Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000226505
Ethics application status
Approved
Date submitted
30/01/2024
Date registered
7/03/2024
Date last updated
28/07/2024
Date data sharing statement initially provided
7/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Tailored to me: Evaluating the effectiveness and acceptability of behavioural assessments for people living with dementia
Scientific title
Tailored to me: Evaluating the effectiveness and acceptability of behavioural assessments for people living with dementia
Secondary ID [1] 311431 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
major neurocognitive disorder 332718 0
Condition category
Condition code
Neurological 329433 329433 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We are collecting baseline data of a) the preferences of participants with dementia and b) indices of happiness of participants living with dementia in order to measure the effectiveness and acceptability of conducting a traditional preference assessment with people living with dementia. After we have collected baseline data and have gathered information from the survey sent out to behaviour analysts on different experiences and challenges of conducting preference assessments with people living with dementia, we will run the preference assessment again with the same participants but with the adapted changes. This is an intervention as we are measuring the difference between the baseline (standard) preference assessment and the adapted preference assessment for people living with dementia, in order to test whether these adaptions make the preference assessment more acceptable, effective and socially valid for this group population.

Survey (professional care givers and whanau): Professional caregivers and whanau will be given a social validity survey in paper form to fill out before the beginning of the project, after the first preference assessment and after the second preference assessment. The social validity survey will be multiple choice and take approximately 5-10 minutes to complete.

(Phase 1): Preference assessment (participants living with dementia): During the baseline session, participants with major neurocognitive disorder will participate in a preference assessment used to assess the participants preference of food, objects and activities. This preference assessment may be multiple stimulus with- or without replacement (MSW/MSWO), paired stimulus, or free-operant, depending on the individual participant. The participant will be instructed by the researcher to choose between the options available, and make their preference of the options. Or in the case of the free-operant preference assessment, researchers will be observing the participants interaction with different objects food or activities. The baseline sessions will be approximately 30 minutes, and there will be one to four baseline sessions conducted with each participant (no more than two sessions a day). The number of sessions will be determined through data-based decision making of the repeated measures data.. We will analyse the data after every session, looking specifically at variability and richness of the data (e.g., stability of preference, the number and topography of vocalisations). The more variable the data, the more likely we are to conduct another session (up to the maximum number). Two or more sessions of this phase is preferable to one, but one is acceptable. The baseline conditions will run for approximately 4 weeks. These sessions will occur in where the person lives (i.e., the care home). Procedural integrity will be measured in approximately 30% of sessions by a second observer. They will record integrity (adherence) based on a task analysis (a list of the investigator behaviours in which we will engage in each session).

(Phase 2): Adapted preference assessment (participants with dementia): We will conduct adapted preference assessments with the participants involved, through cooperation with behaviour analysts, professional carers and whanau through social validity surveys and questionnaires. Adaptations will be individualised for each participant. The participants will undergo another preference assessment, however, this time it is adapted to measure the effect on different indices of happiness and effectiveness of the procedure. The participants will again be given options of preferred items, food or activities, same as in baseline condition, however with the adaptions made to the procedure by the experimenters. Examples of adaptations include providing more or fewer options; having a support person present to assist the preference process, conducting the sessions in a different location, changing the language used to present the items etc. .These sessions will also be approximately 30 minutes, and there will be one to four adapted preference assessments per participant (no more than two sessions a day). The number of sessions will be determined through data-based decision making of the repeated measures data.. We will analyse the data after every session, looking specifically at variability and richness of the data (e.g., stability of preference, the number and topography of vocalisations). The more variable the data, the more likely we are to conduct another session (up to the maximum number). Two or more sessions of this phase is preferable to one, but one is acceptable. This adapted preference assessment phase will run for approximately 4 weeks. Procedural integrity will be measured in approximately 30% of sessions by a second observer. They will record integrity (adherence) based on a task analysis (a list of the investigator behaviours in which we will engage in each session).

(Phase 3): Participants living with dementia will continue to take part in the two preference assessment phases, alternating randomly between the two. This phase will involve the same participants as in Phases 1 and 2. Preference assessments will continue to be 30 minute long, one to four sessions per week (no more than two sessions a day). These will run for up to 15 weeks and we will run between 5-15 sessions per participant. The number of sessions will be determined through data-based decision making of the repeated measures data.. We will analyse the data after every session, looking specifically at variability and richness of the data (e.g., stability of preference, the number and topography of vocalisations). The more variable the data, the more likely we are to conduct another session (up to the maximum number). This specific design is called an alternating treatments design. Procedural integrity will be measured in approximately 30% of sessions by a second observer. They will record integrity (adherence) based on a task analysis (a list of the investigator behaviours in which we will engage in each session).

Participants will proceed to each subsequent phase immediately following completion of the previous phase.
Intervention code [1] 327875 0
Behaviour
Comparator / control treatment
The baseline (standard) preference assessment without adaptation will serve as the control condition. In this small-N design, each participant serves as their own control, and is exposed to all conditions.
Control group
Active

Outcomes
Primary outcome [1] 337254 0
Choice responding (selecting an item) during a multiple stimulus with replacement assessment. An array of between 5 and 7 items will be shown to the participant, they will be invited to make a choice and given access to that item for 30 seconds. After this time, the item will be placed back in the array, the item locations randomised, and choice invited again. This will occur 7 times in a session (i.e., when there are 7 items).
Timepoint [1] 337254 0
Repeated measures - data collected in every preference assessment session
Primary outcome [2] 337255 0
Indices of affect (including facial expression, vocalisations, body language). Behaviours to be operationally defined for each participant.
Timepoint [2] 337255 0
Repeated measures - data collected in every preference assessment session
Primary outcome [3] 337431 0
Choice responding (selecting an item) during a multiple stimulus without replacement assessment. An array of between 5 and 7 items will be shown to the participant, they will be invited to make a choice and given access to that item for 30 seconds. After this time, the item will be removed from the array, the item locations randomised, and choice invited again. This will occur until all items have been selected
Timepoint [3] 337431 0
Repeated measures - data collected in every preference assessment session
Secondary outcome [1] 431208 0
Acceptability of assessment (carers)
Timepoint [1] 431208 0
At the time of enrolment, after the first (baseline) preference assessment session and after the last adapted preference assessment session
Secondary outcome [2] 431825 0
Primary outcome:
Choice responding (selecting an item) during a paired stimulus assessment. Between 6 and 8 items will be offered two at a time, each item will be paired with each other item in a session and the location randomised. In each trial, the participant will be offered a choice between the two items.
Timepoint [2] 431825 0
Repeated measures - data collected in every preference assessment session
Secondary outcome [3] 431826 0
Primary outcome:
Choice responding (selecting an item) during a free operant assessment. Between 6 and 8 items will be available on a table. The participant will be invited to interact with any item they would like.
Timepoint [3] 431826 0
Repeated measures - data collected in every preference assessment session
Secondary outcome [4] 431827 0
Acceptability of assessment (whanau)
Timepoint [4] 431827 0
At the time of enrolment, after the first (baseline) preference assessment session and after the last adapted preference assessment session
Secondary outcome [5] 431828 0
Acceptability of assessment (participant)
Timepoint [5] 431828 0
At the time of enrolment, after the first (baseline) preference assessment session and after the last adapted preference assessment session

Eligibility
Key inclusion criteria
a) People living with mate wareware / dementia (independently diagnosed prior to the study).
b) A whanau member of each person with mate wareware
c) A professional carer / staff member for each person with mate wareware

Therefore, we will be working with triads of participants, comprising and a), b), and c).
It is possible that we may obtain consent from someone with dementia, but not a whanau member or professional carer. For each person with dementia, we require at least ONE of either b) or c) for inclusion in the study.
.
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 adapting preference assessments. 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
None

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
Recruiting
Date of first participant enrolment
Anticipated
1/04/2024
Actual
15/07/2024
Date of last participant enrolment
Anticipated
1/08/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
30
Accrual to date
3
Final
Recruitment outside Australia
Country [1] 26124 0
New Zealand
State/province [1] 26124 0

Funding & Sponsors
Funding source category [1] 315705 0
University
Name [1] 315705 0
The University of Auckland
Country [1] 315705 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 317809 0
None
Name [1] 317809 0
Address [1] 317809 0
Country [1] 317809 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314574 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 314574 0
Ethics committee country [1] 314574 0
New Zealand
Date submitted for ethics approval [1] 314574 0
09/02/2024
Approval date [1] 314574 0
10/04/2024
Ethics approval number [1] 314574 0

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

Contacts
Principal investigator
Name 132054 0
Dr Rebecca Sharp
Address 132054 0
Science Centre, Symonds Street, Auckland 1010, The University of Auckland
Country 132054 0
New Zealand
Phone 132054 0
+642102467280
Fax 132054 0
Email 132054 0
[email protected]
Contact person for public queries
Name 132055 0
Rebecca Sharp
Address 132055 0
Science Centre, Symonds Street, Auckland 1010, The University of Auckland
Country 132055 0
New Zealand
Phone 132055 0
+642102467280
Fax 132055 0
Email 132055 0
[email protected]
Contact person for scientific queries
Name 132056 0
Rebecca Sharp
Address 132056 0
Science Centre, Symonds Street, Auckland 1010, The University of Auckland
Country 132056 0
New Zealand
Phone 132056 0
+642102467280
Fax 132056 0
Email 132056 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21524Study protocol  [email protected] 387249-(Uploaded-19-02-2024-06-30-07)-Study-related document.docx



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.