Advancing Understanding of Transportation Options (AUTO)
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|ClinicalTrials.gov Identifier: NCT04141891|
Recruitment Status : Recruiting
First Posted : October 28, 2019
Last Update Posted : June 11, 2020
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|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 10, 2019|
|Estimated Primary Completion Date :||August 1, 2023|
|Estimated Study Completion Date :||August 1, 2023|
Experimental: Driving Decision Aid
Web-based Driving Decision Aid
Behavioral: Driving Decision Aid
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
- 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
- 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
- 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
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Lauren Meador, MPHfirstname.lastname@example.org|
|United States, California|
|University of California, San Diego||Recruiting|
|La Jolla, California, United States, 92037|
|Contact: Natalie Moursund 858-822-7632 email@example.com|
|United States, Colorado|
|CU Anschutz Medical Center||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Lauren Meador, MPH 303-724-3915 firstname.lastname@example.org|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|Contact: Shelley Suarez, MSN, RN 317-274-9509 email@example.com|
|Principal Investigator:||Marian E Betz, MD, MPH||University of Colorado - Anschutz Medical Campus|