Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001100684
Ethics application status
Approved
Date submitted
23/09/2014
Date registered
16/10/2014
Date last updated
9/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the cognitive impact of booster brain training in older adults attending day care centres or residing in retirement villages.
Scientific title
A single-blind, randomised equivalence clinical trial of cognitive changes in response to computerised cognitive training in older adults attending day care centres or residing in retirement villages, as measured by a battery of neuropsychological tests.
Secondary ID [1] 285218 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 292843 0
Mild Cognitive Impairment 292844 0
Condition category
Condition code
Neurological 293145 293145 0 0
Alzheimer's disease
Neurological 293496 293496 0 0
Dementias
Mental Health 293497 293497 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Computer-assisted Cognitive Training (CCT):

The intervention will be conducted over a period of 6 months. All training session will be approximately 40 minutes in duration and conducted by an experienced trainer in a group setting in the computer rooms of day centres/retirement villages. Training sessions will become part of regular activities at the day care centres/retirement village. Times will be discussed in advanced, and every effort will be made to keep training sessions the same time each week. Participants who do not show up for a session are contacted to enquire about their absence, and a make-up session will be scheduled.

The CCT intervention will use Captain’s Log MindPower Bulider. This suite of cognitive training exercises was developed in collaboration with clinical staff and is largely based upon well-established neuropsychological tests and principles, and has been used extensively in neuropsychiatric research. It has been used in numerous studies, and was shown to to be effective in preserving cognition/preventing further decline in older adults with cognitive impairments. Multiple exercises will be used to target a range of cognitive domains and will include both verbal and visual modalities. This helps to ensure that exercises remain novel, challenging and fun. The intervention will be adapted for difficulty levels, and some can involve use of a touchscreen. A pre-training session will be provided to all participants.

Both groups will initially undergo 24 sessions of CCT over 3 months (2/week for 12 weeks). For the following 3 months, one group will undergo monthly training, whilst the other will undergo fortnightly training. There will be a no contact period for the remaining 3 months.
Intervention code [1] 290092 0
Treatment: Other
Comparator / control treatment
This trial is comparing two doses or schedules of treatment.
Control group
Dose comparison

Outcomes
Primary outcome [1] 293001 0
Alzheimer’s Disease Assessment Scale-Cognitive-Plus (ADAS-Cog-Plus)
Timepoint [1] 293001 0
Baseline
3 month follow-up
6 month follow-up
9 month follow-up
Secondary outcome [1] 310119 0
Neurotrax - a validated computer-based neuropsychological assessment system which tests Verbal Memory, Non Verbal Memory, Staged Information Processing Speed, Visual-Spatial Processing, Stroop Interference.
Timepoint [1] 310119 0
Baseline
3 month follow-up
6 month follow-up
9 month follow-up
Secondary outcome [2] 310120 0
Stockings of Cambridge - a validated computerized test for executive functioning designed by CANTAB
Timepoint [2] 310120 0
Baseline
3 month follow-up
6 month follow-up
9 month follow-up
Secondary outcome [3] 310121 0
Bayer Activities of Daily Living Scale
Timepoint [3] 310121 0
Baseline
6 month follow-up
9 month follow-up
Secondary outcome [4] 310122 0
Observed Task of Daily Living
Timepoint [4] 310122 0
Baseline
6 month follow-up
9 month follow-up

Eligibility
Key inclusion criteria
1. Age of 60 years or above
2. Ability to read, write and communicate in English
3. Sufficient physical ability (motor, eyesight, hearing) to use a computer.
4. Mini Mental State Examination (MMSE) score >23
5. Regularly attend day care centres or resident of retirement village
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Cognitive training in the past 6 months.
2. MMSE < 24
3. Severe depression as indicated by the depression score (greater than or equal to 21) from the Depression Anxiety and Stress Scale (DASS)

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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
20/10/2014
Actual
13/11/2014
Date of last participant enrolment
Anticipated
Actual
30/05/2016
Date of last data collection
Anticipated
30/03/2017
Actual
24/04/2017
Sample size
Target
80
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 289833 0
Self funded/Unfunded
Name [1] 289833 0
Associate Professor Michael Valenzuela
Country [1] 289833 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
NSW 2006, Australia
Country
Australia
Secondary sponsor category [1] 288523 0
None
Name [1] 288523 0
Address [1] 288523 0
Country [1] 288523 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291566 0
Human Research Ethics Committee - The University of Sydney
Ethics committee address [1] 291566 0
71/79 Arundel St
The University of Sydney
Forest Lodge NSW 2037
Ethics committee country [1] 291566 0
Australia
Date submitted for ethics approval [1] 291566 0
Approval date [1] 291566 0
30/07/2014
Ethics approval number [1] 291566 0
2014/176

Summary
Brief summary
No study has yet investigated the therapeutic impact of computerized cognitive training (CCT) in frail or cognitively impaired daycare centre (DCC) clients or residents of retirement vilages, nor the relative merits of any particular booster training schedule. DCCs and retirement villages are an ideal health care setting to test CCT for primary and secondary prevention as they engage ultra high risk frail and old-old individuals and routinely deliver activities to their clients. This study will therefore compare two different booster training schedules in these settings with the aim of determining whether monthly booster sessions are equally effective at maintaining CCT gains as fortnightly booster sessions over a 3-month period. Specifically we aim to:
1. Compare the efficacy of monthly vs fortnightly booster sessions, by measuring cognitive function 3-months post-training;
2. Test the impact of the two booster schedules on everyday functional activities;

If booster sessions can be spaced out like this without major loss in efficacy, then this will have significant ramifications for the practical and widespread implementation of computerized cognitive training in DCCs and retirement villages. Positive findings may also result in delaying the onset of cognitive impairment or loss of functional independence. In turn, these outcomes may benefit individuals, carers, communities and the health system.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50898 0
A/Prof Michael Valenzuela
Address 50898 0
Regenerative Neuroscience Group,
Brain and Mind Research Institute
94 Mallett St, Camperdown
NSW 2050, Australia
Country 50898 0
Australia
Phone 50898 0
+61 2 9114 4135
Fax 50898 0
Email 50898 0
[email protected]
Contact person for public queries
Name 50899 0
A/Prof Michael Valenzuela
Address 50899 0
Regenerative Neuroscience Group,
Brain and Mind Research Institute
94 Mallett St, Camperdown
NSW 2050, Australia
Country 50899 0
Australia
Phone 50899 0
+61 2 9114 4135
Fax 50899 0
Email 50899 0
[email protected]
Contact person for scientific queries
Name 50900 0
A/Prof Michael Valenzuela
Address 50900 0
Regenerative Neuroscience Group,
Brain and Mind Research Institute
94 Mallett St, Camperdown
NSW 2050, Australia
Country 50900 0
Australia
Phone 50900 0
+61 2 9114 4135
Fax 50900 0
Email 50900 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
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Documents added automatically
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