Condition: Diabetic Polyneuropathy · Diabetes Mellitus, Type 2 · Sponsor: Manchester Metropolitan University
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…
This description comes directly from the study's public registry record.
Maaike Esselaar, PhD · +44 787 310 9658 · m.esselaar@mmu.ac.uk
Dilwyn Marple-Horvat, DPhil · +44 782 444 7605 · d.e.marple-horvat@mmu.ac.uk
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| Manchester Metropolitan University | Manchester, United Kingdom | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06739135