Aging and Health and Impact on DrivingCANDRIVENCT01237626
CIHR Team in Driving in Older Persons
An observational study of Aging and Health and Impact on Driving, run by Ottawa Hospital Research Institute at 7 sites in Canada.
Trial summary
The following study is designed in order to effectively collaborate and coordinate information amongst colleagues to advance knowledge on information related to older drivers. Candrive is dedicated to improving the safety and quality of life of older drivers. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging and Health and Impact on Driving
- How many people
- 932 participants
- Where
- 7 sitesCanada
- Study dates
- Oct 2008to Dec 2017
- Phase
- Observational
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: The cohort will be established in 7 cities in 4 provinces, including Ontario (Ottawa, Thunder Bay, Toronto, Hamilton), Quebec (Montreal), Manitoba (Winnipeg) and British Columbia (Victoria). Participants will be recruited through the media - newspapers (community and city), radio, public presentations and newsletters to senior associations. We have established collaboration with two senior organizations; Canada's Association for the Fifty-plus (CARP) and the Federal Superannuates National Association (FSNA). These senior organizations will be targeted through mail out letters and presentations at annual meetings. Additionally, recruitment posters will be displayed at local community centres, fitness centres, doctor's offices, hospitals and other clinic waiting rooms.
Who may be able to join
- have a general class driver's license and actively driving for at least 1 year
- have vehicle access
- drive at least 4 times a week (4 round trips)
- reside in the local regions of one of the study cities (Victoria, Winnipeg, Thunder Bay, Ottawa, Toronto, Hamilton or Montreal)
- consent to release driving information from the provincial Ministry of Transportation
- agree to undergo annual physical and cognitive assessment and be contacted at least quarterly for data pick up and interview
Show all 13Show fewer
- be under the care of a family physician
- have a primary vehicle for driving that is model year 1996 or newer
- be age 70 or greater
- have a life expectancy of at least 5 years
- be fluent in either French or English
- drive one vehicle 70% of the time or greater
- reside in the province at least 10 months of the year.
Who cannot join
- moved out of the province
- contradiction to driving, within the last 6 months, according to the Canadian Medical Association Guidelines (7th edition), such as heart attack or low blood sugar
- diagnosis of a progressive condition, such as dementia, Alzheimer's disease, and/or macular degeneration.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
McMaster University
Hamilton, Ontario, H3C 3J7
School of Physical and Occupational Therapy McGill University
Montreal, Quebec, H3G 1Y5
The Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8M2
Lakehead University
Thunder Bay, Ontario, P7B 5E1
Toronto Rehabilitation Institue
Toronto, Ontario, M5G 2A2
University of Victoria
Victoria, British Columbia, V8W 2Y2
University of Manitoba
Winnipeg, Manitoba, R3T 2N2
About this study
Official title: The CIHR Team in Driving in Older Persons (Candrive II) Research Program
The following study is designed in order to effectively collaborate and coordinate information amongst colleagues to advance knowledge on information related to older drivers. Candrive is dedicated to improving the safety and quality of life of older drivers. The major objective is to develop a valid, easy to use in office screening tool that will help clinicians identify older drivers who need further assessment of their driving. Over the course of the study, the goal will be to provide enough data to establish findings relating to knowledge generation, translation of research into action, training and sustainability. It is our hope that the research process will translate to help increase the knowledge of public policy makers, clinicians and the general public. A 5 year study will create an opportunity to document the natural course of an older adult's driving patterns up until driving cessation. This will not only provide data for road safety but also help understand the psychosocial factors leading to driving cessation. The data relating to psychosocial factors may also lead the way in establishing ways of extending the safe driving period for older adults.
The investigators hypothesize that the knowledge derived from this interdisciplinary research will be used by transportation policy makers, clinicians, and general public to improve safety and quality of life for older drivers.
Read the detailed description
Driving a motor vehicle has become an everyday necessity in modern Canadian culture. The privilege of maintaining a valid driver's license promotes an independent lifestyle (Voelker, 1999). Since driving is a demanding task that requires a high level of mental and physical skills, it is critical that those who obtain a valid driver's license are medically fit to operate a motor vehicle. Adverse health conditions make driving difficult based on the high cognitive and physical demand (Man-Son-Hing, 2007, Marshall, 2008). The loss of driving privileges due to chronic health conditions can have a negative effect on an individual's quality of life. These individuals require greater community support and suffer from low self-esteem (Fonda, 2001, Ragland, 2004, Ansley et al., 2004). As much as it is desirable to promote independence, the safety implications of driving require careful consideration.
In Canada, persons over the age of 65 represent the fastest growing segment of the population. This age group is predicted to make up 24 % of the total population by the year 2030 (CMA Journal, 1994, Stats Can, 2005). As a result, the number of older persons holding a driver's license has increased in both percentage and absolute terms (Ont Road Safety, 2004, Transport Can, 2001, Ragland, 2004, Ansley et al., 2004). Therefore, it is not surprising that those over 70 years of age have the highest crash rates per mile driven (Brorsson, 1989, Stutts \& Wilkins, 2003, Gresset \& Meyer, 1994, Cotrell \& Wild, 1999, Rizzo et al., 2001, Meddinger-Rapport, 2002, Ansley et al., 2004).
Candrive is an interdisciplinary health research program dedicated to improving the safety of older drivers in Canada. The members of Candrive believe that establishing a comprehensive approach to aging driver issues will reduce the morbidity and mortality associated with motor vehicle crashes and allow older Canadian drivers to maintain their independence and healthy lifestyles.
A major focus of the Canadian Institutes of Health Research (CIHR) Team Grant is to conduct the Common Cohort study, a study in which 1000 drivers age 70 or older will be recruited and followed for 5 years. The Common Cohort study involves 7 sites (Victoria, Winnipeg, Thunder Bay, Hamilton, Toronto, Ottawa, and Montreal) in 4 provinces. Participants in the Common Cohort study will undergo comprehensive annual assessments as well as having their driving patterns monitored for 5 years. One of the major objectives of the Common Cohort study will be the development of a valid, easy-to-use in-office screening tool that will help clinicians identify older drivers who may need further assessment of their driving ability.
The vision of Candrive is to use a national interdisciplinary research approach to improve the safety and health-related quality-of-life of older drivers. Collaboration with key stakeholders throughout the process ensures that research products will translate into public policy and clinical practice.
- Conditions
- Aging and Health and Impact on Driving
- Keywords
- Driving, Aging, Older drivers, Medical Fitness to drive, Health Status, At-fault collisions
What is being measured
The primary outcome is the main question the study is designed to answer.
At-Fault Motor Vehicle Collisions (MVC)
Motor Vehicle Collision as determined through the provincial Ministry of Transportation records.
Measured: Throughout the 5-year period
Secondary outcomes (1)
Health Status
Physical, cognitive (i.e. Montreal Cognitive Assessment) and psychological assessment measures
Measured: Any point throughout 5-year study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startOct 2008
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Aging and Health and Impact on DrivingStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 932 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ottawa, Lakehead University, McGill University, University of British Columbia, University of Manitoba, University of Waterloo, University of Toronto, University of Western Ontario, Canada, University of Victoria, McMaster University
- Responsible party
- Sponsor
- Investigators
- Shawn C Marshall, MD MSc FRCPC, Principal investigator, Ottawa Hospital Research InstituteMalcom Man-Son-Hing, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237626
- Sponsor's protocol ID
- #2008610-01H
- Acronym
- CANDRIVE
- Status last verified
- Apr 2017
- First submitted
- 8 Nov 2010
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Eby DW, Molnar LJ. Driving fitness and cognitive impairment: issues for physicians. JAMA. 2010 Apr 28;303(16):1642-3. doi: 10.1001/jama.2010.495. No abstract available.
PubMed 20424255Caragata, G.E., Tuokko, H., & Damini, A. (2009). Fit to Drive: A Pilot Study to Improve the Physical Fitness of Older Drivers. Activities, Adaptation & Aging, 33(4), 240-255.
Marshall SC. The role of reduced fitness to drive due to medical impairments in explaining crashes involving older drivers. Traffic Inj Prev. 2008 Aug;9(4):291-8. doi: 10.1080/15389580801895244.
PubMed 18696384Dickerson AE, Molnar LJ, Eby DW, Adler G, Bedard M, Berg-Weger M, Classen S, Foley D, Horowitz A, Kerschner H, Page O, Silverstein NM, Staplin L, Trujillo L. Transportation and aging: a research agenda for advancing safe mobility. Gerontologist. 2007 Oct;47(5):578-90. doi: 10.1093/geront/47.5.578.
PubMed 17989400Tuokko HA, Rhodes RE, Dean R. Health conditions, health symptoms and driving difficulties in older adults. Age Ageing. 2007 Jul;36(4):389-94. doi: 10.1093/ageing/afm032. Epub 2007 Mar 24.
PubMed 17384420Man-Son-Hing M, Marshall SC, Molnar FJ, Wilson KG. Systematic review of driving risk and the efficacy of compensatory strategies in persons with dementia. J Am Geriatr Soc. 2007 Jun;55(6):878-84. doi: 10.1111/j.1532-5415.2007.01177.x.
PubMed 17537088Marshall SC, Wilson KG, Molnar FJ, Man-Son-Hing M, Stiell I, Porter MM. Measurement of driving patterns of older adults using data logging devices with and without global positioning system capability. Traffic Inj Prev. 2007 Sep;8(3):260-6. doi: 10.1080/15389580701281792.
PubMed 17710716Rapoport MJ, Naglie G, Weegar K, Myers A, Cameron D, Crizzle A, Korner-Bitensky N, Tuokko H, Vrkljan B, Bedard M, Porter MM, Mazer B, Gelinas I, Man-Son-Hing M, Marshall S. The relationship between cognitive performance, perceptions of driving comfort and abilities, and self-reported driving restrictions among healthy older drivers. Accid Anal Prev. 2013 Dec;61:288-95. doi: 10.1016/j.aap.2013.03.030. Epub 2013 Mar 30.
PubMed 23601097Marshall SC, Man-Son-Hing M, Bedard M, Charlton J, Gagnon S, Gelinas I, Koppel S, Korner-Bitensky N, Langford J, Mazer B, Myers A, Naglie G, Polgar J, Porter MM, Rapoport M, Tuokko H, Vrkljan B, Woolnough A. Protocol for Candrive II/Ozcandrive, a multicentre prospective older driver cohort study. Accid Anal Prev. 2013 Dec;61:245-52. doi: 10.1016/j.aap.2013.02.009. Epub 2013 Mar 7.
PubMed 23541299Smith A, Marshall S, Porter M, Ha L, Bedard M, Gelinas I, Man-Son-Hing M, Mazer B, Rapoport M, Tuokko H, Vrkljan B. Stability of physical assessment of older drivers over 1 year. Accid Anal Prev. 2013 Dec;61:261-6. doi: 10.1016/j.aap.2013.02.007. Epub 2013 Feb 13.
PubMed 23489912
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CIHR Team in Driving in Older Persons (Candrive II) Research Program
- ClinicalTrials.gov ID
- NCT01237626
- Acronym / sponsor ID
- CANDRIVE / #2008610-01H
- Conditions
- Aging and Health and Impact on Driving
- Keywords
- Driving, Aging, Older drivers, Medical Fitness to drive, Health Status, At-fault collisions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 932 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- University of Ottawa, Lakehead University, McGill University, University of British Columbia, University of Manitoba, University of Waterloo, University of Toronto, University of Western Ontario, Canada, University of Victoria, McMaster University
- Study start
- Oct 2008
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 9 Nov 2010 (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.
The following study is designed in order to effectively collaborate and coordinate information amongst colleagues to advance knowledge on information related to older drivers. Candrive is dedicated to improving the safety and quality of life of older drivers. The major objective is to develop a valid, easy to use in office screening tool that will help clinicians identify older drivers who need further assessment of their driving. Over the course of the study, the goal will be to provide enough data to establish findings relating to knowledge generation, translation of research into action, training and sustainability. It is our hope that the research process will translate to help increase the knowledge of public policy makers, clinicians and the general public. A 5 year study will create an opportunity to document the natural course of an older adult's driving patterns up until driving cessation. This will not only provide data for road safety but also help understand the psychosocial factors leading to driving cessation. The data relating to psychosocial factors may also lead the way in establishing ways of extending the safe driving period for older adults.
The investigators hypothesize that the knowledge derived from this interdisciplinary research will be used by transportation policy makers, clinicians, and general public to improve safety and quality of life for older drivers.
