NCT06394141

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Dec 2022

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

May 1, 2024

Status Verified

April 1, 2024

Enrollment Period

2.1 years

First QC Date

April 20, 2024

Last Update Submit

April 27, 2024

Conditions

Keywords

Occupational freight driversStress reductionTechnological interventions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Work Ability Index

    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

    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

    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

    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

    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).

  • +3 more secondary outcomes

Study Arms (6)

Real-time triggers

EXPERIMENTAL

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

Personalized tailored feedback

EXPERIMENTAL

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

Real-time triggers + Personalized tailored feedback

EXPERIMENTAL

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

App-supported exercise therapy

EXPERIMENTAL

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

Conventional intervention

ACTIVE COMPARATOR

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

Behavioral: Conventional intervention

Control group

NO INTERVENTION

The passive control group (n= 20 professional drivers) will get no intervention and will continue as normal without receiving any feedback.

Interventions

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

Real-time triggers

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.

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.

Real-time triggers + Personalized tailored feedback

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.

App-supported exercise therapy

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

Conventional intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasselt University

Hasselt, Limburg, 3500, Belgium

Location

Related Links

Study Officials

  • An Neven, PhD

    Hasselt University - Transportation Research Institute (IMOB)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 20, 2024

First Posted

May 1, 2024

Study Start

December 15, 2022

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

May 1, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

GDPR

Locations