Advancing Understanding of Transportation Options

NCT04141891 | Completed Results DMC

• 2 other identifiers: 19-0059R01AG059613
• Study Type: interventional
• Target: 529
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Decisional Conflict Scale (DCS) Scores at Day 0 (Post-intervention)

  Decision conflict scale (DCS) is calculated from 16 items, with each item ranging from 0 (strongly agree) to 4 (strongly disagree). The total score is reported on a 0-100 scale by summing all responses, dividing by 16 and multiplying by 25. Higher scores represent greater levels of uncertainty in decision-making (higher decision conflict = worse outcome), and interventions often aim to reduce decision conflict (lower decision conflict = greater likelihood of implementing a decision = better outcome).

  Day 0 (Post-intervention)

Secondary Outcomes (10)

• Values Clarity Subscale Score at Day 0 (Post-intervention)

  Day 0 (Post-intervention)

• Older Adult Driving Safety Knowledge Scores as Assessed by True/False Questions at Day 0 (Post-intervention)

  Day 0 (Post-intervention)

• Decision Self Efficacy Score at Day 0 (Post-intervention)

  Day 0 (Post-intervention)

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item Depression Score

  6 months, 12 months, 18 months, 24 months

• Change in Ottawa Decision Regret Score

  12 months, 18 months, 24 months

Study Arms (2)

Driving Decision Aid

EXPERIMENTAL

Web-based Driving Decision Aid

Behavioral: Driving Decision Aid

Older Drivers Website

ACTIVE COMPARATOR

National Institute on Aging (NIA) Older Drivers website

Behavioral: Older Drivers Website

Interventions

Driving Decision Aid BEHAVIORAL

Healthwise DDA

Also known as: DDA

Driving Decision Aid

Older Drivers Website BEHAVIORAL

National Institute on Aging (NIA) Older Drivers Website

Older Drivers Website

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• minute MoCA score greater or equal to 21

You may not qualify if:

• 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)
• years or older
• Fluent in English
• Identified by Driver participant to contact for potential participation, i.e., part of a driver-study partner dyad
• minute MoCA score greater or equal to 21
• In legal custody or institutionalized
• Significant cognitive impairment as measured by 5-minute Montreal Cognitive Assessment (MoCA)

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute on Aging (NIA): collaborator

Study Sites (3)

University of California, San Diego

La Jolla, California, 92037, United States

Location

CU Anschutz Medical Center

Aurora, Colorado, 80045, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Related Publications (3)

• Hansmann KJ, Meuser T, Johnson RL, Peterson RA, Fowler NR, DiGuiseppi C, Han D, Moran R, Omeragic F, Betz ME. Internal Factors that Influence Coping in Older Drivers' Transition to Non-Driving. J Appl Gerontol. 2025 Jul;44(7):1172-1180. doi: 10.1177/07334648241298670. Epub 2024 Dec 3.

  PMID: 39626218 DERIVED

• Betz ME, Hill LL, Fowler NR, DiGuiseppi C, Han SD, Johnson RL, Meador L, Omeragic F, Peterson RA, Matlock DD. "Is it time to stop driving?": A randomized clinical trial of an online decision aid for older drivers. J Am Geriatr Soc. 2022 Jul;70(7):1987-1996. doi: 10.1111/jgs.17791. Epub 2022 Apr 20.

  PMID: 35441700 DERIVED

• Betz ME, Omeragic F, Meador L, DiGuiseppi CG, Fowler NR, Han SD, Hill L, Johnson RL, Knoepke CE, Matlock DD, Moran R; AUTO Research Team. The Advancing Understanding of Transportation Options (AUTO) study: design and methods of a multi-center study of decision aid for older drivers. Inj Epidemiol. 2021 May 3;8(1):23. doi: 10.1186/s40621-021-00310-4.

  PMID: 33934709 DERIVED

MeSH Terms

Conditions

Diabetic Retinopathy; Macular Degeneration; Glaucoma; Retinitis Pigmentosa; Vision Disorders; Acute Coronary Syndrome; Heart Failure; Cardiomyopathy, Hypertrophic; Hypotension, Orthostatic; Syncope; Narcolepsy; Dementia; Multiple Sclerosis; Parkinson Disease; Brain Injuries; Spinal Cord Injuries; Stroke; Vertigo; Dizziness; Seizures; Substance-Related Disorders; Diabetes Mellitus, Type 1; Arthritis; Pulmonary Disease, Chronic Obstructive; Sleep Apnea, Obstructive; Kidney Failure, Chronic; Sleep Apnea Syndromes; Sleep Initiation and Maintenance Disorders; Restless Legs Syndrome

Interventions

bis(p-chlorophenyl)acetic acid

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Retinal Degeneration; Ocular Hypertension; Eye Diseases, Hereditary; Retinal Dystrophies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Cardiomyopathies; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Hypotension; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Neurocognitive Disorders; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Spinal Cord Diseases; Cerebrovascular Disorders; Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Chemically-Induced Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Joint Diseases; Musculoskeletal Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Apnea; Respiration Disorders; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Parasomnias

Results Point of Contact

• Title: Dr. Marian Betz
• Organization: University of Colorado

marian.betz@cuanschutz.edu

303-550-5669

Study Officials

• Marian E Betz, MD, MPH

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 28, 2019
• Study Start: December 12, 2019
• Primary Completion: June 23, 2023
• Study Completion: December 21, 2023
• Last Updated: February 21, 2025
• Results First Posted: February 21, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)