Video Feedback Intervention for Cognitively Impaired Older Drivers
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Oczekiwany)
Faza
- Faza 2
- Faza 1
Kontakty i lokalizacje
Lokalizacje studiów
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Rhode Island
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Providence, Rhode Island, Stany Zjednoczone, 02903
- Rekrutacyjny
- Rhode Island Hospital
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Kontakt:
- Memory Center
- Numer telefonu: 1-844-5MEMORY
- E-mail: Memory@lifespan.org
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Kontakt:
- Gauri Vasudevan
- Numer telefonu: 401-444-7111
- E-mail: gvasudevan1@lifespan.org
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Video Camera: Intervention
DriveCam video event recorder with feedback
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Video event monitoring device
Video feedback intervention
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Komparator placebo: Video Camera: Monitoring
DriveCam video event recorder with no feedback
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Video event monitoring device
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Number of unsafe driving events
Ramy czasowe: 9 months
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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.
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9 months
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Severity score of unsafe driving events
Ramy czasowe: 9 months
|
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.
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9 months
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Time to driving cessation
Ramy czasowe: 1-2 years
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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.
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1-2 years
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Brian Ott, MD, Rhode Island Hospital
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Oczekiwany)
Ukończenie studiów (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- 799824-2
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