Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06437665
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-24
Brief Title:
Tech-wise Driver Technology Acceptance of Targeted ADAS for Older Adults
Sponsor:
Western University Canada
Organization:
Western University Canada
Study Overview
Official Title:
The Tech-wise Driver Exploring the Sustained Efficacy and Technology Acceptance of Targeted ADAS for Older Drivers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The tech-wise driver Exploring the sustained efficacy and technology acceptance of targeted ADAS for older drivers A significant percentage of road traffic fatalities registered in Canada occurred among older adults According to the studies the Advanced Driver Assistance Systems ADAS can enhance the safety and mitigate the age-related declines of older drivers Whether sustained use results in declines in driving performance in older drivers relying on ADAS remains largely unexplored This is problematic given emerging evidence on ADAS use by older drivers Furthermore exploring changes in ADAS technology acceptance in relation to sustained use can inform the correlation between perceived safety and intention to use
The investigators hypothesize that compared to driving simulator training alone lane departure warning LDW cruise control CC and forward proximity warning FPW technology will result in a sustained decrease of critical driving errors in this population and that exposure to the technology will increase participants perceived usability and ease of use To achieve this goal the investigators will explore the determination of sustained efficacy establish the impact of technology exposure evaluate the concurrent validity of a computerized model of driving error type and severity using trained occupational therapy in-vehicle evaluation as the criterion when evaluating older drivers performance
Our findings may significantly impact the ability of older drivers to choose in-vehicle technologies and our study will be the first to assess the criterion validity of a simulator-derived computerized model against the findings of an evaluator-based functional assessment
The investigators hypothesize that compared to driving simulator training alone lane departure warning LDW cruise control CC and forward proximity warning FPW technology will result in a sustained decrease of critical driving errors in this population and that exposure to the technology will increase participants perceived usability and ease of use To achieve this goal the investigators will explore the determination of sustained efficacy establish the impact of technology exposure evaluate the concurrent validity of a computerized model of driving error type and severity using trained occupational therapy in-vehicle evaluation as the criterion when evaluating older drivers performance
Our findings may significantly impact the ability of older drivers to choose in-vehicle technologies and our study will be the first to assess the criterion validity of a simulator-derived computerized model against the findings of an evaluator-based functional assessment
Detailed Description:
The driving simulator will be used to collect data on drivers in driving scenarios that include situations that may be more challenging for some drivers eg pedestrian stepping into a crosswalk a vehicle pulling out of a parking spot a vehicle suddenly changing lanes Vehicle data and gaze data will be collected for drivers along with images from the simulated environment The simulator will measure driving performance through metrics generated from the simulator eg pedal ie gas and brake reaction time vehicle velocity headway distancetime etc
Participants Licensed older drivers 65 years of age will be included in this study Participants will be excluded if they have neurological or psychiatric conditions that would preclude full participation in driving activity or if they take medications that may have a sustained negative impact on their mental andor physical functioning during driving
Sample Size A sample size of n68 will be recruited to achieve 80 power to detect a medium effect size of 50 based on a two-sided significance test with a significance level of 005
Procedure
1 Interested potential participants will reach to the team using the information distributed during recruitment
2 Upon confirm eligibility criteria the first session will be scheduled
3 Participants will receive a parking pass to park on the premises
4 The first session will take approximately 1 hr to complete
5 The objective of the study will be reviewed with each participant and they will be shown the simulator
2b Participants will complete a battery of paper and pencil and computer tests Of these tests the first will be vision screening testing to make sure they meet inclusion criteria Visual acuity monocular and binocular will be assessed via Snellen vision charts visual acuity peripheral fields contrast sensitivity color discrimination depth perception lateral phorias and vertical phorias will be assessed via the Optec 5000 Visual Analyzer Stereo Optical Company Inc Chicago IL After vision screening participants will complete an intake form This is a standardized intake form adapted by the research team which will collect the following information age gender preferred method of contact information for scheduling purposes self-identified ethnicity level of education occupation and medications The questions regarding ethnic origin and population group are based on Statistics Canada updated standards
2c Driving History and Habits The participants will complete several tests germane to their driving history First participants will complete a driving history form adapted by the research team based on Ali et al 2014 The form will collect information in three sections Section one will include age at which participants obtained their first license type of vehicle participants normally drive whether participants have been involved in a motor vehicle crash and previous use of ADAS technology Second participants will complete the computer-based Useful Field of View UFOV The UFOV is a standardized test which assesses visual perception and attention Edwards et al 2005 This test has shown to be correlated with driving performance among older drivers The UFOV consists of three subtests that assess attention divided attention and selective attention Finally the participants will complete the Comprehensive Trail Making Test CTMT a normed test in which participants are presented with a standardized set of five visual search and sequencing tasks using pen and paper Reynolds 2002
