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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG059613 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Driving Decision Aid | Experimental | Web-based Driving Decision Aid |
|
| Older Drivers Website | Active Comparator | National Institute on Aging (NIA) Older Drivers website |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Driving Decision Aid | Behavioral | Healthwise DDA |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria for drivers:
Exclusion Criteria for drivers:
Inclusion Criteria for study partners:
Exclusion Criteria for study partners:
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| Name | Affiliation | Role |
|---|---|---|
| Marian E Betz, MD, MPH | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | La Jolla | California | 92037 | United States | ||
| CU Anschutz Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39626218 | Derived | 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. | |
| 35441700 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Older Drivers Website | National Institute on Aging (NIA) Older Drivers website Older Drivers Website: National Institute on Aging (NIA) Older Drivers Website |
| FG001 | Driving Decision Aid |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Baseline Enrollment (Drivers + SPs) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 3, 2024 |
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| Older Drivers Website | Behavioral | National Institute on Aging (NIA) Older Drivers Website |
|
| 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. | 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 | 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). | 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). | 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. | 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. | 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. | 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. | 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. | 6 months, 12 months, 18 months, 24 months |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| 33934709 | 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. |
Web-based Driving Decision Aid
Driving Decision Aid: Healthwise DDA
| COMPLETED |
|
| NOT COMPLETED |
|
| 6 Month Follow-up (Drivers Only) |
|
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| 12 Month Follow-up (Drivers + SPs) |
|
|
| 18 Month Follow-up (Drivers Only) |
|
|
| 24 Month Follow-up (Drivers and SPs) |
|
|
Comprised of older adult drivers with 1+ medical condition linked to driving cessation (N = 301) and their family/friends acting as study partners (N = 228)
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| ID | Title | Description |
|---|---|---|
| BG000 | Older Drivers Website | National Institute on Aging (NIA) Older Drivers website Older Drivers Website: National Institute on Aging (NIA) Older Drivers Website |
| BG001 | Driving Decision Aid | Web-based Driving Decision Aid Driving Decision Aid: Healthwise DDA |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | N = 1 participant refused to share their age with the study team. | Count of Participants | Participants |
| |||||||||||||||
| Age, Continuous | N = 1 participant refused to share their age with the study team. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Pre-randomization decision conflict scale (DCS) score) | 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). | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Drivers post-randomization at baseline visit. Missing N = 8 participants' outcomes (N = 3 control, N = 5 DDA) because they did not respond to one or more questions required to calculate this outcome. | Posted | Mean | Standard Deviation | units on a scale | Day 0 (Post-intervention) |
|
|
| ||||||||||||||||||||||||||||
| Secondary | 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. | Drivers at post-intervention. Missing N = 3 participants' outcomes (N = 2 control, N = 1 DDA) because they did not respond to one or more questions required to calculate this outcome. | Posted | Mean | Standard Deviation | units on a scale | Day 0 (Post-intervention) |
|
| |||||||||||||||||||||||||||||
| Secondary | 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. | Drivers at post-randomization. Missing N = 7 participants' outcomes (N = 5 control, N = 2 DDA) because they did not respond to one or more questions required to calculate this outcome. | Posted | Mean | Standard Deviation | percentage of correct questions | Day 0 (Post-intervention) |
| ||||||||||||||||||||||||||||||
