Clinical trial NCT02600026: Video Feedback Intervention for Cognitively Impaired Older Drivers
Official title: Video Feedback Intervention for Cognitively Impaired Older Drivers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Impaired Driving
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: Alzheimer's Association
First posted: 2015-11-09
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* age 50-90
* will be categorized as CDR= 0.5, or 1
* English speaking
* currently driving adults
* have a valid driving license
* have at least 10 years of driving experience
* have a MMSE \< 28
* have an adult family member or other caregiver, age \>21, to participate in video feedback

Exclusion Criteria:

* ophthalmologic, physical, or neurologic disorders other than dementia that impair their driving abilities
* visual acuity worse than 20/40 in best eye using distance vision measured by wall chart
* homonymous hemianopia or bitemporal hemianopia
* musculoskeletal disorders causing major physical handicaps
* history of alcohol or substance abuse by DSM V criteria within the past year
* sedating medications that impair level of consciousness or attention
* language impairment that would interfere with the ability to participate in the educational intervention
* previous road test evaluation or opinion of caregiver or health professional that participant is unsafe to drive.

Primary outcomes:
measure: Number of unsafe driving events
timeFrame: 9 months
Secondary outcomes:
measure: Severity score of unsafe driving events
timeFrame: 9 months
measure: Time to driving cessation
timeFrame: 1-2 years
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Brian Ott, MD
role: PRINCIPAL_INVESTIGATOR
References: