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Trial registered on ANZCTR


Registration number
ACTRN12616000369426
Ethics application status
Approved
Date submitted
16/03/2016
Date registered
22/03/2016
Date last updated
22/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Sleep health management for healthcare workers
Scientific title
Individual-level toolkit for sleep health management in healthcare shift workers who working evening/night shift
Secondary ID [1] 288773 0
nil known
Universal Trial Number (UTN)
Trial acronym
S.W.I.M

Shift Work Individual Management
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shift Work 298034 0
Circadian Rhythm Sleep Problems 298035 0
Condition category
Condition code
Neurological 298192 298192 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention for poor shift work responsiveness has two components. Firstly, the participant will receive a group education session (approx 20 minutes) about the impact of shift work on sleep, health and other factors. The education sessions will be delivered by the trial co-coordinator/Phd in sleep, ICU nurse/PhD for this study, researcher/PhD for this study, The education will also outline some general principles that will help the participant to adapt their sleep cycle to shift work. The education will be based on the following general recommendations:
1. Nap approximately 8 to 9 hours after wake time in the afternoon prior to the first night shift. Ideally, nap for approximately 2 hours (or as long as possible), but the earlier the awakening the longer the nap required. For example, those who awake at 6am should nap for 2 hours, whereas those who awake at 10am may only require a 30 minute nap. For subsequent night shifts that nap time would be in the late afternoon to early evening.
2. Bright light during all work hours;
3. Caffeine use (excluding those with contraindications to caffeine use): Recommend caffeine use of 60 mg (approximately one 250ml cup of instant coffee OR one 55ml latte/cappuccino) up to every 2 hours until 6 hours before you plan to sleep when working night shifts and 9 hours before you plan to sleep on day shifts;
4. Exercise during breaks on the overnight shift for approximately 20 minutes (low to moderate intensity, e.g., go for a short walk);
5. Go home and attempt to sleep as soon as possible after ending work, and sleep in as long as possible;
6. Use eye mask, ear plugs and turning off phones and pagers. Tell others in your house that you are not to be disturbed;
7. Melatonin (1-3 mg), no additives, taken as soon as arrive home (note that melatonin will not be provided as a part of the study to the participants; if the participant decides they want melatonin they will be told to see their GP and obtain a referral);
8. Limit exposure to light and remain indoors immediately upon arrival at home.

Secondly, the participant will be coached by the researcher who conduct the education session on how to develop a more individualised schedule that helps plan the undertaking of necessary measures to adapt to shift work. The individualised schedule will be based on the participants’ rostered sequence of shift type (e.g., night) and are therefore likely to differ across participants. Each schedule will consider the following factors: scheduling sleep/nap times; sleep hygiene; melatonin; dietary factors such as meal planning and caffeine intake; timed bright light exposure; and exercise. The researcher will receive the participants roster before the meeting so they can plan the schedule before the meeting, with the assistance of the rest of the research team (included in the researcher team are experts on circadian rhythm and sleep, sleep physician, experts on sleep in shift workers).




The intervention will last for 8 to 12 weeks, and consist of four meetings (20 minutes each meeting) approximately every fortnight between the researcher and the participant to discuss the participant’s response to the schedule. The meetings will also serve to improve compliance, resolve issues they may have encountered.


Participants who are at-risk for OSA or insomnia will Receive a referral to a sleep physician (OSA) or sleep psychologist (Insomnia)
Intervention code [1] 294213 0
Treatment: Other
Intervention code [2] 294228 0
Lifestyle
Intervention code [3] 294229 0
Behaviour
Comparator / control treatment
The control group will be structured exactly the same way as the intervention group (e.g., 4 fortnightly meetings), except it will focus on low GI diet rather than sleep and circadian rhythm processes. The idea was to find something that has high face validity in helping improve how people respond to shift work, but theoretically will impact little or not at all. Since focusing on a low GI diet only has high face validity and doesn't effect the circadian rhythm and therefore is unlikely to affect sleep in shift workers, we deemed this approach good for the control group. It will act like a placebo group.

The information that will be given to participant low in the control group the fact that shift worker are at higher risk for more unhealthy diets, GI diets to be given to the participant will focus on the effect of high GI food on health, alertness; the effect of low GI food on health, alertness. The type most common that are low GI and high GI.

Participant will also receive a diet-related equivalent indivualised schedule.

This program will be given only to participant who are who found to be at-risk for poor shift-work responsiveness.
Control group
Placebo

Outcomes
Primary outcome [1] 297698 0
Sick Leave

Linkage to hospital HR database.
Timepoint [1] 297698 0
Baseline

Follow-up 1 (approximately 12-14 weeks after baseline)

Follow-up 2 (approximately 3 months after follow-up 1)
Primary outcome [2] 297699 0
Medical Errors

link to hospital HR
Timepoint [2] 297699 0
Baseline

Follow-up 1 (approximately 12-14 weeks after baseline)

Follow-up 2 (approximately 3 months after follow-up 1)
Secondary outcome [1] 321899 0
Depression
Patient-Health Questionnaire
Timepoint [1] 321899 0
Baseline

Follow-up 1 (approximately 12-14 weeks after baseline)

Follow-up 2 (approximately 3 months after follow-up 1)
Secondary outcome [2] 321902 0
Functionality after Sleepiness

Functional Outcomes of Sleep Questionnaire
Timepoint [2] 321902 0
Baseline

Follow-up 1 (approximately 12-14 weeks after baseline)

Follow-up 2 (approximately 3 months after follow-up 1)
Secondary outcome [3] 321905 0
Sleepiness

Epworth Sleepiness Scale
Timepoint [3] 321905 0
Baseline

Follow-up 1 (approximately 12-14 weeks after baseline)

Follow-up 2 (approximately 3 months after follow-up 1)
Secondary outcome [4] 321907 0
Sleepiness whilst driving

Driving Diary
Timepoint [4] 321907 0
Baseline

Follow-up 1 (approximately 12-14 weeks after baseline)

Follow-up 2 (approximately 3 months after follow-up 1)
Secondary outcome [5] 321908 0
Sleep initiation

Sleep diary
Timepoint [5] 321908 0
Baseline

Follow-up 1 (approximately 12-14 weeks after baseline)

Follow-up 2 (approximately 3 months after follow-up 1)
Secondary outcome [6] 321969 0
Total Sleep Time

Sleep Diaries
Timepoint [6] 321969 0
Baseline (completed daily for 2 week before intervention begins)

Follow-up 1 (approximately 12-14 weeks after baseline)
- completed daily for 2 week directly after intervention finishes

Follow-up 2 (approximately 3 months after follow-up 1)
- completed daily for 2 week approximately 3 months after follow-up diaries
Secondary outcome [7] 322041 0
Near misses

Driving diary
Timepoint [7] 322041 0
Baseline

Follow-up 1 (approximately 12-14 weeks after baseline)

Follow-up 2 (approximately 3 months after follow-up 1)
Secondary outcome [8] 322042 0
Dangerous driving events

Driving diary
Timepoint [8] 322042 0
Baseline

Follow-up 1 (approximately 12-14 weeks after baseline)

Follow-up 2 (approximately 3 months after follow-up 1)
Secondary outcome [9] 322978 0
Anxiety
Generalised Anxiety Disorder
Timepoint [9] 322978 0
Baseline
Follow-up 1 (approximately 12-14 weeks after baseline)
Follow-up 2(approximately 3 months after follow-up 1)

Eligibility
Key inclusion criteria
* For screening, participants must be 18+ and employed by either Austin Health or Flinders Medical Centre in any capacity.

*Rotating, or permanent evening/night shifts
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Staff member is expected to change ward before the follow-up period.

* Participants in program 2 (the control group) who have received treatment for sleep disorders during the follow-up period.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
First, wards were paired based on sick leave statistics and number of eligible staff members in ward. Then, simple randomisation using procedures like coin-tossing and dice-rolling.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Clustered Randomised Control Trial
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/03/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
552
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 5454 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 5455 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment hospital [3] 5456 0
Flinders Medical Centre - Bedford Park

