Multiple Sclerosis Clinical Trial

Advancing Understanding of Transportation Options

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.

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Full 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.

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Eligibility 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)
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)

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

530

Study ID:

NCT04141891

Recruitment Status:

Active, not recruiting

Sponsor:

University of Colorado, Denver

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There are 3 Locations for this study

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University of California, San Diego
La Jolla California, 92037, United States
CU Anschutz Medical Center
Aurora Colorado, 80045, United States
Indiana University
Indianapolis Indiana, 46202, United States

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Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

530

Study ID:

NCT04141891

Recruitment Status:

Active, not recruiting

Sponsor:


University of Colorado, Denver

How clear is this clinincal trial information?

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