Clinical trial NCT05450159: The Refreshing Older Adults' Driving Skills (ROADSkills) Program
Official title: Evaluating the Acceptability and Feasibility of an Evidence-based and User-informed Approach to Refreshing Older Adults' Driving Skills (ROADSkills)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Drive
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Transportation
First posted: 2022-07-08
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Maximum age (years): 79
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2-arm, parallel-group, double-blinded Randomized Controlled trial
Primary purpose: TREATMENT

Brief summary: Drivers aged 65+ depend on their car(s) to get to the places and see the people that are important to them. Losing a license in later life has been linked to higher rates of loneliness, depression, and even admission to long-term care; a fact that is particularly relevant when considering the impact of the COVID-19 pandemic. While drivers in this age group are among the safest on the road, they have one of the highest risks of collision when distance driven is considered and are more likely to be seriously injured or killed. Motor vehicle crashes and falls are the top causes of injury-related hospitalizations in seniors. Through a partnership with older adults, driving instructors, and health professionals, we developed the Refreshing Older Adult Driving Skills (ROADSkills) program. This program uses a Global Positioning System (GPS) device that can be placed in people's cars, which can track their real-world, everyday driving patterns, including speeding and hard braking, alongside video data of their behind-the-wheel behaviour. Using this data, a personalized video will be created using information captured by the device in the older driver's car. This study will determine if the older drivers who receive this video feedback perform better than those who do not receive such feedback. Because this is the first time a study will use this type of behavioural intervention, we are interested in hearing from older drivers about their experience of participating in the study. The findings will help us to design a larger, national study of the ROADSkills program in Canada.


Eligibility criteria: Inclusion Criteria:

* Aged 65-79 to reduce co-intervention bias, as the Ministry of Transportation has a Senior Driver Renewal program that screens drivers aged 80 and older
* Hold a valid driver's license
* Owner and access to insured vehicle
* Speak and understand English fluently
* Visited an optometrist in last two years
* if corrective lens are required for driving, prescriptions should be up-to-date

Exclusion Criteria:

* If participated in a recent Randomized Controlled Trial that examined the effectiveness of video-based intervention, will be excluded due to potential for bias
* Known serious or terminal illness or presence of contraindications for driving
* Performance on cognitive screening: 1) score of \< 21 on the Montreal Cognitive Assessment (MoCA; Nasreddine et al., 2005) 2) taking longer than 180 seconds or 3 or more errors on the Trail Making Test B (Bowie \& Harvey, 2006).

Primary outcomes:
measure: weighted electronic Driving Observation Schedule (eDOS)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Automotive Resource Centre
state: Ontario
Study officials:
References:
citation: Chen YT, Gelinas I, Mazer B. Development of a weighted scoring system for the Electronic Driving Observation Schedule (eDOS). MethodsX. 2020 Oct 12;7:101099. doi: 10.1016/j.mex.2020.101099. eCollection 2020.
citation: Mazer B, Chen YT, Vrkljan B, Marshall SC, Charlton JL, Koppel S, Gelinas I. Comparison of older and middle-aged drivers' driving performance in a naturalistic setting. Accid Anal Prev. 2021 Oct;161:106343. doi: 10.1016/j.aap.2021.106343. Epub 2021 Aug 18.
citation: Koppel S, Charlton JL, Langford J, Di Stefano M, MacDonald W, Vlahodimitrakou Z, Mazer BL, Gelinas I, Vrkljan B, Eliasz K, Myers A, Tuokko HA, Marshall SC. Driving Task: How Older Drivers' On-Road Driving Performance Relates to Abilities, Perceptions, and Restrictions. Can J Aging. 2016 Jun;35 Suppl 1:15-31. doi: 10.1017/S0714980816000015. Epub 2016 Mar 29.
citation: Koppel S, Charlton JL, Richter N, Di Stefano M, Macdonald W, Darzins P, Newstead SV, D'Elia A, Mazer B, Gelinas I, Vrkljan B, Eliasz K, Myers A, Marshall S. Are older drivers' on-road driving error rates related to functional performance and/or self-reported driving experiences? Accid Anal Prev. 2017 Jun;103:1-9. doi: 10.1016/j.aap.2017.03.006. Epub 2017 Mar 31. No abstract available.