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Trial registered on ANZCTR


Registration number
ACTRN12612001161819
Ethics application status
Approved
Date submitted
23/10/2012
Date registered
1/11/2012
Date last updated
1/11/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial of the Tailored Activities Program (TAP) for reducing challenging behaviours in persons with dementia
Scientific title
The TAP program: Tailored activities to reduce challenging behaviours in persons with dementia - a randomized trial of effectiveness and cost effectiveness
Secondary ID [1] 281425 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
TAP Tailored Activities Program for people with dementia and their carers
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 287676 0
Condition category
Condition code
Neurological 288016 288016 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 8 session intervention program involves an occupational therapist identifying preserved capabilities, deficit areas, and previous interests of the person with dementia from which they prescribe specific activities. The 8 sessions run for around 1-1.5 hours each and occur over a 4 month period. Sessions involve both the person with dementia and their family caregiver. Family caregivers are then trained to use activities as part of daily care at home as a management strategy to reduce behavioural symptoms.
Intervention code [1] 285933 0
Treatment: Other
Intervention code [2] 285934 0
Behaviour
Comparator / control treatment
The control group is designed to control for the empathetic listening and targeted information received by caregivers in the experimental group. The carer will receive three telephone education sessions of between 15 to 30 minutes each over a 4 month period. The sessions will be based on selected chapters from a current book by Prof. Brian Draper about dementia.
Control group
Active

Outcomes
Primary outcome [1] 288224 0
Measurement of neuropsychiatric symptoms measured using the NPI-C- frequency of apathy, agitation, depression, sleep and irritibility domains.
Timepoint [1] 288224 0
4 months.
Secondary outcome [1] 299638 0
Measurement of neuropsychiatric symptoms measured using the NPI-C- frequency and severity of the 14 domains.
Timepoint [1] 299638 0
4 months and 8 months.
Secondary outcome [2] 299639 0
Measurement of function using the Disability Assessment for Dementia (DAD).
Timepoint [2] 299639 0
4 months and 8 months.
Secondary outcome [3] 299640 0
Measurement of carer quality of life using the Life Satisfaction Scale.
Timepoint [3] 299640 0
4 months and 8 months
Secondary outcome [4] 299641 0
Measurement of carer burden using the Zarit Burden Inventory (ZBI).
Timepoint [4] 299641 0
4 months and 8 months.
Secondary outcome [5] 299642 0
Measurement of carer stress, anxiety and depression, using the Depression, Anxiety and Stress Scale (DASS).
Timepoint [5] 299642 0
4 months and 8 months.
Secondary outcome [6] 299643 0
Measurement of caregiver skill using the Task Management Scale.
Timepoint [6] 299643 0
4 months and 8 months
Secondary outcome [7] 299644 0
Measurement of caregiver confidence in using activities using the Caregiver Confidence in Using Activities Scale.
Timepoint [7] 299644 0
4 months and 8 months.
Secondary outcome [8] 299645 0
Measurement of carer vigilance using the Vigilance Items Scale.
Timepoint [8] 299645 0
4 months and 8 months.
Secondary outcome [9] 299646 0
Measurement of carer work productivity and activity impairment using the Work Productivity and Activity Impairement Questionnaire: Specific Health Problem (WPAI-SHP).
Timepoint [9] 299646 0
4 months and 8 months.
Secondary outcome [10] 299647 0
Measurement of patient quality of life via proxy assessment with carer using the Euro Quality of Life (EQ-5D-3L Proxy).
Timepoint [10] 299647 0
4 months and 8 months.
Secondary outcome [11] 299648 0
Measurement of resource utilisation in dementia using the Resource Utilisation in Dementia (RUD-Lite).
Timepoint [11] 299648 0
4 months 8 months.
Secondary outcome [12] 299649 0
Measurement of health utilities using the proxy version of the Health Utilities Index (HUI).
Timepoint [12] 299649 0
4 months 8 months.
Secondary outcome [13] 299650 0
Measurement of carer willingness to pay for potential services using the Willingness to Pay questionnaire.
Timepoint [13] 299650 0
4 months.

