DepressionNCT01380340
Seniors Driving Cessation Early Intervention Group
A study testing Seniors Early Intervention Planning and Discussion. in people with Depression and Quality of Life, run by Fraser Health at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Depression, Quality of Life
- What is being tested?
- Seniors Early Intervention Planning and Discussion.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesCanada
- Study dates
- Jul 2011to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
New Westminster Specialized Seniors Clinic
New Westminster, British Columbia, V3L 0B2
White Rock Specialized Seniors Clinic
White Rock, British Columbia, V4B 2R4
About this study
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
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.
Read the 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.
- Conditions
- Depression, Quality of Life
- Being tested
- Seniors Early Intervention Planning and Discussion.
- Keywords
- Seniors, Driving, Group work
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraser Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jane Rodwell, Fraser Health
- Investigators
- Jane Rodwell, MA, Principal investigator, Fraser Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01380340
- Sponsor's protocol ID
- FHREB# 2011-051
- Status last verified
- Feb 2019
- First submitted
- 22 Jun 2011
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01380340
- Acronym / sponsor ID
- FHREB# 2011-051
- Conditions
- Depression, Quality of Life
- Keywords
- Seniors, Driving, Group work
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Fraser HealthUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seniors early intervention driving group | Experimental | 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. |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Seniors early intervention driving group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane Rodwell, MA principal investigator
Fraser Health Authority
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seniors Early Intervention Planning and Discussion. in people with Depression and Quality of Life, run by Fraser Health at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geriatric Depression Scale (time frame: 10 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.