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| Name | Class |
|---|---|
| Alzheimer's Association | OTHER |
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This study will use an in-car monitoring system supplemented with video feedback to reduce the number of unsafe driving behaviors. If successful, this technology will provide a means to enhance public safety on the roads that could be adopted immediately in this at-risk group of drivers. The intervention will also maximize the time for independent driving, improving the overall quality of life of these individuals.
The goals of this clinical trial are to 1) document real-time impaired driving behaviors, and 2) reduce their occurrence, to improve the safety of cognitively impaired elders who continue to drive. This will be accomplished by placing small digital video event recording devices in the vehicles of 60 older cognitively impaired drivers. A 3-month baseline will establish the frequency of unsafe driving events, followed by a 3-month video feedback intervention during which the driver and family member will review the video recorded errors on a weekly basis. Active treatment will be compared to video monitoring with no feedback. A 6-month post-intervention phase will establish sustainability of the treatment.
The results of this clinical trial will confirm the potential to improve driving safety among older drivers with cognitive impairment using a behavior modification approach aimed directly at the problem behaviors observed in their natural driving environment. Knowledge gained about the magnitude and duration of the treatment effect and the potential of using an internet based feedback program will provide the impetus to optimize and ultimately implement the intervention to improve the safety of older drivers with mild cognitive impairment and early AD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Video Camera: Intervention | Experimental | DriveCam video event recorder with feedback |
|
| Video Camera: Monitoring | Placebo Comparator | DriveCam video event recorder with no feedback |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DriveCam | Device | Video event monitoring device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of unsafe driving events | Unsafe events rated as > 5 points using a modification of standard scale developed by Drivecam monitoring video service. This includes incidents, near-crashes, and crashes, sub classified as being triggered by hard turns, severe braking, and/or impact, adjusted for miles driven. | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Severity score of unsafe driving events | Measured by sum of all demerit points for events rated >5 adjusted for miles driven, during intervention and 6-month follow-up. The severity rating score derived and reported by DriveCam experts has been previously used in a longitudinal study of ambulance drivers demonstrating reduction in not only events, but also severity scores for events, as well as our own feasibility study. This measure will provide additional evidence supporting improvement in safe driving for our intervention trial. To demonstrate safe driving as an outcome, one would like to show not only a reduction in frequency of events, but also a reduction in the severity of those driving errors. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gauri Vasudevan, B.S. | Contact | 401-444-7111 | gvasudevan1@lifespan.org | |
| Memory Center | Contact | 1-844-5MEMORY | memory@lifespan.org |
| Name | Affiliation | Role |
|---|---|---|
| Brian Ott, MD | Rhode Island Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rhode Island Hospital | Recruiting | Providence | Rhode Island | 02903 | United States |
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| Feedback | Behavioral | Video feedback intervention |
|
| 9 months |
| Time to driving cessation | Time to driving cessation (e.g., due to road-test failure, at-fault motor vehicle accident, cognitive decline progression) measured over one to two years from baseline. Information on time to driving cessation, i.e., "driving retirement," will be obtained from annual telephone follow-up calls to the driving participant and family member up to the end of the 3-year study period. | 1-2 years |