Advancing Understanding of Transportation Options

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

529 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-12

Study Completion Date

2023-12-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Driving Decision Aid

Web-based Driving Decision Aid

Group Type EXPERIMENTAL

Driving Decision Aid

Intervention Type BEHAVIORAL

Healthwise DDA

Older Drivers Website

National Institute on Aging (NIA) Older Drivers website

Group Type ACTIVE_COMPARATOR

Older Drivers Website

Intervention Type BEHAVIORAL

National Institute on Aging (NIA) Older Drivers Website

Interventions

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Driving Decision Aid

Healthwise DDA

Intervention Type BEHAVIORAL

Older Drivers Website

National Institute on Aging (NIA) Older Drivers Website

Intervention Type BEHAVIORAL

Other Intervention Names

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DDA

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

* 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)

* In legal custody or institutionalized
* Significant cognitive impairment as measured by 5-minute Montreal Cognitive Assessment (MoCA)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes