- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02593552
Video Intervention to Enhance the Safety Of Cognitively Impaired Older Drivers
May 25, 2016 updated by: Brian Ott, Rhode Island Hospital
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.
Study Overview
Detailed Description
The goals of this pilot study were to demonstrate that 1) g-force technology can effectively detect unsafe driving events by older adults, and 2) cognitively impaired older adults can improve their driving safety with an in-car video feedback intervention.
Unsafe driving events were triggered by g-forces leading to capture of a video record that was then transmitted wirelessly to a remote office where the events were analyzed and scored.
During the baseline phase (3 months), there was no feedback.
During the intervention phase (4-6 months), participants received a weekly progress report in the mail along with DVD of recorded unsafe driving events with recommendations.
The research team then contacted the participant and informant weekly to provide additional coaching, and verify that participants reviewed the information and videos.
During the post-intervention monitoring phase (7-9 months), there was no further feedback.
The primary quantitative outcomes were total number of unsafe driving events/1,000 miles and total safety driving score/1,000 miles.
Secondary qualitative outcomes included the types and severity of unsafe driving events that were recorded.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 2
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
68 years to 90 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
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 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Video camera
DriveCam video event recorder with counseling feedback
|
Video event monitoring device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of unsafe driving events
Time Frame: 9 months
|
Scale
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Severity score of unsafe driving events
Time Frame: 9 months
|
Scale
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
October 28, 2015
First Submitted That Met QC Criteria
October 29, 2015
First Posted (Estimate)
November 1, 2015
Study Record Updates
Last Update Posted (Estimate)
May 27, 2016
Last Update Submitted That Met QC Criteria
May 25, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 263758-14
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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