Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000059965
Ethics application status
Approved
Date submitted
18/12/2019
Date registered
24/01/2020
Date last updated
19/10/2023
Date data sharing statement initially provided
24/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
QAS & Sleepfit Project: Investigating the impact of a healthy sleep practice-based intervention on the sleep, health, and wellbeing of shift working paramedics
Scientific title
QAS & Sleepfit Project: Investigating the impact of a healthy sleep practice-based intervention on the sleep, health, and wellbeing of shift working paramedics
Secondary ID [1] 299963 0
Nil known
Universal Trial Number (UTN)
U1111-1244-7409
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Disturbances 315420 0
Physiological Wellbeing 315801 0
Condition category
Condition code
Public Health 313716 313716 0 0
Health promotion/education
Neurological 314240 314240 0 0
Studies of the normal brain and nervous system
Mental Health 314241 314241 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sleepfit is a mobile application (m-health intervention) being utilised in an attempt to improve the healthy sleep practices amongst shift working paramedics. Sleepfit contains educational content that has been developed by sleep researchers, utilising current, best-practice literature. Specifically, it contains educational material (in the form of quizzes, short reading items etc.) that aim to address the healthy sleep practices of: consistency of sleep schedule, daytime napping, consumption of caffeine, nicotine, and alcohol, eating a healthy diet, engaging in regular exercise, engaging in relaxing bedtime activities, and maintaining a cool, dark, and quiet bedroom environment. Sleepfit will aim to improve engagement with these healthy sleep practices through a range of educational formats, including interactive reading material and quizzes. Participants who have access to Sleepfit (those in the intervention group) will be able to access the application on their smartphone device at any time of the day or night, and in any location of their choosing, over a 2-week period. Participants will have access to Sleepfit at no cost, and are free to utilise as much or as little as they see fit. However, they will be encouraged to complete a sleep diary each day, which will require approximately 5 minutes of active usage. Participant usage will be assessed through app analytics, with data collected including number and nature of activities completed and number of diary entries made during the intervention period. This intervention is based on an existing Sleepfit product, which has been tailored for use in shift working individuals. The original mobile application has been successfully utilised in individuals who work standard hours (i.e., 9am-5pm), and alterations have been made in collaboration between sleep researchers and Sleepfit developers. Pre- and post-test measures (online questionnaires) will be utilised to assess a range of health and lifestyle factors, mainly: sleep quality and quantity and engagement with healthy sleep practices (those listed earlier), as well as intervention engagement metrics.
Intervention code [1] 316228 0
Behaviour
Intervention code [2] 316513 0
Treatment: Devices
Intervention code [3] 316514 0
Lifestyle
Comparator / control treatment
Participants not engaging with the Sleepfit intervention (waitlist control group) will be delayed in accessing the app for a period of 2 weeks, to allow for an intervention-control analysis between groups. All participants will be rotated through the intervention period, allowing all to engage with the app for a period of 2 weeks. All participants will complete the same pre-/post-test measures.
Control group
Active

Outcomes
Primary outcome [1] 322136 0
Standard Shiftwork Index
Timepoint [1] 322136 0
Pre-Intervention, immediately Post-Intervention (4 weeks apart)
Primary outcome [2] 322137 0
Sleep Hygiene Index
Timepoint [2] 322137 0
Pre-Intervention, immediately Post-Intervention (4 weeks apart)
Primary outcome [3] 322138 0
Shiftwork Disorder Screening Questionnaire
Timepoint [3] 322138 0
Pre-Intervention, immediately Post-Intervention (4 weeks apart)
Secondary outcome [1] 377452 0
WHO Health and Work Performance Questionnaire
Timepoint [1] 377452 0
Pre-Intervention, immediately Post-Intervention (4 weeks apart)

Eligibility
Key inclusion criteria
Current employee with Queensland Ambulance Service, acting in operational or communications role (and therefore engaging in shift work) which includes: on-road paramedics, emergency call-takers and dispatchers, non-acute patient transport services, various on-road managerial roles
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Queensland Ambulance Service employees who: are not engaging in shift work (e.g., those in managerial roles who are office-based and work set, standard hours), or do not have daily access to a smartphone.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation via randomisation table created by statistical software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A minimum total sample size of 30 participants (i.e., 15 participants per group) is required, given the pilot trial nature of the study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/02/2020
Actual
9/08/2021
Date of last participant enrolment
Anticipated
17/02/2020
Actual
30/04/2022
Date of last data collection
Anticipated
30/03/2020
Actual
30/08/2022
Sample size
Target
30
Accrual to date
Final
58
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 304425 0
University
Name [1] 304425 0
Central Queensland University
Country [1] 304425 0
Australia
Primary sponsor type
University
Name
Central Queensland University
Address
Appleton Institute; 44 Greenhill Road, Wayville, Adelaide, SA 5034
Country
Australia
Secondary sponsor category [1] 304683 0
None
Name [1] 304683 0
Address [1] 304683 0
Country [1] 304683 0
Other collaborator category [1] 281082 0
Government body
Name [1] 281082 0
Queensland Ambulance Service
Address [1] 281082 0
Corner Park & Kedron Park Road, Kedron Park, QLD 4031
Country [1] 281082 0
Australia
Other collaborator category [2] 281083 0
Commercial sector/Industry
Name [2] 281083 0
Sleepfit
Address [2] 281083 0
223 Liverpool Street, Darlinghurst, NSW 2010
Country [2] 281083 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304861 0
CQUniversity Human Research Ethics Committee
Ethics committee address [1] 304861 0
Ethics committee country [1] 304861 0
Australia
Date submitted for ethics approval [1] 304861 0
Approval date [1] 304861 0
16/07/2019
Ethics approval number [1] 304861 0
0000021715

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

Contacts
Principal investigator
Name 98438 0
Mrs Alexandra Shriane
Address 98438 0
CQUniversity/Appleton Institute; 44 Greenhill Road, Wayville, Adelaide SA 5034
Country 98438 0
Australia
Phone 98438 0
+61 411543796
Fax 98438 0
Email 98438 0
[email protected]
Contact person for public queries
Name 98439 0
Alexandra Shriane
Address 98439 0
CQUniversity/Appleton Institute; 44 Greenhill Road, Wayville, Adelaide SA 5034
Country 98439 0
Australia
Phone 98439 0
+61 411543796
Fax 98439 0
Email 98439 0
[email protected]
Contact person for scientific queries
Name 98440 0
Alexandra Shriane
Address 98440 0
CQUniversity/Appleton Institute; 44 Greenhill Road, Wayville, Adelaide SA 5034
Country 98440 0
Australia
Phone 98440 0
+61 411543796
Fax 98440 0
Email 98440 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified participant data directly pertaining to results published
When will data be available (start and end dates)?
From time of formal publication (estimated mid-late 2021), with no formal end date anticipated.
Available to whom?
Case-by-case basis at the discretion of research team
Available for what types of analyses?
Case-by-case basis at the discretion of research team
How or where can data be obtained?
Access subject to approval by research team, with emailing of principal investigator ([email protected]) required to discuss dissemination of results.


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.