The Refreshing Older Adults' Driving Skills (ROADSkills) Program

Drive Clinical Trial

— ROADSkills  

Official title:

Evaluating the Acceptability and Feasibility of an Evidence-based and User-informed Approach to Refreshing Older Adults' Driving Skills (ROADSkills)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05450159
• Other study ID #: 14707
• Status: Recruiting
• Phase: N/A
• Start date: October 17, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: October 2023
• Source: McMaster University
• Contact: Brenda H Vrkljan, PhD
• Phone: 905-745-3789
• Email: vrkljan[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 79 Years

Eligibility

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).

Related Conditions & MeSH terms

• Drive

Intervention

Behavioral:
• ROADskills program
Participants in the intervention arm of the study will watch a 30-minute personalized video on their driving that uses information compiled from a GPS device that will be installed in their vehicle during their baseline visit.
• Healthy Aging
Participants in active comparator arm of the study will watch a 30-min video and receive a written brochure that provide tips for maintaining a healthy lifestyle in later life, including the importance of community mobility.

Locations

Country	Name	City	State
Canada	McMaster Automotive Resource Centre	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Ontario Ministry of Transportation

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weighted electronic Driving Observation Schedule (eDOS)	The weighted eDOS (Chen et al., 2020; Mazer et al., 2021) will be used to evaluate the behind-the-wheel performance of older drivers. The weighted eDOS accounts for route complexity where a total score is calculated, as the sum of errors weighted for its risk level. For each driving error, a weight is given (1=low risk; 2=moderate risk; 3=high risk) based on the type of error and the environment where it was made. For example, no signal at intersection with only one lane in low speed is considered a low-risk error whereas an inappropriate gap when making a left turn across more than one lane of traffic is a high-risk error. The weighted eDOS will be scored by a trained rater (blinded) using the GPS data of a 20-25- minute route. The weighted eDOS emerged from research examining the real-world driving of older drivers and has good inter-rater reliability, internal consistency and ecological validity; acceptability among older drivers was high (Koppel et al., 2016; 2017).	3 months