Driving with Neuropathy

Conditions studied

Diabetic Polyneuropathy, Diabetes Mellitus, Type 2

About this study

This study is a proof-of-concept randomised controlled trial (RCT). The goal of the study is to investigate the effectiveness of a feedback intervention to improve use of the accelerator pedal in patients driving with diabetes and peripheral neuropathy (DPN). The main (primary) question it aims to answer is: What is the effect of a visual feedback intervention (over 6 sessions a month apart), compared to no feedback, on accelerator pedal use by drivers with diabetic peripheral neuropathy? Our working hypothesis is that the visual feedback intervention will reduce the % of drive time with the accelerator pedal pushed down further than 9 degrees (about halfway down), the point at which the visual feedback (a warning signal) is triggered. Secondary research questions are: 1. What is the effect of the feedback intervention on drivers with diabetic peripheral neuropathy at the first visit, and at the third visit? When does the biggest improvement happen? Our working hypothesis is that the visual feedback intervention will reduce the % of drive time spent driving with the accelerator pedal pushed down further than 9 degrees, the point at which the feedback is triggered, in the first visit (ie with the first exposure to feedback) and by additional amounts in subsequent visits ie there will be an immediate benefit, and additional benefits that accrue gradually with repetition over the 6 monthly visits. 2. What is the effect of the feedback intervention on a second variable, % of drive time with the vehicle 'out of control'. Out of control is defined as extreme use of the steering wheel, large and rapid movements that reach the full range of motion of the steering wheel or large swings back and forth together with excursion out of lane which the driver fails to prevent. Our working hypothesis is that the visual feedback intervention will reduce the % of drive time with the vehicle out of control. Researchers will compare the group of drivers with neuropathy who receive the intervention with a control group who do not. In addition, a group of drivers who have diabetes but no diagnosed neuropathy will be studied. This is to seek confirmatory evidence (previously seen in a small sample in a previous study) that most drivers who have no diagnosed neuropathy do not push the accelerator pedal down more than 9 degrees and so do not need to improve their use of the accelerator pedal. Participants will have their driving assessed in a driving simulator…

Interventions

• Behavioral: Visual feedback training — Visual feedback training to modify use of the accelerator pedal when driving in a driving simulator, to reduce the % of time driving with the pedal pushed down more than 9 degrees

Primary outcomes

• Percent of drive time with the accelerator pedal pushed down further than 9 degrees at the end of the intervention (visit 6) (The intervention arm of the study has 6 visits that are spaced 1 month apart, with visit 1 being the baseline/randomisation visit. Thus, visit 6 happens at 5 months post-baseline/randomisation.)

Eligibility information

Study locations

• Manchester Metropolitan University, Manchester, United Kingdom