Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001068853
Ethics application status
Approved
Date submitted
20/09/2012
Date registered
5/10/2012
Date last updated
16/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of cognitive stimulation therapy for people with dementia in Australia
Scientific title
Acceptability of a pilot Australian adaption of Cognitive Stimulation Therapy for people with dementia
Secondary ID [1] 281278 0
Nil
Universal Trial Number (UTN)
U1111-1134-9383
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 287480 0
Cognition 287481 0
Condition category
Condition code
Neurological 287811 287811 0 0
Dementias
Mental Health 287812 287812 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive Stimulation Therapy is a nonpharmacological intervention for people with a mild to moderate dementia. It is a structured group or one-to-one program that incorporates Reality Orientation and reminiscence therapy using multisensory activities to stimulate thinking, concentration and memory.

There will be 2 x 45 minute sessions held each week for 7 weeks in the initial CST program followed by weekly 45 minute sessions for 24 weeks in the maintenance program. Each session will have 2 facilitators; all sessions will be group sessions.
Intervention code [1] 285750 0
Treatment: Other
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288035 0
Acceptability & satisfaction - measured by self report of participant and by evaluation of support person on qualitative measure
Timepoint [1] 288035 0
After Initial course (week 7) and after maintenance course (week 32)
Secondary outcome [1] 299314 0
Quality of life - Quality of Life AD
Timepoint [1] 299314 0
After Initial course (week 7) and after maintenance course (week 32)
Secondary outcome [2] 299315 0
Depression - Cornell Scale for Depression in Dementia
Timepoint [2] 299315 0
After Initial course (week 7) and after maintenance course (week 32)
Secondary outcome [3] 299316 0
Cognition - MMSE
Timepoint [3] 299316 0
After Initial course (week 7) and after maintenance course (week 32)

Eligibility
Key inclusion criteria
Patients of Prince of Wales Aged Care Psychiatry Services
Meet DSM–IV criteria for dementia; (American Psychiatric Association, 1994)
Score between 16 and 28 on the Mini-Mental State Exam ;
Able to provide informed consent
Mobile and able to attend the group sessions
Ability to communicate and understand communication in English;
Be able to see and hear well enough to participate in the group sessions;
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Behaviour that would make group participation impossible, such as constant wandering, shouting, or aggression;
Diagnosis of learning disability or current severe clinical depression, which would make reliable assessment difficult

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)
Clinicians within the Aged Care Psychiatry Department at Prince of Wales Hospital will be asked to approach potential participants that meet inclusion criteria
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
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
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/10/2012
Actual
8/02/2013
Date of last participant enrolment
Anticipated
Actual
8/02/2013
Date of last data collection
Anticipated
Actual
27/09/2013
Sample size
Target
8
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 286045 0
University
Name [1] 286045 0
University of NSW
Country [1] 286045 0
Australia
Primary sponsor type
University
Name
University of NSW
Address
Sydney, NSW 2052
Country
Australia
Secondary sponsor category [1] 284858 0
Hospital
Name [1] 284858 0
Prince of Wales Hospital
Address [1] 284858 0
Barker Street
Randwick
NSW 2031
Country [1] 284858 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288094 0
South East Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 288094 0
Ethics committee country [1] 288094 0
Australia
Date submitted for ethics approval [1] 288094 0
Approval date [1] 288094 0
20/09/2012
Ethics approval number [1] 288094 0
1/12/0155

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

Contacts
Principal investigator
Name 34744 0
Prof Brian Draper
Address 34744 0
Euroa Centre, Prince of Wales Hospital, Barker Street, Randwick, NSW, 2031
Country 34744 0
Australia
Phone 34744 0
+61-2-93823753
Fax 34744 0
Email 34744 0
[email protected]
Contact person for public queries
Name 17991 0
Professor Brian Draper
Address 17991 0
Academic Department for Old Age Psychiatry
Prince of Wales Hospital
Barker Street
Randwick
NSW 2031
Country 17991 0
Australia
Phone 17991 0
+61-2-9382 3753
Fax 17991 0
Email 17991 0
[email protected]
Contact person for scientific queries
Name 8919 0
Professor Brian Draper
Address 8919 0
Academic Department for Old Age Psychiatry
Prince of Wales Hospital
Barker Street
Randwick
NSW 2031
Country 8919 0
Australia
Phone 8919 0
61-2-9382 3753
Fax 8919 0
Email 8919 0
[email protected]

No information has been provided regarding IPD availability


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.