Impaired DrivingPhase 1/2NCT02593552
Video Intervention to Enhance the Safety Of Cognitively Impaired Older Drivers
A Phase 1/2 study testing DriveCam in people with Impaired Driving, run by Rhode Island Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 68 to 90 years
- Conditions the study is for
- Impaired Driving
- What is being tested?
- DriveCam
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Jul 2014
- 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 68 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
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 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.
About this study
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.
Read the 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.
- Conditions
- Impaired Driving
- Being tested
- DriveCam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DriveCamDevice
Video event monitoring device
| Study group | Role | What they receive |
|---|---|---|
| Video camera | Experimental | DriveCam video event recorder with counseling 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
Scale
Measured: 9 months
Secondary outcomes (1)
Severity score of unsafe driving events
Scale
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study startSep 2011
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Ott, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02593552
- Sponsor's protocol ID
- 263758-14
- Status last verified
- May 2016
- First submitted
- 28 Oct 2015
- Last updated
- 27 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28218593
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Intervention to Enhance the Safety Of Cognitively Impaired Older Drivers
- ClinicalTrials.gov ID
- NCT02593552
- Acronym / sponsor ID
- 263758-14
- Conditions
- Impaired Driving
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 2 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 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Video camera | Experimental | Device: DriveCamDriveCam video event recorder with counseling feedback |
Who may qualify
- Ages
- 68 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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)
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 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
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 |
Primary outcome
Number of unsafe driving events
Time frame: 9 months
Scale
1 secondary outcome
Severity score of unsafe driving events
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
- Derived from this study: PubMed 28218593Ott 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DriveCam in people with Impaired Driving, run by Rhode Island Hospital.
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 7 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: finished, as of the sponsor's last update on 27 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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?
On the ClinicalTrials.gov record for NCT02593552, which also lists 1 linked publication.
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 27 May 2016.