Advancing Understanding of Transportation Options

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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) 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04141891
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Colorado, Denver
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Marian E Betz, MD, MPH
Principal Investigator Affiliation University of Colorado - Anschutz Medical Campus
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherNIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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
Additional Details

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.

Arms & Interventions

Arms

Experimental: Driving Decision Aid

Web-based Driving Decision Aid

Active Comparator: Older Drivers Website

National Institute on Aging (NIA) Older Drivers website

Interventions

Behavioral: - Driving Decision Aid

Healthwise DDA

Behavioral: - Older Drivers Website

National Institute on Aging (NIA) Older Drivers Website

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California, San Diego, La Jolla, California

Status

Recruiting

Address

University of California, San Diego

La Jolla, California, 92037

Site Contact

Natalie Moursund

nmoursund@ucsd.edu

858-822-7632

CU Anschutz Medical Center, Aurora, Colorado

Status

Recruiting

Address

CU Anschutz Medical Center

Aurora, Colorado, 80045

Site Contact

Lauren Meador, MPH

lauren.e.meador@cuanschutz.edu

303-724-3915

Indiana University, Indianapolis, Indiana

Status

Recruiting

Address

Indiana University

Indianapolis, Indiana, 46202

Site Contact

Shelley Suarez, MSN, RN

sdsuarez@regenstrief.org

317-274-9509