Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

Decision Making Among Older Adults: the AUTO Study

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.

Keywords

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 Apnea Sleep Apnea Syndromes Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Sleep Apnea, Obstructive Hypotension, Orthostatic Retinitis Kidney Failure, Chronic Heart Failure Cardiomyopathies Hypotension Cardiomyopathy, Hypertrophic Diabetes Mellitus, Type 1 Syndrome Wounds and Injuries Driving Decision Aid Older Drivers Website

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

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)

Locations

  • University of California, San Diego accepting new patients
    La Jolla California 92037 United States
  • CU Anschutz Medical Center accepting new patients
    Aurora Colorado 80045 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Colorado, Denver
ID
NCT04141891
Study Type
Interventional
Last Updated