NCT01380340

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Jul 2011

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
4 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

10 months

First QC Date

June 22, 2011

Last Update Submit

February 13, 2019

Conditions

Keywords

SeniorsDrivingGroup work

Outcome Measures

Primary Outcomes (2)

  • Geriatric Depression Scale

    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.

    10 months

  • World Health Organization Quality of Life Measure (Brief)

    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.

    10 months

Study Arms (2)

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.

Other: Seniors Early Intervention Planning and Discussion.

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.

Interventions

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.

Seniors early intervention driving group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

New Westminster Specialized Seniors Clinic

New Westminster, British Columbia, V3L 0B2, Canada

Location

White Rock Specialized Seniors Clinic

White Rock, British Columbia, V4B 2R4, Canada

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Jane Rodwell, MA

    Fraser Health Authority

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Occupational Therapist

Study Record Dates

First Submitted

June 22, 2011

First Posted

June 27, 2011

Study Start

July 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations