Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000931370p
Ethics application status
Help: Ethics application status
Submitted, not yet approved
Date submitted
Help: Date submitted
6/07/2026
Date registered
Help: Date registered
29/07/2026
Date last updated
Help: Date last updated
29/07/2026
Date data sharing statement initially provided
Help: Data sharing statement date
29/07/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Culturally adapted cognitive stimulation therapy over zoom for kaumatua/"older Maori" with mate wareware "dementia". Haumanu Whakaohooho Whakaaro Maori a Ipurangi.
Scientific title
Haumanu Whakaohooho Whakaaro Maori a Ipurangi. "Culturally adapted cognitive stimulation therapy over zoom for kaumatua/older Maori with mate wareware "dementia:: a pilot study of virtual CST Maori.
Additional trial identifiers [1] 317909 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Dementia 342725 0
Condition category
Condition code
Neurological 338864 338864 0 0
Dementias
Mental Health 339081 339081 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Culturally adapted cognitive stimulation therapy delivered over zoom. It is a psychosocial intervention involving a series of themed activities that stimulate communication, executive functioning, verbal fluency, and memory. The intervention is delivered by trained facilitators with a background working with older Maori in community health and social services and involves 15 sessions of approximately one hour presented via Zoom.
To monitor fidelity, the 15 sessions are recorded over zoom, and facilitators are provided feedback and supervision on their adherence to the intervention.
The intervention has been culturally adapted for older Maori which includes use of Maori language, cultural imagery, and customary practices such as traditional karakia (prayer, incantations) before and at the end of sessions.
Intervention code [1] 333807 0
Treatment: Other
Description of the comparator or control
this is a pre-post test pilot study where participants act as their own control group. The kaumatua participants be assessed at least one week prior to receiving the CST-Maori intervention. They will be assessed on measures of cognitive function and also quality of life.
Control group
Active

Outcomes
Primary outcome [1] 345123 0
Change in cognitive functioning as measured by the cognitive subtest of the Maori Assessment of Neuropsychological Abilities (MANA-COG tool)
Timepoint [1] 345123 0
The MANA-COG tool will be administered to the older kaumatua participants prior to and following completion of 15 sessions of the CST-Maori intervention
Secondary outcome [1] 460548 0
Change in Quality of Life
Timepoint [1] 460548 0
The NZ-WHOQOL-Brief questionnaire will be administered to the older kaumatua participants prior to and following completion of 15 sessions of the CST-Maori intervention

Eligibility
Key inclusion criteria
Kaumatua participants:
- Inclusion criteria: Self-identified as Maori, all genders, diagnosed with mild or moderate dementia, aged 55 years or older. Must be medically stable.
. Whanau/Family participants:
Inclusion criteria: any individuals identified as whanau by the kaumatua participants (whether whakapapa or kaupapa whanau); all genders.

Facilitator participants:
Inclusion criteria: any individuals who are contracted to be facilitators of the virtual CST-Maori sessions; all genders.
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Kaumatua participants:
-exclusion criteria: lack the capacity to consent, refuse to be audio-recorded; unable to utilize the study computer tablet or an alternative computer to participate in the online CST-Maori sessions.

Whanau participants:
Exclusion criteria: refuse to be audio-recorded

Facilitator participants:
Exclusion criteria: refuse to be audio-recorded

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
Efficacy
Statistical methods / analysis
This is a small pilot study so power analysis is not indicated.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2026
Actual
Date of last participant enrolment
Anticipated
18/06/2027
Actual
Date of last data collection
Anticipated
31/07/2027
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 28296 0
New Zealand
State/province [1] 28296 0

Funding & Sponsors
Funding source category [1] 321644 0
Government body
Name [1] 321644 0
Health Research Council
Country [1] 321644 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 325273 0
None
Name [1] 325273 0
Address [1] 325273 0
Country [1] 325273 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 320171 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 320171 0
Ethics committee country [1] 320171 0
New Zealand
Date submitted for ethics approval [1] 320171 0
16/07/2026
Approval date [1] 320171 0
Ethics approval number [1] 320171 0

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

Contacts
Principal investigator
Name 149666 0
Dr Tai Kake
Address 149666 0
University of Auckland, 24 Symonds St, Auckland 1010
Country 149666 0
New Zealand
Phone 149666 0
+64 0272338206
Fax 149666 0
Email 149666 0
[email protected]
Contact person for public queries
Name 149667 0
Tai Kake
Address 149667 0
University of Auckland, 24 Symonds St, Auckland 1010
Country 149667 0
New Zealand
Phone 149667 0
+64 9 373 7999
Fax 149667 0
Email 149667 0
[email protected]
Contact person for scientific queries
Name 149668 0
Tai Kake
Address 149668 0
University of Auckland, 24 Symonds St, Auckland 1010
Country 149668 0
New Zealand
Phone 149668 0
+64 9 373 7999
Fax 149668 0
Email 149668 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol    Protocol Kaupapa Maori Pilot study 2.07.26.docx


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.