MILESTONE - MobILe and tEchnological SoluTions for OccupatioNal drivErs (MILESTONE)

MILESTONE: MobILe and tEchnological SoluTions for OccupatioNal drivErs

Professional drivers in freight transport often experience difficult, exhausting and stressful working conditions due to various reasons: irregular sleep patterns, uncertainty in traffic, frequently changing schedules, busy schedules, a lot of time away from home, etc. These working conditions can lead to significant health problems with a significant impact on road safety. According to the International Road Transport Union, Europe is currently facing the most acute driver shortage in decades; which threatens the continued growth of the road transport sector, and its ability to provide solutions to expected volume growth. Technology will play an important role in making road transport safer and more efficient. MILESTONE's overall objective is to develop and test technological interventions which are expected to reduce the difficult working conditions, stress, negative health effects of professional drivers.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy
• Intervention / Treatment: Behavioral: Real-time triggers; Behavioral: Personalized tailored feedback; Behavioral: Real-time triggers + Personalized tailored feedback; Behavioral: App-supported exercise therapy; Behavioral: Conventional intervention

Detailed Description

The overall objective of MILESTONE is to develop and test technological interventions to reduce the difficult working conditions, stress, negative health effects of professional drivers.

1. Understanding the impact of personal state and contextual stress on driving behavior and road safety, and aims to analyze the relationship between physiological and mental state (e.g., sleep quality, fatigue, sleepiness, stress, thermal comfort), general health status, work-related factors, external stressors, and driving parameters linked to road safety.
2. Developing an intervention to keep drivers within their "stress tolerance zone" (STZ) (personal zone within which stress is acceptable)
3. Analyzing the impact of the MILESTONE interventions for different categories of drivers (long-haul, short-haul and local delivery), compared to an active and passive control group

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Limburg
    • Hasselt, Limburg, Belgium, 3500
      • Hasselt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Working as long-haul, short-haul, or local delivery driver (in a transport company or self-employed)
• Having a smartphone
• Dutch-speaking

Exclusion Criteria:

