Tech4Rest Trial With Team Truck Drivers

Sponsor

Oregon Health and Science University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03108599

Collaborator

National Institute for Occupational Safety and Health (NIOSH/CDC) (U.S. Fed), Washington State, Department of Labor and Industries (Other), University of Washington (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The current project is a safety and health intervention focused on sleep and fatigue among truck driver teams (pairs), where one driver sleeps in a moving vehicle while the other partner drives. This study is conducted within the Oregon Healthy Workforce Center (OHWC), a NIOSH Center of Excellence in Total Worker Health. We will evaluate engineering and behavioral interventions to improve sleep, reduce fatigue, and impact Total Worker Health. An enhanced cab intervention will alter whole body vibrations during driving and sleep periods, and includes a therapeutic mattress system and an active suspension seat. The enhanced cab will be evaluated alone and in combination with a behavioral sleep intervention adapted from our effective SHIFT (Safety &Health Involvement For Truckers) program. The interventions prioritize hazard reduction according to the hierarchy of controls, and will be evaluated with a randomized controlled design.

Condition or Disease	Intervention/Treatment	Phase
Sleep Sleep Disturbance Sleep Disorder, Shift Work Health Knowledge, Attitudes, Practice Health Behavior Fatigue Vibration; Exposure	Other: Enhanced Cab Behavioral: Fit4Sleep	N/A

Detailed Description

Total Worker Health® (TWH) is defined as policies, programs, and practices that integrate protection from work-related safety and health hazards with promotion of injury and illness prevention efforts to advance worker well-being. Sleep deficiency is a cross-cutting factor for TWH that not only impacts workplace safety, but also generates excess risk for obesity, chronic disease, and early mortality. Long-haul truck drivers average less sleep per night on the road than they do when sleeping at home due to long, irregular work hours and unfavorable sleeping conditions in truck sleeper berths (e.g., low quality mattresses, vibrations, noise, temperature). Sleep deficiency in trucking is a likely contributor to the 69% prevalence of obesity among US drivers, which increases the risk of obstructive sleep apnea and deadly crashes. Despite the severity of these interacting problems, research on engineering controls in commercial truck cabs to improve sleep and reduce fatigue is limited. Behavioral interventions to improve sleep among truck drivers are also limited. We must address these gaps and evaluate the economic cost-utility of interventions to stimulate industry investment in factors that substantially improve drivers' TWH.

The primary goal of this proposal is to evaluate the effects of an enhanced cab intervention on long-haul truck drivers' sleep and TWH with a randomized controlled design. A secondary goal is to evaluate the additive effects of a behavioral sleep intervention. We focus on truck driver teams (pairs), where one driver sleeps in a moving vehicle while the other partner drives, who experience twice as many awakenings as solo drivers. Our enhanced cab intervention will alter whole body vibrations during driving and sleep periods, and includes a therapeutic mattress system with anti-vibration characteristics (Thevorest) and an active suspension seat (BoseRide III). The enhanced cab will be evaluated alone and in combination with a behavioral sleep intervention adapted from our effective SHIFT program. Our preliminary studies show that the therapeutic mattress system alters vibrations and is strongly preferred by drivers, the active suspension seat reduces vibration exposure and fatigue, and that SHIFT produces robust health behavior changes. Our primary hypotheses are that relative to a control group, the enhanced cab intervention will improve objective measures of (a) sleep duration and quality, (b) fatigue, and (c) driver performance. We will also measure impacts on musculoskeletal pain, well-being, and health behaviors (diet, physical activity). We also hypothesize that intervention effects will be larger when combined with a behavioral sleep intervention. Our propensity for success is bolstered by our unique prior accomplishments and strong trucking industry support. To accomplish our goals and test our hypotheses we propose a 5-year project to accomplish 3 specific aims:

Pilot test intervention and experimental procedures. We will conduct formative research with dispatchers and driving teams and adapt our SHIFT intervention to focus explicitly on improving sleep. We will then pilot data collection and intervention procedures (enhanced cab and behavioral interventions) with team truck drivers. This preliminary work will guide adjustments prior to our randomized controlled trial.
Determine the effectiveness of an enhanced cab intervention alone and in combination with a behavioral sleep intervention for improving truck drivers' sleep, fatigue, and performance. Teams will be randomized into intervention and control groups. Intervention teams will complete 3 phases: baseline, enhanced cab intervention, and enhanced cab intervention + behavioral sleep intervention. Control teams will be measured at the same time points. Primary outcomes will include sleep duration and quality (actigraphy), fatigue (psychomotor vigilance task), and driver performance (fuel efficiency and hard braking events). Secondary outcomes will include musculoskeletal symptoms, well-being, diet, and exercise.
Conduct cost-utility analyses for interventions. We will gather historical data from trucking companies and model the cost-utility of intervention components. Model variables will include intervention costs and estimated returns or savings based on intervention effects, such as improvements in driver performance (e.g., fuel efficiency), reduced lost workdays, and reduced probability of fatigue-related crashes.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

In the RCT, participants will be randomly assigned to either the control or intervention groups. Following a baseline period, intervention participants will receive the cab engineering portion of the intervention on its own. Then, for the following intervention phase, intervention participants will participate in the behavioral sleep intervention in addition to continuing the cab engineering intervention.In the RCT, participants will be randomly assigned to either the control or intervention groups. Following a baseline period, intervention participants will receive the cab engineering portion of the intervention on its own. Then, for the following intervention phase, intervention participants will participate in the behavioral sleep intervention in addition to continuing the cab engineering intervention.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Engineering and Behavioral Controls for Truck Drivers' Sleep, Safety, and Health

Actual Study Start Date :

May 1, 2017

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention All participants in the intervention arm will receive two interventions: an enhanced cab intervention alone, and then the enhanced cab conditions combined with a behavioral sleep intervention.	Other: Enhanced Cab The cab engineering intervention includes the introduction of an active suspension seat and a therapeutic mattress system. After a baseline phase, the intervention arm will receive the enhanced cab intervention alone, and then the enhanced cab plus a behavioral sleep intervention. Behavioral: Fit4Sleep The behavioral sleep intervention includes a friendly dyad-based physical activity competition; self-monitoring and logging of physical activity, sleep hygiene behaviors, and sleep; and individual coaching. The intervention arm will receive the behavioral sleep intervention in combination with the enhanced cab intervention. Other Names: Behavioral Sleep Intervention
No Intervention: Control Usual practices with regards to cab conditions and access to workplace programs for preventing sleep and fatigue problems.

Arm

Intervention/Treatment

Experimental: Intervention

All participants in the intervention arm will receive two interventions: an enhanced cab intervention alone, and then the enhanced cab conditions combined with a behavioral sleep intervention.

Other: Enhanced Cab

The cab engineering intervention includes the introduction of an active suspension seat and a therapeutic mattress system. After a baseline phase, the intervention arm will receive the enhanced cab intervention alone, and then the enhanced cab plus a behavioral sleep intervention.

Behavioral: Fit4Sleep

The behavioral sleep intervention includes a friendly dyad-based physical activity competition; self-monitoring and logging of physical activity, sleep hygiene behaviors, and sleep; and individual coaching. The intervention arm will receive the behavioral sleep intervention in combination with the enhanced cab intervention.

Other Names:

Behavioral Sleep Intervention

No Intervention: Control

Usual practices with regards to cab conditions and access to workplace programs for preventing sleep and fatigue problems.

Outcome Measures

Primary Outcome Measures

Change from baseline in actigraphic measures of sleep quality/quantity at 3 and 6 months [One week samples at Baseline, 3 months, and 6 months]
Direct measurement via Actigraph GT3x+ BT
Change from baseline in self-reported sleep quality/quantity at 3 and 6 months [Baseline, 3 months, and 6 months]
Pittsburgh Sleep Quality Index (Buysse et al., 1989)
Change from baseline in sleep-related impairment at 3 and 6 months [Baseline, 3 months, and 6 months]
PROMIS Sleep-Related Impairment (Cella et al., 2010; Yu et al., 2012)
Change from baseline in objectively measured fatigue at 3 and 6 months [One week samples at Baseline, 3 months, and 6 months]
Psychomotor Vigilance Task (Dinges & Powell, 1985; Basner & Dinges, 2011)
Change from baseline in self-reported fatigue at 3 and 6 months [Baseline, 3 months, and 6 months]
Swedish Occupational Fatigue Inventory (Ahsberg, 2000)
Change from baseline in driving performance at 3 and 6 months [Baseline, 3 months, and 6 months]
Objective truck engine records of fuel efficiency and hard brakes (decelerations >7mph per second) per 10,000 miles driven will be collected from companies

Secondary Outcome Measures

Change from baseline in actigraphy measures of exercise and sedentary time at 3 and 6 months [One week samples at Baseline, 3 months, and 6 months]
Direct measurement via Actigraph GT3x+ BT
Change from baseline in self-reported exercise at 3 and 6 months [Baseline, 3 months, and 6 months]
Healthy physical activity scale (Elliot et al., 2007)
Change from baseline in self-reported sedentary time at 3 and 6 months [Baseline, 3 months, and 6 months]
Sedentary Behavior Questionnaire for adults (Rosenberg et al., 2010)
Change from baseline in sleep hygiene practices at 3 and 6 months [Baseline, 3 months, and 6 months]
Sleep Hygiene Index (Mastin et al., 2006)
Change from baseline in well-being at 3 and 6 months [Baseline, 3 months, and 6 months]
PROMIS Global Health (Cella et al., 2007, Hays et al., 2009)
Change from baseline in musculoskeletal pain at 3 and 6 months [Baseline, 3 months, and 6 months]
Adapted Nordic questionnaire for musculoskeletal symptoms (Kuorinka et al., 1987)
Change from baseline in disability due to low back pain at 3 and 6 months [Baseline, 3 months, and 6 months]
Roland Morris Disability Index (Roland et al., 1983)
Change from baseline in work-related injuries at 3 and 6 months [Baseline, 3 months, and 6 months]
Self-reported and/or company collected data on worker injuries and lost work days due to injury
Change from baseline in driving moving violations at 3 and 6 months [Baseline, 3 months, and 6 months]
Self-reported and/or company collected data
Change from baseline in driving vehicle collisions at 3 and 6 months [Baseline, 3 months, and 6 months]
Self-reported and/or company collected data
Change from baseline in body weight at 3 and 6 months [Baseline, 3 months, and 6 months]
Direct measurement via Tanita TBF-310GS Bioelectric Impedance Analyzer
Change from baseline in percent body fat at 3 and 6 months [Baseline, 3 months, and 6 months]
Direct measurement via Tanita TBF-310GS Bioelectric Impedance Analyzer
Change from baseline in blood pressure at 3 and 6 months [Baseline, 3 months, and 6 months]
Direct measurement via Omron HEM-907 automatic blood pressure monitor
Change from baseline in high sugar/fat food and drink consumption at 3 and 6 months [Baseline, 3 months, and 6 months]
Buxton et al., 2009
Change from baseline in fruit and vegetable consumption at 3 and 6 months [Baseline, 3 months, and 6 months]
Single-item on number of fruit and vegetable servings developed for study

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Currently working as a team truck driver with a driving partner who is also willing to participate.
Employed at a company that supports the project requirements