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Trial registered on ANZCTR


Registration number
ACTRN12616000662460
Ethics application status
Approved
Date submitted
9/05/2016
Date registered
20/05/2016
Date last updated
20/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Can lifelike baby dolls provide a positive therapeutic response for people living with
dementia?
Scientific title
A parallel-randomised controlled trial to examine the effect of a Lifelike Baby Doll intervention on anxiety, agitation and aggression symptoms in people with dementia.
Secondary ID [1] 289100 0
None
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 298560 0
Behavioural and psychological symptoms of Dementia (BPSD) 298562 0
Anxiety 298719 0
Agitation 298720 0
Aggression 298721 0
Condition category
Condition code
Mental Health 298644 298644 0 0
Anxiety
Neurological 298774 298774 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will receive three individual non-facilitated doll sessions per week, for 30 minutes (Mon, Wed, Fri), anytime outside of meal and rest times, for a period of 3 weeks (dose = 4.5 hrs).When given the Lifelike Baby Doll and the research assistant will read a short script, such as “Here is a doll. It looks a lot like a real baby but it’s not. I will leave the doll here with you for a short time”. Adherence to the intervention will be monitored via a GoPro Hero camera.
Intervention code [1] 294605 0
Treatment: Other
Intervention code [2] 294706 0
Behaviour
Comparator / control treatment
Participants in the usual care group will not receive any intervention. Usual care in nursing homes, randomised to the usual care arm, no intervention (Lifelike Baby Doll), training or support will be provided by the study team. The level, duration and type of service provider initiatives in relation to BPSD will be documented so these can be controlled for as potential confounders.
Control group
Active

Outcomes
Primary outcome [1] 298136 0
A composite primary outcome to compare a Lifelike Baby Doll Intervention with Usual Care in terms of reducing anxiety, agitation and aggression. These symptoms are frequently referred to as behavioural and psychological symptoms of dementia (BPSD).

Facility staff will complete the revised Neuropsychiatric Inventory – Nursing Home (NPINH) to measure BPSD exhibited in the previous 2 weeks. Based on Carer report, the NPI-NH is a valid and reliable instrument to assess frequency (0 = never to 4 = very frequently) and severity (0 = none to 3 = marked) of 14 behavioural domains.

Video recordings via a GoPro Hero camera and will be used to measure BPSD and reflect the person’s interaction or non-interaction with the doll. Recordings will take place in a naturalistic setting, i.e. where the participant is given the doll. Similar scheduled times will be organized for the usual care control,
Timepoint [1] 298136 0
Baseline and Post-intervention (end of Week 3) - Facility staff will complete the revised Neuropsychiatric Inventory – Nursing Home (NPINH) to measure BPSD.
Week 0 (Baseline), 1 and 3 - 5 minutes of video recordings before the intervention, 30 minutes during the intervention and 5 minutes following the intervention to measure BPSD and reflect the person’s interaction or non-interaction with the doll.
Secondary outcome [1] 323259 0
To evaluate the acceptability of the Lifelike Baby Doll for people with
dementia. 40 minutes of video recordings during the intervention will be used to observe acceptability.
Timepoint [1] 323259 0
Week 0 (Baseline), 1 and 3 - 5 minutes of video recordings before the intervention, 30 minutes during the intervention and 5 minutes following the intervention to observe acceptability of the Lifelike Baby Doll.
Secondary outcome [2] 323912 0
To evaluate the acceptability of the Lifelike Baby Doll for families of people with
dementia and associated staff within the facility. Semi-structured interviews will be conducted to evaluate acceptability by families and staff.
Timepoint [2] 323912 0
Post-intervention

Eligibility
Key inclusion criteria
1) Participants will be recruited from Australian government approved Residential Aged Care Facilities (RACFs) within a 60km radius of Brisbane CBD in SE Queensland.
2) Have a confirmed or probable diagnosis of dementia
3) A documented history (within last 4 weeks) of anxiety, agitation or aggression.
Minimum age
55 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Residents who are already using dolls or other plush toys.

