Advancing Understanding of Transportation Options (NCT04141891) | Clinical Trial Compass
CompletedNot Applicable
Advancing Understanding of Transportation Options
United States529 participantsStarted 2019-12-12
Plain-language summary
This Stage II randomized, controlled, longitudinal trial seeks to assess the acceptability, feasibility, and effects of a driving decision aid use among geriatric patients and providers. This multi-site trial will (1) test the driving decision aid (DDA) in improving decision making and quality (knowledge, decision conflict, values concordance and behavior intent); and (2) determine its effects on specific subpopulations of older drivers (stratified for cognitive function, decisional capacity, and attitudinally readiness for a mobility transition). The overarching hypotheses are that the DDA will help older adults make high-quality decisions, which will mitigate the negative psychosocial impacts of driving reduction, and that optimal DDA use will target certain populations and settings.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for drivers:
* 70 years or older
* Fluent in English
* At least one medical condition linked in driving cessation
* Drive at least one time per week
* Have a study partner\* (\*drivers interested in participating in the study without a study partner will be placed on a wait list; they may be contacted as a later date for enrollment once 200 driver-study partner dyads have been enrolled across all sites)
* 5-minute MoCA score greater or equal to 21
Exclusion Criteria for drivers:
* In legal custody or institutionalized
* Significant cognitive impairment as measured by 5-minute Montreal Cognitive Assessment (MoCA)
* Since the last time they had their license renewed, has had at least one major change to health, vision, or hearing that has seriously impaired driving (based on potential participant self-report)
* Feels the Department of Motor Vehicles would have serious concerns about their driving (based on potential participant self-report)
Inclusion Criteria for study partners:
* 18 years or older
* Fluent in English
* Identified by Driver participant to contact for potential participation, i.e., part of a driver-study partner dyad
* 5-minute MoCA score greater or equal to 21
Exclusion Criteria for study partners:
* In legal custody or institutionalized
* Significant cognitive impairment as measured by 5-minute Montreal Cognitive Assessment (MoCA)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Decisional Conflict Scale (DCS) Scores at Day 0 (Post-intervention)