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Trial registered on ANZCTR


Registration number
ACTRN12623000891628
Ethics application status
Approved
Date submitted
4/08/2023
Date registered
21/08/2023
Date last updated
19/10/2024
Date data sharing statement initially provided
21/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Treating dementia-related sleep deprivation with weighted blankets
Scientific title
Weighted blankets as a non pharmacological sleep intervention for people with dementia: A pilot randomized controlled crossover effectiveness-implementation trial
Secondary ID [1] 310128 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Behavioural and Psychological Symptoms of Dementia 330715 0
Condition category
Condition code
Neurological 327554 327554 0 0
Dementias
Public Health 327893 327893 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A weighted blanket, up to 12% of the person’s body weight, for overnight use for two consecutive weeks under nursing supervision. No wash out period is required as the effects of the weighted blanket cease on removal of the the weight. The intervention will follow the service Clinical Protocol for Sensory Modulation which states the user needs to be able independently remove or free themselves from the weighted blanket. Use of weighted blankets will be recorded daily in patient records. Weighted blankets used are commercially available and have soft glass bead fillings and a fleece cover.
Intervention code [1] 326544 0
Treatment: Devices
Comparator / control treatment
Treatment as usual, which is usual hospital blankets that are not weighted overnight.
Control group
Active

Outcomes
Primary outcome [1] 335527 0
Change in sleep duration as measured via the Withings sleep analyser and/or fitbit work
Timepoint [1] 335527 0
Sleep data collection will occur at three time points for 14 days during the intervention cycle. These time points points will be at Week 1-2 (prior to randomisation), Week 3-4 (following completion of intervention by intervention group) and week 6 (following completion of intervention by control group).
Primary outcome [2] 335657 0
Change in sleep efficiency as measured via the Withings sleep analyser and/or fitbit work
Timepoint [2] 335657 0
Three time points for 14 days during the intervention cycle. These time points points will be at Week 1-2 (prior to randomisation), Week 3-4 (following completion of intervention by intervention group) and week 6 (following completion of intervention by control group).
Primary outcome [3] 335737 0
Changes in frequency and severity in sleep disordered behaviours assessed as a composite outcome as measured by the sleep disorder inventory (SDI).
Timepoint [3] 335737 0
Three time points for 14 days during the intervention cycle. These time points points will be at Week 1-2 (prior to randomisation), Week 3-4 (following completion of intervention by intervention group) and week 6 (following completion of intervention by control group).
Secondary outcome [1] 424407 0
Changes in responsive behaviours as measured by the Neuropsychiatric Inventory (NPI). A validated tool that measures severity levels of behavioral symptoms.
Timepoint [1] 424407 0
NPI will occur at three time points for 14 days during the intervention cycle. These time points points will be at Week 1-2 (prior to randomisation), Week 3-4 (following completion of intervention by intervention group) and week 6 (following completion of intervention by control group).
Secondary outcome [2] 424902 0
Changes in falls incidents as measured via the service safety learning system.
Timepoint [2] 424902 0
Three time points for 14 days during the intervention cycle. These time points points will be at Week 1-2 (prior to randomisation), Week 3-4 (following completion of intervention by intervention group) and week 6 (following completion of intervention by control group).
Secondary outcome [3] 424903 0
Changes in restrictive practice incidents as measured by the service safety learning system.
Timepoint [3] 424903 0
Three time points for 14 days during the intervention cycle. These time points points will be at Week 1-2 (prior to randomisation), Week 3-4 (following completion of intervention by intervention group) and week 6 (following completion of intervention by control group).
Secondary outcome [4] 424904 0
Changes in as needed psychotropic medication use as recorded in patient clinical notes.
Timepoint [4] 424904 0
Three time points for 14 days during the intervention cycle. These time points points will be at Week 1-2 (prior to randomisation), Week 3-4 (following completion of intervention by intervention group) and week 6 (following completion of intervention by control group).

Eligibility
Key inclusion criteria
Adults admitted to the specialised dementia care unit with severe dementia as assessed using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition and assessed as having at least one sleep problem as assessed using the Sleep Disorder Inventory (SDI).
Trialling a weighted blanket as a non-pharmacological sleep intervention, will be discussed with potential participants nearest relative/guardian within their usual multi-disciplinary care and consent gained by proxy. The researchers will provide educational sessions about the trial to families and information about the project will be included in unit newsletters for families. Following consent, a weighted blanket risk assessment will be conducted by an occupational therapist to determine safety and suitability.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People who are unable to independently remove a lesser weight blanket (3kg) or who are receiving palliative care.

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)
Central randomisation by independent researcher; allocation concealed from investigators, recruitment and site staff until the time of randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomisation sequence stratified by clinical pod and in random blocks of two or four.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
This study will aim to recruit between 14-18 participants, in accordance with findings that a pilot study should involve at least 12 subjects to ensure considerable precision in mean and variance values, and pragmatic consideration of what can realistically be implemented and collected within the time frames in this clinical setting.

The data collected to evaluate the use of the weighted blankets will be interpreted using a
convergent-parallel design, in which data will first be analysed and synthesised individually and then triangulated to allow for a detailed complementary understanding of the two data sets. All analyses will be on an intention to treat basis. For the primary outcome, the sleep duration and sleep efficiency (continuous variables) will be compared between the intervention and control groups (as a dichotomous variable) using independent sample t-tests. For the primary outcome, the prevalence of sleep problems (the SDI score) will be compared between the intervention and control groups (as a dichotomous variable) in the population by applying a X2-test. Different parametric and non-parametric tests will be used to determine the significant differences between experimental and control groups for secondary outcomes. A Repeated-Measures of Analysis of Variance (ANOVA) method for multiple measures of the same outcome variables at different time points will be used to determine changes in the outcomes within and between groups. Further a mixed method approach will be used to measure the effect of intervention, considering the random variability within variables at different study points. Level of significance will be a = 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/08/2023
Actual
28/08/2023
Date of last participant enrolment
Anticipated
27/11/2023
Actual
11/12/2023
Date of last data collection
Anticipated
17/03/2024
Actual
23/01/2024
Sample size
Target
16
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 25325 0
Repat Neuro-Behavioural Unit - Daw Park
Recruitment postcode(s) [1] 41029 0
5041 - Daw Park

Funding & Sponsors
Funding source category [1] 314288 0
Charities/Societies/Foundations
Name [1] 314288 0
Dementia Australia
Country [1] 314288 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
GPO Box 2100, Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 316232 0
Hospital
Name [1] 316232 0
Repat Neuro Behavioural Unit
Address [1] 316232 0
Repat Health Precinct, 216 Daws Road, DAW PARK SA 5041
Country [1] 316232 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313405 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 313405 0
Ethics committee country [1] 313405 0
Australia
Date submitted for ethics approval [1] 313405 0
10/06/2022
Approval date [1] 313405 0
03/08/2022
Ethics approval number [1] 313405 0
2020/HREC00028

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

Contacts
Principal investigator
Name 128038 0
Dr Suzanne Dawson
Address 128038 0
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 128038 0
Australia
Phone 128038 0
+61 0435 716 477
Fax 128038 0
Email 128038 0
suzanne.dawson@flinders.edu.au
Contact person for public queries
Name 128039 0
Suzanne Dawson
Address 128039 0
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 128039 0
Australia
Phone 128039 0
+61 0435 716 477
Fax 128039 0
Email 128039 0
suzanne.dawson@flinders.edu.au
Contact person for scientific queries
Name 128040 0
Suzanne Dawson
Address 128040 0
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 128040 0
Australia
Phone 128040 0
+61 0435 716 477
Fax 128040 0
Email 128040 0
suzanne.dawson@flinders.edu.au

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.