• No excessive alcohol use
• No drugs use
• Not having an infectious disease
• Not being pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Real-time triggers; The first intervention group (n= 30 professional drivers) will receive real-time triggers related to acute stress and sleepiness/fatigue. The real-time feedback involves giving relevant triggers when exceeding some critical stress values or detecting events of 'energy-takers' based on accurate measurements of mental energy in a fully automated way. The selected triggers will be based on the co-creation workshops with drivers (e.g., auditive, visual) in order to select the most efficient (type or combination of) trigger(s) for the real-time feedback. The warning messages will be tailored to the preferences of the driver (e.g., personalized comfort- and safety-related settings) and aim to generate a warning message/signal meant to alert drivers and prevent they might end up with high stress levels.	Behavioral: Real-time triggers; The first intervention group (n= 30 professional drivers) will receive real-time triggers related to acute stress and sleepiness/fatigue. The real-time feedback involves giving relevant triggers when exceeding some critical stress values or detecting events of 'energy-takers' based on accurate measurements of mental energy in a fully automated way. The selected triggers will be based on the co-creation workshops with drivers (e.g., auditive, visual) in order to select the most efficient (type or combination of) trigger(s) for the real-time feedback. The warning messages will be tailored to the preferences of the driver (e.g., personalized comfort- and safety-related settings) and aim to generate a warning message/signal meant to alert drivers and prevent they might end up with high stress levels
Experimental: Personalized tailored feedback; The second intervention group (n= 30 professional drivers) will receive personalized tailored feedback to reduce chronic stress and sleepiness/fatigue. The advice involves personalized (semi-)automatic feedback to drivers about a reduced stress level via the mobile app with automatic reports, as well as post-intervention during the next work break or at the end of the workday, based on the preferences of the driver. The (semi-)automatic feedback is based on the theory of Stages of Change, by which a driver will only receive relevant feedback based on their attitude and willingness during daily life.	Behavioral: Personalized tailored feedback; The second intervention group (n= 30 professional drivers) will receive personalized tailored feedback to reduce chronic stress and sleepiness/fatigue. The advice involves personalized (semi-)automatic feedback to drivers about a reduced stress level via the mobile app with automatic reports, as well as post-intervention during the next work break or at the end of the workday, based on the preferences of the driver. The (semi-)automatic feedback is based on the theory of Stages of Change, by which a driver will only receive relevant feedback based on their attitude and willingness during daily life.
Experimental: Real-time triggers + Personalized tailored feedback; The third intervention group (n= 30 professional drivers) will receive both real-time feedback related to acute stress and sleepiness/fatigue, as well as personalized tailored feedback related to chronic stress and sleepiness/fatigue, similar as in the first and second intervention groups.	Behavioral: Real-time triggers + Personalized tailored feedback; The third intervention group (n= 30 professional drivers) will receive both real-time feedback related to acute stress and sleepiness/fatigue, as well as personalized tailored feedback related to chronic stress and sleepiness/fatigue, similar as in the first and second intervention groups.
Experimental: App-supported exercise therapy; The fourth intervention group (n= 30 professional drivers) will receive app-supported exercise therapy. The intervention will be based on principles of high-intensity training exercises that focus on the improvement of cardiorespiratory exercise capacity, as well as on the reduction of stress levels during work. Participants will receive instructions via the app to do some short, vigorous exercises adapted to their work environment at regular intervals, e.g., bending-and-stretching exercises with a weight in their hands, walking up and down the stairs of their vehicle for a few minutes, etc.	Behavioral: App-supported exercise therapy; The fourth intervention group (n= 30 professional drivers) will receive app-supported exercise therapy. The intervention will be based on principles of high-intensity training exercises that focus on the improvement of cardiorespiratory exercise capacity, as well as on the reduction of stress levels during work. Participants will receive instructions via the app to do some short, vigorous exercises adapted to their work environment at regular intervals, e.g., bending-and-stretching exercises with a weight in their hands, walking up and down the stairs of their vehicle for a few minutes, etc.
Active Comparator: Conventional intervention; The active control group (n= 20 professional drivers) will get a conventional intervention to reduce stress, e.g., mindfulness.	Behavioral: Conventional intervention; The active control group (n= 20 professional drivers) will get a conventional intervention to reduce stress, e.g., mindfulness.
No Intervention: Control group; The passive control group (n= 20 professional drivers) will get no intervention and will continue as normal without receiving any feedback.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accumulated heart rate-based load measure (average of all trips during past 2 weeks)	Mental load (derived from the energy balance estimation, as an indication of stress), measured by accumulated heart rate-based load measure via wearable (average of all trips during past 2 weeks)	At the beginning of the intervention, intermediate after 2 months (mid of intervention), at the end of the intervention after 4,5 months, and 3 months after the intervention (to measure the impact on a longer-term).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Work Ability Index	A summary measure of 7 items (e.g., the demands of work, the worker's health status and resources) identifying the health risks and risks of early retirement. The final WAI score is calculated as the total unweighted score covering the WAI's seven dimensions, or indicators. The combination of dimension values results in a total WAI score that can range from 7 (unable to work) to 49 (full work ability).	At the beginning of the intervention, intermediate after 2 months (mid of intervention), at the end of the intervention after 4,5 months, and 3 months after the intervention (to measure the impact on a longer-term).