Rapid Pace Walk Administration A physical assessment involving walking at a brisk pace potentially used to evaluate gait and mobility which can impact a persons ability to operate pedals and controls in a vehicle
Finger to Nose Administration A motor coordination test where the participant touches their nose with their finger assessing fine motor skills and coordination relevant for tasks like steering and operating switches while driving
Adelaide Self-Efficacy Driving Scale A self-report questionnaire assessing the participants confidence and perceived ability in various driving situations helping to understand their subjective assessment of their driving skills
Modified Simulator Sickness Questionnaire A questionnaire measuring symptoms of simulator sickness or discomfort experienced during driving simulation sessions important for evaluating the usability and comfort of simulation-based assessments
Driving Simulation Evaluation Form A structured form or checklist used to evaluate the participants performance and behavior during driving simulation scenarios providing objective data on driving skills and behaviors
Manchester Driving Behavior Questionnaire A questionnaire assessing self-reported driving behaviors and attitudes offering insights into the participants driving style risk perception and adherence to traffic rules
The post-assessment tests generally involve reassessing specific aspects measured during the baseline assessment or evaluating any changes or improvements following interventions or training
2d Following these tests participants will complete their simulation drives The investigators will employ a clinical driving simulator DriveSafety Inc Salt Lake City UT Prior to each drive participants will be exposed to an acclimation drive Acclimation drives are part of a mitigation protocol aimed at reducing the likelihood of participants experiencing discomfort caused by simulation Such drives last no longer than 7 minutes and slowly introduce the participant to the simulation starting with simple maneuvers eg accelerate ad stop and progressively introducing more complex maneuvers eg turning
2e Each Participants will then complete a randomized 15-minute drive Participants will then take part in three sets of four training sessions in which the ADAS will be simulated experimental group or a training script will be provided control After each set of four drives a simulator assessment post-test will be completed with the final post-test also including the battery of clinical assessments Available routes will be randomly allocated and counterbalanced across participants All drives will be recorded frontal view of the driver as well as simulated drive Once a participant has completed all drives the recordings will be sent to a blinded trained evaluator occupational therapist and driving rehabilitation specialist The study will use a high-fidelity clinical driving simulator DriveSafety Inc configured with three 19 inch flat-panel displays 110-degree field of view 1920 x 1080 pixelsscreen Raw files will be used to develop and compute the model for comparison The drive using the simulator will be recorded mp4 This will allow the post-drive evaluation of the number and type of driving errors conducted by the research team In addition to recording the simulation drive a camera located in the simulator records the face of the driver to enable scoring of visual scanning errors All video files are stored in the password protected research drive connected to the simulator computer in the research lab and only accessible to members of this research team There will also be a stereo camera attached to the simulator for collecting gaze information of the driver This camera is connected to a computer running gaze analysis software and records only the gaze directions as vector in the 3D space of the camera and head direction also a vector in the 3D space of the camera This data is numeric and will be stored using the identifier assigned to the participant no images are collected from this camera Prior to and after each drive the Adapted Motion Sickness Questionnaire will be used to monitor for any signs of simulator sickness If a participant scores over 5 in any of the items the session will be suspended the participants remunerated and provided with access to water ginger ale crackers and cool room No further drives will be attempted to avoid any risk of increasing simulator sickness
2f After the driving session the research team will thank the participant and provide remuneration
3In order to give the team access to the driving simulator metrics of each drive a password protected One Drive folder within Westerns license will be used Only deidentified driving simulator data will be uploaded to the One Drive
Participants Licensed older drivers 65 years of age will be included in this study Participants will be excluded if they have neurological or psychiatric conditions that would preclude full participation in driving activity or if they take medications that may have a sustained negative impact on their mental andor physical functioning during driving
Sample Size A sample size of n68 will be recruited to achieve 80 power to detect a medium effect size of 50 based on a two-sided significance test with a significance level of 005
Procedure
1 Interested potential participants will reach to the team using the information distributed during recruitment
2 Upon confirm eligibility criteria the first session will be scheduled
3 Participants will receive a parking pass to park on the premises
4 The first session will take approximately 1 hr to complete
5 The objective of the study will be reviewed with each participant and they will be shown the simulator
2b Participants will complete a battery of paper and pencil and computer tests Of these tests the first will be vision screening testing to make sure they meet inclusion criteria Visual acuity monocular and binocular will be assessed via Snellen vision charts visual acuity peripheral fields contrast sensitivity color discrimination depth perception lateral phorias and vertical phorias will be assessed via the Optec 5000 Visual Analyzer Stereo Optical Company Inc Chicago IL After vision screening participants will complete an intake form This is a standardized intake form adapted by the research team which will collect the following information age gender preferred method of contact information for scheduling purposes self-identified ethnicity level of education occupation and medications The questions regarding ethnic origin and population group are based on Statistics Canada updated standards
2c Driving History and Habits The participants will complete several tests germane to their driving history First participants will complete a driving history form adapted by the research team based on Ali et al 2014 The form will collect information in three sections Section one will include age at which participants obtained their first license type of vehicle participants normally drive whether participants have been involved in a motor vehicle crash and previous use of ADAS technology Second participants will complete the computer-based Useful Field of View UFOV The UFOV is a standardized test which assesses visual perception and attention Edwards et al 2005 This test has shown to be correlated with driving performance among older drivers The UFOV consists of three subtests that assess attention divided attention and selective attention Finally the participants will complete the Comprehensive Trail Making Test CTMT a normed test in which participants are presented with a standardized set of five visual search and sequencing tasks using pen and paper Reynolds 2002
Rapid Pace Walk Administration A physical assessment involving walking at a brisk pace potentially used to evaluate gait and mobility which can impact a persons ability to operate pedals and controls in a vehicle
Finger to Nose Administration A motor coordination test where the participant touches their nose with their finger assessing fine motor skills and coordination relevant for tasks like steering and operating switches while driving
Adelaide Self-Efficacy Driving Scale A self-report questionnaire assessing the participants confidence and perceived ability in various driving situations helping to understand their subjective assessment of their driving skills
Modified Simulator Sickness Questionnaire A questionnaire measuring symptoms of simulator sickness or discomfort experienced during driving simulation sessions important for evaluating the usability and comfort of simulation-based assessments
Driving Simulation Evaluation Form A structured form or checklist used to evaluate the participants performance and behavior during driving simulation scenarios providing objective data on driving skills and behaviors
Manchester Driving Behavior Questionnaire A questionnaire assessing self-reported driving behaviors and attitudes offering insights into the participants driving style risk perception and adherence to traffic rules
The post-assessment tests generally involve reassessing specific aspects measured during the baseline assessment or evaluating any changes or improvements following interventions or training
2d Following these tests participants will complete their simulation drives The investigators will employ a clinical driving simulator DriveSafety Inc Salt Lake City UT Prior to each drive participants will be exposed to an acclimation drive Acclimation drives are part of a mitigation protocol aimed at reducing the likelihood of participants experiencing discomfort caused by simulation Such drives last no longer than 7 minutes and slowly introduce the participant to the simulation starting with simple maneuvers eg accelerate ad stop and progressively introducing more complex maneuvers eg turning
2e Each Participants will then complete a randomized 15-minute drive Participants will then take part in three sets of four training sessions in which the ADAS will be simulated experimental group or a training script will be provided control After each set of four drives a simulator assessment post-test will be completed with the final post-test also including the battery of clinical assessments Available routes will be randomly allocated and counterbalanced across participants All drives will be recorded frontal view of the driver as well as simulated drive Once a participant has completed all drives the recordings will be sent to a blinded trained evaluator occupational therapist and driving rehabilitation specialist The study will use a high-fidelity clinical driving simulator DriveSafety Inc configured with three 19 inch flat-panel displays 110-degree field of view 1920 x 1080 pixelsscreen Raw files will be used to develop and compute the model for comparison The drive using the simulator will be recorded mp4 This will allow the post-drive evaluation of the number and type of driving errors conducted by the research team In addition to recording the simulation drive a camera located in the simulator records the face of the driver to enable scoring of visual scanning errors All video files are stored in the password protected research drive connected to the simulator computer in the research lab and only accessible to members of this research team There will also be a stereo camera attached to the simulator for collecting gaze information of the driver This camera is connected to a computer running gaze analysis software and records only the gaze directions as vector in the 3D space of the camera and head direction also a vector in the 3D space of the camera This data is numeric and will be stored using the identifier assigned to the participant no images are collected from this camera Prior to and after each drive the Adapted Motion Sickness Questionnaire will be used to monitor for any signs of simulator sickness If a participant scores over 5 in any of the items the session will be suspended the participants remunerated and provided with access to water ginger ale crackers and cool room No further drives will be attempted to avoid any risk of increasing simulator sickness
2f After the driving session the research team will thank the participant and provide remuneration
3In order to give the team access to the driving simulator metrics of each drive a password protected One Drive folder within Westerns license will be used Only deidentified driving simulator data will be uploaded to the One Drive
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None