Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000411246
Ethics application status
Approved
Date submitted
12/04/2009
Date registered
3/06/2009
Date last updated
8/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cognitive training for 'at risk' older people
Scientific title
Does a healthy brain ageing cognitive training group program improve cognition in 'at risk' older people?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mild cognitive impairment 4585 0
depression 4586 0
Condition category
Condition code
Mental Health 4882 4882 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive training and a psychoeducational program covering healthy brain ageing. This consists of a two hour session every week for 10 weeks. The first hour delivers information pertinent to healthy ageing including use of cognitive strategies, and information on diet and exercise, vascular risk factors, depression, and sleep. The second hour is a computer-based cognitive training program.
Intervention code [1] 4351 0
Lifestyle
Comparator / control treatment
Treatment as usual. This includes standard clinical care by usual health care professionals. There is no prescribed intervention administered by the trial. The control arm is a waitlist control arm. It also runs for 10-weeks, and then participants are re-assessed, and offered the opportunity to participate in the cognitive training groups.
Control group
Active

Outcomes
Primary outcome [1] 5734 0
Cognition as assessed by formal neuropsychological testing.
Timepoint [1] 5734 0
10-12 weeks from study entry. Participants are assessed at trial entry, and again after 10-weeks of either 'cognitive training' or 'treatment as usual' (ie. waitlist).
Secondary outcome [1] 241679 0
Depression, as assessed by a clinician, as well as self-reported measures of mood state.
Timepoint [1] 241679 0
10-12 weeks from study entry. Participants are assessed at trial entry, and again after 10-weeks of either 'cognitive training' or 'treatment as usual' (ie. waitlist).

Eligibility
Key inclusion criteria
Cognitive impairment or depression or vascular risk factors
Minimum age
50 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Stroke, transient ischaemic attack (TIA), poor English skills, unable to attend 10-weeks of therapy, neurological disorder, dementia, psychiatric disorder, medical illness with known cognitive effects, prior head injury.

Study design
Purpose of the study
Educational / counselling / training
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
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/04/2008
Actual
1/02/2008
Date of last participant enrolment
Anticipated
Actual
14/05/2009
Date of last data collection
Anticipated
20/12/2017
Actual
Sample size
Target
80
Accrual to date
Final
86
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4775 0
Government body
Name [1] 4775 0
National Health and Medical Research Council (NHMRC)
Country [1] 4775 0
Australia
Primary sponsor type
Individual
Name
Sharon Naismith
Address
94 Mallett St, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 4313 0
Individual
Name [1] 4313 0
Ian Hickie
Address [1] 4313 0
94 Mallett St, Camperdown NSW 2050
Country [1] 4313 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6821 0
University of Sydney
Ethics committee address [1] 6821 0
Camperdown NSW 2050
Ethics committee country [1] 6821 0
Australia
Date submitted for ethics approval [1] 6821 0
Approval date [1] 6821 0
10/10/2007
Ethics approval number [1] 6821 0

Summary
Brief summary
This trial will assess the effects of a 'healthy brain ageing program' for older adults at risk of cognitive decline and/or dementia. It incorporates both cognitive training as well as information that will equip participants with knowledge regarding preventative risks for depression and cognitive decline. It is expected that those who participate in the treatment will improve in terms of memory functioning.
Trial website
www.bmri.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29481 0
Address 29481 0
Country 29481 0
Phone 29481 0
Fax 29481 0
Email 29481 0
Contact person for public queries
Name 12728 0
Dr Keri Diamond
Address 12728 0
94 Mallett St, Camperdown NSW 2050
Country 12728 0
Australia
Phone 12728 0
+612 9351 0746
Fax 12728 0
+612 9351 0855
Email 12728 0
kdiamond@med.usyd.edu.au
Contact person for scientific queries
Name 3656 0
Dr Sharon Naismith
Address 3656 0
94 Mallett St, Camperdown NSW 2050
Country 3656 0
Australia
Phone 3656 0
+612 9351 0781
Fax 3656 0
+612 9351 0855
Email 3656 0
snaismith@med.usyd.edu.au

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.