Seniors Driving Cessation Early Intervention Group

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Fraser Health.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Fraser Health
ClinicalTrials.gov Identifier:
NCT01380340
First received: June 22, 2011
Last updated: June 27, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Depression
Quality of Life
Other: Seniors Early Intervention Planning and Discussion.

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official 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

Further study details as provided by Fraser Health:

Primary Outcome Measures:
  • Geriatric Depression Scale [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: July 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Seniors early intervention driving group
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.
Other: Seniors Early Intervention Planning and Discussion.
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.
No Intervention: Matched comparison group
The subjects will be recruited from a parallel service and will be paired with similar subjects in the experimental group.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01380340

Contacts
Contact: Jane Rodwell, MA 604 535 4500 ext 757974 jane.rodwell@fraserhealth.ca
Contact: Anne McCreary, BSc 604 535 4500 ext 757709 anne.mcceary@fraserhealth.ca

Locations
Canada, British Columbia
New Westminster Specialized Seniors Clinic Not yet recruiting
New Westminster, British Columbia, Canada, V3L 0B2
Contact: Susan Waldron, BSC    604 528 5031    susan.waldron@fraserhealth.ca   
White Rock Specialized Seniors Clinic Not yet recruiting
White Rock, British Columbia, Canada, V4B 2R4
Contact: Jane Rodwell, MA    604 535 4500 ext 757974    jane.rodwell@fraserhealth.ca   
Contact: Anne McCreary, BSc    604 535 4500 ext 757709    anne.mccreary@fraserhealth.ca   
Principal Investigator: Jane Rodwell, MA         
Sub-Investigator: Anne McCreary, BSc         
Sponsors and Collaborators
Fraser Health
Investigators
Principal Investigator: Jane Rodwell, MA Fraser Health Authority
  More Information

No publications provided

Responsible Party: Jane Rodwell, Occupational Therapy Practice Leader, Fraser Health Authority
ClinicalTrials.gov Identifier: NCT01380340     History of Changes
Other Study ID Numbers: FHREB# 2011-051
Study First Received: June 22, 2011
Last Updated: June 27, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Fraser Health:
Seniors
Driving
Group work

Additional relevant MeSH terms:
Depression
Behavioral Symptoms

ClinicalTrials.gov processed this record on October 23, 2014