NCT02593552

Brief Summary

This pilot study was done to assess the feasibility and possible efficacy of a video feedback intervention to improve the safety of cognitively impaired older drivers.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2011

Typical duration for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 2, 2015

Completed
Last Updated

May 27, 2016

Status Verified

May 1, 2016

Enrollment Period

2.8 years

First QC Date

October 28, 2015

Last Update Submit

May 25, 2016

Conditions

Impaired Driving

Outcome Measures

Primary Outcomes (1)

  • Number of unsafe driving events

    Scale

    9 months

Secondary Outcomes (1)

  • Severity score of unsafe driving events

    9 months

Study Arms (1)

Video camera

EXPERIMENTAL

DriveCam video event recorder with counseling feedback

Device: DriveCam

Interventions

DriveCamDEVICE

Video event monitoring device

Video camera

Eligibility Criteria

Age68 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • age 60-90
  • English speaking
  • currently driving adults with a valid driving license and at least 10 years of driving experience
  • neurological examinations judged to be normal for age or consistent with AD
  • questionable to mild dementia (CDR 0.5 to 1)
  • MMSE \< 28
  • have an adult family member or other caregiver, age \>21 to participate in counseling 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 on confrontation testing
  • musculoskeletal disorders causing major physical handicaps such as frozen joints, inadequately healed fractures, and amputations
  • history of alcohol or substance abuse by DSM V diagnostic 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 subject is unsafe to drive.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ott BR, Davis JD, Bixby K. Video Feedback Intervention to Enhance the Safety of Older Drivers With Cognitive Impairment. Am J Occup Ther. 2017 Mar/Apr;71(2):7102260020p1-7102260020p7. doi: 10.5014/ajot.2017.020404.

    PMID: 28218593DERIVED

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Brian R. Ott, MD

Study Record Dates

First Submitted

October 28, 2015

First Posted

November 2, 2015

Study Start

September 1, 2011

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

May 27, 2016

Record last verified: 2016-05