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Trial registered on ANZCTR


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

Titles & IDs
Public title
Implementing the Tailored Activity Program for people with dementia or possible dementia living at home, and their family or informal carer: (i-TAP Australia)
Scientific title
Feasibility of implementing the Tailored Activity Program for people with dementia or possible 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
Possible 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 possible 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 and has been adapted by the Australian research team to for better suit the Australian context.

Prior to implementing TAP-Australia, OTs will receive training in TAP methods and education about dementia. The training will take place over a 6 week period (approximately) and 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 processes and procedures (approximately 6 hours plus some reading time),
- online training about dementia, BPSD and effective intervention and communication strategies (approximately 3 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),
- 3 x 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. We are planning on bring TAP to Australia (TAP-Australia). The OTs will keep a record of the number of sessions provided to clients and interventions implemented and will forward this information onto 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
12 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/possible dementia. This will be measured by using the Dementia Quality of Life (DEMQOL) – a 31 item questionnaire answered by a carer (Smith et al., 2005).
Smith SC, Lamping DL, Banerjee S, Harwood R, Foley B, Smith P, et al. Measurement of health-related quality of life for people with dementia: development of a new instrument (DEMQOL) and an evaluation of current methodology. Health Technol Assess. 2005;9(10):1-93, iii-iv.
Timepoint [2] 397911 0
1 week after completing TAP-Australia.
Secondary outcome [3] 397914 0
The health status of the person with dementia/ possible dementia. This will be assessed by the EQ-5D (Herdman et al., 2011).
Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36.
Timepoint [3] 397914 0
1 week after completing TAP-Australia.
Secondary outcome [4] 397915 0
Carer Burden - this will be assessed by the Zarit Burden Inventory (short-form) – a 12 item scale (Bédard et al., 2001).

Bédard M, Molloy DW, Squire L, Dubois S, Lever JA, O'Donnell M. The Zarit Burden Interview: a new short version and screening version. Gerontologist. 2001: 41(5):652-7.
Timepoint [4] 397915 0
1 week after completing TAP-Australia.
Secondary outcome [5] 397916 0
Carer depression, anxiety and distress. This will be assessed by the Depression, Anxiety & Stress Scale (DASS-21; Lovibond et al., 1995).

Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995;33(3):335-43.

Timepoint [5] 397916 0
1 week after completing TAP-Australia.
Secondary outcome [6] 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 [6] 397917 0
1 week after completing TAP-Australia.
Secondary outcome [7] 397918 0
The carer's health status will be assessed by the EQ-5D (Herdman et al., 2011).

Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9. PMID: 21479777; PMCID: PMC3220807.
Timepoint [7] 397918 0
1 week after completing TAP-Australia.

Eligibility
Key inclusion criteria
Any registered Occupational therapist who provides services for people with dementia/ possible dementia who lives in the community.
Inclusion criteria:
Person with dementia/ possible dementia - any person with a confirmed diagnosis of probable dementia from a medical practitioner OR has a cognitive screening score suggestive of dementia (e.g. a Mini-mental examination score < 24)in the absence of other cause,
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/ possible dementia, visits very regularly (at least 4-5 times per week) AND
has some behavioural or psychological symptoms associated with dementia as reported by a healthcare professional or carer, AND
who speaks english comfortably, AND
is able to participate in at least 2 activities of daily living,

Minimum age
21 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any person with dementia/ possible 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
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)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 309081 0
Government body
Name [1] 309081 0
NHMRC
Address [1] 309081 0
16 Marcus Clarke St,
Canberra ACT 2601
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
Townsville Hospital Health Services Human Research Ethics Committee
Ethics committee address [1] 308955 0
IMB 52, PO Box 670
Townsville, Qld 4810
Ethics committee country [1] 308955 0
Australia
Date submitted for ethics approval [1] 308955 0
20/10/2018
Approval date [1] 308955 0
20/12/2018
Ethics approval number [1] 308955 0
HREC/2018/QTHS/44139

Summary
Brief summary
The Tailored Activity program (TAP) is a structured, occupational therapist-led intervention for people with dementia and their care partners living in the community. It has been shown to be effective in reducing behavioural and psychological symptoms (BPSD) in people living with dementia and carer stress and improving quality of life. TAP is provided by Occupational Therapists (OTs) in up to eight home visits over 3-4 months. 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. Despite evidence of its effectiveness, however, TAP is not currently available in Australia. We plan to bring the program to Australia where it will be called TAP-Australia, and aim to train up to 75 OTs across Australia who will then be able to provide the program to people living with dementia/ possible dementia and their carer living in the community.
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
Dr 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
Prof 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?
Study protocol
Ethical approval
How or where can supporting documents be obtained?
Type [1] 12446 0
Study protocol
Citation [1] 12446 0
The study protocol may be obtained by contacting the study's Principal Investigator
Link [1] 12446 0
Email [1] 12446 0
sally.bennett@uq.edu.au
Other [1] 12446 0
Attachment [1] 12446 0
Type [2] 12447 0
Ethical approval
Citation [2] 12447 0
Link [2] 12447 0
Email [2] 12447 0
Other [2] 12447 0
Attachment
Summary results
No Results