STABLE trial of spectacle provision and driving safety among myopic motorcycle users in Vietnam: study protocol for a stepped-wedge, cluster randomised trial
Abstract Background Traffic crashes are the leading cause of death globally for people aged 5–29 years, with 90% of mortality occurring in low- and middle-income countries (LMICs). The STABLE (Slashing Two-wheeled Accidents by Leveraging Eyecare) trial was designed to determine whether providing spe...
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2024-12-01
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| author | Vinh Chi Le Kien Gia To Van Dat Le Le Nguyen Graeme MacKenzie Lovemore Nyasha Sigwadhi Prabhath Piyasena Mai Tran Ving Fai Chan Rohit C. Khanna Mike Clarke Lynne Lohfeld Heather Dickey Augusto Azuara-Blanco Asha Latha Mettla Sridevi Rayasam Han Thi Ngoc Doan Dung Van Do Phuoc Hong Le Charlie Klauer Richard Hanowski Zeb Bowden Lynn Murphy Joanne Thompson Susan McMullan Cliona McDowell Raja Narayanan Julie-Anne Little Huong Thu Ha Sangchul Yoon Rahul Goel Lan Luong Xuan Nguyen Nathan Congdon |
| author_facet | Vinh Chi Le Kien Gia To Van Dat Le Le Nguyen Graeme MacKenzie Lovemore Nyasha Sigwadhi Prabhath Piyasena Mai Tran Ving Fai Chan Rohit C. Khanna Mike Clarke Lynne Lohfeld Heather Dickey Augusto Azuara-Blanco Asha Latha Mettla Sridevi Rayasam Han Thi Ngoc Doan Dung Van Do Phuoc Hong Le Charlie Klauer Richard Hanowski Zeb Bowden Lynn Murphy Joanne Thompson Susan McMullan Cliona McDowell Raja Narayanan Julie-Anne Little Huong Thu Ha Sangchul Yoon Rahul Goel Lan Luong Xuan Nguyen Nathan Congdon |
| author_sort | Vinh Chi Le |
| collection | DOAJ |
| description | Abstract Background Traffic crashes are the leading cause of death globally for people aged 5–29 years, with 90% of mortality occurring in low- and middle-income countries (LMICs). The STABLE (Slashing Two-wheeled Accidents by Leveraging Eyecare) trial was designed to determine whether providing spectacles could reduce risk among young myopic motorcycle users in Vietnam. Methods This investigator-masked, stepped-wedge, cluster randomised naturalistic driving trial will recruit 625 students aged 18–23 years, driving ≥ 50 km/week, with ≥ 1-year driving experience and using motorcycles as their primary means of transport, in 25 clusters of 25 students in Ho Chi Minh City, Vietnam. Motorcycles of consenting students who have failed self-testing on the WHOeyes app will be fitted with Data Acquisition Systems (DAS) with video cameras and accelerometers. Video clips (± 30 s) of events flagged by the accelerometer will be reviewed for crash and near-crash events per 1000 km driven (main outcome). Five clusters of 25 students will be randomly selected every 12 weeks to undergo ocular examination and an estimated 40% of these will have bilateral spherical equivalent < − 0.5 D, and better-eye presenting distance visual acuity < 6/12, correctable bilaterally to ≥ 6/7.5. They will be given free distance spectacles and their driving data before receiving spectacles will be analysed as the control condition and subsequent data as the intervention condition. Secondary outcomes include visual function, cost-effectiveness and self-reported crash events. Discussion STABLE will be the first randomised trial of vision interventions and driving safety in a LMIC. Trial registration ClinicalTrials.gov, NCT05466955 . Initial registration: 20 July 2022, most recent update: 9 July 2024. |
| format | Article |
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| spelling | doaj-art-2a9387ce316f48d289e9d30ec06642f32025-08-20T02:31:50ZengBMCTrials1745-62152024-12-012511810.1186/s13063-024-08644-2STABLE trial of spectacle provision and driving safety among myopic motorcycle users in Vietnam: study protocol for a stepped-wedge, cluster randomised trialVinh Chi Le0Kien Gia To1Van Dat Le2Le Nguyen3Graeme MacKenzie4Lovemore Nyasha Sigwadhi5Prabhath Piyasena6Mai Tran7Ving Fai Chan8Rohit C. Khanna9Mike Clarke10Lynne Lohfeld11Heather Dickey12Augusto Azuara-Blanco13Asha Latha Mettla14Sridevi Rayasam15Han Thi Ngoc Doan16Dung Van Do17Phuoc Hong Le18Charlie Klauer19Richard Hanowski20Zeb Bowden21Lynn Murphy22Joanne Thompson23Susan McMullan24Cliona McDowell25Raja Narayanan26Julie-Anne Little27Huong Thu Ha28Sangchul Yoon29Rahul Goel30Lan Luong31Xuan Nguyen32Nathan Congdon33Centre for Public Health, School of Medicine Dentistry and Biomedical Sciences, Queen’s University BelfastFaculty of Public Health, University of Medicine and Pharmacy at Ho Chi Minh CityTransport Development and Strategy InstituteAsia Injury Prevention FoundationRiemann LimitedHyderabad Eye Research Foundation, L V Prasad Eye InstituteVision and Eye Research Institute, Anglia Ruskin UniversityAsia Injury Prevention FoundationCentre for Public Health, School of Medicine Dentistry and Biomedical Sciences, Queen’s University BelfastHyderabad Eye Research Foundation, L V Prasad Eye InstituteCentre for Public Health, School of Medicine Dentistry and Biomedical Sciences, Queen’s University BelfastCentre for Public Health, School of Medicine Dentistry and Biomedical Sciences, Queen’s University BelfastCentre for Health Research at the Management School Economics, Queen’s