Identifying Driving Risk Factors in Type 1 Diabetes and Their Reduction Via Internet Program (DiabetesDriving.Com)
| Status: | Completed |
|---|---|
| Conditions: | Endocrine, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | February 2012 |
| End Date: | October 2014 |
Identifying Driving Risk Factors in T1DM and Their Reduction Via Behavioral Intervention
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.
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.
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.).
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.).
Inclusion Criteria:
1. Have been diagnosed with Type 1 diabetes for at least one year
2. Started taking insulin less than a year after being diagnosed with Type 1 diabetes
3. Measure blood glucose at least twice a day
4. Legal and valid driver's license
5. Drives greater than 5,000 per year
6. Regular access to the Internet, either through family computer or another readily
accessible computer
7. Age 18 - 70 years
8. English speaker
Exclusion Criteria:
1. Type 2 diabetes
2. Does not take insulin
3. Does not drive
4. Does not have legal and valid driver's license
5. Does not have routine access to the internet
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