Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001818224
Ethics application status
Approved
Date submitted
24/10/2018
Date registered
8/11/2018
Date last updated
8/11/2018
Date data sharing statement initially provided
8/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
HealthBreak Education and Screening Program at Transport Workplaces
Scientific title
Relationships between sleep disturbances, occupational demands, cardiovascular risk factors and motor vehicle accidents assessed during a sleep disorder and health screening program in transport industry workers, and the impact of this program on workplace injuries in a sub-set of participants
Secondary ID [1] 290487 0
Nil known
Universal Trial Number (UTN)
U1111-1219-9161
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep disorders 300868 0
Obesity 300869 0
Workplace injuries 300870 0
Motor vehicle accidents 300871 0
Hypersomnolence 310247 0
Hypertension 310292 0
Impaired glucose tolerance (pre-diabetes risk) 310293 0
Condition category
Condition code
Cardiovascular 300690 300690 0 0
Other cardiovascular diseases
Injuries and Accidents 300691 300691 0 0
Other injuries and accidents
Public Health 300707 300707 0 0
Health promotion/education

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Phase 1: Sleep disorders and cardiovascular health education and screening program

Educational programs were conducted at participating commercial road transport companies and all drivers at these companies were invited to participate in the health screening program.

Education program: Educational material about the causes and risks associated with sleepiness (hypersomnolence), sleep disorders, cardiovascular disease and associated risk factors was presented to transport workers through the distribution of posters, health information sheets, and a video about sleep disorders. In addition, trained medical and nursing staff attended workplaces and transport industry functions to deliver presentations to groups of workers on sleep disorders and cardiovascular health.

Health screening: Trained nurses visited workplaces to give face-to-face presentations to workers and provide confidential screening for sleep disorders, cardiovascular risk factors, smoking and alcohol use. The screening procedure consisted of the following measures:

Self-reported general information:
• Gender
• Age
• Amount of days and hours worked
• Hours of sleep during work and rest days
• Motor vehicle accident history (accidents where either the police were called, someone was injured, or a vehicle was damaged and required repair)

Measured health information:
• Height
• Weight
• Blood pressure
• Diabetes risk (blood glucose levels)

Self-reported health information:
• Current smoking status and amount of cigarettes smoked
• Amount of alcoholic drinks on work and rest days
• Frequency of falling asleep while driving
• Frequency of fearing falling asleep while driving
• Daytime sleepiness (Epworth Sleepiness Scale (Johns 1991))
• Obstructive Sleep Apnea risk (Multivariable Apnea Prediction Index (Maislin, Pack et al. 1995))
• Family history of diabetes, hypertension

The health education and screening program was conducted at workplaces in the Victorian transport industry (Victoria, Australia) over a three-year period. A total of 134 companies were approached to participate in the health education and screening program and 87% (95% CI 81.31-92.69) of these participated. In total, 3873 of the 11992 transport industry workers at the participating companies undertook individual health screening.

Duration and timing of health education and screening: The health educational program performed at workplaces to groups of transport workers usually lasted around 30 minutes, and this was normally followed by health screening sessions. The health screening session lasted around 15 minutes per participant. The health educational program was administered at the workplace. The health screening was also conducted at the workplace, and within the same week of the program.

Program materials: The health program support materials provided to participants were developed specifically for the program. The support materials outlining risk factors and symptoms for obstructive sleep apnoea, type 2 diabetes, heart disease and cholesterol were consistent with evidence based guidelines (Australasian Sleep Association, 2018, Obstructive Sleep Apnoea, Retrieved: from https://www.sleep.org.au/documents/item/78; Sleep Health Foundation, 2011, Obstructive Sleep Apnea (OSA) Fact Sheet, Retrieved from: https://www.sleephealthfoundation.org.au/files/pdfs/Obstructive%20Sleep%20Apnoea.pdf; Diabetes Australia, 2015, Type 2 Diabetes, Retrieved from: https://www.diabetesaustralia.com.au/type-2-diabetes; The Heart Foundation, 2018, What is coronary heart disease? Retrieved from: https://www.heartfoundation.org.au/your-heart/heart-conditions/what-is-coronary-heart-disease; The Heart Foundation, 2018, What is cholesterol?, Retrieved from: https://www.heartfoundation.org.au/images/uploads/main/For_professionals/Cholesterol_brochure_2018.pdf). Where appropriate, these support materials also included information and contact details for organisations to help with specific conditions. This was in addition to medical follow-up (outlined below). This included links for the following problems:
Alcohol abuse - Direct Line, counselling service
Smoking cessation - Quit Help line and the Smoking Cessation Unit, Austin Hospital
Diabetes - Diabetes Association, information, education and counselling service
Obesity - Gut busters, weight loss program
Heart Disease - National Heart Foundation, information and support services
Chronic lung disease - Australian Lung Foundation, information and support services
Sleep Disorders - Institute for Breathing & Sleep, Australasian Sleep Association
Mens’ Line – depression, suicide, relationship problems

Phase 2: Program evaluation - medical follow-up

The results for each measure collected during the health screening (see above) were entered into a database and categorised as normal, abnormal or severely abnormal for each health outcome. Participants with severely abnormal results were recommended for urgent medical follow-up, whilst those with other abnormal results were recommended for non-urgent medical follow-up.

Written feedback and results from the health screening were provided directly to the participant, along with recommendations for (urgent or non-urgent) medical follow-up with their medical practitioner for specialist medical evaluation if required (i.e., abnormal or severely abnormal results). In addition to recommendations for medical follow-up, the feedback provided to participants included specific advice about lifestyle modifications, for example the likely causes of sleepiness and specific advice about minimising sleepiness based on this information.

To evaluate the number of participants attending for medical follow-up, general practitioner doctors were asked to sign and return a reply-paid postcard indicating the conditions that were followed-up. In addition, a random telephone survey was undertaken of those participants referred for follow-up but whose card was not returned.

Participants medical follow-up was monitored for the duration of the health education and screening program (i.e., a three-year period).

Phase 3: Program evaluation – Injury and accident follow-up

Company workplace injury data was collected for a 12-month period prior to and following completion of the heath education and screening program using data from a group of companies involved in the first year of the program. This included participants new lost time injuries and days lost due to new lost time injuries calculated for before and after the program. This information was used to further evaluate the impact of the health education and screening program on workplace injuries and accidents.
Intervention code [1] 312825 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300108 0
Relationship between hypersomnolence and motor vehicle accident risk (composite primary outcome).

Hypersomnolance, or excessive daytime sleepiness, was assessed using the Epworth Sleepiness Scale (ESS), The ESS is a validated questionnaire. Questions were also used to assess the frequency of sleepiness and falling asleep whilst driving on major roads. These questions have not been formally validated and were designed specifically for this study.

To assess rate of Motor Vehicle Accidents, participants completed a questionnaire instructing them to self-report any motor vehicle accidents in the last three years where either the police were called, someone was injured, or a vehicle was damaged and required repair. This questionnaire has not been formally validated but has been previously used in research examining commercial drivers (Howard ME, et al. (2004) Sleepiness, sleep-disordered breathing, and accident risk factors in commercial vehicle drivers. Am J Respir Crit Care Med 170(9):1014-21).
Timepoint [1] 300108 0
Data collected once at the time of health screening.
Primary outcome [2] 300109 0
Relationship between sleep duration and motor vehicle accident risk (composite primary outcome).

Participants self-reported their estimated average sleep duration on work nights and non-work nights. These questions have not been formally validated and were designed specifically for this study.

To assess rate of Motor Vehicle Accidents, participants completed a questionnaire instructing them to self-report any motor vehicle accidents in the last three years where either the police were called, someone was injured, or a vehicle was damaged and required repair. This questionnaire has not been formally validated but has been previously used in research examining commercial drivers (Howard ME, et al. (2004) Sleepiness, sleep-disordered breathing, and accident risk factors in commercial vehicle drivers. Am J Respir Crit Care Med 170(9):1014-21).
Timepoint [2] 300109 0
Data collected once at time of health screening.
Primary outcome [3] 307937 0
Relationships between cardiovascular health conditions (obesity, hypertension, impaired glucose tolerance) and occupational demands (driving and work hours, driving distance and shift type; composite primary outcome).
Timepoint [3] 307937 0
Cardiovascular health conditions assessed using the following point-of-care measures:
high blood pressure, or hypertension, was assessed using a digital blood pressure monitor; body mass index was calculated based on height measured using a stadiometer and weight determined using digital weighing scales, and; risk of diabetes was assessed based on non-fasting blood glucose levels determined on-site using a point-of-care testing device.

Participants’ smoking status (yes/no) and number of cigarettes smoked per day were assessed using a questionnaire. A questionnaire was also used to assess occupational demands including self-reported work and driving hours (estimated average work and driving hours per week), driving distance (estimated average kilometres driven per week) and shift type (day, afternoon, night). These questionnaires have not been formally validated and were designed specifically for this study.
Secondary outcome [1] 329069 0
Effectiveness of health education and screening program on workplace injury rates (new lost time injuries and days lost due to new lost time injuries) pre- and post-completion of the program in a subset of the companies (composite secondary outcome).
Timepoint [1] 329069 0
Workplace injury data was collected 12-months pre- and post-completion of the program in a subset of companies involved in the first year of the program (i.e., a sub-set of participants) following completion of the health education and screening program. This included new lost-time injuries and days lost due to new lost-time injuries.

This data was collected internally by this sub-set of companies.
Secondary outcome [2] 329070 0
Compliance with recommended medical (general practitioner) follow-up after health screening.

To evaluate the number of drivers attending follow-up, general practitioners signed and returned a reply-paid postcard indicating the conditions followed-up. In addition, a random telephone survey was undertaken of drivers referred for follow-up, but whose card was not returned.
Timepoint [2] 329070 0
Recommendations for medical follow-up provided once at time of health screening. Participants compliance with medical follow-up was monitored for the duration of the study (three-year period).
Secondary outcome [3] 329071 0
Alcohol intake on work and rest days assessed using a questionnaire (composite secondary outcome).

Alcohol use was assessed by asking participants to report the number of standard drinks they consumed on work and non-work/rest days. This questionnaire has not been formally validated but has been previously used in research examining commercial drivers (Howard ME, et al. (2004) Sleepiness, sleep-disordered breathing, and accident risk factors in commercial vehicle drivers. Am J Respir Crit Care Med 170(9):1014-21).
Timepoint [3] 329071 0
Alcohol intake data collected once at a time of health screening.
Secondary outcome [4] 329072 0
Self-reported family history of diabetes and hypertension (composite secondary measure).

Participants were asked about whether they had family history of diabetes and/or hypertension. This questionnaire has not been formally validated and was designed specifically for this study.
Timepoint [4] 329072 0
Data collected once at a time of health screening.
Secondary outcome [5] 353395 0
Prevalence of sleep apnea.
Timepoint [5] 353395 0
Sleep apnea assessed using the Multivariable Apnea Prediction (MAP) questionnaire to predict the likelihood of having sleep apnea. The MAP is a validated measure.

Eligibility
Key inclusion criteria
Victorian (Victoria, Australia) transport industry workers employed at one of the companies participating in the educational and screening program. Individual drivers and independent contractors were also included.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Retrospective
Statistical methods / analysis
Sample size determination:

The sample size for this project was based on determining an adequate sample of participants to determine Primary Outcomes 1, 2 and 3.

Primary Outcome 1 - Relationship between hypersomnolence and motor vehicle accidents (MVA): To estimate the relationship between MVA and mild moderate excessive daytime sleepiness we assume that 35% of drivers with no excessive sleepiness and 66% of drivers with mild/moderate excessive sleepiness has an MVA with an alpha error of 0.01, a power of 95% and a prevalence of excessive sleepiness of 13% requires 370 drivers. To estimate the relationship between MVA and severe excessive daytime sleepiness we assume that 35% of drivers with no-excessive sleepiness and 70% of drivers with severe excessive sleepiness has an MVA with an alpha error of 0.01, a power of 95% and a prevalence of excessive sleepiness of 13% requires 294 drivers.

Primary Outcome 2 - Relationship between sleep duration and MVA risk: To estimate the relationship between MVA and short sleep (<6 hours) we assume that 79% of drivers with long sleep duration (8-<9 hours) and 91% of drivers with short sleep duration (<6 hours) has an MVA with an alpha error of 0.01, a power of 95% and a prevalence of short sleep of 45% requires 468 drivers.

Primary Outcome 3 - Relationships between cardiovascular health conditions (obesity, hypertension, impaired glucose tolerance) and occupational demands (driving and work hours, driving distance and shift type): To estimate the relationship between obesity and extended (>6 hours/day) sitting at work (to reflect extended driving time in commercial road transport drivers) we assume that 56% of drivers with no extended sitting at work and 66% of drivers with extended sitting at work has obesity with an alpha error of 0.01, a power of 95% and a prevalence of extended sitting at work of 25% requires 1659 drivers.

To ensure a suitable sample we aim to include 2000 participants. All sample size calculations are made using the software G*Power version 3.1.9.2.

Statistical analyses:
Cluster analysis was used, with company as the cluster variable. Individual drivers (n=19) and independent contractors (n=23) were assigned to two separate clusters. Descriptive analysis was undertaken of company and driver participation and the frequency of medical conditions. Proportions with 95 percent confidence intervals (95% CI) were used for binary and categorical variables and means with standard deviations were used for normally distributed continuous variables. The relationship between self-reported measures of sleepiness (hypersomnolence) and motor vehicle accident risk were calculated using odds ratios (ORs) adjusted for the established risk factors age, gender, driving location (metro, country, interstate) and hours of driving per week. Univariate logistic regression and multivariate logistic modelling was used to determine the relationship between occupational factors (driving and work hours, driving distance, and shift type) and health outcomes of obesity, hypertension and impaired glucose (adjusted for age, gender and work cluster). The rates of new lost time injuries and days lost due to new lost time injuries were calculated for before and after the program and rate ratios were calculated. All statistical analyses were conducted using STATA 11 (Statacorp, College Station, Texas).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/08/2011
Date of last participant enrolment
Anticipated
Actual
31/07/2012
Date of last data collection
Anticipated
Actual
31/07/2012
Sample size
Target
2000
Accrual to date
Final
3873
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 294905 0
Government body
Name [1] 294905 0
Transport Accident Commission (TAC)
Country [1] 294905 0
Australia
Funding source category [2] 294906 0
Other
Name [2] 294906 0
Worksafe Victorian Education and Information Fund
Country [2] 294906 0
Australia
Primary sponsor type
Hospital
Name
Dr Mark Howard
Address
Level 5, Harold Stokes Building,
Austin Hospital
145 Studley Road
Heidelberg, VIC, 3084
Country
Australia
Secondary sponsor category [1] 300708 0
None
Name [1] 300708 0
N/A
Address [1] 300708 0
N/A
Country [1] 300708 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296282 0
The University of Melbourne Human Ethics Committee - Behavioural and Social Sciences Human Ethics Sub-Committee
Ethics committee address [1] 296282 0
Ethics committee country [1] 296282 0
Australia
Date submitted for ethics approval [1] 296282 0
14/05/2011
Approval date [1] 296282 0
25/07/2011
Ethics approval number [1] 296282 0
1135599

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70258 0
A/Prof Mark Howard
Address 70258 0
Institute for Breathing and Sleep
Level 5, Harold Stokes Building, Austin Hospital
145 Studley Road
Heidelberg, Victoria, 3084
Country 70258 0
Australia
Phone 70258 0
+61 3 9496 3685
Fax 70258 0
Email 70258 0
[email protected]
Contact person for public queries
Name 70259 0
Mark Howard
Address 70259 0
Institute for Breathing and Sleep,
Level 5, Harold Stokes Building, Austin Hospital
145 Studley Road
Heidelberg, Victoria, 3084
Country 70259 0
Australia
Phone 70259 0
+61 3 9496 3685
Fax 70259 0
Email 70259 0
[email protected]
Contact person for scientific queries
Name 70260 0
Mark Howard
Address 70260 0
Institute for Breathing and Sleep,
Level 5, Harold Stokes Building, Austin Hospital
145 Studley Road
Heidelberg, Victoria, 3084
Country 70260 0
Australia
Phone 70260 0
+61 3 9496 3685
Fax 70260 0
Email 70260 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.