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Trial registered on ANZCTR


Registration number
ACTRN12619001316190
Ethics application status
Approved
Date submitted
8/07/2019
Date registered
26/09/2019
Date last updated
26/09/2019
Date data sharing statement initially provided
26/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of therapeutic activities to reduce the stress of patients with dementia in the emergency department
Scientific title
A pragmatic randomised controlled trial of the effects of therapeutic activity kits in emergency department patients with dementia and responsive behaviours.
Secondary ID [1] 298649 0
Nil Known
Universal Trial Number (UTN)
U1111-1236-3980
Trial acronym
TACK
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Dementia with responsive Behaviours 313537 0
Condition category
Condition code
Neurological 311967 311967 0 0
Dementias
Emergency medicine 312791 312791 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Therapeutic Activity Kit

The therapeutic activity kit is a container that contains a number of different activities and sensory stimuli with the aim of engaging the person with dementia. Similar kits have been previously used in reported literature; however, no commercially available kit is available (all of the constituents are commercially available). The investigators will assemble the kits prior to the commencement of the study.

Specifically, the kit contains:
• Word Search Puzzles
• Doodling
• Colouring
• Reminiscence Cards
• Playing Cards
• Colour Changing Egg
• Towel Folding
• Music
• Doll

Participants who are randomised to the intervention will receive the kit, and in conjunction with the investigator and significant others (family), all of the contents will be explained and shown to the participant. The participant is free to use any of the contents of the kit, and they may also choose not to interact with the kit. The patient is monitored every 30min for the first two hours and then hourly after that for the entirety of their emergency stay by the study investigator, part of this monitoring is noting what aspects of the kit the participant is interacting with and what behaviours they may be displaying. Patients will only be monitored for the duration of their emergency department stay (median of 6 hours from previous work).

Intervention code [1] 314938 0
Prevention
Comparator / control treatment
Usual care is the care that would usually be afforded to the participants if they were not enrolled in the study. The only changes to usual care for this study is that the participant will be monitored for responsive behaviours and will have the 4AT test administered at the beginning and end of their emergency department stay.
Control group
Active

Outcomes
Primary outcome [1] 320643 0
The primary outcome is the time elapsed (since the time of triage) before a participant requires one-on-one nursing. The time of triage is documented in the electronic medical record, the time of one-on-one is documented in the case report form by the investigator monitoring the participant in conjunction with the primary nurse.
Timepoint [1] 320643 0
At emergency department discharge (when the patient physically leaves the emergency department, denoted as the actual departure time on the electronic medical record).
Secondary outcome [1] 372306 0
The proportion of participants who have one-on-one nursing. This is measured by direct observation of the participant and the nursing care provided to them.
Timepoint [1] 372306 0
At emergency department discharge (when the patient physically leaves the emergency department, denoted as the actual departure time on the electronic medical record).
Secondary outcome [2] 372307 0
The administration of chemical restraint. Chemical restraint is defined as the administration of medications such as Benzodiazepines (Diazepam, Oxazepam, Lorazepam etc.), antipsychotics (Droperidol, Haloperidol, Olanzapine, Risperidone, Quetiapine). This information is obtained from the medication administration records kept in the patients medical record.
Timepoint [2] 372307 0
At emergency department discharge (when the patient physically leaves the emergency department, denoted as the actual departure time on the electronic medical record).
Secondary outcome [3] 372308 0
The use of physical restraint. The use of any form of restraint that aims to restrict the movement of the patient, such as an arm or leg straps, belts or vests. This restraint will be documented in real-time by the investigator observing the patient.
Timepoint [3] 372308 0
At emergency department discharge (when the patient physically leaves the emergency department, denoted as the actual departure time on the electronic medical record).

Eligibility
Key inclusion criteria
Participants will be eligible for randomisation if they are exhibiting responsive behaviours or are at risk of responsive behaviours and have a surrogate decision-maker available to the research team to consent on behalf of the patient. As all Participants who have dementia and are being treated in an ED are at risk of developing responsive behaviours then all Participants with dementia who present to the ED will be eligible for this study. Responsive behaviours will be assessed by a standardised checklist that has been developed from the literature specifically for this study