36-item Short Form Healthy Survey	Measuring health-related quality of life, consisting of both a physical and mental component. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	At the beginning of the intervention, intermediate after 2 months (mid of intervention), at the end of the intervention after 4,5 months, and 3 months after the intervention (to measure the impact on a longer-term).
Perceived Stress Scale 10	Measuring perceived stress. The questions ask about feelings and thoughts during the last month. In each case, respondents are asked how often they felt a certain way on a five-point scale from 'never' to 'very often'. Answers are then scored as follow: Never = 0; Almost never = 1; Sometimes = 2; Fairly often = 3; Very often = 4. To calculate a total PSS score, responses to the four positively stated items (items 4, 5, 7 and 8) first need to be reversed (i.e. 0 => 4; 1 => 3; 2 => 2; 3 => 1; 4 => 0). The PSS score is then obtained by summing across all items. Higher scores indicate higher levels of perceived stress.	At the beginning of the intervention, intermediate after 2 months (mid of intervention), at the end of the intervention after 4,5 months, and 3 months after the intervention (to measure the impact on a longer-term).
Driving Behaviour Inventory - General Driver Stress	A 16-item instrument extracted from the Driver Behaviour Inventory that measures general driver stress. The DBI-Gen consists of 16 items that tap a general disposition, or "trait" susceptibility, to driver stress. Responses are made on a Likert scale ranging from 0 to 100, indicating the level of agreement with each statement. Scoring consisted of the mean response to the 16 tems, with higher scores indicating greater trait driver stress susceptibility.	At the beginning of the intervention, intermediate after 2 months (mid of intervention), at the end of the intervention after 4,5 months, and 3 months after the intervention (to measure the impact on a longer-term).
General Self-Efficacy Scale	Measuring a broad and stable sense of personal competence to deal effectively with a variety of stressful situations. The total score is calculated by finding the sum of all 10 items. For the GSE, the total score ranges between 10 and 40, with a higher score indicating more self-efficacy.	At the beginning of the intervention, intermediate after 2 months (mid of intervention), at the end of the intervention after 4,5 months, and 3 months after the intervention (to measure the impact on a longer-term).
Depression Anxiety Stress Scales	A 42-item self-report instrument designed to measure the related negative emotional states of depression, anxiety, tension/stress.The DASS assesses negative emotional symptoms by using a 4-point Likert scale, ranging from 0 to 3. It has 3 subscales (depression, anxiety, and stress) with 14 items in each subscale for the DASS 42. These subscales are scored by the addition of the total item scores, which can range from 0 to 42. Maximum score: 126 for the 42-item DASS. A higher score on the DASS indicates greater severity or frequency of these negative emotional symptoms.	At the beginning of the intervention, intermediate after 2 months (mid of intervention), at the end of the intervention after 4,5 months, and 3 months after the intervention (to measure the impact on a longer-term).
Fatigue Assessment Scale	A short, valid, reliable and easy to administer unidimensional fatigue questionnaire. The FAS is a 10-item general fatigue questionnaire to assess fatigue. Five questions reflect physical fatigue and 5 questions (questions 3 and 6-9) mental fatigue. An answer to every question has to be given, even if the person does not have any complaints at the moment. Scores on question 4 and 10 should be recoded (1=5, 2=4, 3=3, 4=2, 5=1). Subsequently, the total FAS score can be calculated by summing the scores on all questions (recoded scores for questions 4 and 10). The total score ranges from 10 to 50. A total FAS score < 22 indicates no fatigue, a score ≥ 22 indicates fatigue.	At the beginning of the intervention, intermediate after 2 months (mid of intervention), at the end of the intervention after 4,5 months, and 3 months after the intervention (to measure the impact on a longer-term).
Epworth Sleepiness Scale	To measure daytime sleepiness, asking the subject how likely he/she is to doze off or fall asleep in different situations of everyday life. The test is a list of eight situations in which the respondents rates his/her tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing. All answers to the questions need to be added.The total score is based on a scale of 0 to 24, with a higher score means a higher respondent's sleepiness.	At the beginning of the intervention, intermediate after 2 months (mid of intervention), at the end of the intervention after 4,5 months, and 3 months after the intervention (to measure the impact on a longer-term).

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: University Hospital, Antwerp
• Investigators: Principal Investigator: An Neven, PhD, Hasselt University - Transportation Research Institute (IMOB)

Publications and helpful links

Helpful Links

• MILESTONE website

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: April 20, 2024
• First Submitted That Met QC Criteria: April 27, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 27, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Stress reduction; Occupational freight drivers; Technological interventions
• Other Study ID Numbers: MILESTONE; HBC.2021.0387 (Other Grant/Funding Number: Flanders Innovation & Entrepreneurship (VLAIO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: GDPR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No