Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621001121853
Ethics application status
Approved
Date submitted
6/07/2021
Date registered
23/08/2021
Date last updated
30/11/2023
Date data sharing statement initially provided
23/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementing the Tailored Activity Program in Australia.
Scientific title
Implementing the Tailored Activity Program for people with dementia or probable dementia living at home, and their family or informal carer: (i-TAP Australia)
Secondary ID [1] 304711 0
Nil known
Universal Trial Number (UTN)
U1111-1267-6695
Trial acronym
i-TAP (Australia)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 322727 0
Probable dementia 322728 0
Condition category
Condition code
Neurological 320316 320316 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is the Tailored Activity Program (TAP) which is an occupational therapist-led intervention for people with dementia or probable dementia and their care partners living in the community. TAP is an evidence-based program that was developed in the USA and has been shown to effectively reduce behavioural and psychological symptoms (BPSD) in people living with dementia, in addition to other positive outcomes. TAP is provided by Occupational Therapists (OTs) in 7-8 X 1 hour home visits over 3-4 months (i.e. approximately one visit per fortnight, one visit may be via telephone). The program manual was developed by researchers at Johns Hopkins University in the US.

TAP has been adapted by the Australian research team to better suit the Australian context and occupational therapists will be asked to provide the program in 6 sessions (approximately one per fortnight), and three sessions may be conducted remotely.

Prior to implementing TAP-Australia, OTs will receive training in TAP methods and education about dementia. The training will include:
- 6 X 50 minute online learning modules about TAP from Drexel University in the USA (where TAP was developed and validated),
- additional online training about the implementation of TAP-Australia provided by the Research team, including education about dementia, BPSD and effective intervention and communication strategies, as well as strategies for implementing TAP (approximately 8 hours). This training will be provided by experts in the field who will employ sound educational strategies to promote learning and understanding of dementia and dementia care (e.g. factual information, interactive learning, case studies),
- Coaching calls (approximately 1 hour in total) by the research team to support OTs when they have commenced providing TAP-Australia.
OTs will be able to implement TAP-Australia immediately following completion of the training.

TAP procedures are detailed in the TAP manual that includes assessments, session plans and intervention strategies. The OT assesses the person’s capabilities and strengths, and teaches carers to tailor and adapt meaningful activities (any activity that is important or personally meaningful to the person with dementia), use effective communication strategies, generalise these skills to other activities of daily living, understand environmental triggers for BPSD, and utilise stress reduction strategies for themselves. The OTs will keep a record of the number of sessions provided to clients and interventions implemented and will forward this information to the research team.
Intervention code [1] 321091 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328166 0
The extent to which TAP-Australia is implemented by occupational therapists in Australia. This will be measured by the number of people who receive TAP-Australia. OTs will provide the research team with information regarding the number of sessions completed with clients.
Timepoint [1] 328166 0
Nine months post-training of occupational therapists.
Secondary outcome [1] 397910 0
Neuropsychiatric symptoms in the person with dementia/possible dementia. This will be assessed by the Neuropsychiatric Inventory (NPIQ) – a 12 item scale assessing frequency & severity of behavioural and psychological symptoms, and associated carer distress (Cummings, 1997).
Cummings JL. The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology. 1997 May;48(5 Suppl 6):S10-6.
Timepoint [1] 397910 0
1 week after completing TAP-Australia.
Secondary outcome [2] 397911 0
The quality of life of the person with dementia/probable dementia and his/her carer. This will be assessed by the Quality of Life in Alzheimer's Disease Scale (Logsdon, R. G., Gibbons, L. E., McCurry, S. M., & Teri, L. (1999). Quality of life in Alzheimer’s disease: Patient and caregiver reports. Journal of Mental Health and Aging, 5, 21–32). The carer will complete the scale for him/herself as well as for the person with dementia/probable dementia.
Timepoint [2] 397911 0
1 week after completing TAP-Australia.
Secondary outcome [3] 397915 0
Carer burden will be assessed by the Caregiver Assessment of Function and Upset Scale (CAFU) which is a measure of functional dependence of the person who is cared for, and the degree of upset the carer feels as a result. (CAFU: Gitlin LN, Roth D, Burgio LD et al. Caregiver appraisals of functional dependence in individuals with dementia and associated caregiver upset: Psychometric properties of a new scale and response patterns by caregiver and care recipient characteristics. J Aging Health 2005;17:148–171.)
Timepoint [3] 397915 0
1 week after completing TAP-Australia.
Secondary outcome [4] 397916 0
Carer Depression. This will be assessed by the Patient Health Questionnaire (PHQ-9) - a 9-item questionnaire for assessing depression. (Spitzer, R. L., Kroenke, K., & Williams, J. B. (1999). Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA, 282(18), 1737–1744. https://doi.org/10.1001/jama.282.18.1737)
Timepoint [4] 397916 0
1 week after completing TAP-Australia.
Secondary outcome [5] 397917 0
Carer vigilance will be assessed using a 4 item scale that measures the time spent ‘doing things’ (tangible) and ‘being there’ (non-tangible) aspects of caring (Mahoney et al., 2003).

Mahoney DF, Jones RN, Coon DW, Mendelsohn AB, Gitlin LN, Ory M. The Caregiver Vigilance Scale: application and validation in the Resources for Enhancing Alzheimer's Caregiver Health (REACH) project. Am J Alzheimers Dis Other Demen. 2003 Jan-Feb;18(1):39-48.
Timepoint [5] 397917 0
1 week after completing TAP-Australia.

Eligibility
Key inclusion criteria
Any registered Occupational therapist who provides services for people with dementia/ probable dementia who lives in the community.
Inclusion criteria:
A person with dementia/ probable dementia (e.g. cognitive impairments in 2 or more domains),
AND
who lives in the community (either in their own home or in an independent unit in a retirement village), AND
has a co-resident carer over the age of 18 years OR if the carer does not reside with the person with dementia/ probable dementia, visits very regularly (at least 4-5 times per week) AND
has some changes in behaviour or psychological symptoms (identified through referral information, medical charts or carer report), AND
who speaks english comfortably.
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any person with dementia/ probable dementia who is bed-bound.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2023
Actual
30/05/2023
Date of last participant enrolment
Anticipated
29/12/2023
Actual
Date of last data collection
Anticipated
29/12/2023
Actual
Sample size
Target
100
Accrual to date
40
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 309081 0
Government body
Name [1] 309081 0
NHMRC
Country [1] 309081 0
Australia
Primary sponsor type
Individual
Name
Professor Sally Bennett
Address
School of Health and Rehabilitation Sciences,
The University of Queensland
St Lucia Qld 4072
Country
Australia
Secondary sponsor category [1] 310027 0
None
Name [1] 310027 0
Address [1] 310027 0
Country [1] 310027 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308955 0
The University of Queensland Human research Ethics Committee
Ethics committee address [1] 308955 0
Ethics committee country [1] 308955 0
Australia
Date submitted for ethics approval [1] 308955 0
07/11/2022
Approval date [1] 308955 0
09/11/2022
Ethics approval number [1] 308955 0
2019/HE000434

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

Contacts
Principal investigator
Name 112462 0
Prof Sally Bennett
Address 112462 0
School of Health and Rehabilitation Sciences,
The University of Queensland
84a Services Rd.,
St Lucia Qld 4072
Country 112462 0
Australia
Phone 112462 0
+61 07 3365 3451
Fax 112462 0
Email 112462 0
sally.bennett@uq.edu.au
Contact person for public queries
Name 112463 0
Catherine Travers
Address 112463 0
School of Health and Rehabilitation Sciences,
The University of Queensland
84a Services Rd.,
St Lucia Qld 4072
Country 112463 0
Australia
Phone 112463 0
+61408583332
Fax 112463 0
Email 112463 0
c.travers1@uq.edu.au
Contact person for scientific queries
Name 112464 0
Sally Bennett
Address 112464 0
School of Health and Rehabilitation Sciences,
The University of Queensland
84 a Services Rd.,
St Lucia Qld 4072
Country 112464 0
Australia
Phone 112464 0
+61 07 3365 3451
Fax 112464 0
Email 112464 0
sally.bennett@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The information that we will be collecting is potentially sensitive and we have not asked participants to consent to this use of data in our Information Sheets and Consent Forms.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12446Study protocolThe study protocol may be obtained by contacting the study's Principal Investigator sally.bennett@uq.edu.au
12447Ethical approval    Attachment 382351-(Uploaded-06-07-2021-14-51-37)-Study-related document.pdf



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.