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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.


Clinical Trial 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. ;


Study Design


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

NCT number NCT04141891
Study type Interventional
Source University of Colorado, Denver
Contact
Status Active, not recruiting
Phase N/A
Start date December 12, 2019
Completion date February 28, 2024

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