Diabetic RetinopathyAUTONCT04141891
Advancing Understanding of Transportation Options
A study testing Driving Decision Aid and Older Drivers Website in people with Diabetic Retinopathy and Macular Degeneration, run by University of Colorado, Denver at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Retinopathy, Macular Degeneration, Glaucoma
- What is being tested?
- Driving Decision Aid and Older Drivers Website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 529 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Dec 2019to 21 Dec 2023
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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)
- In legal custody or institutionalized
- Significant cognitive impairment as measured by 5-minute Montreal Cognitive Assessment (MoCA)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
CU Anschutz Medical Center
Aurora, Colorado, 80045
Indiana University
Indianapolis, Indiana, 46202
University of California, San Diego
La Jolla, California, 92037
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetic Retinopathy, Macular Degeneration, Glaucoma, Retinitis Pigmentosa, Vision Disorders, Acute Coronary Syndrome
- Being tested
- Driving Decision Aid, Older Drivers Website
- Medical subject headings
- Diabetic Retinopathy, Macular Degeneration, Glaucoma, Retinitis Pigmentosa, Vision Disorders, Acute Coronary Syndrome, Heart Failure, Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Driving Decision AidBehavioural
Also called DDA
Healthwise DDA
Older Drivers WebsiteBehavioural
National Institute on Aging (NIA) Older Drivers Website
| Study group | Role | What they receive |
|---|---|---|
| Driving Decision Aid | Experimental | Web-based Driving Decision Aid Receives: Behavioral: Driving Decision Aid |
| Older Drivers Website | Active comparator | National Institute on Aging (NIA) Older Drivers website Receives: Behavioral: Older Drivers Website |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 0 (Post-intervention)
Secondary outcomes (10)
Values Clarity Subscale Score at Day 0 (Post-intervention)
For the values clarity subscale, three decision conflict scale (DCS) items (Likert scale responses from 0 ['strongly agree'] to 4 ['strongly disagree']) are summed, divided by 3 and multiplied by 25; scores range from 0 (extremely clear) to 100 (extremely unclear about personal values); lower scores represent higher values clarity, which is a better outcome. Lower values clarity subscale scores are associated with positive outcomes. The measure will be assessed in drivers immediately following administration of control condition or intervention.
Measured: Day 0 (Post-intervention)
Older Adult Driving Safety Knowledge Scores as Assessed by True/False Questions at 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. Knowledge will be defined as the percentage of correct scores of the 5 questions (ranging from 0% [worst outcome] to 100% [best outcome]). The measure will be assessed in drivers immediately following administration of control condition or intervention.
Measured: Day 0 (Post-intervention)
Decision Self Efficacy Score at Day 0 (Post-intervention)
The Decision Self-Efficacy Scale will be used to assess decision self efficacy. Scores range from 0 (extremely low self-efficacy; worst outcome) to 100 (extremely high self-efficacy; best outcome). Higher scores indicate better outcomes. The measure will be assessed in drivers immediately following administration of control condition or intervention
Measured: Day 0 (Post-intervention)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item Depression Score
Depression will be measured using the PROMIS Short Form 4-item scale (4a Adult v1.0), with higher PROMIS scores indicating higher depression. PROMIS scores are presented as standardized T-scores (mean=50, standard deviation=10). Lower PROMIS depression scores indicate better outcomes (lower depression).
Change in depression is calculated as the PROMIS depression score at each time point (6, 12, 18, or 24 months) minus the score at baseline (pre-randomization). Since PROMIS scores at each time point can range from 41.0 to 79.4, change in depression PROMIS scores can range from -38.4 to +38.4. Change-scores > 0 represent increases in depression (poor outcome), and changes <= 0 represent maintained or decreased depression (better outcome).
Measured: 6 months, 12 months, 18 months, 24 months
Change in Ottawa Decision Regret Score
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.
Decision regret was measured at 6, 12, 18, and 24 months, so change in decision regret can be calculated from 12 months (vs. 6 months), 18 months (vs. 6 months), and 24 months (vs 6 months). Since decision regret scores range from 0-100, change in decision regret scores range from -100 to + 100, with change-scores <= 0 representing maintenance or decreases in decision regret (positive outcome) and change-scores > 0 representing increased decision regret over time (negative outcome).
Measured: 12 months, 18 months, 24 months
Change in Life Space Score
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.
Change in life space can be calculated at 6 months (vs baseline), 12 months (vs baseline), 18 months (vs baseline), and 24 months (vs baseline). Since life space scores range from 0-120, change-scores in life space can range from -120 to +120. Maintained or increased life space (change-scores >= 0) are positive outcomes, and decreased life space (change-scores < 0) are negative outcomes.
Measured: 6 months, 12 months, 18 months, 24 months
Change in Self-reported Driving Frequency
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.
In the final study survey, this question was reworded, so participants were asked "during the past 6 months, have you reduced the number of days per week you normally drive?" with response options of "yes", "no", "I don't know". Percentage of those who answered "yes" at each time point are reported.
Measured: 6 months, 12 months, 18 months, 24 months
Change in Self-reported Situational Driving Avoidance
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.
Avoidance of night driving was worded as: "Using a scale from 1 to 7 where 1 is Not At All Comfortable and 7 is Completely Comfortable, how comfortable do you feel in the following situation?", and the situation presented was "Driving at night?". Higher scores indicate greater comfort with driving at night, and lower scores represent less comfort. Therefore, change-scores can range from -6 to + 6, with change-scores >= 0 indicate maintained or increased comfort with driving at night, and change-scores < 0 indicate reduced comfort in driving at night.
Measured: 6 months, 12 months, 18 months, 24 months
Occurrence of Driving Cessation
Driving cessation will be measured by asking participants whether they are currently driving; all participants were currently driving at study baseline. 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. This question was worded as "Do you currently drive?" with response options of "yes" and "no". The numbers reported are those who said "no", which represents driving cessation.
The wording of this question was added to the study after an early DSMB meeting, so less data are available for it at earlier time points.
Measured: 6 months, 12 months, 18 months, 24 months
Occurrence of Self-reported Crashes
Occurrence of self-reported crashes will be measured by ≥1 crash versus no crashes, where ≥1 crash is a negative outcome.
Measured: 6 months, 12 months, 18 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start12 Dec 2019
- Primary completion23 Jun 2023
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 529 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Marian E Betz, MD, MPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141891
- Sponsor's protocol ID
- 19-0059
- Other IDs
- R01AG059613
- Acronym
- AUTO
- Status last verified
- Jan 2025
- First submitted
- 22 Oct 2019
- Last updated
- 21 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39626218Betz 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.
PubMed 35441700Betz 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.
PubMed 33934709