Advancing Understanding of Transportation Options

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Diabetic Retinopathy

778 studies on the registry are indexed under Diabetic Retinopathy; 142 are open to participants now.

This study's enrollment of 529 is above the median of 80 across 481 interventional studies indexed under Diabetic Retinopathy.

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.

Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.

Study arms

• Experimental
  Driving Decision Aid

  Web-based Driving Decision Aid

  Behavioral: Driving Decision Aid

• Active comparator
  Older Drivers Website

  National Institute on Aging (NIA) Older Drivers website

  Behavioral: Older Drivers Website

Interventions

• BehavioralDriving Decision Aid

  Healthwise DDA

  Also known as: DDA

• BehavioralOlder Drivers Website

  National Institute on Aging (NIA) Older Drivers Website

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).

   Time frame: Day 0 (Post-intervention)

Secondary outcomes

1. 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.

   Time frame: Day 0 (Post-intervention)

2. 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.

   Time frame: Day 0 (Post-intervention)

3. 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

   Time frame: Day 0 (Post-intervention)

4. 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).

   Time frame: 6 months, 12 months, 18 months, 24 months

5. 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).

   Time frame: 12 months, 18 months, 24 months

6. 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.

   Time frame: 6 months, 12 months, 18 months, 24 months

7. 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.

   Time frame: 6 months, 12 months, 18 months, 24 months

8. 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.

   Time frame: 6 months, 12 months, 18 months, 24 months

9. 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.

   Time frame: 6 months, 12 months, 18 months, 24 months

10. 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.

    Time frame: 6 months, 12 months, 18 months, 24 months

Baseline characteristics

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. PubMed 35441700 ↗
• 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. PubMed 33934709 ↗

Study documents

• Protocol and statistical analysis plan ↗ · Dec 3, 2024

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No