Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12620000394943
Ethics application status
Approved
Date submitted
6/03/2020
Date registered
23/03/2020
Date last updated
18/06/2020
Date data sharing statement initially provided
23/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial to evaluate the effectiveness of ACCESS (Airline Cabin Crew Educational Strategies for Sleep) program for tired airline cabin crew.
Scientific title
A randomised controlled trial to evaluate the effectiveness of ACCESS (Airline Cabin Crew Educational Strategies for Sleep) program for tired airline cabin crew.
Secondary ID [1] 300594 0
None
Universal Trial Number (UTN)
Trial acronym
ACCESS (Airline Cabin Crew Educational Strategies for Sleep)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleepiness 316339 0
Insomnia 316340 0
Fatigue 316468 0
Condition category
Condition code
Mental Health 314598 314598 0 0
Depression
Public Health 314599 314599 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There is only one intervention group in this study - ACCESS (Airline Cabin Crew Educational Strategies for Sleep). Eligible participants will be randomised into either intervention or control group. ACCESS participants will receive an online education program based on the relevant components from the cognitive behavioural therapy of insomnia (CBTi). This will be carried out over four weeks, with 2 emails per week (a total of 8 emails for the duration of the intervention). Intervention emails will include information on sleep education focusing on the science of sleep and its benefits, shift work and jet lag management strategies, sleep hygiene and relaxation.
This program differs from the control treatment, whereby participants are introduced to lifestyle and behavioural strategies to improve sleep. Strategies such as the use of stimulus control (i.e. use bedroom for sleep only, and leave bedroom if not sleepy), strategic napping, use of caffeine, alcohol and nicotine, environment setup for better sleep and relaxation techniques. The control treatment will receive basic sleep education that is information based, with no suggested behavioural changes.
At the mid-point and endpoint of the intervention, participants will receive a survey which includes some progress tracking questions, and measures on their sleepiness, insomnia symptoms and fatigue. The progress tracking questions are related to the contents of the participated program (i.e. either ACCESS treatment or control treatment) and will be used to monitor adherence to the intervention.
Participants wearing a Fitbit will be asked to share their sleep data with the researcher, and local participants (Victoria, Australia) will be offered an actigraphy watch (an activity watch similar to a Fitbit, however, only monitors sleep / wake data based on body movement) to send to them to wear for the duration of the study. Participants are asked to provide their work roster to act as a work diary, and send updates on the roster as necessary.
Pre and post intervention survey will be carried out for all participants, this measures insomnia, sleepiness, fatigue, shift work disorder, depression, anxiety, chronotype, individual habits and their operation details.
Intervention code [1] 316910 0
Behaviour
Intervention code [2] 317105 0
Treatment: Other
Comparator / control treatment
Eligible participants that are randomly allocated to the control group will receive a standard sleep education program. There will be a total of 8 emails over 4 weeks, and the emails are information based, with no suggested behaviour change. Email contents include sleep and its benefits, sleep drive, stages of sleep, sleep across lifespan, sleep disorders, and sleep deprivation and its consequences.
As participants are not aware which group they were randomly allocated to, therefore the study flow design will remain the same as the intervention group:
At the mid-point and endpoint of the intervention, participants will receive a survey which includes some progress tracking questions, and measures on sleepiness, insomnia symptoms and fatigue.
As with intervention/ exposure condition, participants wearing a Fitbit will be asked to share their sleep data with the researcher, and local participants (Victoria, Australia) will be offered an actigraphy watch to send to them to wear for the duration of the study. Participants are asked to provide their work roster to act as a work diary, and send updates on the roster as necessary.
Pre and post intervention survey will be carried out for all participants, this measures insomnia, sleepiness, fatigue, shift work disorder, depression, anxiety, chronotype, individual habits and their operation details.
Control group
Active

Outcomes
Primary outcome [1] 322939 0
Sleep Condition Indicator
Timepoint [1] 322939 0
Pre-intervention, mid intervention (at mid point and end point of intervention) and one week post intervention
Primary outcome [2] 322940 0
Epworth Sleepiness Scale
Timepoint [2] 322940 0
Pre-intervention, mid intervention (at mid point and end point of intervention) and one week post intervention
Primary outcome [3] 322941 0
Flinders Fatigue Scale
Timepoint [3] 322941 0
Pre-intervention, mid intervention (at mid point and end point of intervention) and one week post intervention
Secondary outcome [1] 380305 0
Shift Work Disorder Questionnaire
Timepoint [1] 380305 0
Pre- intervention and one week post intervention
Secondary outcome [2] 380306 0
Depression Anxiety Stress Scale
Timepoint [2] 380306 0
Pre- intervention and one week post intervention
Secondary outcome [3] 381004 0
Objective Sleep (actigraphy) Measures
Timepoint [3] 381004 0
Participant will wear the actigraphy watch from pre-intervention until one week post intervention

Eligibility
Key inclusion criteria
Currently active cabin crew from around the world who are working full-time. This includes cabin crew who flies all routes, ie. international, domestic or both. From the screening process, only cabin crew that score in the unhealthy range of either daytime sleepiness (Epworth Sleepiness Score greater than 10 ) or insomnia (Sleep Condition Indicator less than or equal to 16) scales will be included for study.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Full time cabin crew that scores in the healthy range for both daytime sleepiness and insomnia scales.

Study design
Purpose of the study
Educational / counselling / training
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2021
Actual
Date of last participant enrolment
Anticipated
1/10/2021
Actual
Date of last data collection
Anticipated
15/11/2021
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 305014 0
University
Name [1] 305014 0
The University of Melbourne
Country [1] 305014 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Parkville, Victoria 3010
Country
Australia
Secondary sponsor category [1] 305371 0
None
Name [1] 305371 0
Address [1] 305371 0
Country [1] 305371 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305411 0
The University of Melbourne. Psychology, Health and Applied Sciences Human Ethics Sub-Committee (HESC)
Ethics committee address [1] 305411 0
Ethics committee country [1] 305411 0
Australia
Date submitted for ethics approval [1] 305411 0
03/10/2019
Approval date [1] 305411 0
01/11/2019
Ethics approval number [1] 305411 0
1955023

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

Contacts
Principal investigator
Name 100290 0
Prof Amy Jordan
Address 100290 0
Level 9, Redmond Barry Building, Tin Alley
The University of Melbourne
Parkville, VIC, 3010
Country 100290 0
Australia
Phone 100290 0
+61 38344 6357
Fax 100290 0
Email 100290 0
[email protected]
Contact person for public queries
Name 100291 0
Candice Chien-Yu Wen
Address 100291 0
Level 9, Redmond Barry Building, Tin Alley
The University of Melbourne
Parkville, VIC, 3010
Country 100291 0
Australia
Phone 100291 0
+61 383444911
Fax 100291 0
Email 100291 0
[email protected]
Contact person for scientific queries
Name 100292 0
Christian Nicholas
Address 100292 0
Level 9, Redmond Barry Building, Tin Alley
The University of Melbourne
Parkville, VIC, 3010
Country 100292 0
Australia
Phone 100292 0
+61 3 8344 3935
Fax 100292 0
Email 100292 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.