Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000493448
Ethics application status
Approved
Date submitted
4/04/2016
Date registered
15/04/2016
Date last updated
20/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The Young Adults Working Nights program: developing and evaluating a web- and app-based fatigue intervention for young employees.
Scientific title
The Young Adults Working Nights program: developing and evaluating a web- and app-based fatigue intervention for young employees.
Secondary ID [1] 288536 0
None
Universal Trial Number (UTN)
U1111-1179-6576
Trial acronym
YAWN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Loss 297635 0
Fatigue 297636 0
Condition category
Condition code
Public Health 297827 297827 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a website where participants can log in, answer questions about their sleep and work behaviours, and receive personal advice regarding their sleep habits, and how they might improve their sleep. The intervention also includes a smartphone application for tracking sleep behaviour. The overall intervention duration is 4 weeks, with a follow-up survey administered 12-weeks after the intervention is completed. Duration the intervention, participants will log into the website weekly to complete a new module about sleep. The smartphone application will be completed before and after every sleep period. The intervention and smartphone content were developed from focus group findings using a sample of 57 adolescents (32 female, 25 male; mean + SD = 21.12 years + 2.77 years). Focus group questions were developed in line with the key tenets of Social Cognitive Theory, the Theory of Planned Behaviour, and the Elaboration Likelihood Model. Focus group data were analysed using a general inductive approach.

When beginning the intervention, participants log into the YAWN website and receive access to the Baseline survey: You and Your Sleep. The baseline survey assesses demographic information and includes questions about work, study, living and sleeping arrangements, general health status, technology use, sleep quality and hygiene, daytime sleepiness, chronotype (morningness vs. eveningness), sleep behaviours and beliefs, facilitators and impediments to sleep, behavioural sleep strategies, physical activity, and sedentary behaviour. Based on their responses, participants in the intervention condition then receive tailored, personalised feedback. Following this, participants are instructed to use some of the things they have learnt and to use the YAWN app to help them keep track of their sleep habits. The baseline survey will take ~20 minutes to complete.

One week post-baseline, participants are prompted to return to the YAWN website. Intervention participants then gain access to Module 1: Creating the Perfect Sleep Environment. Module 1 assesses participant's bedroom environment, such as comfort, light, temperature and volume. Intervention participants then receive tailored, personalised feedback, are instructed to use some of the things they have learnt and to use the YAWN app to help them keep track of their sleep habits. Module 1 will take ~15 minutes to complete.

Two weeks post-baseline, participants are prompted to return to the YAWN website. Intervention participants then gain access to Module 2: Designing Your Pre-bed Routine. Module 2 assesses participant’s pre-bed behaviours like exercise, napping, eating, and computer/screen time. Intervention participants then receive tailored, personalised feedback, are instructed to use some of the things they have learnt and to use the YAWN app to help them keep track of their sleep habits. Module 2 will take ~15 minutes to complete.

Three weeks post-baseline, participants are prompted to return to the YAWN website. Intervention participants will then gain access to Module 3: Falling Asleep and Staying Asleep. Module 3 assesses participant’s variations in sleep and wake times, ability to fall and stay asleep, and things that prevent them falling asleep and staying asleep. Intervention participants then receive tailored, personalised feedback, are instructed to use some of the things they have learnt and to use the YAWN app to help them keep track of their sleep habits. Module 3 will take ~15 minutes to complete.

For each of the three modules, participants receive tailored feedback immediately after completion of the module. The feedback will use their answers regarding sleep/wake habits and behaviour and provide advice about changes they could make to improve their sleep.

Four weeks post-baseline, participants are prompted to return to the YAWN website. Participants then gain access to the immediate follow-up survey. This re-assesses many of the items from the baseline survey (to observe changes in work, study, living or sleeping arrangements, general health status, technology use, sleep quality and hygiene, daytime sleepiness, chronotype (morningness vs. eveningness), sleep behaviours and beliefs, facilitators and impediments to sleep, behavioural sleep strategies, physical activity, and sedentary behaviour. Both conditions will received questions about the utility of the YAWN website and information. Participants will also complete an assessment of the utility of the YAWN app. Participants will receive a thank you message for participating in the research so far, encouraged to keep working on improving their sleep habits, and informed that the research team will be in touch in eight weeks to check in one last time. The immediate follow-up survey will take ~25 minutes to complete.

Twelve weeks post-baseline, participants are prompted to return to the YAWN website. All participants then gain access to the delayed follow-up survey. This re-assesses many of the items from the baseline and immediate follow up survey. Participants will receive questions about whether they have used the YAWN website or app since completing the study. After completion of the delayed follow-up survey, participants will receive a link to follow in order to enter the draw to win an iPad mini (10 to give-away). The delayed follow-up survey will take ~25 minutes to complete.

Participants are asked to use a smartphone application to log their sleep and wake behaviour. The application is to be completed at the beginning and end of every sleep period (i.e. at bed time and wake time). The smartphone application asks participants to set a goal bed and wake time. The participant can then set reminders when their goal bed time is approaching, and alarms to wake them at their desired wake time. Before bed time participants record their bed time, pre-sleep fatigue level (on a scale of 1 = full alert to 7= completely exhausted), and set their wake alarm. After waking participants record their wake time, post-sleep fatigue level (on a scale of 1 = full alert to 7= completely exhausted), sleep quality (1= very poor - 5 = very good), and sleep sufficiency rating (1=definitely too little - 5 = definitely enough). Completion of the app should take ~5 minutes per day.

Intervention adherence will be tracked by log-ins to the website, as well as the completion of the website modules, and the daily tracking of sleep/wake behaviours via the app. We have included multiple-choice response and free text response questions for participants about the utility of the website and app, and reasons for use or non-use.
Intervention code [1] 293912 0
Behaviour
Intervention code [2] 293913 0
Lifestyle
Intervention code [3] 294477 0
Treatment: Devices
Comparator / control treatment
The control condition will receive weekly access to static information about healthy sleep and wake behaviour via the YAWN website.

When beginning the intervention, control participants log into the YAWN website and receive access to the Baseline survey: You and Your Sleep. The baseline survey assesses demographic information and includes questions about work, study, living and sleeping arrangements, general health status, technology use, sleep quality and hygiene, daytime sleepiness, chronotype (morningness vs. eveningness), sleep behaviours and beliefs, facilitators and impediments to sleep, behavioural sleep strategies, physical activity, and sedentary behaviour. They then receive access to a page of static information with general hints and tips for getting a better sleep. The baseline survey will take ~20 minutes to complete.

One week post-baseline, participants are prompted to return to the YAWN website. Control participants can then access a page of static information with general tips about creating a good sleep environment, i.e. comfort, light, temperature and volume. Reading this information will take ~10 minutes.

Two weeks post-baseline, participants are prompted to return to the YAWN website. Control participants can then access a page of static information with general tips about pre-bed routines, i.e. exercise, napping, eating, and computer/screen time. Reading this information will take ~10 minutes.

Three weeks post-baseline, participants are prompted to return to the YAWN website. Control participants can then access a page of static information with general tips about falling asleep and staying asleep, i.e. variations in sleep and wake times, ability to fall and stay asleep, and things that prevent people falling asleep and staying asleep. Reading this information will take ~10 minutes.

Four weeks post-baseline, participants are prompted to return to the YAWN website. Participants then gain access to the immediate follow-up survey. This re-assesses many of the items from the baseline survey (to observe changes in work, study, living or sleeping arrangements, general health status, technology use, sleep quality and hygiene, daytime sleepiness, chronotype (morningness vs. eveningness), sleep behaviours and beliefs, facilitators and impediments to sleep, behavioural sleep strategies, physical activity, and sedentary behaviour. There will also be questions about the utility of the YAWN website and information. Participants will receive a thank you message for participating in the research so far, encouraged to keep working on improving their sleep habits, and informed that the research team will be in touch in eight weeks to check in one last time. The immediate follow-up survey will take ~25 minutes to complete.

Twelve weeks post-baseline, participants are prompted to return to the YAWN website. All participants then gain access to the delayed follow-up survey. This re-assesses many of the items from the baseline and immediate follow up survey. Participants will receive questions about whether they have used the YAWN website since completing the study. After completion of the delayed follow-up survey, participants will receive a link to follow in order to enter the draw to win an iPad mini (10 to give-away). The delayed follow-up survey will take ~25 minutes to complete.
Control group
Active

Outcomes
Primary outcome [1] 297884 0
Subjective sleep duration as determined by self-reported sleep and wake times
Timepoint [1] 297884 0
4-weeks post baseline, as well as 12-weeks post baseline.
Primary outcome [2] 297885 0
Subjective sleep quality as determined by scores on the Pittsburgh Sleep Quality Index
Timepoint [2] 297885 0
4-weeks post baseline, as well as 12-weeks post baseline.
Secondary outcome [1] 322518 0
Sleep hygiene behaviours as measured by self-report. The questions used to assess sleep hygiene behaviours were designed specifically for this study based on the findings of focus groups with n=57 young workers (16-25y).
Timepoint [1] 322518 0
4-weeks post baseline, as well as 12-weeks post baseline.
Secondary outcome [2] 322837 0
Subjective fatigue as measured by the Samn-Perelli Fatigue Scale
Timepoint [2] 322837 0
4-weeks post baseline, as well as 12-weeks post baseline.

Eligibility
Key inclusion criteria
Currently employed, living in Australia, must own an Apple or Android phone device with Internet access. Participants also need to be able to access the Internet on a computer, laptop, or tablet device.
Minimum age
16 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of sleep disorders

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/05/2016
Actual
Date of last participant enrolment
Anticipated
31/03/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 293273 0
Government body
Name [1] 293273 0
SafeWork South Australia
Country [1] 293273 0
Australia
Primary sponsor type
Individual
Name
Dr. Jessica L Paterson
Address
Central Queensland University
Appleton Institute
PO Box 42, Goodwood SA 5034
Country
Australia
Secondary sponsor category [1] 292079 0
None
Name [1] 292079 0
Address [1] 292079 0
Country [1] 292079 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294751 0
Central Queensland University Human Research Ethics Committee
Ethics committee address [1] 294751 0
Ethics committee country [1] 294751 0
Australia
Date submitted for ethics approval [1] 294751 0
30/03/2016
Approval date [1] 294751 0
30/03/2016
Ethics approval number [1] 294751 0

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

Contacts
Principal investigator
Name 63542 0
Dr Jessica L. Paterson
Address 63542 0
Central Queensland University
Appleton Institute
PO Box 42, Goodwood SA 5034
Country 63542 0
Australia
Phone 63542 0
+618 8378 4519
Fax 63542 0
Email 63542 0
[email protected]
Contact person for public queries
Name 63543 0
Jessica L. Paterson
Address 63543 0
Central Queensland University
Appleton Institute
PO Box 42, Goodwood SA 5034
Country 63543 0
Australia
Phone 63543 0
+618 8378 4519
Fax 63543 0
Email 63543 0
[email protected]
Contact person for scientific queries
Name 63544 0
Jessica L. Paterson
Address 63544 0
Central Queensland University
Appleton Institute
PO Box 42, Goodwood SA 5034
Country 63544 0
Australia
Phone 63544 0
+618 8378 4519
Fax 63544 0
Email 63544 0
[email protected]

No information has been provided regarding IPD availability


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.