Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000316404p
Ethics application status
Submitted, not yet approved
Date submitted
1/04/2025
Date registered
16/04/2025
Date last updated
16/04/2025
Date data sharing statement initially provided
16/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Enhancing Therapies for People with Dementia
Scientific title
Assessing the impact of incorporating changes to therapy materials and therapeutic presentation on wellbeing in People with Dementia
Secondary ID [1] 314094 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dementia 336876 0
Condition category
Condition code
Neurological 333349 333349 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Observational data: The study will begin with a stage of data collection, associated with baseline (or initial) information gathering. This will involve researchers observing (watching) the behaviours of consented participants (individuals with dementia and/or care or support people) and recording behaviours (e.g., indices of affect, engagement, vocal verbal responses) using pen and paper methods or unobtrusive technology (i.e., through the use of an iPad or similar) at various times. No specific actions will be required of participants at this stage. Baseline observational data will be collected during 10 to 20-minute periods at different times of the day across a between one and four weeks to capture the majority of behaviours, etc.

Assessment (1): This stage will involve gathering information by asking informants (participants who support an individual with dementia, including whanau and/or staff, the person with dementia themselves) to comment on the person's preferred therapies, hobbies, interests, and what is available in the home. This will be achieved through a short (no longer than 20 minutes) interview (modality may vary depending on the preference of the research team and participants, i.e., online, in person, pen and paper survey).

Assessment (2): This stage will involve brief assessments where the research team modifies activities to determine which factors enhance their effectiveness (e.g., duration of the activity, the presence or absence of someone doing the activity alongside the person with dementia etc) and measure any change to behaviours of interest after the change. The purpose of this assessment is to identify which factors make the activities more preferred or effective in increasing engagement. The assessments will comprise multiple sessions lasting no longer than 20 minutes, and have structured protocols and ending-session criteria to protect participants and to minimise disturbance of their time. This phase will occur after the completion of Assessment 1.

The changes implemented will be selected by the CI, using their clinical judgement and the data collected in Assessment 1 (i.e., based on participant preferences, mobility, any medical contraindications, feasibility, available resource). Proposed changes will be presented to the organisation for their approval prior to implementation and to provide an additional check for safety and feasibility (for example, we will not suggest a change in location of a therapy for a participant whose mobility would make it unsafe to move them to another room in the space). he changes will be implemented by the CI (registered psychologist), supporting staff (e.g., occupational therapists, rehabilitation assistants), and other members of the research team. A researcher will interact with an individual participant in a shared space where other participants may be present, or in private quarters (depending on the change to be implemented). Sessions will be between 10 and 20-min in duration, implemented up to five times per week for up to 2 months. This stage will be implemented upon completion of the assessment phases.

A second observer will be present in approximately 30% of sessions to record treatment integrity data.

The changes implemented will only be made for the individual participant (i.e., not others in the organisation, even if the activity is available to them as well). Some examples are:

1. Changes to the therapy materials:
• The participant is presented with games available in the setting and new games to evaluate whether new games are more desirable due to their novelty.
• A button on the radio is made more obvious so that the participant can change the music during music therapy rather than someone else doing it for them.
• Written text is added to memory books to evaluate whether it helps the person to recall events and people more accurately.

2. Changes to the way the therapy is presented:
• The participant is provided with written prompts or a ‘cheat sheet’ to help them understand how to play a game.
• The participant is shown how to play with a particular toy and the dog to evaluate whether they enjoy this more than more passive interactions with the dog such as petting.
• Regular ‘check-ins’ are added to doll therapy, by which the participant is provided with regular social interactions from others while they have the doll in their lap.

Intervention (1): This step of the study involves teaching and supporting consented care and support staff to modify the approaches they use when interacting with individuals they support to increase participation and engagement in therapies. Again, the specific intervention technologies will be tied to baseline data and specific to each participant, but may include the use of behavioural skills training (such as didactic instruction, modelling, rehearsal and feedback). Data will be collected at this stage through observation of consented participant behaviour (that of care support people and individuals with dementia). The teaching and support will be delivered by the research team and will include both analogue and in-situ components (i.e., in training rooms and during interactions with participants). This stage will be implemented upon completion of Intervention 1. Sessions will be between 10 and 30-min in duration and will be delivered up to 3 times per week for up to a month.

A second observer will be present in approximately 30% of sessions to record treatment integrity data.

Social validity: The perspectives and opinions of consented whanau, care and support people will be recorded using informant methods (as described in Assessment: 1). Care will be taken to minimise the response time and effort required for this task. Data will be analysed using quantitative and qualitative methods. Consented individuals with dementia may also be asked to provide their perspectives of participation through a modified tool, aligned with the cognitive skills of participants and in line with participant preference.

The overall duration of the project for each participant is 6 months from enrolment to completion of final sessions.
Intervention code [1] 330671 0
Behaviour
Comparator / control treatment
Across stages of the project, single-subject design (i.e., small-n design) will be used. This approach involves measuring the behaviour of participants at various stages of the research / within various phases, to assess any change by comparing that participant's data with a record of their baseline performance (otherwise described as 'subject as their own control').
Control group
Active

Outcomes
Primary outcome [1] 340921 0
Indices of affect (including facial expression, vocalisations, body language). Behaviours to be operationally defined for each participant- composite outcome.
Timepoint [1] 340921 0
Repeated measures - data collected in every baseline, functional assessment, and intervention session that occurs for 6 months from enrolment.
Primary outcome [2] 340922 0
Engagement in therapy - operationally defined for each participant with regard to objective descriptions of what they do and / or say.
Timepoint [2] 340922 0
Repeated measures - data collected in every baseline, functional assessment, and intervention session that occurs for 6 months from enrolment.
Secondary outcome [1] 445474 0
Acceptability of assessment and intervention (participant) - composite outcome
Timepoint [1] 445474 0
At the time of enrolment, after assessment phases, and after the last intervention session.
Secondary outcome [2] 445475 0
Acceptability of assessment and intervention (whanau or professional carer) - composite outcome
Timepoint [2] 445475 0
At the time of enrolment, after assessment phases, and after the last intervention session.

Eligibility
Key inclusion criteria
Group 1: People diagnosed with dementia prior to participating in the study (i.e., have an existing, independent diagnosis) who engage in misremembering behaviour.
Group 2. Whanau/ family members of participants with dementia.
Group 3. Professional caregivers or support staff members who provide care to participants with dementia.

.We do not have an inclusion criterion for age, as we wish to include individuals with young-onset dementia because this is likely to be beneficial for these groups and future research. However, participants must be over 16 years old in order to be included as a legal adult in NZ.

We also do not have a criterion for specific diagnosis (e.g., type of dementia). We are not seeking to make broad generalisations about people with a specific diagnosis, but start to understand some of the factors that should be considered in enhancing engagement with therapies. As such, and due to our small-N design approach, we are not seeking an homogenous sample.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People with dementia who are unable to provide informed consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Behaviour-analytic approaches will be employed. The majority of the data will be collected by direct observational measurement of behaviours and environmental variables, operationally defined, and collected via pen-and-paper methods (e.g., Johnson & Pennypacker, 2009; Sharp, Mudford, & Elliffe, 2015). Experimental control will be demonstrated with small-N designs, which do not require statistical analyses. In a small-N design, each participant serves as their own control, and is exposed to all conditions. Comparisons of behaviour are made within a participant rather than across participants and we conduct repeated measures of our behaviour of interest (i.e., we measure behaviour throughout each session and phase rather than just pre- and post-intervention). We will use visual inspection of graphed data (based on baseline logic; Kazdin, 1982), a common method of data analysis employed in most of behaviour-analytic research. This involves tracking data visually on graphs, and making data-based decisions during the study. Under this approach, small samples can be highly informative. A key component of small-N design is that we publish our methods in detail (principle of technological). This enables replication; as a field, we are more likely to conduct 20 studies including 5 participants in each rather than one study with 100 participants. This approach allows for a nuanced evaluation of the individual factors that contribute to the effectiveness of an intervention. When working with people with major neurocognitive disorder, a small-N approach is useful because experimental control is unaffected by individual differences in behaviour and the progression of dementia (see Steingrimsdottir & Artnzen, 2015 for a detailed discussion).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/04/2025
Actual
Date of last participant enrolment
Anticipated
30/04/2027
Actual
Date of last data collection
Anticipated
30/04/2028
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 26927 0
New Zealand
State/province [1] 26927 0

Funding & Sponsors
Funding source category [1] 318602 0
University
Name [1] 318602 0
The University of Auckland
Country [1] 318602 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 321003 0
None
Name [1] 321003 0
Address [1] 321003 0
Country [1] 321003 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317204 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 317204 0
Ethics committee country [1] 317204 0
New Zealand
Date submitted for ethics approval [1] 317204 0
30/01/2025
Approval date [1] 317204 0
Ethics approval number [1] 317204 0

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

Contacts
Principal investigator
Name 140334 0
Dr Rebecca Sharp
Address 140334 0
Science Centre, Symonds Street, 1010, Auckland, The University of Auckland
Country 140334 0
New Zealand
Phone 140334 0
+64 09 923 2073
Fax 140334 0
Email 140334 0
[email protected]
Contact person for public queries
Name 140335 0
Rebecca Sharp
Address 140335 0
Science Centre, Symonds Street, 1010, Auckland, The University of Auckland
Country 140335 0
New Zealand
Phone 140335 0
+64 09 923 2073
Fax 140335 0
Email 140335 0
[email protected]
Contact person for scientific queries
Name 140336 0
Rebecca Sharp
Address 140336 0
Science Centre, Symonds Street, 1010, Auckland, The University of Auckland
Country 140336 0
New Zealand
Phone 140336 0
+64 09 923 2073
Fax 140336 0
Email 140336 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.