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Trial registered on ANZCTR


Registration number
ACTRN12616000827437
Ethics application status
Approved
Date submitted
16/06/2016
Date registered
23/06/2016
Date last updated
29/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Individual Cognitive Stimulation Therapy for people with mild to moderate dementia
Scientific title
The effect of individual Cognitive Stimulation Therapy delivered by health professionals and trained volunteers on cognition and quality of life in people with mild to moderate dementia
Secondary ID [1] 289479 0
Nil known
Universal Trial Number (UTN)
U1111-1184-3646
Trial acronym
iCST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dementia 299164 0
Condition category
Condition code
Neurological 299179 299179 0 0
Dementias
Neurological 299205 299205 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
30 Participants will be randomised into one of the 3 arms: (i) individual Cognitive Stimulation Therapy (iCST) delivered by health professionals employed by Alzheimers Auckland; (ii) iCST delivered by Alzheimers Auckland volunteers trained by the research team; and (iii) Treatment as usual.

iCST will be delivered at home two 45-minute sessions per week for 12 weeks.

The iCST programme (delivered by health professionals or volunteers): The iCST facilitator has completed the one day master class iCST training delivered by members of the research team.

The iCST programme is:
15 minutes warming up (discuss the day, date, weather and season; discuss recent or current events in the news; listen to a piece of music or sing along to a favourite song; engage in gentle movement/stretches; breathing exercise)
20 minutes of the iCST activity
10 minutes warming down (refreshment; discuss topic of next 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

NB 1: The participant's carer is NOT involved in intervention sessions.
NB 2: The intervention (i.e. the iCST activities) follow the 37 topics of iCST sessions described in the manual of Individual Cognitive Stimulation Therapy (Making a difference 3. Hawker Publications)
NB 3: The intervention adherence or fidelity will not be assessed. All iCST facilitators have attended a 1-day training workshop on how to deliver iCST and will strictly follow the manual.
NB 4: The intervention is NOT a physical activity intervention. It is cognitive stimulation.
Intervention code [1] 295065 0
Treatment: Other
Comparator / control treatment
People allocated to the treatment as usual arm will receive routine follow up by Alzheimers Auckland. For a new referral to Alzheimers Auckland, the Key Worker will complete 4-6 home visits within the first six months to provide practical strategies for the carer/family. The Key Worker will refer the carer to Carer Education. The key Worker will refer the person with dementia (PWD) to the Socialisation service for community based group activities. The Key Worker 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] 298660 0
Person with dementia: Montreal Cognitive Assessment (MoCA)
Timepoint [1] 298660 0
12 weeks post treatment commencement
Primary outcome [2] 298697 0
Person with dementia: Quality of life Alzheimer’s disease Scale (QoL- AD)
Timepoint [2] 298697 0
12 weeks post treatment commencement
Secondary outcome [1] 324873 0
Person with dementia: CNS Vital Signs (CNSVS, a computerised neurocognitive test battery)
Timepoint [1] 324873 0
12 weeks post treatment commencement
Secondary outcome [2] 324992 0
Person with dementia: Dementia Quality of Life (DEMQOL)
Timepoint [2] 324992 0
12 weeks post treatment commencement
Secondary outcome [3] 324993 0
Person with dementia: Geriatric Depression Scale (GDS-15)
Timepoint [3] 324993 0
12 weeks post treatment commencement
Secondary outcome [4] 324994 0
Person with dementia: Quality of the carer-patient relationship (QCPR)
Timepoint [4] 324994 0
12 weeks post treatment commencement
Secondary outcome [5] 324995 0
Carer of the person with dementia: Short Form-12 Health Survey (SF-12)
Timepoint [5] 324995 0
12 weeks post treatment commencement
Secondary outcome [6] 324996 0
Carer of the person with dementia: Self-reported health related quality of life EQ-5D

Timepoint [6] 324996 0
12 weeks post treatment commencement
Secondary outcome [7] 324997 0
Carer of the person with dementia: Hospital Anxiety and Depression Scale (HDAS)
Timepoint [7] 324997 0
12 weeks post treatment commencement
Secondary outcome [8] 324998 0
Carer of the person with dementia: Quality of the carer-patient relationship (QCPR)
Timepoint [8] 324998 0
12 weeks post treatment commencement

