- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04141891
Advancing Understanding of Transportation Options (AUTO)
January 26, 2024 updated by: University of Colorado, Denver
Decision Making Among Older Adults: the AUTO Study
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.
Study Overview
Status
Active, not recruiting
Conditions
- Stroke
- Multiple Sclerosis
- Glaucoma
- Brain Injuries
- Macular Degeneration
- Arthritis
- Chronic Obstructive Pulmonary Disease
- Parkinson Disease
- Restless Legs Syndrome
- Diabetic Retinopathy
- Insomnia
- Retinitis Pigmentosa
- Obstructive Sleep Apnea
- Dementia
- End Stage Renal Disease
- Sleep Apnea
- Syncope
- Seizures
- Vertigo
- Dizziness
- Acute Coronary Syndrome
- Substance Use
- Spinal Cord Injuries
- Vision Disorders
- Orthostatic Hypotension
- Congestive Heart Failure
- Implantable Defibrillator User
- Hypertrophic Obstructive Cardiomyopathy
- Narcolepsy
- Presyncope
- Insulin Dependent Diabetes Mellitus
- Foot--Abnormalities
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
530
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 Locations
-
-
California
-
La Jolla, California, United States, 92037
- University of California, San Diego
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- CU Anschutz Medical Center
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Indiana University
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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)
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Driving Decision Aid
Web-based Driving Decision Aid
|
Healthwise DDA
Other Names:
|
Active Comparator: Older Drivers Website
National Institute on Aging (NIA) Older Drivers website
|
National Institute on Aging (NIA) Older Drivers Website
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decisional Conflict Scale (DCS) Scores at Day 0 (Post-intervention)
Time Frame: Day 0 (Post-intervention)
|
The DCS is a 16-item scale (with Likert scale response options) that has high reliability and test-retest correlation (Cronbach's alpha coefficients > 0.78).
In prior work, the DCS has been shown to discriminate between known groups who make or delay decisions (effect size 0.4-0.8),53
with lower scores indicating low decision conflict (and greater likelihood of implementing a decision).
Scores <25 (out of 100 total) are associated with implementing decisions; scores <25 represent positive outcomes.
The measure will be assessed immediately following administration of control condition or intervention
|
Day 0 (Post-intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Values Clarity Subscale Score at Day 0 (Post-intervention)
Time Frame: Day 0 (Post-intervention)
|
The "Values Clarity" subscale of the DCS will be used to examine specifically how much participants feel their decisions are in line with their values.
Three DCS items are summed and multiplied by 8.33; scores range from 0 (extremely clear) to 100 (extremely unclear about personal values).
Lower Values Clarity Subscale Scores are associated with positive outcomes.
The measure will be assessed immediately following administration of control condition or intervention
|
Day 0 (Post-intervention)
|
Older adult driving safety knowledge scores as assessed by true/false questions at Day 0 (Post-intervention)
Time Frame: Day 0 (Post-intervention)
|
The following true/false questions will be used to examine participants' safe driving knowledge: 1) Older drivers pose a bigger risk to other drivers and pedestrians than younger drivers do; 2) Drivers aged 70 years and older are more likely to be hurt or killed if they are in a crash; 3) There is a milestone age when everyone should stop driving; 4) With age, a person needs more light to see well; 5) Getting lost on familiar roads is a sign that it might be time to stop driving.
A higher number of correctly answered questions indicate better outcomes.
The measure will be assessed immediately following administration of control condition or intervention
|
Day 0 (Post-intervention)
|
Decision Self Efficacy score at Day 0 (Post-intervention)
Time Frame: Day 0 (Post-intervention)
|
The Decision Self-Efficacy Scale will be used to assess decision self efficacy.
Scores range from 0 (extremely low) to 100 (extremely high self-efficacy).
Higher scores indicate better outcomes.
The measure will be assessed immediately following administration of control condition or intervention
|
Day 0 (Post-intervention)
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item depression score
Time Frame: 6 months, 12 months, 18 months, 24 months
|
Change in depression will be measured using the PROMIS 4-item scale, with higher scores indicating higher depression.
All PROMIS scores are analyzed as standardized T-scores (mean=50, standard deviation=10).
Lower scores indicate better outcomes.
|
6 months, 12 months, 18 months, 24 months
|
Change in Ottawa Decision Regret score
Time Frame: 6 months, 12 months, 18 months, 24 months
|
Change in decision regret will be measured by the Ottawa Decision Regret Scale.
This validated measure correlates with decision satisfaction and conflict, and overall quality of life.
Scored from 0-100, high scores represent higher regret.