Detailed description
Driving a motor vehicle has become an everyday necessity in modern Canadian culture. The privilege of maintaining a valid driver's license promotes an independent lifestyle (Voelker, 1999). Since driving is a demanding task that requires a high level of mental and physical skills, it is critical that those who obtain a valid driver's license are medically fit to operate a motor vehicle. Adverse health conditions make driving difficult based on the high cognitive and physical demand (Man-Son-Hing, 2007, Marshall, 2008). The loss of driving privileges due to chronic health conditions can have a negative effect on an individual's quality of life. These individuals require greater community support and suffer from low self-esteem (Fonda, 2001, Ragland, 2004, Ansley et al., 2004). As much as it is desirable to promote independence, the safety implications of driving require careful consideration.
In Canada, persons over the age of 65 represent the fastest growing segment of the population. This age group is predicted to make up 24 % of the total population by the year 2030 (CMA Journal, 1994, Stats Can, 2005). As a result, the number of older persons holding a driver's license has increased in both percentage and absolute terms (Ont Road Safety, 2004, Transport Can, 2001, Ragland, 2004, Ansley et al., 2004). Therefore, it is not surprising that those over 70 years of age have the highest crash rates per mile driven (Brorsson, 1989, Stutts \& Wilkins, 2003, Gresset \& Meyer, 1994, Cotrell \& Wild, 1999, Rizzo et al., 2001, Meddinger-Rapport, 2002, Ansley et al., 2004).
Candrive is an interdisciplinary health research program dedicated to improving the safety of older drivers in Canada. The members of Candrive believe that establishing a comprehensive approach to aging driver issues will reduce the morbidity and mortality associated with motor vehicle crashes and allow older Canadian drivers to maintain their independence and healthy lifestyles.
A major focus of the Canadian Institutes of Health Research (CIHR) Team Grant is to conduct the Common Cohort study, a study in which 1000 drivers age 70 or older will be recruited and followed for 5 years. The Common Cohort study involves 7 sites (Victoria, Winnipeg, Thunder Bay, Hamilton, Toronto, Ottawa, and Montreal) in 4 provinces. Participants in the Common Cohort study will undergo comprehensive annual assessments as well as having their driving patterns monitored for 5 years. One of the major objectives of the Common Cohort study will be the development of a valid, easy-to-use in-office screening tool that will help clinicians identify older drivers who may need further assessment of their driving ability.
The vision of Candrive is to use a national interdisciplinary research approach to improve the safety and health-related quality-of-life of older drivers. Collaboration with key stakeholders throughout the process ensures that research products will translate into public policy and clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- The cohort will be established in 7 cities in 4 provinces, including Ontario (Ottawa, Thunder Bay, Toronto, Hamilton), Quebec (Montreal), Manitoba (Winnipeg) and British Columbia (Victoria). Participants will be recruited through the media - newspapers (community and city), radio, public presentations and newsletters to senior associations. We have established collaboration with two senior organizations; Canada's Association for the Fifty-plus (CARP) and the Federal Superannuates National Association (FSNA). These senior organizations will be targeted through mail out letters and presentations at annual meetings. Additionally, recruitment posters will be displayed at local community centres, fitness centres, doctor's offices, hospitals and other clinic waiting rooms.
Key inclusion criteria (13 listed)
- have a general class driver's license and actively driving for at least 1 year
- have vehicle access
- drive at least 4 times a week (4 round trips)
- reside in the local regions of one of the study cities (Victoria, Winnipeg, Thunder Bay, Ottawa, Toronto, Hamilton or Montreal)
- consent to release driving information from the provincial Ministry of Transportation
Key exclusion criteria (3 listed)
- moved out of the province
- contradiction to driving, within the last 6 months, according to the Canadian Medical Association Guidelines (7th edition), such as heart attack or low blood sugar
- diagnosis of a progressive condition, such as dementia, Alzheimer's disease, and/or macular degeneration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
At-Fault Motor Vehicle Collisions (MVC)
Time frame: Throughout the 5-year period
Motor Vehicle Collision as determined through the provincial Ministry of Transportation records.