Funding & Sponsors
Funding source category [1] 293139 0
Other
Name [1] 293139 0
Cooperative Research Centre for Alertness, Safety and Productivity
Country [1] 293139 0
Australia
Primary sponsor type
Other
Name
Austin Health
Address
Bowen Centre, Austin Hospital
145 Studley Road
Heidelberg, Victoria, 3084
Country
Australia
Secondary sponsor category [1] 291935 0
Hospital
Name [1] 291935 0
Flinders Medical Centre
Address [1] 291935 0
Flinders Dr, Bedford Park SA 5042
Country [1] 291935 0
Australia
Other collaborator category [1] 278892 0
University
Name [1] 278892 0
Monash University
Address [1] 278892 0
Ground Floor, BASE

270 Ferntree Gully Road,

NOTTING HILL VIC 3168
Country [1] 278892 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294636 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 294636 0
145 Studley Rd, Heidelberg VIC 3084
Ethics committee country [1] 294636 0
Australia
Date submitted for ethics approval [1] 294636 0
06/05/2015
Approval date [1] 294636 0
02/07/2015
Ethics approval number [1] 294636 0
HREC/15/Austin/162

Summary
Brief summary
This study aims to develop and assess the effectiveness of an individual based intervention for sleep problems in shift workers, and will be conducted in operational settings (i.e., Austin Hospital and Flinders Medical Centre). The targeted sleep problems include poor shift work responsiveness, insomnia and obstructive sleep apnoea/sleep disordered breathing. The effectiveness of the treatment will be based on whether or not shift work responsiveness, insomnia, obstructive sleep apnoea, sick and carers leave, RiskMan data (e.g., staff and patient related incidents), symptoms of mental health problems (depression and anxiety), sleepiness and functionality decrease from before the treatment to after the treatment. The project will also determine whether or not those who have been randomly assigned to the intervention group (labeled program 1) have lower levels of the aforementioned than those randomly assigned to the control group (labeled program 2). The labels “program 1” and “program 2” will be used to help blind the participants to the intervention and control group.
While laboratory and clinical studies demonstrate benefits from the proposed interventions, research has yet to assess the impact of comprehensive sleep health management for shift workers in an operational setting. Developing an individual-level treatment method to improve sleep health and to identify and manage sleep problems in hospital staff will lead to better health outcomes for staff, improved alertness and patient outcomes, and in turn reduced costs of days lost (e.g., from sick leave) within the workplace.
Participants will be allocated to Program 1 or Program 2. Both groups will receive an educational presentation; the talk for Program 1 will focus on sleep health, circadian rhythms and scheduling, whereas the talk for program 2 will be designed to seemingly but not actually assist in improving sleep or scheduling. From here, both groups will be given a questionnaire that will take approximately 30 minutes. For those in the intervention group, the answers to the questionnaire will then be used to identify those who are at risk for poor shift work responsiveness, insomnia and obstructive sleep apnoea. Those who are identified with a potential sleep problem will then receive further treatment. Follow-up questionnaires that are identical to those answered originally will then be completed directly after the treatment procedures end for those in the intervention group. Sick leave data will be collected at the end of each financial year with help from the Austin Hospital and Flinders Medical Centre.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64434 0
A/Prof Mark Howard
Address 64434 0
Bowen Centre, Austin Hospital
145 Studley Road
Heidelberg, Victoria, 3084
Country 64434 0
Australia
Phone 64434 0
+61 3 94963663
Fax 64434 0
Email 64434 0
[email protected]
Contact person for public queries
Name 64435 0
Mark Howard
Address 64435 0
Bowen Centre, Austin Hospital
145 Studley Road
Heidelberg, Victoria, 3084
Country 64435 0
Australia
Phone 64435 0
+61 3 94963663
Fax 64435 0
Email 64435 0
[email protected]
Contact person for scientific queries
Name 64436 0
Mark Howard
Address 64436 0
Bowen Centre, Austin Hospital
145 Studley Road
Heidelberg, Victoria, 3084
Country 64436 0
Australia
Phone 64436 0
+61 3 94963663
Fax 64436 0
Email 64436 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
SourceTitleYear of PublicationDOI
EmbaseExploring the associations between shift work disorder, depression, anxiety and sick leave taken amongst nurses.2020https://dx.doi.org/10.1111/jsr.12872
EmbaseThe role of sleep hygiene in the risk of Shift Work Disorder in nurses.2020https://dx.doi.org/10.1093/sleep/zsz228
N.B. These documents automatically identified may not have been verified by the study sponsor.