Clinical trial NCT06688721: Does Eco-driving Assistance (EDA) Have an Impact on Bus Driver's Health and Well-being?
Official title: Does Eco-driving Assistance (EDA) Have an Impact on Bus Driver's Health and Well-being? A Pseudo-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Public transport
Eco-driving assistance
Occupational health
Health and well-being
Bus drivers
Lead sponsor: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Within subject design Each participant will be allocated to both the intervention (i.e. driving shifts with EDA-equipped buses) and the control (i.e. driving shifts with non-EDA-equipped buses) conditions
Primary purpose: PREVENTION

Brief summary: The goal of this pragamatic trial is to assess the impact of eco-driving assistance (EDA) system on professional bus drivers' health and well-being.

The main questions it aims to answer are:

* Does the eco-driving assistance (EDA) act as a stressor for bus drivers ?
* Does the physiological and psychological perceived stress increase when bus drivers are driving bus equipped with eco-driving assistance (EDA) ?

An additional question consists in assessing the association between stress measurements and biomarkers in biological samples.

Researchers will compare the heart rate variability (HRV) and perceived stress level when participant are allocated to EDA-equipped buses and non-EDA-equipped buses

Participants will:

* Drive buses equipped with eco-driving assistance (EDA)
* Drive buses without eco-driving assistance (EDA)
* Wear a wearable electrocardiogram (ECG) device (Bittium Faros) to record the heart rate variability (HRV)
* Answer a questionnaire at the end of each working day (end-of-service questionnaire)
* When allocated to bus with eco-driving assistance (EDA), read the EDA-generated report and answer some related questions in the end-of-service questionnaire
* Upon acceptance only, a collection of biological samples and physiological measurement will be performed

Detailed description: This pragmatic pseudo-randomized trial will allow the investigators to assess the effect of eco-driving assistance (EDA) on bus drivers' health and well-being. Each bus driver will be randomly allocated to either buses equipped with eco-driving assistance (EDA) (i.e. intervention) and buses without eco-driving assistance (EDA) (i.e. control). The research team will use the within-subject design, allowing to allocate both the intervention and the control to each participant.

Throughout the working day, each bus driver will continuously wear an ECG device (Bittium Faros) to record the HRV. At the end of each working day, participants will receive a questionnaire (i.e. end-of-service questionnaire) to fill in. If they have been allocated to at least one EDA-equipped bus during their working day, they will need to read the EDA-generated report and come back to the questionnaire to fill in additionnal questions.

To record enough data, participants will need to reach at least 5 hours driving shifts with an EDA-equipped bus and 5 hours driving shifts without EDA. When this endpoint is reached, the study is over.

Eligibility criteria: Inclusion Criteria:

* adult active bus driver
* having signed the informed consent
* having worked for at least one year as TPF bus driver
* working at least 30 hours a week
* no planned extended absences in the next 6 months (civil service, military service, long- term leave, retirement)

Exclusion Criteria:

* wearing a medical active implant (pacemaker, cardiac defibrillator, neurostimulator, other electronic implant)
* known allergy or skin sensitivity to plasters

Primary outcomes:
measure: Heart rate variability (HRV)
timeFrame: From enrollment in the study to at least 5 days and until the endpoint is reached (i.e. at least 5 hours driving shifts with buses equipped with EDA and 5 hours driving shifts with buses without EDA) but for a maximum duration of 14 days
Secondary outcomes:
measure: Perceived stress
timeFrame: 1 day at the beginning of the study, once the eligibility has been confirmed
measure: Perceived stress
timeFrame: From enrollment in the study to at least 5 days and until the endpoint is reached (i.e. at least 5 hours driving shifts with buses equipped with EDA and 5 hours driving shifts with buses without EDA) but for a maximum duration of 14 days
measure: Perceived stress
timeFrame: From enrollment in the study to at least 5 days and until the endpoint is reached (i.e. at least 5 hours driving shifts with buses equipped with EDA and 5 hours driving shifts with buses without EDA) but for a maximum duration of 14 days
measure: Stress biomarkers in saliva samples
timeFrame: From enrollment in the study to at least 5 days and until the endpoint is reached (i.e. at least 5 hours driving shifts with buses equipped with EDA and 5 hours driving shifts with buses without EDA) but for a maximum duration of 14 days
measure: Perceived stress linked with eco-driving assistance system generated report
timeFrame: From enrollment in the study to at least 5 days and until the endpoint is reached but for a maximum duration of 14 days and only when allocated to the intervention
Other outcomes:
Locations:
city: Givisiez
country: Switzerland
facility: TPF
state: Fribourg
Study officials:
affiliation: Unisanté
name: Irina Guseva Canu, Professor
role: PRINCIPAL_INVESTIGATOR
References: