Trial Review

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
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.
Scientific title
Effectiveness of adapted Cognitive Stimulation Therapy for Maori and Pasifika people with mild to moderate dementia: a pilot study
Secondary ID [1] 297350 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dementia 311471 0
Condition category
Condition code
Neurological 310110 310110 0 0
Dementias

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 313597 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319004 0
The Rowland Universal Dementia Assessment Scale (RUDAS)
Timepoint [1] 319004 0
7 weeks
Secondary outcome [1] 366700 0
World Health Organization Quality of Life (WHOQOL-BREF)
Timepoint [1] 366700 0
7 weeks

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
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/06/2019
Actual
1/10/2019
Date of last participant enrolment
Anticipated
28/02/2020
Actual
Date of last data collection
Anticipated
30/04/2020
Actual
Sample size
Target
32
Accrual to date
12
Final
Recruitment outside Australia
Country [1] 21270 0
New Zealand
State/province [1] 21270 0

Funding & Sponsors
Funding source category [1] 301915 0
Other Collaborative groups
Name [1] 301915 0
Brain Research New Zealand
Country [1] 301915 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
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



Country
New Zealand
Secondary sponsor category [1] 301669 0
None
Name [1] 301669 0
Address [1] 301669 0
Country [1] 301669 0
Other collaborator category [1] 280538 0
Charities/Societies/Foundations
Name [1] 280538 0
Dementia Wellington
Address [1] 280538 0
55 Hutt Road,
Petone,
5012 PO Box 39393,
Wellington Mail Centre,
Lower Hutt, 5045
Country [1] 280538 0
New Zealand
Other collaborator category [2] 280539 0
Charities/Societies/Foundations
Name [2] 280539 0
Alzheimers Eastern Bay of Plenty
Address [2] 280539 0
Professionals Building, Units 3-5, 38 Landing Road, Whakatane 3120
Country [2] 280539 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302600 0
Northern B Health and Disability Ethics Committee, New Zealand
Ethics committee address [1] 302600 0
Ethics committee country [1] 302600 0
New Zealand
Date submitted for ethics approval [1] 302600 0
01/06/2019
Approval date [1] 302600 0
05/09/2019
Ethics approval number [1] 302600 0

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

Contacts
Principal investigator
Name 90778 0
Dr Gary Cheung
Address 90778 0
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


Country 90778 0
New Zealand
Phone 90778 0
+64 21 332 823
Fax 90778 0
Email 90778 0
[email protected]
Contact person for public queries
Name 90779 0
Gary Cheung
Address 90779 0
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
Country 90779 0
New Zealand
Phone 90779 0
+64 21 332 823
Fax 90779 0
Email 90779 0
[email protected]
Contact person for scientific queries
Name 90780 0
Gary Cheung
Address 90780 0
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
Country 90780 0
New Zealand
Phone 90780 0
+64 21 332 823
Fax 90780 0
Email 90780 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This trial has not started yet and we will decide on this once we have some data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1333Study 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.