Video Feedback Intervention for Cognitively Impaired Older Drivers

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.

Study Overview

• Status: Unknown
• Conditions: Impaired Driving
• Intervention / Treatment: Device: DriveCam; Behavioral: Feedback

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Gauri Vasudevan, B.S.; Phone Number: 401-444-7111; Email: gvasudevan1@lifespan.org
• Study Contact Backup: Name: Memory Center; Phone Number: 1-844-5MEMORY; Email: Memory@lifespan.org

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Rhode Island Hospital
      • Contact: Memory Center; Phone Number: 1-844-5MEMORY; Email: Memory@lifespan.org
      • Contact: Gauri Vasudevan; Phone Number: 401-444-7111; Email: gvasudevan1@lifespan.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Video Camera: Intervention; DriveCam video event recorder with feedback	Device: DriveCam; Video event monitoring device; Behavioral: Feedback; Video feedback intervention
Placebo Comparator: Video Camera: Monitoring; DriveCam video event recorder with no feedback	Device: DriveCam; Video event monitoring device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Rhode Island Hospital
• Collaborators: Alzheimer's Association
• Investigators: Principal Investigator: Brian Ott, MD, Rhode Island Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: November 5, 2015
• First Submitted That Met QC Criteria: November 5, 2015
• First Posted (Estimate): November 9, 2015

Study Record Updates

• Last Update Posted (Actual): May 15, 2018
• Last Update Submitted That Met QC Criteria: May 9, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 799824-2