The Refreshing Older Adults' Driving Skills (ROADSkills) Program (ROADSkills)

October 17, 2023 updated by: McMaster University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8P 0A6
        • Recruiting
        • McMaster Automotive Resource Centre
        • Contact:
        • Principal Investigator:
          • Brenda Vrkljan, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 79 years (Older Adult)

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Participants 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.
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.
Active Comparator: Control group
Four 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weighted electronic Driving Observation Schedule (eDOS)
Time Frame: 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

Ontario Ministry of Transportation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2023

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

July 4, 2022

First Submitted That Met QC Criteria

July 4, 2022

First Posted (Actual)

July 8, 2022

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 14707

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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