| Secondary | 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 | Drivers post-randomization. Missing N = 3 participants' outcomes (N = 1 control, N = 2 DDA) because they did not respond to one or more questions required to calculate this outcome. | Posted | Mean | Standard Deviation | units on a scale | Day 0 (Post-intervention) |
|
| |||||||||||||||||||||||||||||
| Secondary | 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). | Drivers with any depression change-scores that could be calculated (had to have baseline depression and data at at least one follow-up). Missing N = 12 participants' outcomes (N = 7 control, N = 5 DDA) either of for two reasons: (i) they withdrew from the study between baseline and 6 month follow-up (N = 8 total; N = 4 control, N = 4 DDA) or (ii) they did not respond to one or more questions needed to calculate this outcome at baseline and/or follow-up (N = 4 total; N = 3 control, N = 1 DDA). | Posted | Mean | Standard Deviation | units on a scale | 6 months, 12 months, 18 months, 24 months |
| ||||||||||||||||||||||||||||||
| Secondary | 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). | Drivers who had 1+ change-score(s) that could be calculated for decision regret (had to have 6 month decision regret and at least one subsequent follow-up). Missing N = 53 participants' outcomes (N = 20 control, N = 33 DDA) because: (i) they withdrew from the study between baseline and 12 months (N = 15; N = 8 control, N = 7 DDA) or (ii) they did not respond question(s) required to calculate this outcome at 6 month and/or subsequent follow-up visits (N = 38 total, N = 12 control, N = 26 DDA). | Posted | Mean | Standard Deviation | units on a scale | 12 months, 18 months, 24 months |
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| Secondary | 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. | Drivers who have at least one life space change-score that can be calculated (required to have baseline life space score and data at at least one follow-up). Missing N = 19 participants' outcomes (N = 11 control, N = 8 DDA) because: (i) they withdrew between baseline and 6 month FU (N = 8 total, N = 4 control, N = 4 DDA) or (ii) they did not respond to one or more questions required to calculate this outcome at baseline and/or follow-up visits (N = 11 total, N = 7 control, N = 4 DDA). | Posted | Mean | Standard Deviation | units on a scale | 6 months, 12 months, 18 months, 24 months |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Drivers with a driving frequency response at at least one time point (6 months, 12 months, 18 months, and/or 24 months). Missing N = 11 participants' outcomes (N = 6 control, N = 5 DDA) because they (i) withdrew from the study between baseline and 6 month follow-up (N = 8 total, N = 4 control, N = 4 DDA) or (ii) did not respond to this question at any follow-up visits (N = 3 total, N = 2 control, N = 1 DDA). | Posted | Count of Participants | Participants | 6 months, 12 months, 18 months, 24 months |
| |||||||||||||||||||||||||||||||
| Secondary | 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. | Drivers with any situational driving avoidance change-scores that could be calculated (had to have baseline and data at at least one follow-up). Missing N = 11 participants' outcomes (N = 6 control, N = 5 DDA) for two reasons: (i) they withdrew from the study between baseline and 6 month follow-up (N = 8 total; N = 4 control, N = 4 DDA) or (ii) they did not respond to one or more questions needed to calculate this outcome at baseline and/or follow-up (N = 3 total, N = 2 control, N = 1 DDA). | Posted | Mean | Standard Deviation | units on a scale | 6 months, 12 months, 18 months, 24 months |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Drivers with 1 or more time points of data on driving cessation. Missing N = 21 participants' outcomes (N = 8 control, N = 13 DDA) for two reasons: (i) they withdrew from the study between baseline and 6 month (N = 8 total; N = 4 control, N = 4 DDA) or (ii) they did not respond to this question follow-up (N = 13 total, N = 4 control, N = 9 DDA). This question was inadvertently not added to data collection until the 6 month follow-up period, which is why sample sizes were smaller at 6 months. | Posted | Count of Participants | Participants | 6 months, 12 months, 18 months, 24 months |
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| Secondary | 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. | Drivers with 1 or more time points of data on self-reported crashes. Missing N = 10 participants' outcomes (N = 6 control, N = 4 DDA) for two reasons: (i) they withdrew from the study between baseline and 6 month follow-up (N = 8 total; N = 4 control, N = 4 DDA) or (ii) they did not respond to this question follow-up (N = 2 total, N = 2 control, N = 0 DDA). | Posted | Count of Participants | Participants | 6 months, 12 months, 18 months, 24 months |
