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临床试验/NCT02593552
NCT02593552已完成1 期

Video Intervention to Enhance the Safety Of Cognitively Impaired Older Drivers

Rhode Island Hospital0 个研究点目标入组 12 人开始时间: 2011年9月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
12
主要终点
Number of unsafe driving events

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • 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

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 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.

结局指标

主要结局

Number of unsafe driving events

时间窗: 9 months

Scale

次要结局

  • Severity score of unsafe driving events(9 months)

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

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