Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06394141
Other study ID # MILESTONE
Secondary ID HBC.2021.0387
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 15, 2022
Est. completion date February 2025

Study information

Verified date April 2024
Source Hasselt University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 160
Est. completion date February 2025
Est. primary completion date February 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
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.
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.
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.
Conventional intervention
The active control group (n= 20 professional drivers) will get a conventional intervention to reduce stress, e.g., mindfulness.

Locations

Country Name City State
Belgium Hasselt University Hasselt Limburg

Sponsors (2)

Lead Sponsor Collaborator
Hasselt University University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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).
Secondary 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).
Secondary 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).
Secondary 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).
Secondary 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).
Secondary 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).
Secondary 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).
Secondary 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).
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1

External Links