Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001369314
Ethics application status
Approved
Date submitted
13/06/2017
Date registered
27/09/2017
Date last updated
3/09/2019
Date data sharing statement initially provided
3/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Individual Cognitive Stimulation Therapy delivered by trained volunteers for people with dementia
Scientific title
The effect of individual Cognitive Stimulation Therapy delivered by
trained volunteers on cognition and quality of life in people with mild to
moderate dementia: A pilot randomized controlled trial
Secondary ID [1] 292178 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12616000827437

Health condition
Health condition(s) or problem(s) studied:
Dementia 303655 0
Condition category
Condition code
Neurological 303041 303041 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
(i) The individual Cognitive Stimulation Therapy (iCST) programme (delivered by trained volunteers)
The iCST facilitator has completed the one day master class iCST training delivered by members of the research team.

iCST will be delivered at home twice a week for 45-minute per sessions for 10 weeks.

The iCST programme is:
15 minutes warming up, orientation, current affairs, refreshments and gentle stretches
20 minutes of the iCST activity
10 minutes warm down, discuss topic for following session
TOTAL 45 minutes

The key principles of iCST are
1. Mental stimulation
2. Developing new idea, thoughts and associations
3. Using orientation in a sensitive manner
4. Focusing on opinions, rather than facts
5. Using reminiscence as an aid to the here and now
6. Providing triggers to support memory
7. Stimulate language and communication
8. Stimulate every day planning ability
9. Using a “person-centred” approach
10. Offering a choice of activities
11. Enjoyment and fun
12. Maximising potential
13. Strengthening the relationship by spending quality time together

Adherence will be measured by the total number of sessions over the 10 weeks period
Intervention code [1] 298337 0
Treatment: Other
Comparator / control treatment
(ii) Treatment as Usual (TAU)
People allocated to the treatment as usual arm will receive routine follow up by Dementia Auckland. For a new referral to Dementia Auckland, the keyworker usually completes 4-6 home visits within the first six months to provide practical strategies for the carer/family. The Keyworker will refer the carer to Carer Education if this is a carer preference. The keyworker can refer the person with dementia (PWD) to the Socialisation service for community based group activities. The keyworker will integrate the carer into monthly support groups. Following the initial six months, there are regular phone calls, home visits if required, support groups and Socialisation. Each person is re-assessed with a home visit annually.
Control group
Active

Outcomes
Primary outcome [1] 302414 0
Montreal Cognitive Assessment
Timepoint [1] 302414 0
pre- and post- iCST intervention (10 weeks)
Primary outcome [2] 303480 0
World Health Organization Quality of Life (WHOQOL)
Timepoint [2] 303480 0
pre- and post-iCST intervention (10 weeks)
Secondary outcome [1] 335906 0
Carer Reaction Assessment

NB: Carer Reaction Assessment is a rating scale in itself measuring carer burden
Timepoint [1] 335906 0
pre- and post-iCST intervention (10 weeks)
Secondary outcome [2] 335907 0
World Health Organization Quality of Life (WHOQOL) on carer
Timepoint [2] 335907 0
pre- and post-iCST intervention (10 weeks)

Eligibility
Key inclusion criteria
1. People aged 50 years or above with a diagnosis of mild to moderate dementia (Montreal Cognitive Assessment score of 10 or more).
2. The person can have a ‘meaningful’ conversation.
3. The person can hear well enough to participate in a 1-to-1 discussion.
4. The person’s vision is good enough to see most pictures.
5. The person is likely to remain in a session for 45 minutes
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Those within the past 6 weeks who have had a recent acute medical illness such as stroke or heart attack.
2. Those who is currently participating in a cognitive stimulation treatment

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)
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
single-blinded (researchers collecting post-intervention outcome measures are blinded to allocation group i.e. iCST or TAU)

simple randomisation by a statistician
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
ANOVA will be used for comparing the pre- and post-outcome measures in the two intervention groups and treatment as usual group. Significant will be tested at 5%.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/10/2017
Actual
17/08/2018
Date of last participant enrolment
Anticipated
30/09/2018
Actual
19/12/2018
Date of last data collection
Anticipated
31/12/2018
Actual
Sample size
Target
60
Accrual to date
Final
5
Recruitment outside Australia
Country [1] 8980 0
New Zealand
State/province [1] 8980 0
Auckland

Funding & Sponsors
Funding source category [1] 296720 0
Charities/Societies/Foundations
Name [1] 296720 0
Perpetual Guardian Ted and Mollie Carr Trust
Country [1] 296720 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
85 Park Road, Grafton
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 295686 0
None
Name [1] 295686 0
None
Address [1] 295686 0
None
Country [1] 295686 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297941 0
Health and Disability Ethics Committee
Ethics committee address [1] 297941 0
Northern B Health and Disability Ethics Committee
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 297941 0
New Zealand
Date submitted for ethics approval [1] 297941 0
16/06/2017
Approval date [1] 297941 0
22/09/2017
Ethics approval number [1] 297941 0
17/NTB/121

Summary
Brief summary
This pilot study will build on the work we have already completed on testing the feasibility of delivering iCST for people with dementia by trained volunteers. The aim is to recruit a larger sample that will allow power calculation for a future multi-centre trial comparing the efficacy of iCST delivered by trained volunteers with treatment as usual (TAU). The null hypothesis is that when compared to treatment as usual, iCST (delivered by trained volunteers) has no positive benefit on cognition or quality of life for people with mild to moderate dementia.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2080 2080 0 0
/AnzctrAttachments/373118-iCST Pilot Study Protocol FINAL.pdf

Contacts
Principal investigator
Name 75530 0
Dr Gary Cheung
Address 75530 0
Room 12.003, Level 12
Auckland Hospital Support Building
Grafton, Auckland 1142
Country 75530 0
New Zealand
Phone 75530 0
+6421332823
Fax 75530 0
Email 75530 0
g.cheung@auckland.ac.nz
Contact person for public queries
Name 75531 0
Gary Cheung
Address 75531 0
Room 12.003, Level 12
Auckland Hospital Support Building
Grafton, Auckland 1142
Country 75531 0
New Zealand
Phone 75531 0
+6421332823
Fax 75531 0
Email 75531 0
g.cheung@auckland.ac.nz
Contact person for scientific queries
Name 75532 0
Gary Cheung
Address 75532 0
Room 12.003, Level 12
Auckland Hospital Support Building
Grafton, Auckland 1142
Country 75532 0
New Zealand
Phone 75532 0
+6421332823
Fax 75532 0
Email 75532 0
g.cheung@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



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.