Inclusion Criteria
To be included in the trial a Participant must meet all of the following criteria:
• Participant has a history of dementia
• Participant is currently exhibiting responsive behaviours or are at risk of developing responsive behaviours.
• Participant has a surrogate decision maker available to provide informed consent to participate in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A Participant who meets any of the following criteria will be excluded from participation in the trial:
• Participant has cognitive impairment due to cause other than dementia (e.g. organic illness, traumatic brain injury, hypoxia, etc.)
• Participants with end stage dementia who are unlikely to benefit from any therapeutic intervention.
• Patents whose illness or injury is of a sufficiently serious nature to prevent them from interacting with the therapeutic activity kit.
• No surrogate decision maker is available to provide informed consent to participate.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will occur via sequentially numbered envelopes. . When a new Participant is recruited to the study then the investigator will remove the next sequentially numbered envelope and follow the intervention outlined in this envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Fifty-six numbers between one and 112 will be generated by the random number generator found at random.org
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The data collected will be summarised using appropriate descriptive statistics. For continuous variables, this will be means and standard deviations for normally distributed data and medians and inter-quartile ranges for non-normally distributed data. Categorical data will be presented as frequencies/ratios as appropriate.
To ascertain the differences in time to on-on-one nursing and time to chemical restraint Kaplan-Meier analysis will be used. Specifically, the log rank test will be used to assess the differences between the survival curves for Participants who receive the intervention and those who do not receive the intervention. This form of analysis takes into consideration the Participants who do and do not receive one-on-one nursing and chemical restraint and also allows for variable observed periods, i.e. differences in length of stay between Participants.

Differences in proportions of Participants that receive one-on-one nursing and those that receive chemical restraint between the intervention and usual care group will be assessed using the chi-squared test of independence.

Differences in total one-on-one nursing time between intervention and usual care will be calculated by a t-test or the non-parametric equivalent Mann-Whitney U test depending on the distribution of the times.

It is unlikely that the numbers of physically restrained Participants will allow for statistical testing; however, these figures will be reported using appropriate summary statistics.

A cost consequence analysis will be conducted to assess the value of the therapeutic activity kits. Cost consequences analysis aims to compare the costs (such as utilisation of one-on-one nursing) and the consequences (such as the use of one-on-one nursing or chemical restraint) of a test or treatment with a suitable alternative. Unlike cost-benefit analysis or cost- effectiveness analysis, it does not attempt to summarise the value of the intervention in a single measure (such as the cost per quality-adjusted life year). Instead, outcomes are shown in their natural units such as hours of nursing care or medication administration

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2019
Actual
Date of last participant enrolment
Anticipated
1/08/2020
Actual
Date of last data collection
Anticipated
1/08/2020
Actual
Sample size
Target
112
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 14147 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 27117 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 303187 0
Charities/Societies/Foundations
Name [1] 303187 0
Rosemarry Bryant Foundation
Country [1] 303187 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Rosemarry Bryant Foundation
Address
191 Torrens Road
Ridleyton SA 5008
Country
Australia
Secondary sponsor category [1] 303222 0
None
Name [1] 303222 0
Nil
Address [1] 303222 0
Country [1] 303222 0
Other collaborator category [1] 280838 0
University
Name [1] 280838 0
Queensland University of Technology
Address [1] 280838 0
School of Nursing
QUT
Cnr Musk and Victoria Park Road
Kelvin Grove, Queensland, 4059
Country [1] 280838 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303751 0
Royal Brisbane and Women's Hospital Ethics Committee
Ethics committee address [1] 303751 0
Ethics committee country [1] 303751 0
Australia
Date submitted for ethics approval [1] 303751 0
20/09/2018
Approval date [1] 303751 0
20/09/2018
Ethics approval number [1] 303751 0
HREC/2018/QRBW/44702

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

Contacts
Principal investigator
Name 94666 0
Dr James Hughes
Address 94666 0
Emergency and Trauma Centre
Royal Brisbane and Women's Hospital
Dr James Mayne Building
Butterfield Street Herston
QLD 4029
Country 94666 0
Australia
Phone 94666 0
+61 7 36465136
Fax 94666 0
Email 94666 0
james.hughes@health.qld.gov.au
Contact person for public queries
Name 94667 0
James Hughes
Address 94667 0
Emergency and Trauma Centre
Royal Brisbane and Women's Hospital
Dr James Mayne Building
Butterfield Street Herston
QLD 4029
Country 94667 0
Australia
Phone 94667 0
+61 7 36465136
Fax 94667 0
Email 94667 0
james.hughes@health.qld.gov.au
Contact person for scientific queries
Name 94668 0
James Hughes
Address 94668 0
Emergency and Trauma Centre
Royal Brisbane and Women's Hospital
Dr James Mayne Building
Butterfield Street Herston
QLD 4029
Country 94668 0
Australia
Phone 94668 0
+61 7 36465136
Fax 94668 0
Email 94668 0
james.hughes@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual data will not be published


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.