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DriveROADSkillsNCT05450159

The Refreshing Older Adults' Driving Skills (ROADSkills) Program

A study testing ROADskills program and Healthy Aging in people with Drive, run by McMaster University at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 65 to 79 yearsHealthy volunteers can take part
Conditions the study is for
Drive
What is being tested?
ROADskills program and Healthy Aging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteCanada
Study dates
17 Oct 2023to 31 Jul 2024
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 to 79 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Brenda H Vrkljan, PhD contact

905-745-3789

vrkljan@mcmaster.ca

Canada1 site, 1 recruiting

  • McMaster Automotive Resource Centre

    Hamilton, Ontario, L8P 0A6

    Jessica Petrunti, B.A., 905-525-9140, petruntij@mcmaster.ca

    Brenda Vrkljan, PhD

    Recruiting

Other trials in Canada

About this study

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

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.

Conditions
Drive
Being tested
ROADskills program, Healthy Aging

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ROADskills programBehavioural

    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 AgingBehavioural

    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.

Study groups in NCT05450159
Study groupRoleWhat they receive
Intervention groupExperimentalParticipants in the intervention group will watch their respective training video individually approximately four to six weeks after their baseline visit. Each training video will be 20-25 minutes in length where they will receive voice-over feedback on their driving from a member of the study team alongside video clips taken from the device of their behind-the-wheel performance. They will also receive a written summary of their feedback to keep at the end of their feedback session.
Receives: Behavioral: ROADskills program
Control groupActive comparatorFour to six weeks after their first baseline visit, control group participants individually will watch a 30-minute (generic) video that describes the benefits and challenges of aging-in-place that discusses the importance of community mobility in later life. At the end of their session, participants will be given a government brochure on this topic.
Receives: Behavioral: Healthy Aging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2022
  2. Study start17 Oct 2023
  3. Primary completion31 May 2024 (estimated)
  4. Study completion31 Jul 2024 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
2-arm, parallel-group, double-blinded Randomized Controlled trial
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05450159
Sponsor's protocol ID
14707
Acronym
ROADSkills
Status last verified
Oct 2023
First submitted
4 Jul 2022
Last updated
19 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33224736

  • 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.

    PubMed 34418687

  • 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.

    PubMed 27021591

  • 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.

    PubMed 28365398

Questions about this trial

What is this clinical trial studying?

A study testing ROADskills program and Healthy Aging in people with Drive, run by McMaster University at 1 site 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 6 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 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Contact Brenda H Vrkljan, PhD (905-745-3789, vrkljan@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

weighted electronic Driving Observation Schedule (eDOS) (time frame: 3 months). 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 NCT05450159, which also lists 4 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 19 Oct 2023.

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