywords
- risk factor, physician, road accident, prevalence
What is being measured
The primary outcome is the main question the study is designed to answer.
The Prevalence of Road Crash Involvement among Medical Doctors
Self reported in sociodemographic questionnaire
Measured: Since joining medical profession ( anywhere from one year up to 20 years )
fatigue among Medical Doctors
Checklist Individual Strength Questionnaire (CISQ)
Measured: Since joining medical profession ( anywhere from one year up to 20 years )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start1 Apr 2020
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Traffic AccidentStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aneesa Abdul Rashid, Universiti Putra Malaysia
- Investigators
- Aneesa Abdul Rashid, Principal investigator, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243291
- Sponsor's protocol ID
- 40609
- Other IDs
- 04-01-18-1972FR
- Status last verified
- May 2022
- First submitted
- 16 Jan 2020
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aneesa AR, Suhazeli A, Nur Asyikin M, Munawar S, Nur Asyraf M , Siti Illiana M, et al. Post Call MVA Survey: An 18 Hour Online Survey. In: 17th Islamic Association of Malaysia (IMAM) Annual Scientific Conference (ASC). Penang, Malaysia; 2015.
Marcus CL, Loughlin GM. Effect of sleep deprivation on driving safety in housestaff. Sleep. 1996 Dec;19(10):763-6. doi: 10.1093/sleep/19.10.763.
PubMed 9085483Steele MT, Ma OJ, Watson WA, Thomas HA Jr, Muelleman RL. The occupational risk of motor vehicle collisions for emergency medicine residents. Acad Emerg Med. 1999 Oct;6(10):1050-3. doi: 10.1111/j.1553-2712.1999.tb01191.x.
PubMed 10530665Veasey S, Rosen R, Barzansky B, Rosen I, Owens J. Sleep loss and fatigue in residency training: a reappraisal. JAMA. 2002 Sep 4;288(9):1116-24. doi: 10.1001/jama.288.9.1116.
PubMed 12204082Pertubuhan Keselamatan Sosial. Laporan Tahunan Perkeso. 2015.
Azhar A. Commuting Accidents : What Does Research Shows ? COMMUTING ACCIDENTS PREVENTION SEMINAR MONASH UNIVERSITY MALAYSIA 9 - 10 DECEMBER 2014. 2014.
Barger LK, Cade BE, Ayas NT, Cronin JW, Rosner B, Speizer FE, Czeisler CA; Harvard Work Hours, Health, and Safety Group. Extended work shifts and the risk of motor vehicle crashes among interns. N Engl J Med. 2005 Jan 13;352(2):125-34. doi: 10.1056/NEJMoa041401.
PubMed 15647575Owens JA. Sleep loss and fatigue in healthcare professionals. J Perinat Neonatal Nurs. 2007 Apr-Jun;21(2):92-100; quiz 101-2. doi: 10.1097/01.JPN.0000270624.64584.9d.
PubMed 17505227World Health Organization Western Pacific Region. Human Resource s for health country profiles : Malaysia. 2014.
Fruchtman Y, Moser AM, Perry ZH. Fatigue in medical residents--lessons to be learned. Med Lav. 2011 Sep-Oct;102(5):455-63.
PubMed 22022764Rashid AA, Devaraj NK, Mohd Yusof H, Mustapha F, Wong SV, Ismail AF, Ismail KI, Qureshi AM, Nordin RB. Prevalence and predictors of road crash involvement among medical doctors in Malaysia: a cross-sectional study protocol. BMJ Open. 2020 Jul 2;10(7):e037653. doi: 10.1136/bmjopen-2020-037653.
PubMed 32616493
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Road Crash Involvement and Its Associated Factors Among Medical Doctors in Malaysia : A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT04243291
- Acronym / sponsor ID
- 40609
- Conditions
- Traffic Accident
- Keywords
- risk factor, physician, road accident, prevalence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 28 Jan 2020 (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.
