Slashing Two-wheeled Accidents by Leveraging Eyecare: a Stepped-wedge Cluster Randomised Controlled Trial to Assess Impact of Spectacles on Reducing Crash and Near-crash Events Among Myopic Motorcycle Drivers in Ho Chi Minh City Vietnam
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 158
- 试验地点
- 3
- 主要终点
- Crash and near-crash (CNC) events per 1,000 km driven
研究概览
简要总结
STABLE is a stepped-wedge cluster randomised controlled trial and its primary aim is to determine whether the provision of spectacles for the correction of myopia can reduce the average number of crash-near-crash (CNC) events among eligible motorcycle drivers in Vietnam as measured under naturalistic driving conditions with the Data Acquisition System (DAS).
STABLE is designed to assess the impact of vision correction on the safety of road users in a a Low and Middle income countries (LMIC) setting. A positive trial outcome would demonstrate the safety benefits of vision correction and would create pressure for tighter regulation of drivers' vision and the promotion of vision correction.
The study will be conducted in the peri-urban universities in Ho Chi Minh City, Vietnam and 625 students from five universities will be recruited into the trial.
Before conducting the main trial, a pilot of 35 students will be recruited to test DAS and build CNC dictionary.
Duration of the trial is 33 months from enrolment to completion of primary analysis, with 18 months for data collection.
Study participants can be both male and female motorcycle drivers aged 18 to 23 years years with at least one year of driving experience; they must use their motorcycle as their primary means of transport; drive at least 25 km per week and present with un- or under-corrected myopia that can be corrected with spectacles.
Participants with any ocular or systemic abnormality affecting vision, other than un-or under-corrected myopia will be excluded from the trial.
STABLE's primary outcome is CNC events per 1,000 km driven the DAS mounted to the motorcycles of trial participants. An interim analysis of the primary outcome will take place 9 months after data collection begins. The interim analysis will be reviewed by the trial's Data Monitoring and Ethics Committee. Unless a change is needed because of this review, the trial's primary analysis will take place 18 months after the DAS units are fitted to participants' motorcycle).
Compliance with study glasses; self-reported visual function (driving-adapted Visual Function Questionnaire-25 [VFQ-25]); Dula Dangerous Driving Index (DDDI), for all crashes; self-reported CNC events for comparison with recorded CNC events and total delivery cost per CNC event avoided with the intervention (indicator of cost-effectiveness).
详细描述
The primary aim of STABLE is to determine whether the provision of spectacles for the correction of myopia can reduce the average number of crash-near-crash (CNC) events among young motorcycle drivers in Vietnam.
Road traffic crashes kill more people aged 5 to 29 years worldwide than any other cause and are predicted to become the 7th leading global causes of death for all ages by 2030. The Southeast Asia has among the world's highest burdens of traffic mortality, with 20.7 fatalities per 100,000 population. The United Nations reports that motorcycles account for 93.3% of all motorized vehicles on the road in Vietnam, the highest number as a proportion of all motorized vehicles of any Association of Southeast Asian Nations country.
The investigators recently published a meta-analysis in Lancet Global Health which revealed that drivers with poor vision in Low and Middle-Income Countries (LMICs) had a 46% greater risk of experiencing a road traffic crash than those with good vision Risk Ratio (RR) 1·46, 95% Confidence Interval 1·20 to 1·78, p<0·001, 13 studies). Nevertheless, the impact of poor vision on the safety of young road users in LMICs, where many drivers do not undergo vision testing, remains poorly understood. There is a particular dearth of information for adolescent drivers, who are at greatest risk for crash-related death and the lack of reliable data has proven a significant barrier to inference of cause and effect.
Trials with robust measurement of CNC events with appropriate equipment under conditions of naturalistic driving are needed, and these have become possible only recently, due in part to falling costs and aggressive miniaturisation of GPS and on-board video systems.
STABLE will be the first cluster randomised controlled trial to investigate whether there is a link between vision correction with glasses and road safety in a LMIC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
The trial will be investigator-masked, but not participant-masked, because all participants who are eligible for eye glasses will be given them. The study's outcomes, including Crash and near Crash (CNC) events per 1,000 km, self-reported visual function (Visual Function Questionnaire (VFQ-25), and CI SRQ Crash and Injury Self report Questionnaire for all crashes, Dula Dangerous Driving Index (DDDI) will be masked from assessors.
All care will be taken to ensure that the study team are kept masked and the trial team do not foresee conditions that will require emergency unmasking.
入排标准
- 年龄范围
- 18 Years 至 23 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for DAS fitting
- •Students from selected universities will be eligible to participate if they:
- •are aged 18 to 23 years
- •have at least one year or more years of driving experience
- •are the sole user of their motorcycle
- •use their motorcycle as their primary means of transport
- •drive at least 25 km per week (self-report)
- •hold a valid driving license if their motorcycle has an engine capacity >50cc
- •Inclusion criteria for assignment to Intervention group
- •Participants will be eligible for assignment to transition into the intervention group if, during the STABLE clinical examination, they are found to have:
- •presenting distance visual acuity <= 6/12 in the better-seeing eye due to un- or under-corrected myopia,
- •vision correctable to 6/7.5 or better in both eyes
- •at least 0.5 Dioptre of myopia
排除标准
- •Individuals with any ocular or systemic abnormalities affecting vision will be ineligible to participate.
研究组 & 干预措施
Free eye glasses for un or under-corrected myopia
Free eyeglasses for the correction of uncorrected myopia will be provided to participants at the time of enrolment into the intervention group.
干预措施: Free eye glasses for un or under-corrected myopia (Device)
Control-No treatment
Participants in the control period will not have glasses but the SW-CRT design means that all trial participants with uncorrected myopia will receive free glasses by the trials' completion, and no participant will have glasses withheld after being diagnosed with un- or under-corrected myopia.
结局指标
主要结局
Crash and near-crash (CNC) events per 1,000 km driven
时间窗: up to18 months
CNC events as measured by Global Positioning System (GPS) and a gyroscopic sensor-video data-acquisition system (DAS) mounted to the motorcycles of trial participants.
次要结局
- Cost-effectiveness(18 months, Collected at the end of the trial.)
- Self-reported crashes(up to 18 months)
- Spectacle compliance(up to 18 months)
- Visual Function(VFQ-25 is administered at baseline and one month after receiving glasses.)
研究者
Nathan Congdon
Professor
Queen's University, Belfast