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Trial registered on ANZCTR


Registration number
ACTRN12623000003673
Ethics application status
Approved
Date submitted
21/12/2022
Date registered
9/01/2023
Date last updated
23/05/2024
Date data sharing statement initially provided
9/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase II trial to evaluate the safety, feasibility and efficacy of using therapeutic weighted blankets for agitation in patients with dementia in acute care settings.
Scientific title
Phase II trial to evaluate the safety, feasibility and efficacy of using therapeutic weighted blankets for agitation in patients with dementia in acute care settings.
Secondary ID [1] 308634 0
nil known
Universal Trial Number (UTN)
U1111-1286-2607
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 328541 0
Agitation 328581 0
Condition category
Condition code
Mental Health 325596 325596 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of a therapeutic weighted blanket for patients with a diagnosis of dementia, who have experienced agitation in acute care.
Upon settling acute care patients who have dementia and have experienced agitation during their hospitalisation for the evening (and in conjunction with the nurse caring for the patient), the research assistant will apply an appropriately weighted blanket based on the patient’s weight (less than 10% of the patient’s body weight) on patients randomised to the intervention arm. Each participant will only receive the intervention once and the research assistant will supervise the participant for the duration of blanket use. The blankets to be used in the trial will weigh 5.5kg, 6.6kg or 7.7kgs. Where a blanket is greater than 10% of a patient’s body weight the patient shall be deemed ineligible for the intervention group. Weighted blankets will be able to be removed by individuals should they wish, this will be documented as the study endpoint, and the time applied/ tolerated will be recorded. There are no standardised guidelines for the safe use of weighted blankets by people in hospital settings. Parameters have been adapted from Harris and Titler (2022) whose study tested safety and effectiveness in people with dementia in the home environment and they did not report any adverse events. The blanket will be placed no higher than the patient’s shoulder tip and not below the ankles. Blankets will be placed for a period of no longer than 60 minutes, or until such time as the patient removes the blanket themselves.
Intervention code [1] 325093 0
Treatment: Devices
Intervention code [2] 325095 0
Behaviour
Comparator / control treatment
The comparator will be a control group of patients who are receiving standard care.
Standard care may include but are not limited to administration of anti-psychotic or sedative medications, playing music of the patient's choice, turning off lights or other stimulants, a staff member to sit and talk with the patient.
Control group
Active

Outcomes
Primary outcome [1] 333397 0
The safety of applying weighted blankets to patients with dementia experiencing agitation will be examined through visual observations, recording the patient’s respiratory rate, temperature, pulse rate and oximetry readings by physical examination, checking of skin and bony prominences using the Revised Pressure Injury Staging System (Edsberg et al, 2016). Any injuries (such as pressure injuries, skin redness, skin tears or falls) or near miss accidents related to the use of the blankets will also be recorded.
Timepoint [1] 333397 0
Baseline, 15mins, 30 mins, 45 mins, 60 mins (primary endpoint) 75 mins post-intervention commencement.
Primary outcome [2] 333398 0
Patient acceptance of using weighted blankets assessed by recording the duration of blanket application using a stopwatch.
Timepoint [2] 333398 0
at completion of the intervention
Primary outcome [3] 333417 0
Feasibility:
Number of eligible participants consenting to recruitment, assessed by auditing the screening and contact log.
Timepoint [3] 333417 0
At conclusion of the study
Secondary outcome [1] 416911 0
Agitation: The Pittsburgh Agitation Scale (PAS) is an observational scale designed to monitor and record verbal and physical agitation in patients with dementia (Rosen, et al, 1994). The PAS consists of four categories (aberrant vocalisation; motor agitation; aggressiveness; resisting cares) and is scored from 0 (not present) to 4 (extreme or intense). The total calculated score of the PAS ranges from 0 to 16.
Timepoint [1] 416911 0
The PAS scores will be measured for all participants at baseline, and 15 mins, 30 mins, 45 mins, 60 mins and 75 mins post baseline.
Secondary outcome [2] 416912 0
Administration of anti-psychotic and/or sedative medications to patients will be measured through recording the type, amount and mode of medication administered to all participants, collected from medication charts.
Timepoint [2] 416912 0
Administration of anti-psychotic and/or sedative medications administered within 2 hrs prior to baseline data collection and up to 75 mins after the baseline data collection.
Secondary outcome [3] 416913 0
Cost of the intervention: Cost of material resources to purchase and launder will be calculated by auditing study financial records.
Timepoint [3] 416913 0
On completion of the study
Secondary outcome [4] 417102 0
(Primary outcome) Staff acceptance of using weighted blankets will be measured using the Weiner Acceptability, Appropriateness and Feasibility measure (Weiner et al, 2017)
Timepoint [4] 417102 0
Results of survey at conclusion of the study