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 concealment will be done by a central randomisation by computer, at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
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)
Efficacy
Statistical methods / analysis
In line with outcomes observed in another RCT study of an individualised non-pharmacological intervention for improving BPSD in people with dementia (Moyle W, Cooke ML, Beattie E, Shum DH, O'Dwyer ST, Barrett S., 2014), a total sample size of 72, (36 in each group), will be required (power of 0.90, a = .05 & 20% attrition).

Descriptive statistics will be computed for participant demographics and outcome measures. Where data is not normally distributed, transformations will be conducted. Where transformation is unsuccessful or inappropriate, equivalent non-parametric analyses will be conducted. Baseline variations between intervention and control groups will be examined using Chi squared tests for categorical variables, t-tests for the normally distributed continuous variables and Kruksal Wallis tests for continuous variables with skewed distributions. STATA software programs will be used. Pre- and post- intervention effect will be assessing using repeated analysis of variance with any significant baseline variables as covariates. Effect sizes of statistically significant differences will also be calculated. An ‘Intention-To-Treat’ (ITT) approach will be adopted. Multiple imputations will be used to manage missing data. Qualitative interview data will be analysed thematically to capture
the key elements of the doll intervention on perceptions and attitudes.

Recruitment
Recruitment status
Not yet recruiting
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)
QLD

Funding & Sponsors
Funding source category [1] 293472 0
University
Name [1] 293472 0
Griffith University
Address [1] 293472 0
Menzies Health Institute Queensland
Griffith University
Parklands Drive
Southport
QLD 4222.
Country [1] 293472 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Menzies Health Institute Queensland
Griffith University
Parklands Drive
Southport
QLD 4222.
Country
Australia
Secondary sponsor category [1] 292296 0
None
Name [1] 292296 0
Address [1] 292296 0
Country [1] 292296 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294914 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 294914 0
170 Kessels Road
Nathan
QLD 4111
Ethics committee country [1] 294914 0
Australia
Date submitted for ethics approval [1] 294914 0
31/03/2016
Approval date [1] 294914 0
08/05/2016
Ethics approval number [1] 294914 0
GU Ref No: 2016/281

Summary
Brief summary
People with dementia often have complex health and social needs that do not always receive appropriate attention. This can result in the person exhibiting symptoms such as anxiety, agitation and aggression. These are referred to as behavioural and psychological symptoms of dementia (BPSD) and are often related to the person having a need that has not been fulfilled. Pharmacological treatments have been the preferred treatment to alleviate such symptoms. As a result of a greater understanding about the adverse side effects of pharmacological treatments, a number of psychosocial interventions have been trialled. One psychosocial intervention that is increasingly being used to comfort, occupy and care for people with dementia is Lifelike Baby Dolls even though there is limited evidence for their use. It is imperative that we understand if these dolls are beneficial, harmful or indeed worthless in helping to comfort people with dementia. This parallel-randomised controlled trial will compare a Lifelike Baby Doll intervention with Usual Care in reducing anxiety, agitation and aggression symptoms in people with dementia. Participants will be assessed pre-and post- intervention for BPSD using the Neuropsychiatric Inventory and video recordings. Post intervention interviews with staff and family will evaluate the impact and perceptions of the doll.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65462 0
Prof Wendy Moyle
Address 65462 0
Menzies Health Institute Queensland
Griffith University
Parklands Drive
Southport
QLD 4222.
Country 65462 0
Australia
Phone 65462 0
+61 (0) 7 3735 5526
Fax 65462 0
Email 65462 0
w.moyle@griffith.edu.au
Contact person for public queries
Name 65463 0
Prof Wendy Moyle
Address 65463 0
Menzies Health Institute Queensland
Griffith University
Parklands Drive
Southport
QLD 4222.
Country 65463 0
Australia
Phone 65463 0
+61 (0) 7 3735 5526
Fax 65463 0
Email 65463 0
w.moyle@griffith.edu.au
Contact person for scientific queries
Name 65464 0
Prof Wendy Moyle
Address 65464 0
Menzies Health Institute Queensland
Griffith University
Parklands Drive
Southport
QLD 4222.
Country 65464 0
Australia
Phone 65464 0
+61 (0) 7 3735 5526
Fax 65464 0
Email 65464 0
w.moyle@griffith.edu.au

No information has been provided regarding IPD availability
Summary results
No Results