Lower scores indicate better outcomes.
|
6 months, 12 months, 18 months, 24 months
|
Change in Life Space score
Time Frame: 6 months, 12 months, 18 months, 24 months
|
Life space is a global measure of mobility and community engagement.
The Life-Space Assessment instrument (UAB Study of Aging) is a validated tool assessing recent mobility and function.
Composite scores range from 0 (bedbound) to 120 (travel out of town every day without assistance); scores of ≤60 are correlated with lower levels of social participation and higher mortality.
Higher scores indicate better outcomes.
|
6 months, 12 months, 18 months, 24 months
|
Change in self-reported driving frequency
Time Frame: 6 months, 12 months, 18 months, 24 months
|
Self-reported driving frequency will be measured by number of days per week participants drive, with consideration of higher or lower frequency as a positive or negative outcome in the context of participant's intent to drive with lower or higher frequency.
|
6 months, 12 months, 18 months, 24 months
|
Change in self-reported situational driving avoidance
Time Frame: 6 months, 12 months, 18 months, 24 months
|
Driving avoidance in certain situations will be measured by asking participants about their avoidance of riskier driving situations, e.g., nighttime driving, with consideration of avoidance in certain situations as a positive or negative outcome in the context of participant's intent to avoid these situations.
|
6 months, 12 months, 18 months, 24 months
|
Occurrence of driving cessation
Time Frame: 6 months, 12 months, 18 months, 24 months
|
Driving cessation will be measured by asking participants which of the following driving cessation options best describes their driving behavior: no driving cessation, partial driving cessation, or complete driving cessation.
Consideration of driving cessation as a positive or negative outcome will be determined in the context of participant's intent to engage in driving cessation.
|
6 months, 12 months, 18 months, 24 months
|
Occurrence of self-reported crashes
Time Frame: 6 months, 12 months, 18 months, 24 months
|
Occurrence of self-reported crashes will be measured by ≥1 crash versus no crashes, where ≥1 crash is a negative outcome.
|
6 months, 12 months, 18 months, 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Marian E Betz, MD, MPH, University of Colorado - Anschutz Medical Campus
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
- 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.
- 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.
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)
December 12, 2019
Primary Completion (Actual)
June 23, 2023
Study Completion (Estimated)
February 28, 2024
Study Registration Dates
First Submitted
October 22, 2019
First Submitted That Met QC Criteria
October 24, 2019
First Posted (Actual)
October 28, 2019
Study Record Updates
Last Update Posted (Estimated)
January 29, 2024
Last Update Submitted That Met QC Criteria
January 26, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Pathologic Processes
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Lung Diseases
- Kidney Diseases
- Urologic Diseases
- Eye Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Endocrine System Diseases
- Disease Attributes
- Disease
- Diabetic Angiopathies
- Diabetes Complications
- Diabetes Mellitus
- Retinal Degeneration
- Retinal Diseases
- Renal Insufficiency
- Genetic Diseases, Inborn
- Otorhinolaryngologic Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Labyrinth Diseases
- Ear Diseases
- Parasomnias
- Craniocerebral Trauma
- Trauma, Nervous System
- Signs and Symptoms, Respiratory
- Aortic Valve Disease
- Heart Valve Diseases
- Spinal Cord Diseases
- Eye Diseases, Hereditary
- Retinal Dystrophies
- Renal Insufficiency, Chronic
- Autonomic Nervous System Diseases
- Vestibular Diseases
- Sensation Disorders
- Unconsciousness
- Consciousness Disorders
- Primary Dysautonomias
- Orthostatic Intolerance
- Aortic Stenosis, Subvalvular
- Aortic Valve Stenosis
- Disorders of Excessive Somnolence
- Chronic Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Substance-Related Disorders
- Heart Failure
- Multiple Sclerosis
- Sleep Apnea Syndromes
- Sleep Apnea, Obstructive
- Syndrome
- Macular Degeneration
- Diabetes Mellitus, Type 1
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Parkinson Disease
- Restless Legs Syndrome
- Diabetic Retinopathy
- Brain Injuries
- Apnea
- Wounds and Injuries
- Retinitis
- Retinitis Pigmentosa
- Kidney Failure, Chronic
- Seizures
- Vertigo
- Dizziness
- Cardiomyopathies
- Hypotension
- Acute Coronary Syndrome
- Syncope
- Spinal Cord Injuries
- Hypotension, Orthostatic
- Cardiomyopathy, Hypertrophic
- Vision Disorders
- Narcolepsy
Other Study ID Numbers
- 19-0059
- R01AG059613 (U.S. NIH Grant/Contract)
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
product manufactured in and exported from the U.S.
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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