Driving with Neuropathy

NCT06739135 | Recruiting

• 1 other identifier: 66380
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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.

Conditions

Diabetic Polyneuropathy; Diabetes Mellitus, Type 2

Keywords

randomised controlled trial; diabetic peripheral neuropathy; driving; driving with neuropathy

Outcome Measures

Primary Outcomes (1)

• Percent of drive time with the accelerator pedal pushed down further than 9 degrees at the end of the intervention (visit 6)

  Percent of drive time with the accelerator pedal pushed down further than 9 degrees, the point at which the visual feedback is triggered, measured in Drive 3 (feedback and immediate prior instruction) of the final visit (visit 6) of the intervention, 5 months after baseline (visit 1).

  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.

Secondary Outcomes (3)

• Percent of drive time with the accelerator pedal pushed down further than 9 degrees at visit 1 and visit 3

  Measured at first visit (day 1, baseline), and 3rd visit (2 months later)

• Percent of drive time with the accelerator pedal pushed down further than 9 degrees, the point at which the visual feedback was previously triggered (in Drive 3), measured in Drive 4 (after feedback with no feedback)

  Measured at first visit (day 1), and 3rd visit (2 months later) and 6th visit (5 months later)

• Percent of drive time with the vehicle out of control, measured at visit 1, visit 3 and visit 6

  Measured at first visit (day 1), and 3rd visit (2 months later) and 6th visit (5 months later)

Other Outcomes (5)

• Exploratory outcome: Frequency (percent) of participants who have diabetes but no/low neuropathy who drive with the accelerator pedal pushed down further than 9 degrees.

  Measured at baseline visit (day 1)

• Feasibility outcome 1. Frequency (percent) of driving sessions attended by time-point

  DPN intervention group (6 visits): On day 1, then 1 month later, 2 months later, 3 months later, 4 months later and 5 months later. DPN control group (3 visits): On day 1, then 2 months later, and 5 months later.No/Low DPN group (1 visit): On day 1.

• Feasibility outcome 2. Frequency (percent) of participants completing all the driving sessions in the simulator

  Measured at last visit (5 months after 1st visit on day 1 for DPN intervention and control groups), and at visit on day 1 for No/Low DPN group.

Study Arms (3)

DPN intervention group

EXPERIMENTAL

Drivers with DPN receive visual feedback training in a driving simulator over 6 visits a month apart

Behavioral: Visual feedback training

DPN control group

NO INTERVENTION

Drivers with DPN receive no visual feedback training in a driving simulator over 3 visits (timed to match visits 1, 3 and 6 of the intervention group)

No/Low DPN group

NO INTERVENTION

Drivers with diabetes but no diagnosed neuropathy receive no intervention at a single visit

Interventions

Visual feedback training BEHAVIORAL

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

DPN intervention group

Eligibility Criteria

• Age: 25 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand English and all of the study requirements, including ability to provide informed consent
• Current full UK driving licence held, and for a minimum of 5 years (experienced drivers)
• Drives a car at least once per week on average (current drivers)
• Diagnosed with type 2 diabetes and diabetic peripheral neuropathy
• Diagnosed with type 2 diabetes only (no diagnosed diabetic peripheral neuropathy)

You may not qualify if:

• Active foot ulcer on either foot
• Lower limb amputation involving more than two toes on the right foot
• Dementia
• Current participation in another research study that would compromise safety, or scientific integrity of either study (for example, a pharmaceutical trial that may affect ability to drive safely).

Sponsors & Collaborators

• Manchester Metropolitan University: lead

Study Sites (1)

Manchester Metropolitan University

Manchester, United Kingdom

RECRUITING

MeSH Terms

Conditions

Diabetic Neuropathies; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Dilwyn Marple-Horvat, DPhil

  Manchester Metropolitan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maaike Esselaar, PhD

CONTACT

+44 787 310 9658; m.esselaar@mmu.ac.uk

Dilwyn Marple-Horvat, DPhil

CONTACT

+44 782 444 7605; d.e.marple-horvat@mmu.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Drivers with DPN will be randomly assigned to either the intervention group or the control group. Drivers with no diagnosed DPN will be assigned to the No/Low DPN group.

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 18, 2024
• Study Start: October 25, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)