Video Feedback Intervention for Cognitively Impaired Older Drivers
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Fase 2
- Fase 1
Contactos e Locais
Locais de estudo
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02903
- Recrutamento
- Rhode Island Hospital
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Contato:
- Memory Center
- Número de telefone: 1-844-5MEMORY
- E-mail: Memory@lifespan.org
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Contato:
- Gauri Vasudevan
- Número de telefone: 401-444-7111
- E-mail: gvasudevan1@lifespan.org
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Video Camera: Intervention
DriveCam video event recorder with feedback
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Video event monitoring device
Video feedback intervention
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Comparador de Placebo: Video Camera: Monitoring
DriveCam video event recorder with no feedback
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Video event monitoring device
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of unsafe driving events
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Severity score of unsafe driving events
Prazo: 9 months
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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
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Brian Ott, MD, Rhode Island Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 799824-2
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