Clinical trial NCT05452096: SHIFTPLAN: an RCT Investigating the Effect of a Shift Work Intervention on Fatigue, Sleep and Health.
Official title: A Randomized Controlled Trial Investigating the Effects of a Multimodal Shift-work Intervention on Drivers' Fatigue, Sleep, Health and Performance Parameters.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shift-work Disorder
Insomnia
Fatigue
Mental Health Issue
Quality of Life
Coping Skills
Circadian Rhythm Disorders
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Universiteit Antwerpen
First posted: 2022-07-11
Enrollment: 176
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: SHIFTPLAN is a randomized controlled interventional trial. It can be situated in occupational health and field research. The drivers will be 1:1 randomized to either the intervention or the control group according to a parallel group design.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Shift work is associated with disturbed life rhythms resulting from chronic exposure to circadian misalignment and sleep restriction, with long-term participation in most shift schedules causing serious health problems. Epidemiological data show that shift workers are at increased risk of sleepiness, fatigue and insomnia, cardiovascular disease, breast cancer and shift-work disorder. Prevalence estimates of shift-work disorder vary between 5% and 26,5%.

Given these widespread and serious health and functional consequences of shift work, there is a necessity for treatments that improve shift workers' health and work performance. Most non-pharmacological recommendations mention improved scheduling, bright-light exposure, napping, psychoeducation fostering sleep hygiene, and cognitive-behavioral interventions.

The effects of shift work on the health, fatigue and sleepiness of drivers have been robustly investigated in observational studies, as well as the effects of single measures such as scheduling or resting times. But studies on the effectiveness of countermeasures against the adverse impact of shift work are sparse, especially for high-risk populations such as professional drivers and controlled intervention studies are lacking. Several other investigators expounded the need for a multi-level approach to managing occupational sleep-related fatigue and workplace interventions to promote sleep and health of shift workers. Highlighting the high public-health burden associated with lack of recuperative sleep, the authors pointed out the pressing need to develop policies and implement programs aimed at improving workers' sleep health.

With SHIFTPLAN, the investigators aim to fill this gap in comprehensive approaches. To their knowledge, this is the first randomised controlled trial to systematically gauge the effect of a multimodal program that includes ergonomic shift scheduling and an educational program on well-defined health, sleep and performance outcomes in professional drivers.

Detailed description: The duration of the intervention will be six months. The intervention provided to the intervention group is based on evidence-based good standard of care and includes: 1) Healthy scheduling (fast forward-rotating shift schedules adapted to chronotype, adequate resting times, napping, bright-light therapy); 2) Education program for drivers (psychoeducation promoting sleep hygiene, cognitive-behavioral strategies, stress-management techniques, information on chronotherapy such as bright-light therapy and napping) The control group or "waiting-list group" will include drivers who will continue working according to the default shift schedules while being assigned to a waiting list in anticipation of the education program to which they will able to suscribe after completing the study.

Eligibility criteria: Inclusion Criteria:

* - Professional drivers having worked in shifts with the transport company in full-time or ≥80% part-time employment in the company's regular backward-rotating schedule for at least two years.

Exclusion Criteria:

* Regular medication for high blood pressure and uncontrolled high blood pressure (defined as exceeding 140/90 mmHg) at screening, regular medication for diabetes, sleeping pills or sedative medication for depression (defined as trazodone, mirtazapine and amitriptyline). Because our secondary outcomes imply the evolution of blood-pressure and blood-sugar parameters, drivers with such pre-existing controlled or non-controlled comorbidity will not be eligible for participation.
* High risk of moderate-to-severe obstructive sleep apnea syndrome (OSAS) as assessed with the STOP-Bang questionnaire, a simple, easy to remember and self-reportable screening tool. We will use a cut-off score of 6 or higher to indicate the presence of OSAS.
* Drivers combining their job as a professional driver with another job elsewhere.
* Excessive sleepiness as defined as a score in excess of 12 on the Epworth Sleepiness Scale (ESS). Although the habitual cut-off is \>9, we opted for this higher threshold because we will be examining the effect of the intervention on daytime sleepiness. All applicants with an ESS \>12 will be excluded and referred to a general practitioner for further evaluation.
* A BMI higher than 35. We chose this cut-off value based on the data provided by the external occupational health service, which showed that in 2018, 42.6 % of their drivers had a mean BMI of 25-30 and 27.5 % a BMI between 30-40.
* The presence of major depression as defined by a score exceeding the threshold of 1.75 on the Hopkins Symptom Checklist (HSCL-25), where higher scores were demonstrated to be highly indicative of depressive disorder according to the DSM-5 and characterized as "a case requiring treatment".

Primary outcomes:
measure: Change in sleepiness as assessed with the Epworth Sleepiness Scale (ESS).
timeFrame: Assessed at baseline and monthly up to and including the final 6-month evaluation and the statistical relevance of improvement (first to last score).
Secondary outcomes:
measure: Effect on fatigue indices of the drivers as assessed with the CIS (Checklist Individual Strength). It is to be noted that fatigue and sleepiness are two distinct states of being that may be present or absent independently from each other, whe
timeFrame: Evolution of CIS scores from baseline to three and six months and the statistical relevance of improvement (first to last score).
measure: Sleep outcomes as evaluated by Total sleep time (TST) and sleep efficiency (SE)
timeFrame: Evolution at baseline, three and six months of mean total sleep time (TST) and sleep efficiency (SE)
measure: Sleep outcomes measured as scores on the Pittsburgh Sleep Quality Index (PSQI).
timeFrame: scores on the PSQI at baseline, three and six months and the statistical relevance of the baseline to 6-month change
measure: General health-related quality of life (HR-QoL) as assessed with the SF-36
timeFrame: evolution of total SF-36 scores from baseline to three and six months and the statistical relevance of first-to-last score improvement
measure: Absenteeism: sick leave in terms of number of days off work due to illness will be derived from official records of and provided by the company
timeFrame: Data from baseline and after six months
measure: Clinical health outcome: evolution of blood pressure as measured in mmHg
timeFrame: Evolution of blood pressure from baseline, to three and to six months and the statistical relevance of the improvement (first-to-last change).
measure: Clinical health outcome: evolution of Body Mass Index (BMI) as measured in kg/m²
timeFrame: Evolution of BMI from baseline, to three and to six months and the statistical relevance of the improvement (first-to-last change).
measure: Clinical health outcome: evolution of fasting blood glucose as measured in mmol/l
timeFrame: Evolution of fasting blood glucose from baseline, to three and to six months and the statistical relevance of the improvement (first-to-last change).
measure: Clinical health outcome: evolution of glycosylated hemoglobin (HbA1c) as measured in mmol/mol
timeFrame: Evolution of HbA1c from baseline, to three and to six months and the statistical relevance of the improvement (first-to-last change).
measure: Clinical health outcome: evolution of high-sensitive C-reactive protein (hsCRP) measured in mg/L
timeFrame: Evolution of hsCRP from baseline, to three and to six months and the statistical relevance of the improvement (first-to-last change).
measure: Mood and anxiety as gauged with the Hopkins Symptom Checklist (HSCL-25)
timeFrame: Assessed at baseline and at six months
Other outcomes:
measure: Correlation between the intervention effects and chronotypes as determined by the Morningness-Eveningness questionnaire (MEQ): Exploratory
timeFrame: 6 months
Locations:
Study officials:
affiliation: Antwerp University Hospital (UZA). University of Antwerp (UA)
name: Filip Van Den Eede, MD, PhD
role: STUDY_CHAIR
affiliation: Antwerp University Hospital (UZA). University of Antwerp (UA)
name: Johan Verbraecken, MD, PhD
role: STUDY_CHAIR
References:
citation: Declercq I, Van Den Eede F, Roelant E, Verbraecken J. SHIFTPLAN: a randomized controlled trial investigating the effects of a multimodal shift-work intervention on drivers' fatigue, sleep, health, and performance parameters. Trials. 2022 Aug 17;23(1):662. doi: 10.1186/s13063-022-06573-6.