Eligibility
Key inclusion criteria
Patient participants will be deemed eligible for inclusion based on the following criteria:
a) A diagnosis of dementia by a physician and noted in their medical record
b) admitted to the study unit
c) identified and assessed by health care staff using the PAS as being agitated during their stay (score greater than 0)

Staff participants will be deemed eligible for inclusion in the study based on the following criteria:
a) They have been the primary nurse caring for a patient who has participated in the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The following patient participants will be excluded from the study
a) Those being nursed on an end-of-life pathway
b) Those assessed as clinically deteriorating (identified using the Adult Deterioration Detections System as scoring greater than 3)
c) Patients diagnosed with one of the following
• obstructive sleep apnoea
• Claustrophobia
d) Unable to speak or understand English

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)
Participants meeting the eligibility criteria and consent (or are consented by their authorised representative) to participate will be randomised 1 to 1 to either the control (standard care) or intervention (weighted blanket) arm. Randomisation will be performed by the research team using a centralised web-based randomisation system managed by Queensland University of Technology (REDCap).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised 1 to 1 to either the control (standard care) or intervention (weighted blanket) arm using computerised sequence generation via REDCap.
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
Safety/efficacy
Statistical methods / analysis
Descriptive statistics will be used to report baseline characteristics of the study cohort. Safety outcomes will be reported descriptively, aggregately and compared between the intervention and the control groups. Feasibility outcomes will be reported descriptively and compared against a-priori-determined feasibility threshold of greater than or equal to 25% of eligible patients are recruited, greater than or equal to 60% of participants tolerate the weighted blanket for 60 mins and greater than or equal to 80% staff express acceptance of the use of weighted blankets.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2023
Actual
10/05/2023
Date of last participant enrolment
Anticipated
30/11/2023
Actual
9/01/2024
Date of last data collection
Anticipated
30/11/2023
Actual
9/01/2024
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 23734 0
Redcliffe Hospital - Redcliffe
Recruitment postcode(s) [1] 39175 0
4020 - Redcliffe

Funding & Sponsors
Funding source category [1] 312871 0
Hospital
Name [1] 312871 0
Redcliffe Hospital (Redcliffe Hospital Private Practice Trust Fund)
Country [1] 312871 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
149 Victoria Park Road
Kelvin Grove
Queensland 4059
Country
Australia
Secondary sponsor category [1] 314537 0
Hospital
Name [1] 314537 0
Redcliffe Hospital
Address [1] 314537 0
Anzac Ave
Redcliffe
QLD 4020
Country [1] 314537 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312149 0
Metro North Health Human Research Ethics Committee (HREC) A (EC 00172)
Ethics committee address [1] 312149 0
Ethics committee country [1] 312149 0
Australia
Date submitted for ethics approval [1] 312149 0
10/10/2022
Approval date [1] 312149 0
30/11/2022
Ethics approval number [1] 312149 0
89106; HREC/2022/MNHA/89106;

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

Contacts
Principal investigator
Name 123654 0
A/Prof Amanda Fox
Address 123654 0
Queensland University of Technology
N Block Level 3.
Victoria Park Road
Kelvin Grove, QLD, 4059
Country 123654 0
Australia
Phone 123654 0
+61 07 3138 3884
Fax 123654 0
Email 123654 0
a.fox@qut.edu.au
Contact person for public queries
Name 123655 0
Amanda Fox
Address 123655 0
Queensland University of Technology
N Block
Victoria Park Road
Kelvin Grove, QLD, 4059
Country 123655 0
Australia
Phone 123655 0
+61 07 3138 3884
Fax 123655 0
Email 123655 0
a.fox@qut.edu.au
Contact person for scientific queries
Name 123656 0
Amanda Fox
Address 123656 0
Queensland University of Technology
N Block
Victoria Park Road
Kelvin Grove, QLD, 4059
Country 123656 0
Australia
Phone 123656 0
+61 07 3138 3884
Fax 123656 0
Email 123656 0
a.fox@qut.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication and ending 5 years following main results publication
Available to whom?
Case-by case basis and at the discretion of the primary sponsor.
Available for what types of analyses?
meta-analysis
How or where can data be obtained?
Access subject to approval by Principal Investigator
A/Prof Amanda Fox
a.fox@qut.edu.au
ph +61 7 3138 3884


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.