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Trial registered on ANZCTR


Registration number
ACTRN12617000353392
Ethics application status
Approved
Date submitted
28/02/2017
Date registered
8/03/2017
Date last updated
15/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
How a sleep clinical pathway in an inpatient rehabilitation centre may help with sleep and recovery.
Scientific title
The effectiveness of a sleep clinical pathway an inpatient rehabilitation setting: a randomised control trial
Secondary ID [1] 291302 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poor Sleep 302271 0
Condition category
Condition code
Physical Medicine / Rehabilitation 301864 301864 0 0
Other physical medicine / rehabilitation
Respiratory 301865 301865 0 0
Sleep apnoea
Musculoskeletal 301866 301866 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive management of their sleep disturbance through clinician use of a sleep assessment and management clinical pathway which will be recorded in the medical history of the patient.
This pathway has been developed collaboratively by the rehabilitation and sleep clinicians at the Royal Melbourne Hospital and consists of two parts – a simplified sleep history and a pathway providing sleep optimisation strategies. Guidelines and resources used included the National Sleep Foundation, the Australian National Stroke Foundation, and elements of the Pittsburgh Sleep Quality Index.
Rehabilitation clinicians (with a focus particularly on medical, nursing and pharmacy staff) will be invited to a one hour group face-to-face education session, conducted by a sleep physician on managing sleep in hospitals, including use of the pathway. Sleep hygiene written educational material in three languages (English, Greek and Italian) sourced from the National Sleep Foundation will be made available on the wards for clinicians to provide to the patients. The pathway will be activated on notification of randomisation for the intervention group and reviewed weekly until discharge which can range between two to six weeks on average.

Intervention code [1] 297329 0
Behaviour
Intervention code [2] 297330 0
Treatment: Other
Comparator / control treatment
Control patients will be provided with standard care. As part of current practice, treating clinicians may enquire about a patient’s sleep status although there is no standard process or protocol/pathway to support this.
Control group
Active

Outcomes
Primary outcome [1] 301289 0
The Pittsburgh Sleep Quality Index (PSQI) is a widely-used, 19-item self-report questionnaire that measures sleep disturbance for up to a one-month period. There are 7 sleep component scores (range of 0-3 for each subscale): subjective sleep quality, sleep latency (i.e. time needed to fall asleep), sleep duration (number of hours of actual sleep per night), habitual sleep efficiency (total sleep time divided by time in bed converted to a score 0-3), sleep disturbance (waking up in the middle of the night), use of sleeping medications and daytime sleepiness. The sum of these scores yields an overall score (range 0-21); a lower score reflects better quality of sleep. A score cutoff of 5 is indicative of poor sleep quality and a change in three points suggests clinical effect. This instrument has high test-retest reliability and good validity.
Timepoint [1] 301289 0
Within the first 72 hours after admission
Within 72 hours prior to discharge
Primary outcome [2] 301290 0
The Hopkins Rehabilitation Engagement Rating Scale (HRERS) is a 5-item, clinician-rated measure developed to quantify engagement in acute rehabilitation services. It is a valid and reliable measure and has good internal consistency and interrater reliability. Clinicians (physiotherapist and occupational therapist) will be asked to complete this based on the engagement of the patient in the previous 72 working hours.
Timepoint [2] 301290 0
Within the first 72 hours after admission
Within 72 hours prior to discharge
Primary outcome [3] 301291 0
Fatigue severity scale (FSS) measures fatigue severity through nine items concerning how fatigue affects motivation, exercise, physical functioning, carrying out duties, interfering with work, family or social life, on a 7-point Likert scale where 1=strongly disagree and 7 is strongly agree. Responses are summed and divided by number of items for a scale score (range 1-7). Higher score indicates more severe fatigue. It has excellent validity and reliability.
Timepoint [3] 301291 0
Within the first 72 hours after admission
Within 72 hours prior to discharge
Secondary outcome [1] 332217 0
Actigraphy will provide an objective measure of sleep-wake parameters.. This is a small watch-like device that records motor activity continuously for several days. The data from the actigraph allows estimation of sleep-wake parameters based on presence or absence of motor activity
Timepoint [1] 332217 0
Within the first 72 hours after admission
Within 72 hours prior to discharge
Secondary outcome [2] 332218 0
Patient satisfaction with sleep will be measured with 5 point Likert scale (very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied).
Timepoint [2] 332218 0
Within the first 72 hours after admission
Within 72 hours prior to discharge
Secondary outcome [3] 332421 0
Length of stay in rehabilitation unit.
Timepoint [3] 332421 0
At time of discharge using medical records.

Eligibility
Key inclusion criteria
Ability and willingness to give informed consent, poor sleep quality (scoring = 5 on the Pittsburgh Sleep Quality Index after a negative answer to the initial screening question of “do you currently sleep well?”), musculoskeletal diagnosis (as per rehabilitation sub-group).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they are not able or willing to complete the Pittsburgh Sleep Quality Index due to medical or behavioural instability (such as agitated and aggressive) or severe cognitive communication deficits.

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)
Sealed, sequentially numbered opaque envelopes will be used to conceal allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A statistician (BA) not involved with the study will generate a randomization schedule using a computerized random number sequence. Assignment will be in a ratio of 1:1 intervention to usual care, stratified by primary diagnosis requiring rehabilitation (orthopaedic vs amputation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)
VIC
Recruitment hospital [1] 7579 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment postcode(s) [1] 15473 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 295768 0
Hospital
Name [1] 295768 0
The Royal Melbourne Hospital
Address [1] 295768 0
300 Grattan St, Parkville VIC 3050
Country [1] 295768 0
Australia
Primary sponsor type
Hospital
Name
Rehabilitation Department - Royal Melbourne Hospital
Address
34-54 Poplar Rd, Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 294622 0
None
Name [1] 294622 0
None
Address [1] 294622 0
None
Country [1] 294622 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297066 0
MELBOURNE HEALTH HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 297066 0
Office for Research
The Royal Melbourne Hospital
Level 2 South West
300 Grattan Street
Parkville VIC 3050
Ethics committee country [1] 297066 0
Australia
Date submitted for ethics approval [1] 297066 0
27/09/2016
Approval date [1] 297066 0
18/11/2016
Ethics approval number [1] 297066 0
HREC/16/MH/299

Summary
Brief summary
Sleep is important for health, quality of life and general well being. Patients in rehabilitation often sleep poorly but the reasons for this are not well understood. It is important to better understand why patients sleep poorly in rehabilitation and how this can be managed. Through this study, it is hoped that a “clinical pathway” which consists of guides for clinicians will help clinicians understand and better address sleep problems. Patients will be divided into two groups randomly, with one group receiving care based on the “clinical pathway” and the other group receiving usual care without use of the “clinical pathway”.

Sleep is starting to emerge as an important consideration in the overall management of rehabilitation patients however there is paucity of current literature relating to the efficacy of treatment of sleep disorders to guide treatment. For clinicians who actively manage sleep issues, most rely on evidence obtained in non-rehabilitation patients and commonly use hypnotic agents, Behavioural interventions and where appropriate devices such as continuous positive airway pressure (CPAP). Currently available clinical pathways for the treatment of sleep disorders focus predominantly on the management of obstructive sleep apnoea and do not extrapolate well to sleep disorders in a rehabilitation setting.

This study aims to determine the feasibility and effectiveness of a sleep optimisation clinical pathway within the rehabilitation setting when compared to usual care on sleep quality, patient satisfaction with sleep, engagement with rehabilitation therapy, fatigue and length of inpatient rehabilitation stay through a randomized controlled trial with blinded patients and outcome assessors.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72862 0
A/Prof Louisa Ng
Address 72862 0
Building 21 (Administration Building)
The Royal Melbourne Hospital - Royal Park Campus
34-54 Poplar Rd, Parkville VIC 3052
Country 72862 0
Australia
Phone 72862 0
+61 3 83872350
Fax 72862 0
Email 72862 0
louisa.ng@mh.org.au
Contact person for public queries
Name 72863 0
A/Prof Louisa Ng
Address 72863 0
Building 21 (Administration Building)
The Royal Melbourne Hospital - Royal Park Campus
34-54 Poplar Rd, Parkville VIC 3052
Country 72863 0
Australia
Phone 72863 0
+61 3 83872350
Fax 72863 0
Email 72863 0
louisa.ng@mh.org.au
Contact person for scientific queries
Name 72864 0
A/Prof Louisa Ng
Address 72864 0
Building 21 (Administration Building)
The Royal Melbourne Hospital - Royal Park Campus
34-54 Poplar Rd, Parkville VIC 3052
Country 72864 0
Australia
Phone 72864 0
+61 3 83872350
Fax 72864 0
Email 72864 0
louisa.ng@mh.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary