N/A
N=529
Advancing Understanding of Transportation Options
Diabetic Retinopathy · Macular Degeneration · Glaucoma · Retinitis Pigmentosa · Vision Disorders
Bottom Line
View on ClinicalTrials.gov: NCT04141891 ↗Enrolled (actual)
529
Serious AEs
1.3%
Results posted
Feb 2025
Primary outcome: Primary: Decisional Conflict Scale (DCS) Scores at Day 0 (Post-intervention) — 15.2; 12.3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Driving Decision Aid (Behavioral); Older Drivers Website (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Decisional Conflict Scale (DCS) Scores at Day 0 (Post-intervention) |
15.2; 12.3 | — |
| SECONDARY Values Clarity Subscale Score at Day 0 (Post-intervention) |
13.8; 12.8 | — |
| SECONDARY Older Adult Driving Safety Knowledge Scores as Assessed by True/False Questions at Day 0 (Post-intervention) |
79.9; 88.9 | — |
| SECONDARY Decision Self Efficacy Score at Day 0 (Post-intervention) |
92.9; 93.2 | — |
| SECONDARY Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item Depression Score |
0.56; 0.04; 1.32; 0.26; 1.46; -1.10 | — |
| SECONDARY Change in Ottawa Decision Regret Score |
3.24; -1.98; 2.39; -1.57; 1.71; 0.37 | — |
| SECONDARY Change in Life Space Score |
-1.97; -3.10; 2.68; -2.44; 1.93; -0.16 | — |
| SECONDARY Change in Self-reported Driving Frequency |
64; 70; 44; 45; 32; 43 | — |
| SECONDARY Change in Self-reported Situational Driving Avoidance |
-0.10; -0.40; -0.38; -0.42; -0.42; -0.53 | — |
| SECONDARY Occurrence of Driving Cessation |
4; 1; 2; 2; 6; 5 | — |
| SECONDARY Occurrence of Self-reported Crashes |
15; 9; 10; 10; 10; 12 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT04141891). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.