Advancing Understanding of Transportation Options

Stroke Clinical Trial

— AUTO  

Official title:

Decision Making Among Older Adults: the AUTO Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04141891
• Other study ID #: 19-0059
• Secondary ID: R01AG059613
• Status: Completed
• Phase: N/A
• Start date: December 12, 2019
• Est. completion date: December 21, 2023

Study information

• Verified date: May 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 530
• Est. completion date: December 21, 2023
• Est. primary completion date: June 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Apnea
• Arthritis
• Brain Injuries
• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Chronic Obstructive Pulmonary Disease
• Congestive Heart Failure
• Dementia
• Diabetes Mellitus, Type 1
• Diabetic Retinopathy
• Dizziness
• End Stage Renal Disease
• Foot--Abnormalities
• Glaucoma
• Heart Failure
• Hypertrophic Obstructive Cardiomyopathy
• Hypotension
• Hypotension, Orthostatic
• Implantable Defibrillator User
• Insomnia
• Insulin Dependent Diabetes Mellitus
• Kidney Failure, Chronic
• Lung Diseases, Obstructive
• Macular Degeneration
• Multiple Sclerosis
• Narcolepsy
• Obstructive Sleep Apnea
• Orthostatic Hypotension
• Parkinson Disease
• Presyncope
• Pulmonary Disease, Chronic Obstructive
• Restless Legs Syndrome
• Retinitis
• Retinitis Pigmentosa
• Seizures
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Spinal Cord Injuries
• Stroke
• Substance Use
• Substance-Related Disorders
• Syncope
• Syndrome
• Vertigo
• Vision Disorders
• Wounds and Injuries

Intervention

Behavioral:
• Driving Decision Aid
Healthwise DDA
• Older Drivers Website
National Institute on Aging (NIA) Older Drivers Website

Locations

Country	Name	City	State
United States	CU Anschutz Medical Center	Aurora	Colorado
United States	Indiana University	Indianapolis	Indiana
United States	University of California, San Diego	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decisional Conflict Scale (DCS) Scores at 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	Day 0 (Post-intervention)
Secondary	Values Clarity Subscale Score at 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	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. The measure will be assessed immediately following administration of control condition or intervention	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) to 100 (extremely high self-efficacy). Higher scores indicate better outcomes. The measure will be assessed immediately following administration of control condition or intervention	Day 0 (Post-intervention)
Secondary	Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item depression score	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.	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.	6 months, 12 months, 18 months, 24 months
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.	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.	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.	6 months, 12 months, 18 months, 24 months
Secondary	Occurrence of driving cessation	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.	6 months, 12 months, 18 months, 24 months
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.	6 months, 12 months, 18 months, 24 months