Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01563887 |
| Other study ID # |
15360 |
| Secondary ID |
5R01DK028288-25 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 2012 |
| Est. completion date |
October 2014 |
Study information
| Verified date |
October 2021 |
| Source |
University of Virginia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study will recruit drivers with Type 1 diabetes from across the U.S. and assign them to
four groups based on their presumed risk level- routine care low risk, routine care high
risk, or to one of two Internet interventions focused on reducing hypoglycemia driving. All
subjects will be followed for two years to determine whether and which intervention was most
effective at reducing hypoglycemia related driving collisions.
Description:
The investigators have demonstrated that drivers with Type 1 diabetes have at least twice as
many collisions as their non-diabetic spouses, that about half of drivers with Type 1
diabetes have at least one hypoglycemic driving mishap a year, and 5% have at least six such
events in a year. However, at this point the investigators can not accurately predict those
individuals who will have hypoglycemia driving mishaps, which is one goal of this study. The
investigators have also demonstrated that face-to-face behavioral interventions focusing on
reducing the occurrence of hypoglycemia have lead to significantly fewer vehicular collisions
and citations. The question arises whether such a behavioral intervention, specifically
focused on reducing hypoglycemia while driving, can be effectively delivered over the
internet.
Participants will first complete an Interest form. This questionnaire is used to determine an
individual's presumed risk category (high or low risk). Research staff will use the risk
category to randomly assign participants to one of four groups according to the randomization
scheme. The four groups include: 1) Routine Care - low risk, 2) Routine Care - high risk, 3)
DiabetesDriving.com (DD.com) where they will participate in an Internet intervention, 4)
DiabetesDriving.com + Motivational Interviewing (MI) where subjects will receive the Internet
intervention and two 60 minute MI sessions over the telephone. The MI sessions will take
place once before and once following completion of the Internet intervention (within 7 days).
This interview will focus on making explicit individuals' ambivalence around changing
behavior.
Individuals assigned to the DD.com and DD.com+MI groups will complete 6 Cores, or classes
over the internet, focusing on risk factors and prevention, detection, and management of
hypoglycemia before and while driving. Each core will take approximately 30 minutes to
complete. Core 0 is a tutorial on how to use the internet program. Core 1 focuses on how to
use the Tool Kit; Core 2 focuses on how to be a safer driver in general; Core 3 focuses on
how to prevent hypoglycemia from occurring while driving; Core 4 focuses on detecting and
treating hypoglycemia during a drive; Core 5 focuses on how to maintain the improvements they
have achieved in the previous Core over the next 12 months.
After completing a Core, individuals must wait a week before they can start the next Core.
During this time individuals will complete at least three Daily Progress Notes, where they
will rate their success at achieving their driving goals established in the previous Core.
The Cores will take up to 8 weeks to complete before completing Driving Survey 2.
All participants will complete Driving Surveys and monthly driving diaries. The first Driving
Survey (Driving Survey 0) will be available to participants as soon as they are consented.
Driving Surveys will then be given at 2 and 14 months after submission of Driving Survey 0.
Participants will also complete monthly driving diaries, where they will report their driving
experiences for the full previous month. Monthly driving diaries will be available on the
first day of the next full month 98 days (14 weeks) after completing the Driving Survey at
month 2 and continue for 12 months. Twenty-six months after submitting Driving Survey 0,
participants will be emailed for a two year follow-up. They will be asked to complete a brief
questionnaire on driving outcomes (collisions, citations, etc.).
