Enabling People with Diabetic Neuropathy to Drive Safely: a Proof of Concept Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Percent of drive time with the accelerator pedal pushed down further than 9 degrees at the end of the intervention (visit 6)
研究概览
简要总结
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:
- 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.
- 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. Participants with DPN who push the accelerator pedal down more than 9 degrees will then be randomly allocated to the intervention group or control group. Only drivers in the intervention group will go on to experience the visual feedback intervention (in 6 sessions a month apart). Drivers in the control group will have their driving assessed at their first visit, and then at two later visits timed to coincide with the 3rd and 6th visit by drivers in the intervention group. This is the minimum necessary to be able to compare their driving with the intervention group at the start, midpoint and end of the intervention.
详细描述
Each participant will attend the driving simulator laboratory within the Manchester Institute of Sport at the Manchester Metropolitan University. All participants will, after a practice drive on the simulator (Drive 1) undergo a baseline assessment of their driving (Drive 2).
Participants with DPN who never pushed the accelerator pedal down more than 9 degrees in the baseline assessment drive (Drive 2) will be screened out and take no further part in the study (as they cannot further reduce their use of the accelerator pedal beyond 9 degrees; they already spend no time driving with the pedal in that range).
Participants with DPN who did push the accelerator down more than 9 degrees in the baseline assessment drive (Drive 2) will at the end of that drive be randomly assigned to intervention or control group. The intervention group will experience an active visual feedback intervention during simulated driving which aims to modify their use of the accelerator pedal, specifically to reduce the % of time they spend driving with the accelerator pedal pushed down more than 9 degrees i.e., to moderate their use of the accelerator and so help them to drive safely. The control group will receive a minimal intervention with no visual feedback and the minimum simulated driving experience necessary for us to assess their driving.
Intervention (DPN) The active intervention phase for the DPN group will consist of 6 visits to the simulator with a month between each visit.
Control (DPN) The DPN control group who receive minimal intervention will have an initial visit (baseline assessment), a second visit timed to match visit 3 of the intervention group (the halfway point in the study), and a final visit timed to match visit 6 of the intervention group, to permit comparisons with the intervention group at the start, halfway point, and end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Active foot ulcer on either foot
- •Lower limb amputation involving more than two toes on the right foot
- •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).
结局指标
主要结局
Percent of drive time with the accelerator pedal pushed down further than 9 degrees at the end of the intervention (visit 6)
时间窗: 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.
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).
次要结局
- 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))