Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Advancing Understanding of Transportation Options (AUTO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04141891
Recruitment Status : Active, not recruiting
First Posted : October 28, 2019
Last Update Posted : July 14, 2021
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
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 Behavioral: Driving Decision Aid Behavioral: Older Drivers Website Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 528 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Decision Making Among Older Adults: the AUTO Study
Actual Study Start Date : December 12, 2019
Estimated Primary Completion Date : August 1, 2023
Estimated Study Completion Date : August 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Driving Decision Aid
Web-based Driving Decision Aid
 Behavioral: Driving Decision Aid
Healthwise DDA
Other Name: DDA
Active Comparator: Older Drivers Website
National Institute on Aging (NIA) Older Drivers website
 Behavioral: Older Drivers Website
National Institute on Aging (NIA) Older Drivers Website


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04141891


Locations
Layout table for location information
United States, California
University of California, San Diego
La Jolla, California, United States, 92037
United States, Colorado
CU Anschutz Medical Center
Aurora, Colorado, United States, 80045
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
University of Colorado, Denver
National Institute on Aging (NIA)
Investigators
Layout table for investigator information
Principal Investigator: Marian E Betz, MD, MPH University of Colorado - Anschutz Medical Campus
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04141891    
Other Study ID Numbers: 19-0059
R01AG059613 ( U.S. NIH Grant/Contract )
First Posted: October 28, 2019    Key Record Dates
Last Update Posted: July 14, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Apnea
Sleep Apnea Syndromes
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Sleep Apnea, Obstructive
Vertigo
Parkinson Disease
Multiple Sclerosis
Brain Injuries
Spinal Cord Injuries
Seizures
Restless Legs Syndrome
Syncope
Narcolepsy
Hypotension, Orthostatic
 Vision Disorders
Macular Degeneration
Diabetic Retinopathy
Retinitis
Retinitis Pigmentosa
Kidney Failure, Chronic
Heart Failure
Acute Coronary Syndrome
Cardiomyopathies
Hypotension
Cardiomyopathy, Hypertrophic
Diabetes Mellitus, Type 1
Syndrome
Dizziness
Substance-Related Disorders