1 secondary outcome
Health Status
Time frame: Any point throughout 5-year study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
- Background: PubMed 20424255Eby DW, Molnar LJ. Driving fitness and cognitive impairment: issues for physicians. JAMA. 2010 Apr 28;303(16):1642-3. doi: 10.1001/jama.2010.495. No abstract available.
- BackgroundCaragata, G.E., Tuokko, H., & Damini, A. (2009). Fit to Drive: A Pilot Study to Improve the Physical Fitness of Older Drivers. Activities, Adaptation & Aging, 33(4), 240-255.
- Background: PubMed 18696384Marshall SC. The role of reduced fitness to drive due to medical impairments in explaining crashes involving older drivers. Traffic Inj Prev. 2008 Aug;9(4):291-8. doi: 10.1080/15389580801895244.
- Background: PubMed 17989400Dickerson AE, Molnar LJ, Eby DW, Adler G, Bedard M, Berg-Weger M, Classen S, Foley D, Horowitz A, Kerschner H, Page O, Silverstein NM, Staplin L, Trujillo L. Transportation and aging: a research agenda for advancing safe mobility. Gerontologist. 2007 Oct;47(5):578-90. doi: 10.1093/geront/47.5.578.
- Background: PubMed 17384420Tuokko HA, Rhodes RE, Dean R. Health conditions, health symptoms and driving difficulties in older adults. Age Ageing. 2007 Jul;36(4):389-94. doi: 10.1093/ageing/afm032. Epub 2007 Mar 24.
- Background: PubMed 17537088Man-Son-Hing M, Marshall SC, Molnar FJ, Wilson KG. Systematic review of driving risk and the efficacy of compensatory strategies in persons with dementia. J Am Geriatr Soc. 2007 Jun;55(6):878-84. doi: 10.1111/j.1532-5415.2007.01177.x.
- Background: PubMed 17710716Marshall SC, Wilson KG, Molnar FJ, Man-Son-Hing M, Stiell I, Porter MM. Measurement of driving patterns of older adults using data logging devices with and without global positioning system capability. Traffic Inj Prev. 2007 Sep;8(3):260-6. doi: 10.1080/15389580701281792.
- Derived from this study: PubMed 23601097Rapoport MJ, Naglie G, Weegar K, Myers A, Cameron D, Crizzle A, Korner-Bitensky N, Tuokko H, Vrkljan B, Bedard M, Porter MM, Mazer B, Gelinas I, Man-Son-Hing M, Marshall S. The relationship between cognitive performance, perceptions of driving comfort and abilities, and self-reported driving restrictions among healthy older drivers. Accid Anal Prev. 2013 Dec;61:288-95. doi: 10.1016/j.aap.2013.03.030. Epub 2013 Mar 30.
- Derived from this study: PubMed 23541299Marshall SC, Man-Son-Hing M, Bedard M, Charlton J, Gagnon S, Gelinas I, Koppel S, Korner-Bitensky N, Langford J, Mazer B, Myers A, Naglie G, Polgar J, Porter MM, Rapoport M, Tuokko H, Vrkljan B, Woolnough A. Protocol for Candrive II/Ozcandrive, a multicentre prospective older driver cohort study. Accid Anal Prev. 2013 Dec;61:245-52. doi: 10.1016/j.aap.2013.02.009. Epub 2013 Mar 7.
- Derived from this study: PubMed 23489912Smith A, Marshall S, Porter M, Ha L, Bedard M, Gelinas I, Man-Son-Hing M, Mazer B, Rapoport M, Tuokko H, Vrkljan B. Stability of physical assessment of older drivers over 1 year. Accid Anal Prev. 2013 Dec;61:261-6. doi: 10.1016/j.aap.2013.02.007. Epub 2013 Feb 13.
- Candrive websiteLink provided by the sponsor.
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.
Shawn C Marshall, MD MSc FRCPC principal investigator
Ottawa Hospital Research Institute
Malcom Man-Son-Hing, MD principal investigator
Ottawa Hospital Research Institute
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging and Health and Impact on Driving, run by Ottawa Hospital Research Institute at 7 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 13 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Results are not available in the source record.
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?
At-Fault Motor Vehicle Collisions (MVC) (time frame: Throughout the 5-year period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01237626, which also lists 10 linked publications.
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 5 Apr 2017.