Advancing Understanding of Transportation Options - Clinical Trial for Diabetic Retinopathy | NCT04141891

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Primary Purpose

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Driving Decision Aid

Older Drivers Website

About this trial

This is an interventional health services research trial for Diabetic Retinopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

University of California, San Diego
CU Anschutz Medical Center
Indiana University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Driving Decision Aid

Older Drivers Website

Arm Description

Web-based Driving Decision Aid

National Institute on Aging (NIA) Older Drivers website

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

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.

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.

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 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.

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.

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.

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.

Full Information

NCT ID

NCT04141891

First Posted

October 22, 2019

Last Updated

October 6, 2022

Sponsor

University of Colorado, Denver

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT04141891

Brief Title

Advancing Understanding of Transportation Options

Acronym

AUTO

Official Title

Decision Making Among Older Adults: the AUTO Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 12, 2019 (Actual)

Primary Completion Date

August 1, 2023 (Anticipated)

Study Completion Date

August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Colorado, Denver

Collaborators

National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

530 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Driving Decision Aid

Arm Type

Experimental

Arm Description

Web-based Driving Decision Aid

Arm Title

Older Drivers Website

Arm Type

Active Comparator

Arm Description

National Institute on Aging (NIA) Older Drivers website

Intervention Type

Behavioral

Intervention Name(s)

Driving Decision Aid

Other Intervention Name(s)

DDA

Intervention Description

Healthwise DDA

Intervention Type

Behavioral

Intervention Name(s)

Older Drivers Website

Intervention Description

National Institute on Aging (NIA) Older Drivers Website

Primary Outcome Measure Information:

Title

Decisional Conflict Scale (DCS) Scores at Day 0 (Post-intervention)

Description

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

Time Frame

Day 0 (Post-intervention)

Secondary Outcome Measure Information:

Title

Values Clarity Subscale Score at Day 0 (Post-intervention)

Description

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

Time Frame

Day 0 (Post-intervention)

Title

Older adult driving safety knowledge scores as assessed by true/false questions at Day 0 (Post-intervention)

Description

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

Time Frame

Day 0 (Post-intervention)

Title

Decision Self Efficacy score at Day 0 (Post-intervention)

Description

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

Time Frame

Day 0 (Post-intervention)

Title

Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item depression score

Description

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.

Time Frame