Eligibility
Key inclusion criteria
1) mild to moderate dementia (Montreal Cognitive Examination score of 15 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

NB: Carers do not participate in the intervention. However, the next of kin will provide consent given the person with dementia may have diminished capacity to provide informed consent; the person with dementia will provide assent to participate.
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a recent acute medical illness such as stroke or heart attack within the past 6 weeks will not be eligible

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
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7962 0
New Zealand
State/province [1] 7962 0
Auckland

Funding & Sponsors
Funding source category [1] 293840 0
Charities/Societies/Foundations
Name [1] 293840 0
Alzheimers Auckland Charitable Trust
Address [1] 293840 0
Level 1, Suite 4, 58 Surrey Crescent, Grey Lynn, Auckland 1021
Country [1] 293840 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Level 12, Auckland Hospital Support Building, 2 Park Road, Grafton, Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 292677 0
None
Name [1] 292677 0
None
Address [1] 292677 0
None
Country [1] 292677 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295267 0
Health and Disability Ethics Committee
Ethics committee address [1] 295267 0
Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington 6011
Ethics committee country [1] 295267 0
New Zealand
Date submitted for ethics approval [1] 295267 0
01/07/2016
Approval date [1] 295267 0
31/08/2016
Ethics approval number [1] 295267 0

Summary
Brief summary
Cognitive stimulation is defined as “engagement in a range of activities and discussions (usually in a group) aimed at general enhancement of cognitive and social functioning”. Cognitive stimulation therapy (CST) is a structured and manualised group treatment specifically developed for people with mild to moderate dementia. It involves 14 or more sessions of themed activities. They were designed to run twice a week over a seven-week period. Sessions are aimed to actively stimulate and engage people with dementia, while providing an optimal learning environment and the social benefits of a group. The effects of CST appear to be of a comparable size to those reported with the currently available anti-dementia drugs. A cost effectiveness study found that CST for people with dementia may be more cost-effective than usual treatment. CST was developed in the UK and recommended in the NICE dementia guidelines. It has been adopted in 24 countries including New Zealand. A recent Cochrane review concludes that cognitive stimulation programmes can benefit cognition in people with mild to moderate dementia over and above any medication effects, while the improvements in self-reported quality of life and well-being were promising.

Individual CST (iCST) is a novel home-based approach to deliver CST. There is only one previous study on iCST which was delivered by family carers. The study did not find any significant difference in the primary outcomes (cognition and quality of life for people with dementia, and quality of life for their carer). However, it found people with dementia had better quality of relationship with their carer who delivered the programme and carer had better health-related quality of life and less depression. The researchers suggested future research should investigate the efficacy of iCST when it is delivered by healthcare professionals.

The primary purpose of the study is to compare the efficacy of iCST delivered by health professionals and trained volunteers with treatment as usual (TAU). The null hypothesis is that when compared to treatment as usual, iCST (delivered by health professionals or 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

Contacts
Principal investigator
Name 66706 0
Dr Gary Cheung
Address 66706 0
Room 12.003,Level 12, Auckland Hospital Support Building, 2 Park Rd, Grafton, Auckland 1142
Country 66706 0
New Zealand
Phone 66706 0
+6421332823
Fax 66706 0
Email 66706 0
g.cheung@auckland.ac.nz
Contact person for public queries
Name 66707 0
Dr Gary Cheung
Address 66707 0
Room 12.003,Level 12, Auckland Hospital Support Building, 2 Park Rd, Grafton, Auckland 1142
Country 66707 0
New Zealand
Phone 66707 0
+6421332823
Fax 66707 0
Email 66707 0
g.cheung@auckland.ac.nz
Contact person for scientific queries
Name 66708 0
Dr Gary Cheung
Address 66708 0
Room 12.003,Level 12, Auckland Hospital Support Building, 2 Park Rd, Grafton, Auckland 1142
Country 66708 0
New Zealand
Phone 66708 0
+6421332823
Fax 66708 0
Email 66708 0
g.cheung@auckland.ac.nz

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary