Identifying Driving Risk Factors in Type 1 Diabetes and Their Reduction Via Internet Program (DiabetesDriving.Com)

NCT ID: NCT01563887

Last Updated: 2021-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 568 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-10-31

Brief 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.

Detailed 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.).

Conditions

Type 1 Diabetes; Hypoglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DD.com

Participants in this arm will receive the DiabetesDriving.com internet intervention intended to help reduce their risk of being in a future collision.

Group Type: EXPERIMENTAL

DD.com

Intervention Type: BEHAVIORAL

Internet intervention in which participants will complete 6 Cores, or classes over the internet, focusing on risk factors and prevention, detection, and management of hypoglycemia before and while driving.

DD.com + MI

Participants will receive the DiabetesDriving Internet intervention and two 60 minute Motivational Interview (MI) sessions over the telephone. The MI sessions will take place once before and once following completion of the Internet intervention. This interview will focus on making explicit individual's ambivalence around changing behavior.

Group Type: EXPERIMENTAL

DD.com + MI

Intervention Type: BEHAVIORAL

Prior to starting and immediately after finishing the DiabetesDriving.com internet intervention, a one hour motivational interview will be conducted with participants. Internet intervention in which participants will complete 6 Cores, or classes over the internet, focusing on risk factors and prevention, detection, and management of hypoglycemia before and while driving.

Interventions

DD.com

Internet intervention in which participants will complete 6 Cores, or classes over the internet, focusing on risk factors and prevention, detection, and management of hypoglycemia before and while driving.

Intervention Type: BEHAVIORAL

DD.com + MI

Prior to starting and immediately after finishing the DiabetesDriving.com internet intervention, a one hour motivational interview will be conducted with participants. Internet intervention in which participants will complete 6 Cores, or classes over the internet, focusing on risk factors and prevention, detection, and management of hypoglycemia before and while driving.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Daniel Cox, PhD

Professor, Department of Psychiatry and NB Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel J Cox, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

References

Cox DJ, Gonder-Frederick LA, Singh H, Ingersoll KS, Banton T, Grabman JH, Schmidt K, Clarke W. Predicting and Reducing Driving Mishaps Among Drivers With Type 1 Diabetes. Diabetes Care. 2017 Jun;40(6):742-750. doi: 10.2337/dc16-0995. Epub 2017 Apr 12.

Reference Type: DERIVED

PMID: 28404657 (View on PubMed)

Other Identifiers

5R01DK028288-25

Identifier Type: NIH

Identifier Source: secondary_id

View Link

15360

Identifier Type: -

Identifier Source: org_study_id