Eligibility
Key inclusion criteria
Person with dementia must:
1. Have a diagnosis of dementia by a specialist, or meet the DSM-V (Major Neurocognitive Disorder) criteria
2. Be rated by the carer as having a frequency score of at least 2 or above on any item of the NPI-Q (Neuropsychiatric Inventory) over the past month.
3. Have conversational English
4. Be able to participate (independently or with some help) in at least two activities of daily living (ADLs; eg. bathing, dressing, grooming, toileting, transferring from bed to chair)
5. If on psychotropic medication, be on a stable dose for the past 60 days
6. If on dementia medication, be on a stable dose for the past 3 months.
7. Person with dementia should be living in the community.

Carer must:
1. Report occurrence of one or more behaviours (eg. apathy, passivity, disruptive behaviours) in person with dementia over the past month
2. Have conversational English
3. Be a family member of at least 18 years old and living with person with dementia or have at least 4 days or 7hrs per week contact.
4. Be accessible by phone
5. Indicate a willingness to learn use of activities
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Person with dementia will be excluded if:
1. They are currently involved in another clinical trial
2. They have a history of schizophrenia or bipolar disorder
3. Their dementia is secondary to head trauma, alcohol, brain tumour, HIV
4. They are not responsive to their environment (eg. unable to understand short commands or recognise a person coming in/out of the room)
5. They are bed bound
6. If patient is within the last 3 stages (7d, e, f) on the FAST (Functional assessment staging of Alzheimer’s Disease) which include the patient being unable to sit up without assistance, unable to hold their head up or unable to smile.
7. They do not have capacity for functional communication

Carers will be excluded if:
1. They are currently involved in another clinical trial
2. They are planning to place person in a nursing home within 8 months
3. They are on a psychotropic or cholinesterase inhibitor medication, which has not been a stable dose for past 60 days.
4. They have an active psychiatric disorder and have been admitted to a psychiatric hospital related to this in the past 5 years.

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)
Randomisation will be generated by an investigator not involved in data collection or intervention. Placed in opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted blocks of various sizes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/11/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
198
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5884 0
2101
Recruitment postcode(s) [2] 5885 0
2031

Funding & Sponsors
Funding source category [1] 286188 0
Government body
Name [1] 286188 0
National Health and Medical Research Council (NHMRC)
Country [1] 286188 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Cumberland Campus
75 East St
Lidcombe
NSW 2141
Country
Australia
Secondary sponsor category [1] 284998 0
University
Name [1] 284998 0
University of NSW
Address [1] 284998 0
Kensington Campus

The University of New South Wales
SYDNEY
NSW 2052
AUSTRALIA
Country [1] 284998 0
Australia
Secondary sponsor category [2] 284999 0
Charities/Societies/Foundations
Name [2] 284999 0
Neuroscience Research Australia
Address [2] 284999 0
Barker St
Randwick
NSW 2031
Country [2] 284999 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288263 0
Human Research Ethics Committee of The University of Sydney
Ethics committee address [1] 288263 0
Ethics committee country [1] 288263 0
Australia
Date submitted for ethics approval [1] 288263 0
Approval date [1] 288263 0
10/08/2012
Ethics approval number [1] 288263 0
15018

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

Contacts
Principal investigator
Name 34860 0
Address 34860 0
Country 34860 0
Phone 34860 0
Fax 34860 0
Email 34860 0
Contact person for public queries
Name 18107 0
Lindy Clemson
Address 18107 0
C42 - Cumberland Campus
The University of Sydney
Lidcombe
NSW 2141 Australia
Country 18107 0
Australia
Phone 18107 0
+61 2 9351 9372
Fax 18107 0
+61 2 9351 9672
Email 18107 0
lindy.clemson@sydney.edu.au
Contact person for scientific queries
Name 9035 0
Lindy Clemson
Address 9035 0
C42 - Cumberland Campus
The University of Sydney
Lidcombe
NSW 2141 Australia
Country 9035 0
Australia
Phone 9035 0
+61 2 9351 9372
Fax 9035 0
+61 2 9351 9672
Email 9035 0
lindy.clemson@sydney.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
No additional documents have been identified.