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Trial registered on ANZCTR


Registration number
ACTRN12619001774112
Ethics application status
Approved
Date submitted
8/12/2019
Date registered
13/12/2019
Date last updated
13/12/2019
Date data sharing statement initially provided
13/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The efficacy of sleep education and wrist-activity monitor smartphone apps on improving sleep and performance in shiftworkers.
Scientific title
The efficacy of sleep education and wrist-activity monitors that provide daily feedback on sleep, on the sleep quality, quantity and cognitive performance of shiftworkers.
Secondary ID [1] 300009 0
Nil known
Universal Trial Number (UTN)
U1111-1244-9556
Trial acronym
FRMT (Fatigue Risk Management Trial)
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Sleep Apnoea 315494 0
Insomnia 315495 0
Shiftwork Disorder 315496 0
Condition category
Condition code
Respiratory 313785 313785 0 0
Sleep apnoea
Public Health 313882 313882 0 0
Health promotion/education
Neurological 313883 313883 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study involves participants who undertake shiftwork for a Western Australian mining company. Participants are assigned to one of three intervention groups. Intervention group 1 will attend a 2-hour face to face group sleep education session; intervention group 2 will receive daily feedback on sleep via a wrist-activity monitor mobile app; and intervention group 3 will attend a 2-hour face to face group sleep education session and receive daily feedback on sleep via a wrist-activity monitor mobile app. The sleep education sessions will be delivered onsite by the researcher who has worked in the area of fatigue risk management for the past 7 years and holds a Post Graduate Diploma in Health and Safety, a Graduate Certificate in Public Health and a Bachelor of Science in Health Promotion.

Sleep Education Sessions - Interactive group sessions that include powerpoint presentation, videos, and discussion that address the following:
• What fatigue is and the importance of sleep in maintaining good health.
• The science of sleep, our biological clock and circadian rhythms.
• Common sleep disorders.
• Sleep deprivation and the dangers associated with micro-sleeps.
• How to recognise the signs of fatigue in yourself and others.
• Lifestyle and environmental factors that contribute to good quality and quantity sleep.
• Strategies to prepare for shift work.
• Strategies to manage fatigue and increase alertness during your shift.

Wrist-activity monitors - participants will wear a wrist-activity monitor 24 hrs a day (unless required to remove for safety reasons whilst at work) for the duration of 2 roster cycles (approx 42 days): pre-intervention, 21-days and post-intervention 21-day roster cycle.
The intervention group with access to the mobile app will receive daily info on their sleep quality, quantity and performance ie: sleep duration, sleep fragmentation, alertness levels. This intervention group will be required to sync their data daily with the mobile app allowing the researcher to monitor adherence to the intervention through a overall web app. The researcher will send text message reminders if participants aren't syncing their data.
Intervention code [1] 316276 0
Behaviour
Intervention code [2] 316277 0
Prevention
Intervention code [3] 316340 0
Treatment: Other
Comparator / control treatment
The control group will wear a wrist activity monitor for monitoring purposes only, but will not receive any feedback on their sleep activity via a mobile app or attend any sleep education session.
Control group
Active

Outcomes
Primary outcome [1] 322192 0
Sleep quantity. Measured by wrist-activity monitors.
Timepoint [1] 322192 0
The primary outcomes will be assessed for every day of the study (i.e. across multiple time points). The primary outcomes will be assessed across the pre-intervention phase (21-days) and across the post-intervention phase (21-days).
Primary outcome [2] 322270 0
Sleep Quality (as indicated by wake after sleep onset, fragmentation index, sleep efficiency and time in bed). Measured by wrist-activity monitors.

Timepoint [2] 322270 0
The primary outcomes will be assessed for every day of the study (i.e. across multiple time points). The primary outcomes will be assessed across the pre-intervention phase (21-days) and across the post-intervention phase (21-days).
Primary outcome [3] 322271 0
Cognitive performance. Cognitive performance will be predicted using scientifically validated biomathematical modelling. Biomathematical modelling allows for an objective assessment of fatigue by using scientific data to analyse the relationship between sleep, work and cognitive performance. The Sleep, Activity, Fatigue, and Task Effectiveness Model (SAFTE) model has been selected to conduct biomathematical modelling to predict cognitive performance for this research project
Timepoint [3] 322271 0
Biomathematical models will be run pre-intervention and post-intervention for each of the study groups using sleep data collected from the wrist-activity monitors as inputs (e.g. average sleep onset time, wake time and sleep duration).
Secondary outcome [1] 377653 0
Sleep Apnoea - A positive response to two or more of the categories in the Berlin Questionnaire indicates high risk for sleep apnoea.
indicates risk for OSA
Timepoint [1] 377653 0
The secondary outcomes will be assessed at the commencement of the pre-intervention data collection phase using the survey instrument.
Secondary outcome [2] 377932 0
Insomnia - A score >15 on the Insomnia Severity Scale indicates clinical insomnia.
Timepoint [2] 377932 0
The secondary outcomes will be assessed at the commencement of the pre-intervention data collection phase using the survey instrument.
Secondary outcome [3] 377933 0
Shiftwork Disorder - Questions on the Shiftwork Disorder Questionnaire are weighted by
their discriminant function classification coefficient with an outcome of either low risk or high risk.
Timepoint [3] 377933 0
The secondary outcomes will be assessed at the commencement of the pre-intervention data collection phase using the survey instrument.
Secondary outcome [4] 377934 0
Daytime sleepiness as measured by the Epworth Sleepiness Scale. This self-report assessment measures daytime sleepiness through a series of 8 questions about an individual’s chances of falling asleep during different activities
Timepoint [4] 377934 0
The secondary outcomes will be assessed at the commencement of the pre-intervention data collection phase using the survey instrument.
Secondary outcome [5] 377935 0
Alcohol use. The Alcohol Use Disorders Identification Test (AUDIT). This survey was developed by the World Health Organization (WHO) as a simple method of screening for excessive drinking
Timepoint [5] 377935 0
The secondary outcomes will be assessed at the commencement of the pre-intervention data collection phase using the survey instrument.

Eligibility
Key inclusion criteria
Shiftworkers from the participating organisation who meet the below criteria will be eligible to participate in this research.
1, Participants should be available for the duration of the study with no annual leave booked.
2. Participants should be undertaking the identified roster pattern that includes working days and nights for the duration of the study.
3. Participants shift start and finish times should be those identified for the study.
4. Participants must have access to a smartphone or tablet device to download the Fatigue Science mobile app and receive daily sleep feedback (required if assigned to intervention groups 2 and 3).

Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
There are no exclusion criteria for this study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participant identification (ID) numbers will be randomly assigned to a letter.
As each new person enters the study (i.e. meets the criteria and has signed the consent form) the next ID number and the predetermined group is assigned.
An independent person will assign the groups to A, B, C, D, to ensure the allocation is random. Allocation will involve contacting the holder of the allocation schedule who is “off-site”.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation will be used to randomly and evenly assigned to either the control group or one of the three intervention groups
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size
Statistical power analysis was conducted using G*Power version 3.0.10 and indicated that a minimum total sample of 68 participants would be needed to detect a medium effect (Cohen’s f2=0.25) with 80% power and 1% level of significance (a) based on a repeated measures ANOVA design. The specified a is corrected to account for multiple outcomes, i.e. sleep onset latency, sleep duration, wake after sleep onset, fragmentation index and sleep efficiency.
Assuming an estimated 20% attrition, a total sample of 85 participants will be recruited for this study. This equates to 22 participants (rounded up) across each of the four study groups.

Statistical analysis
This study will test the effect of the independent variables, sleep education and the daily feedback on sleep via the mobile app on the dependent variables, sleep duration, sleep onset latency, wake after sleep onset, fragmentation index, sleep efficiency, sleep onset and time in bed.
Descriptive statistics in the form of mean, standard deviation and frequency will be used to summarise the data. A repeated measures ANOVA analysis will be utilised and the Group×Time interaction effect will be tested to assesses (pre-post) changes in (a) the dependent sleep variables within each of the study group, and whether these changes (if any) (b) are the same across all study groups. All analyses will be performed using SPSS v25. Due to multiple outcomes, Benjamini-Hochberg procedure will be used to correct the ensuing p-values to ensure Type I error is not unduly inflated. Significance is achieved if the corrected p<0.05 . Effect sizes, i.e. Cohen’s d and partial eta-squared will be presented where appropriate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 304461 0
Commercial sector/Industry
Name [1] 304461 0
Melius Consulting
Address [1] 304461 0
45 Ventnor Avenue, West Perth, Western Australia, 6005
Country [1] 304461 0
Australia
Primary sponsor type
Individual
Name
Gemma Maisey
Address
Edith Cowan University
270 Joondalup Drive, Joondalup, Perth WA 6027|
Country
Australia
Secondary sponsor category [1] 304732 0
University
Name [1] 304732 0
Edith Cowan University
Address [1] 304732 0
Edith Cowan University
270 Joondalup Drive, Joondalup, Perth WA 6027|
Country [1] 304732 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304895 0
The ECU Human Research Ethics Committee (HREC)
Ethics committee address [1] 304895 0
Edith Cowan University
270 Joondalup Drive, Joondalup, Perth WA 6027|
Ethics committee country [1] 304895 0
Australia
Date submitted for ethics approval [1] 304895 0
27/10/2019
Approval date [1] 304895 0
03/12/2019
Ethics approval number [1] 304895 0
2019-00813-MAISEY

Summary
Brief summary
A multi-armed randomised control trial to assess the effectiveness of sleep education and wrist-activity monitors that provide daily feedback on sleep . These interventions were selected as they are frequently used by shiftwork organisations as part of a systematic approach to manage fatigue risk. However, the effectiveness of these interventions is somewhat unknown. An assessment of sleep quality, quantity, and cognitive performance will follow these interventions using both subjective and objective measures.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98562 0
Mrs Gemma Maisey
Address 98562 0
Edith Cowan University
270 Joondalup Drive
Joondalup
Western Australia 6027|
Country 98562 0
Australia
Phone 98562 0
+61 0409825087
Fax 98562 0
Email 98562 0
gmaisey@our.ecu.edu.au
Contact person for public queries
Name 98563 0
Mrs Gemma Maisey
Address 98563 0
Edith Cowan University
270 Joondalup Drive
Joondalup
Western Australia 6027|
Country 98563 0
Australia
Phone 98563 0
+61 0409825087
Fax 98563 0
Email 98563 0
gmaisey@our.ecu.edu.au
Contact person for scientific queries
Name 98564 0
Mrs Gemma Maisey
Address 98564 0
Edith Cowan University
270 Joondalup Drive
Joondalup
Western Australia 6027|
Country 98564 0
Australia
Phone 98564 0
+61 0409825087
Fax 98564 0
Email 98564 0
gmaisey@our.ecu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As agreed and requested by the participating organisation individual data will not be available.
What supporting documents are/will be available?
No other documents available
Summary results
No Results