University BelfastCentre for Public Health, School of Medicine Dentistry and Biomedical Sciences, Queen’s University BelfastHyderabad Eye Research Foundation, L V Prasad Eye InstituteHyderabad Eye Research Foundation, L V Prasad Eye InstituteFaculty of Public Health, University of Medicine and Pharmacy at Ho Chi Minh CityFaculty of Public Health, University of Medicine and Pharmacy at Ho Chi Minh CityFaculty of Public Health, University of Medicine and Pharmacy at Ho Chi Minh CityVirginia Tech Transportation InstituteVirginia Tech Transportation InstituteVirginia Tech Transportation InstituteNorthern Ireland Clinical Trials UnitNorthern Ireland Clinical Trials UnitNorthern Ireland Clinical Trials UnitNorthern Ireland Clinical Trials UnitHyderabad Eye Research Foundation, L V Prasad Eye InstituteCentre of Optometry and Vision Science, School of Biomedical Sciences, Ulster UniversityHanoi Medical UniversityDepartment of Medical Humanities and Social Sciences, Yonsei University College of MedicineTransportation Research and Injury Prevention Centre, Indian Institute of TechnologyEye Care FoundationEye Care FoundationCentre for Public Health, School of Medicine Dentistry and Biomedical Sciences, Queen’s University BelfastAbstract Background Traffic crashes are the leading cause of death globally for people aged 5–29 years, with 90% of mortality occurring in low- and middle-income countries (LMICs). The STABLE (Slashing Two-wheeled Accidents by Leveraging Eyecare) trial was designed to determine whether providing spectacles could reduce risk among young myopic motorcycle users in Vietnam. Methods This investigator-masked, stepped-wedge, cluster randomised naturalistic driving trial will recruit 625 students aged 18–23 years, driving ≥ 50 km/week, with ≥ 1-year driving experience and using motorcycles as their primary means of transport, in 25 clusters of 25 students in Ho Chi Minh City, Vietnam. Motorcycles of consenting students who have failed self-testing on the WHOeyes app will be fitted with Data Acquisition Systems (DAS) with video cameras and accelerometers. Video clips (± 30 s) of events flagged by the accelerometer will be reviewed for crash and near-crash events per 1000 km driven (main outcome). Five clusters of 25 students will be randomly selected every 12 weeks to undergo ocular examination and an estimated 40% of these will have bilateral spherical equivalent < − 0.5 D, and better-eye presenting distance visual acuity < 6/12, correctable bilaterally to ≥ 6/7.5. They will be given free distance spectacles and their driving data before receiving spectacles will be analysed as the control condition and subsequent data as the intervention condition. Secondary outcomes include visual function, cost-effectiveness and self-reported crash events. Discussion STABLE will be the first randomised trial of vision interventions and driving safety in a LMIC. Trial registration ClinicalTrials.gov, NCT05466955 . Initial registration: 20 July 2022, most recent update: 9 July 2024.https://doi.org/10.1186/s13063-024-08644-2Road traffic crashNaturalistic drivingMyopiaMotorcycleStepped-wedge randomised trialVietnam |
| spellingShingle | Vinh Chi Le Kien Gia To Van Dat Le Le Nguyen Graeme MacKenzie Lovemore Nyasha Sigwadhi Prabhath Piyasena Mai Tran Ving Fai Chan Rohit C. Khanna Mike Clarke Lynne Lohfeld Heather Dickey Augusto Azuara-Blanco Asha Latha Mettla Sridevi Rayasam Han Thi Ngoc Doan Dung Van Do Phuoc Hong Le Charlie Klauer Richard Hanowski Zeb Bowden Lynn Murphy Joanne Thompson Susan McMullan Cliona McDowell Raja Narayanan Julie-Anne Little Huong Thu Ha Sangchul Yoon Rahul Goel Lan Luong Xuan Nguyen Nathan Congdon STABLE trial of spectacle provision and driving safety among myopic motorcycle users in Vietnam: study protocol for a stepped-wedge, cluster randomised trial Trials Road traffic crash Naturalistic driving Myopia Motorcycle Stepped-wedge randomised trial Vietnam |
| title | STABLE trial of spectacle provision and driving safety among myopic motorcycle users in Vietnam: study protocol for a stepped-wedge, cluster randomised trial |
| title_full | STABLE trial of spectacle provision and driving safety among myopic motorcycle users in Vietnam: study protocol for a stepped-wedge, cluster randomised trial |
| title_fullStr | STABLE trial of spectacle provision and driving safety among myopic motorcycle users in Vietnam: study protocol for a stepped-wedge, cluster randomised trial |
| title_full_unstemmed | STABLE trial of spectacle provision and driving safety among myopic motorcycle users in Vietnam: study protocol for a stepped-wedge, cluster randomised trial |
| title_short | STABLE trial of spectacle provision and driving safety among myopic motorcycle users in Vietnam: study protocol for a stepped-wedge, cluster randomised trial |
| title_sort | stable trial of spectacle provision and driving safety among myopic motorcycle users in vietnam study protocol for a stepped wedge cluster randomised trial |
| topic | Road traffic crash Naturalistic driving Myopia Motorcycle Stepped-wedge randomised trial Vietnam |
| url | https://doi.org/10.1186/s13063-024-08644-2 |
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