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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12619000203156
Ethics application status
Approved
Date submitted
10/02/2019
Date registered
12/02/2019
Date last updated
3/02/2020
Date data sharing statement initially provided
12/02/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Cognitive Stimulation Therapy for Maori and Pasifika people with dementia.
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Scientific title
Effectiveness of adapted Cognitive Stimulation Therapy for Maori and Pasifika people with mild to moderate dementia: a pilot study
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Secondary ID [1]
297350
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
dementia
311471
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Condition category
Condition code
Neurological
310110
310110
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0
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Dementias
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Cognitive Stimulation Therapy (CST) is an evidence based non-pharmacological treatment currently available for people with a diagnosis of mild to moderate dementia. CST consists of 14 twice-weekly group sessions (see below) that take place over the course of 7 weeks. All sessions are diverse in nature and the program offers a wide array of topics to ensure it meets the group’s interests and cognitive abilities. Every CST group has personalized elements to it, such as choice of a group name and song. These are displayed on an reality orientation board during the session. Sessions last 60 minutes including a 10-minute noncognitive warmup and a 10-minute closing activity (summary and/or the group song). The facilitators are encouraged to adhere to the key principles of CST, which helps to create the most optimal environment for mental stimulation and enjoyment. Examples of the 18 key
principles are mental stimulation, using reminiscence as an aid to the here and now,
implicit learning, fun, choice, building/strengthening relationships, and focusing on
opinions, rather than facts. These features are unique to CST.
Cognitive Stimulation Therapy session Content
1 Physical games
2 Sound
3 Childhood
4 Food
5 Current affairs
6 Faces/scenes
7 Associated words
8 Being creative
9 Categorizing objects
10 Orientation
11 Using money
12 Number games
13 Word games
14 Team games
CST was developed in the UK. We have adapted the CST manual for Maori and Pasifika people. This pilot study will involve running 2 CST groups for Maori people and 2 CST for Pasifika people with dementia.
1. A total of 14 sessions delivered twice a week for 7 weeks
2. Each session lasts for 60 minutes
3. Each session is facilitated by 2 facilitators. CST facilitators come from a range of health professional backgrounds including nursing, occupational therapy, diversional therapy and social work. Facilitators are required to attend a 1-day training workshop before delivering CST.
4. Each group has 6 to 8 people with mild to moderate dementia
We are not planning to assess intervention adherence or fidelity in this pilot study.
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Intervention code [1]
313597
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Treatment: Other
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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The Rowland Universal Dementia Assessment Scale (RUDAS)
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Assessment method [1]
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Timepoint [1]
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7 weeks
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Secondary outcome [1]
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World Health Organization Quality of Life (WHOQOL-BREF)
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Assessment method [1]
366700
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Timepoint [1]
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7 weeks
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Eligibility
Key inclusion criteria
We will use the usual CST inclusion criteria:
(i) mild to moderate dementia, defined by a score of 10 or more on the RUDAS (Rowland Universal Dementia Assessment Scale):
(ii) able to have a “meaningful” conversation; can hear well enough to participate in small group discussion;
(iii) vision good enough to see most pictures.
(iv) Maori ethnicity for the Maori CST groups; Pasifika ethnicity for the Pasifika group
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Minimum age
50
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
People will be excluded if they: have had a recent significant illness; have severe visual or hearing impairment; or are receiving terminal or palliative care.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
3/06/2019
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Actual
1/10/2019
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Date of last participant enrolment
Anticipated
28/02/2020
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Actual
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Date of last data collection
Anticipated
30/04/2020
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Actual
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Sample size
Target
32
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Accrual to date
12
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Final
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Recruitment outside Australia
Country [1]
21270
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New Zealand
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State/province [1]
21270
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Funding & Sponsors
Funding source category [1]
301915
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Other Collaborative groups
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Name [1]
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Brain Research New Zealand
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Address [1]
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University of Otago
William James Building
275 Leith Walk
PO Box 56
Dunedin 9016, New Zealand
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Country [1]
301915
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New Zealand
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Primary sponsor type
University
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Name
University of Auckland
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Address
Department of Psychologica Medicinel, School of Medicine, University of Auckland
Room 12.001,Level 12, Auckland Hospital Support Building, Grafton, Auckland 1142
Postal Address: Private Bag 92019, Auckland Mail Centre, Auckland 1142
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
301669
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Country [1]
301669
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Other collaborator category [1]
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Charities/Societies/Foundations
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Name [1]
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Dementia Wellington
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Address [1]
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55 Hutt Road,
Petone,
5012 PO Box 39393,
Wellington Mail Centre,
Lower Hutt, 5045
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Country [1]
280538
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New Zealand
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Other collaborator category [2]
280539
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Charities/Societies/Foundations
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Name [2]
280539
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Alzheimers Eastern Bay of Plenty
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Address [2]
280539
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Professionals Building, Units 3-5, 38 Landing Road, Whakatane 3120
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Country [2]
280539
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New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
302600
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Northern B Health and Disability Ethics Committee, New Zealand
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Ethics committee address [1]
302600
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Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
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Ethics committee country [1]
302600
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New Zealand
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Date submitted for ethics approval [1]
302600
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01/06/2019
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Approval date [1]
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05/09/2019
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Ethics approval number [1]
302600
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Summary
Brief summary
Cognitive Stimulation Therapy (CST) was initially developed in the UK and therefore lacking in Maori and Pasifika cultural content and values. Cultural adaptation is needed to ensure Maori and Pasifika people with dementia will benefit from this evidence based treatment. Internationally CST has been successfully adapted in many non-English speaking countries including Japan, China, Hong Kong, Italy, Denmark, Nigeria and Tanzania. The aim of this project is to test CST that has been adapted for Maori and Pasifika people with mild to moderate dementia.
The research team has worked with Maori and Pasifika community stakeholders in Eastern Bay of Plenty and Wellington respectively and adapted CST for Maori and Pasifika people with mild to moderate dementia. The aim of this study is to pilot and refine the adapted Maori and Pasifika CST manuals in two community settings (Maori: Eastern Bay of Plenty, partnered with Alzheimers Eastern Bay of Plenty; Pasifika: Wellington, partnered with Dementia Wellington).
Two groups based on the Maori manual and two groups based on the Pasifika manual will be conducted.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Gary Cheung
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Address
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Department of Psychological Medicine, School of Medicine, University of Auckland
Room 12.003,Level 12, Auckland Hospital Support Building, Grafton, Auckland 1142
Postal Address: Private Bag 92019, Auckland Mail Centre, Auckland 1142
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Country
90778
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New Zealand
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Phone
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+64 21 332 823
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Gary Cheung
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Address
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Department of Psychological Medicine, School of Medicine, University of Auckland
Room 12.003,Level 12, Auckland Hospital Support Building, Grafton, Auckland 1142
Postal Address: Private Bag 92019, Auckland Mail Centre, Auckland 1142
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Country
90779
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New Zealand
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Phone
90779
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+64 21 332 823
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Fax
90779
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Gary Cheung
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Address
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Department of Psychological Medicine, School of Medicine, University of Auckland
Room 12.003,Level 12, Auckland Hospital Support Building, Grafton, Auckland 1142
Postal Address: Private Bag 92019, Auckland Mail Centre, Auckland 1142
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Country
90780
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New Zealand
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Phone
90780
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+64 21 332 823
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Fax
90780
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Email
90780
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
This trial has not started yet and we will decide on this once we have some data.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
1333
Study protocol
376930-(Uploaded-10-02-2019-06-45-46)-Study-related document.doc
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.
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