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临床试验/NCT02600026
NCT02600026Unknown1 期

Video Feedback Intervention for Cognitively Impaired Older Drivers

Rhode Island Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年11月最近更新:
适应症
干预措施

试验速览

阶段
1 期
入组人数
60
试验地点
2
主要终点
Number of unsafe driving events

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
50 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

Video Camera: Intervention

Experimental

DriveCam video event recorder with feedback

干预措施: DriveCam (Device)

Video Camera: Intervention

Experimental

DriveCam video event recorder with feedback

干预措施: Feedback (Behavioral)

Video Camera: Monitoring

Placebo Comparator

DriveCam video event recorder with no feedback

干预措施: DriveCam (Device)

结局指标

主要结局

Number of unsafe driving events

时间窗: 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.

次要结局

  • Severity score of unsafe driving events(9 months)
  • Time to driving cessation(1-2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brian Ott

Brian R. Ott, MD

Rhode Island Hospital

研究点 (2)

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