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Advancing Understanding of Transportation Options (AUTO)

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status

Completed

Conditions

Brain Injuries
Vertigo
Substance Use
Acute Coronary Syndrome
Insomnia
Vision Disorders
Restless Legs Syndrome
Multiple Sclerosis
Foot--Abnormalities
Chronic Obstructive Pulmonary Disease
Dizziness
Glaucoma
Parkinson Disease
Presyncope
Retinitis Pigmentosa
Dementia
Orthostatic Hypotension
Diabetic Retinopathy
Seizures
Stroke
Spinal Cord Injuries
Implantable Defibrillator User
Sleep Apnea
Narcolepsy
Congestive Heart Failure
Syncope
Macular Degeneration
Arthritis
End Stage Renal Disease
Insulin Dependent Diabetes Mellitus
Obstructive Sleep Apnea
Hypertrophic Obstructive Cardiomyopathy

Treatments

Behavioral: Driving Decision Aid
Behavioral: Older Drivers Website

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04141891
19-0059
R01AG059613 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

The investigators will use a multi-site, two-armed randomized controlled trial of older drivers (n=300; ≥70 years) from clinical settings, and one family member each (n=up to 300), with longitudinal follow-up. Study goals are to test how much the DDA improves outcomes and identify who benefits most from the DDA. Evaluation of the DDA's efficacy (Aim 1) and its relative effect in subgroups (Aim 2) corresponds to Stage II in the NIH Stage Model for Behavioral Intervention Development. Findings from Aims 1 & 2 could identify necessary refinements (Stage I) and inform future efficacy, effectiveness or implementation trials.

Enrollment

530 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

530 participants in 2 patient groups

Driving Decision Aid
Experimental group
Description:
Web-based Driving Decision Aid
Treatment:
Behavioral: Driving Decision Aid
Older Drivers Website
Active Comparator group
Description:
National Institute on Aging (NIA) Older Drivers website
Treatment:
Behavioral: Older Drivers Website

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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