|
|
2 years of study from enrollment to follow-up (baseline, 6 month, 12 month, 18 month, 24 month visits)
Possible adverse events: distress during any assessment (driver or study partner), self-reported motor vehicle accident as driver (drivers only) Possible serious adverse events: DMV report of motor vehicle accident (drivers only), inpatient hospitalization (any reason; drivers or study partners); ED visit (any reason; drivers or study partners); death (all causes; driver or study partner)
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Older Drivers Website | National Institute on Aging (NIA) Older Drivers website Older Drivers Website: National Institute on Aging (NIA) Older Drivers Website | 4 | 267 | 3 | 267 | 16 | 267 |
| EG001 | Driving Decision Aid | Web-based Driving Decision Aid Driving Decision Aid: Healthwise DDA | 5 | 262 | 4 | 262 | 17 | 262 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Motor vehicle accident as driver | Injury, poisoning and procedural complications | Non-systematic Assessment | DMV report; drivers only |
| |
| Inpatient hospitalization | Injury, poisoning and procedural complications | Non-systematic Assessment | Drivers or study partners |
| |
| Emergency department (ED) visit | Injury, poisoning and procedural complications | Non-systematic Assessment | Any reason; drivers or study partners |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Distress during any assessment | Social circumstances | Non-systematic Assessment | Driver or study partner |
| |
| Motor vehicle accident as driver | Injury, poisoning and procedural complications | Non-systematic Assessment | Self-reported; drivers only |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marian Betz | University of Colorado | 303-550-5669 | marian.betz@cuanschutz.edu |
| Dec 3, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| D008268 | Macular Degeneration |
| D005901 | Glaucoma |
| D012174 | Retinitis Pigmentosa |
| D014786 | Vision Disorders |
| D054058 | Acute Coronary Syndrome |
| D006333 | Heart Failure |
| D002312 | Cardiomyopathy, Hypertrophic |
| D007024 | Hypotension, Orthostatic |
| D013575 | Syncope |
| D009290 | Narcolepsy |
| D003704 | Dementia |
| D009103 | Multiple Sclerosis |
| D010300 | Parkinson Disease |
| D001930 | Brain Injuries |
| D013119 | Spinal Cord Injuries |
| D020521 | Stroke |
| D014717 | Vertigo |
| D004244 | Dizziness |
| D012640 | Seizures |
| D019966 | Substance-Related Disorders |
| D003922 | Diabetes Mellitus, Type 1 |
| D001168 | Arthritis |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D020181 | Sleep Apnea, Obstructive |
| D007676 | Kidney Failure, Chronic |
| D012891 | Sleep Apnea Syndromes |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D012148 | Restless Legs Syndrome |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D012162 | Retinal Degeneration |
| D009798 | Ocular Hypertension |
| D015785 | Eye Diseases, Hereditary |
| D058499 | Retinal Dystrophies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D009202 | Cardiomyopathies |
| D001020 | Aortic Stenosis, Subvalvular |
| D001024 | Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D007022 | Hypotension |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D006970 | Disorders of Excessive Somnolence |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D013118 | Spinal Cord Diseases |
| D002561 | Cerebrovascular Disorders |
| D015837 | Vestibular Diseases |
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D064419 | Chemically-Induced Disorders |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020447 | Parasomnias |
Not provided
Not provided
| ID | Term |
|---|---|
| C000849 | bis(p-chlorophenyl)acetic acid |
Not provided
Not provided
Not provided
| Withdrawal by Subject |
|
| Withdrawn by team |
|
| Withdrawal by Subject |
|
| Withdrawn by team for health issues/hospitalization |
|
| Withdrawal by Subject |
|
| Withdrawn by team due to health issues |
|
| Between 18 and 65 years |
|
| >=65 years |
|
|
|
|
|
|
|
| Participants |
|
|
|
|
|
| OG001 |
| Driving Decision Aid |
Web-based Driving Decision Aid Driving Decision Aid: Healthwise DDA |
|
|
| Driving Decision Aid |
Web-based Driving Decision Aid Driving Decision Aid: Healthwise DDA |
|
|
| Driving Decision Aid |
Web-based Driving Decision Aid Driving Decision Aid: Healthwise DDA |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG001 | Driving Decision Aid | Web-based Driving Decision Aid Driving Decision Aid: Healthwise DDA |
|
|
Web-based Driving Decision Aid
Driving Decision Aid: Healthwise DDA
|
|
|