Video Feedback Intervention for Cognitively Impaired Older Drivers
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2015
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 5, 2015
CompletedFirst Posted
Study publicly available on registry
November 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedMay 15, 2018
May 1, 2018
3.6 years
November 5, 2015
May 9, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Severity score of unsafe driving events
9 months
Time to driving cessation
1-2 years
Study Arms (2)
Video Camera: Intervention
EXPERIMENTALDriveCam video event recorder with feedback
Video Camera: Monitoring
PLACEBO COMPARATORDriveCam video event recorder with no feedback
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rhode Island Hospitallead
- Alzheimer's Associationcollaborator
Study Sites (1)
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Brian Ott, MD
Rhode Island Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Brian R. Ott, MD
Study Record Dates
First Submitted
November 5, 2015
First Posted
November 9, 2015
Study Start
November 1, 2015
Primary Completion
June 1, 2019
Study Completion
June 1, 2019
Last Updated
May 15, 2018
Record last verified: 2018-05