This study mainly to investigate the prevalence of road crash involvement and its associated factors (fatigue, demographic factors, sleep quality, and mental health status, number of working hours) among medical doctors in Malaysia.
Detailed description
The incidence reports of road crash involvement among medical doctors in Malaysia have steadily increased in frequency by 28%. Despite the gravity of the situation, there is an obvious absence of further information regarding the causes of such occurrence. A deeper look into literature regarding the phenomenon worldwide indicates that the prevalence of road crash involvement among doctors are less reported on, much less the factors associated with it.
hence, investigators constructed a research to investigate the prevalence of road crash involvement and its associated factors (fatigue, demographic factors, sleep quality, and mental health status, number of working hours) among medical doctors in Malaysia.
It is a cross sectional study where the study population consists of Malaysian Medical Association (MMA) members who are fully or partially registered with the Malaysian Medical Council (MMC) and their contacts.
Respondents will be selected via non probability random sampling among MMA registered member list and their network. The sample will be doctors who are partially or fully registered with the Malaysian Medical Council and following the inclusion and exclusion criteria. The participants who are eligible will need to answer via an online survey link.
Inclusion criteria
- Malaysian citizen
- Full or partial registration with MMC
- Work a minimum of six (6) months in public healthcare sector in Malaysia. Doctors who have just been working for less than six months are still adapting to the duties and atmosphere of the hospital, and the responsibilities they hold are also different from those of a senior doctor making them not suitable to include in this study.
Exclusion criteria
- Medical doctors currently on a long leave. As investigators only have a short period of data collection, so investigators will exclude this group of subject.
- Does not self-commute to work
CALCULATED SAMPLE SIZE = 288.
This study will be in collaboration with Malaysian Medical Associations (MMA) on recruiting sample for this research along with other medical NGOs. MMA will help in dissemination of information throughout their website as well as distribute/email the questionnaires to all MMA members and their contacts.
The questionnaire will be created by using Google Form and then saved on Google Drive. Then MMA will share the form to all their members through email. All responses will be saved in the file stored in Google Drive. Once enough sample acquired, the form will be closed and results will be download for data analysis.
Data entry and analysis will be undertaken by using the 'Statistical Package for Social Sciences' (SPSS) programme, Version 22.0. The statistical significance level is taken at the p value <0.05 with 95% of confidence intervals (CI). The continuous variables will be summarised by using means and standard deviation (SD) and predominantly categorised as required and presented as the number (n) and percentage (%). The statistics analysis will utilise the Pearson Chi-square test for obtaining the statistical difference of the categorical variables.
Lastly, logistic regression analysis will be used to describe the strength of association between the outcome and factors of interest, adjusting for covariates or confounders. It also allows one to determine the important factors affecting the outcome and generate the final model for the factors being studied as the predictor for the outcomes.
Study Instrument: Questionnaire/scoring \& Pilot study
This study's approval for ethical clearance will be obtained from Medical Research Ethics Committee (MREC), "University Putra Malaysia" (UPM). Informed consent will be obtained from each study participant and it will be stated at the beginning of the questionnaire.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Malaysian Medical Association (MMA) members who are fully or partially registered with the Malaysian Medical Council (MMC) and their contacts. MMA is the main representative body for all registered medical practitioners in Malaysia. MMA members include senior and junior doctors, private and public, specialists and general practioners, medical officer and house officer.
Key inclusion criteria (3 listed)
- Malaysian citizen
- Full or partial registration with MMC
- Work a minimum of six (6) months in public healthcare sector in Malaysia. Doctors who have just been working for less than six months are still adapting to the duties and atmosphere of the hospital, and the responsibilities they hold are also different from those of a senior doctor making them not suitable to include in this study.
Key exclusion criteria (2 listed)
- Medical doctors currently on a long leave. As we only have a short period of data collection, so we will exclude this group of subject.
- Does not self-commute to work
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Prevalence of Road Crash Involvement among Medical Doctors
Time frame: Since joining medical profession ( anywhere from one year up to 20 years )
Self reported in sociodemographic questionnaire
fatigue among Medical Doctors
Time frame: Since joining medical profession ( anywhere from one year up to 20 years )
Checklist Individual Strength Questionnaire (CISQ)
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 20 May 2022.
- BackgroundAneesa AR, Suhazeli A, Nur Asyikin M, Munawar S, Nur Asyraf M , Siti Illiana M, et al. Post Call MVA Survey: An 18 Hour Online Survey. In: 17th Islamic Association of Malaysia (IMAM) Annual Scientific Conference (ASC). Penang, Malaysia; 2015.
- Background: PubMed 9085483Marcus CL, Loughlin GM. Effect of sleep deprivation on driving safety in housestaff. Sleep. 1996 Dec;19(10):763-6. doi: 10.1093/sleep/19.10.763.
- Background: PubMed 10530665Steele MT, Ma OJ, Watson WA, Thomas HA Jr, Muelleman RL. The occupational risk of motor vehicle collisions for emergency medicine residents. Acad Emerg Med. 1999 Oct;6(10):1050-3. doi: 10.1111/j.1553-2712.1999.tb01191.x.
- Background: PubMed 12204082Veasey S, Rosen R, Barzansky B, Rosen I, Owens J. Sleep loss and fatigue in residency training: a reappraisal. JAMA. 2002 Sep 4;288(9):1116-24. doi: 10.1001/jama.288.9.1116.
- BackgroundPertubuhan Keselamatan Sosial. Laporan Tahunan Perkeso. 2015.
- BackgroundAzhar A. Commuting Accidents : What Does Research Shows ? COMMUTING ACCIDENTS PREVENTION SEMINAR MONASH UNIVERSITY MALAYSIA 9 - 10 DECEMBER 2014. 2014.
- Background: PubMed 15647575Barger LK, Cade BE, Ayas NT, Cronin JW, Rosner B, Speizer FE, Czeisler CA; Harvard Work Hours, Health, and Safety Group. Extended work shifts and the risk of motor vehicle crashes among interns. N Engl J Med. 2005 Jan 13;352(2):125-34. doi: 10.1056/NEJMoa041401.
- Background: PubMed 17505227Owens JA. Sleep loss and fatigue in healthcare professionals. J Perinat Neonatal Nurs. 2007 Apr-Jun;21(2):92-100; quiz 101-2. doi: 10.1097/01.JPN.0000270624.64584.9d.
- BackgroundWorld Health Organization Western Pacific Region. Human Resource s for health country profiles : Malaysia. 2014.
- Background: PubMed 22022764Fruchtman Y, Moser AM, Perry ZH. Fatigue in medical residents--lessons to be learned. Med Lav. 2011 Sep-Oct;102(5):455-63.
- Derived from this study: PubMed 32616493Rashid AA, Devaraj NK, Mohd Yusof H, Mustapha F, Wong SV, Ismail AF, Ismail KI, Qureshi AM, Nordin RB. Prevalence and predictors of road crash involvement among medical doctors in Malaysia: a cross-sectional study protocol. BMJ Open. 2020 Jul 2;10(7):e037653. doi: 10.1136/bmjopen-2020-037653.
- Taylor AH, Dorn L. STRESS, FATIGUE, HEALTH, AND RISK OF ROAD TRAFFIC ACCIDENTS AMONG PROFESSIONAL DRIVERS: The Contribution of Physical Inactivity. Annu Rev Public Health \[Internet\]. 2006;27(1):371-91Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Aneesa Abdul Rashid principal investigator
Universiti Putra Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traffic Accident, run by Universiti Putra Malaysia at 1 site in Malaysia.
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 3 inclusion and 2 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 20 May 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 Malaysia. 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. 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?
The Prevalence of Road Crash Involvement among Medical Doctors (time frame: Since joining medical profession ( anywhere from one year up to 20 years )). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04243291, which also lists 11 linked publications.
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 20 May 2022.