Impaired DrivingPhase 1/2NCT02600026
Video Feedback Intervention for Cognitively Impaired Older Drivers
A Phase 1/2 study testing DriveCam and Feedback in people with Impaired Driving, run by Rhode Island Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Impaired Driving
- What is being tested?
- DriveCam and Feedback
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Jun 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
Gauri Vasudevan, 401-444-7111, gvasudevan1@lifespan.org
Memory Center, 1-844-5MEMORY, Memory@lifespan.org
About this study
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.
Read the 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.
- Conditions
- Impaired Driving
- Being tested
- DriveCam, Feedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DriveCamDevice
Video event monitoring device
FeedbackBehavioural
Video feedback intervention
| Study group | Role | What they receive |
|---|---|---|
| Video Camera: Intervention | Experimental | DriveCam video event recorder with feedback Receives: Device: DriveCam; Behavioral: Feedback |
| Video Camera: Monitoring | Placebo comparator | DriveCam video event recorder with no feedback Receives: Device: DriveCam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired DrivingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Association
- Responsible party
- Principal investigator, Brian Ott, Rhode Island Hospital
- Investigators
- Brian Ott, MD, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02600026
- Sponsor's protocol ID
- 799824-2
- Status last verified
- May 2018
- First submitted
- 5 Nov 2015
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Feedback Intervention for Cognitively Impaired Older Drivers
- ClinicalTrials.gov ID
- NCT02600026
- Acronym / sponsor ID
- 799824-2
- Conditions
- Impaired Driving
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- Alzheimer's Association
- Study start
- Nov 2015
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 9 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video Camera: Intervention | Experimental | Device: DriveCam, Behavioral: FeedbackDriveCam video event recorder with feedback |
| Video Camera: Monitoring | Placebo comparator | Device: DriveCamDriveCam video event recorder with no feedback |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age 50-90
- will be categorized as CDR= 0.5, or 1
- English speaking
- currently driving adults
- have a valid driving license
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DriveCamVideo event monitoring device | Device | Video Camera: Intervention, Video Camera: Monitoring |
| FeedbackVideo feedback intervention | Behavioural | Video Camera: Intervention |
Primary outcome
Number of unsafe driving events
Time frame: 9 months
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.
2 secondary outcomes
Severity score of unsafe driving events
Time frame: 9 months
Time to driving cessation
Time frame: 1-2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
Related trials for Impaired Driving
Not yet recruitingPhase 1
Examining the Role of Tolerance on Dose-dependent Effects of Acute THC on Oculomotor and Cognitive Performance
Cannabis Use, Impaired Driving
Not yet recruitingObservational study
An AI-Based Prediction of Cognitive Capacity in Older Adults and Individuals With Mild Cognitive Impairment During Virtual Reality Driving Tasks
Mild Cognitive Impairment (MCI), Virtual Reality
Not yet recruiting
Assessing the Effectiveness of Screening, Brief Intervention, and Referral to Treatment (SBIRT) With Personalized Feedback Intervention to Reduce Polysubstance Impaired Driving in Young Adults Aged 18-30
Impaired Driving
Active, not recruitingObservational study
Use of Driving Tests to Evaluate Patient Performance on Oral Opioids
Chronic Pain
Recruiting
Validating a Novel Driving Simulation-based MWT Against the Standard MWT in an OSA-cohort Challenged by CPAP-withdrawal
Excessive Daytime Sleepiness, Obstructive Sleep Apnea (OSA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Ott, MD principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DriveCam and Feedback in people with Impaired Driving, run by Rhode Island Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gauri Vasudevan, B.S. (401-444-7111, gvasudevan1@lifespan.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of unsafe driving events (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2018.