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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT01237626
Other study ID # #2008610-01H
Secondary ID
Status Enrolling by invitation
Phase N/A
First received November 8, 2010
Last updated April 3, 2017
Start date October 2008
Est. completion date December 2017

Study information

Verified date April 2017
Source Ottawa Hospital Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 932
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 70 Years and older
Eligibility Inclusion Criteria:

1. have a general class driver's license and actively driving for at least 1 year

2. have vehicle access

3. drive at least 4 times a week (4 round trips)

4. reside in the local regions of one of the study cities (Victoria, Winnipeg, Thunder Bay, Ottawa, Toronto, Hamilton or Montreal)

5. consent to release driving information from the provincial Ministry of Transportation

6. agree to undergo annual physical and cognitive assessment and be contacted at least quarterly for data pick up and interview

7. be under the care of a family physician

8. have a primary vehicle for driving that is model year 1996 or newer

9. be age 70 or greater

10. have a life expectancy of at least 5 years

11. be fluent in either French or English

12. drive one vehicle 70% of the time or greater

13. reside in the province at least 10 months of the year.

Exclusion Criteria:

1. moved out of the province

2. 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

3. diagnosis of a progressive condition, such as dementia, Alzheimer's disease, and/or macular degeneration.

Study Design


Related Conditions & MeSH terms

  • Aging and Health and Impact on Driving

Locations

Country Name City State
Canada McMaster University Hamilton Ontario
Canada School of Physical and Occupational Therapy McGill University Montreal Quebec
Canada The Ottawa Hospital Research Institute Ottawa Ontario
Canada Lakehead University Thunder Bay Ontario
Canada Toronto Rehabilitation Institue Toronto Ontario
Canada University of Victoria Victoria British Columbia
Canada University of Manitoba Winnipeg Manitoba

Sponsors (11)

Lead Sponsor Collaborator
Ottawa Hospital Research Institute Lakehead University, McGill University, McMaster University, University of British Columbia, University of Manitoba, University of Ottawa, University of Toronto, University of Victoria, University of Waterloo, University of Western Ontario, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (7)

Caragata, 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.

Dickerson AE, Molnar LJ, Eby DW, Adler G, Bédard 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. Review. — View Citation

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. — View Citation

Man-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. Review. — View Citation

Marshall 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. — View Citation

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. Review. — View Citation

Tuokko HA, Rhodes RE, Dean R. Health conditions, health symptoms and driving difficulties in older adults. Age Ageing. 2007 Jul;36(4):389-94. Epub 2007 Mar 24. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary At-Fault Motor Vehicle Collisions (MVC) Motor Vehicle Collision as determined through the provincial Ministry of Transportation records. Throughout the 5-year period
Secondary Health Status Physical, cognitive (i.e. Montreal Cognitive Assessment) and psychological assessment measures Any point throughout 5-year study

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