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Completed

NCT Number: NCT01380340

Seniors Driving Cessation Early Intervention Group

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New Westminster Specialized Seniors Clinic, New Westminster, British Columbia, Canada

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About this study

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.

Justification for Study:

An important justification for this study is to examine the effects of a new concept of early intervention. Previous forms of intervention with existing senior drivers prior to assessment have involved activities such as public education and mature driver workshops. These have been evaluated in terms of the growth of knowledge and driving safety. In contrast, the new concept of early intervention involves activities such as group change strategies, positive psychology approaches and topic based discussion designed to mitigate the health and quality of life effects of regulation and cessation. In researching this new concept of early intervention, this project is intended to open up a new field for research. It will provide evidence of what effects can follow from early intervention and will indicate topics to be explored in subsequent research. In addition it will establish a model for the longitudinal research of senior drivers.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Seniors Early Intervention Planning and Discussion.

Other

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.

Primary outcomes

  1. Geriatric Depression Scale

    Time frame: 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.

  2. World Health Organization Quality of Life Measure (Brief)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fraser Health

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 27, 2011
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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