跳至主要内容
临床试验/NCT01380340
NCT01380340已完成不适用

Study of the Effects of a New Concept of Early Intervention on the Driving Cessation, Mental Health, and Quality of Life of Senior Drivers

Fraser Health2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2011年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
8
试验地点
2
主要终点
Geriatric Depression Scale

研究概览

简要总结

This study will investigate the effects of a new form of early intervention for senior drivers who are at risk of changes to their driving status. The early intervention consists of group activities involving planning and professionally facilitated discussion.

There are three main research hypotheses for this study. Firstly, it is hypothesised that early intervention, in the form of the information and planning group, will not be associated with either increases or decreases in driving assessment failure or driving cessation. Secondly, it is hypothesised that early intervention will be associated with patterns of reduced depression and less persistent negative mood states. Thirdly, it is hypothesised that early intervention will be associated with patterns of sustained levels of important quality of life indicators such as community participation and social relationships.

详细描述

Study Protocol Summary:

This Canadian, British Columbian study, in the Fraser Health Authority region will involve seniors who have been referred to two Specialized Seniors Clinics (SSC) and have been flagged by clinicians for report to the Office of the Superintendent of Motor Vehicles (OSMV) for a driving assessment. At the White Rock/South Surrey (WR/SS) SSC,British Columbia (BC),10 subjects will be invited to participate in an information and planning group. Ten additional subjects from New Westminster (NW), BC SSC, will be matched with group participants. Each subject will be interviewed by an occupational therapist during which time the Geriatric Depression Scale (GDS)and an abbreviated version of the World Health Organization Seniors Quality of Life Brief Questionnaire (WHOQOL-BREF) will be administered. Each subject will be contacted by phone bi-monthly for 10 months and the tests will be re-administered. During the phone calls additional information about each senior's driving status and driving patterns will be collected.

Background Information:

This type of early intervention has not previously been researched or made available. Research has shown that seniors who lose their driving license are at increased risk of depression and social isolation. The PI research that preceded this study demonstrated that seniors who had experienced enforced loss of their driving license often showed long-term negative emotions such as anger and bitterness coupled with a sense of injustice.

Purpose of Study The purpose of the study is to explore evidence of possible effects of an early intervention group in the areas of mood, quality of life and community access.

研究设计

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

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Subjects will be invited to participate in the study if they have been referred to the SSC at the start of the study and have a medical condition which is believed to have a potential impact on their driving. They will be living in the community at the time of their referral and they will also be driving their vehicle at that point in time.

排除标准

  • •Subjects do not qualify to participate in this study if they are not holding a current driving license at the time of recruitment and if they do not have a medical condition that effects their ability to drive.

研究组 & 干预措施

Seniors early intervention driving group

Experimental

The seniors early intervention driving group is for seniors who have been identified by professionals as having to face changes to their driving status. It involves activities such as change strategies, positive psychology approaches and topic based discussion designed to mitigate the health and quality of life effects of driving regulation and cessation.

干预措施: Seniors Early Intervention Planning and Discussion. (Other)

Matched comparison group

No Intervention

The subjects will be recruited from a parallel service and will be paired with similar subjects in the experimental group.

结局指标

主要结局

Geriatric Depression Scale

时间窗: 10 months

The Geriatric Depression Scale (short form)is a well researched, standardized measure of depressive symptoms.It will be administered at the beginning and at the end of the study.

World Health Organization Quality of Life Measure (Brief)

时间窗: 10 months

The WHOQOL-BREF is a short version of the quality of life measure for seniors developed by the World Health Organization. It will be administered at the start and end of the study.

次要结局

未报告次要终点

研究者

发起方
Fraser Health
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jane Rodwell

Occupational Therapist

Fraser Health

研究点 (2)

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