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Trial registered on ANZCTR


Registration number
ACTRN12617000364370
Ethics application status
Approved
Date submitted
5/03/2017
Date registered
10/03/2017
Date last updated
10/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of cognitive training on cognitive function in older people with mild to moderate dementia: a single-blind randomised control trial
Scientific title
The effect of cognitive training on cognitive function in older people with mild to moderate dementia: a single-blind randomised control trial
Secondary ID [1] 291249 0
None
Universal Trial Number (UTN)
Trial acronym
DiCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dementia 302177 0
Condition category
Condition code
Neurological 301787 301787 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The cognitive training group will be provided with a custom made response box and computer to enable them to undertake cognitive training at home for six months . Both the participant and the carer/person responsible will be trained in how to use the equipment and program during an installation visit (approximately 2 hours) conducted by a trained research assistant. Telephone support (in relation to the cognitive training program) will be available to all participant/carers during business hours. The cognitive training will be delivered in the form of computer games which are designed to train executive functions including: visuo-spatial skills, task switching, inhibition and attention. These games are based on popular arcade games such as: Dance Dance Revolution, Tetris, Snake and Space Invaders. Instructions on how to play each game will be provided with on screen text and video demonstrations. The cognitive training program is progressive and each game has three levels (easy, moderate, hard). Participants will be encouraged to train at least three times per week for 10 – 30 minutes per session (total recommended dose 90 minutes). Carer involvement in the intervention will depend on the individual participant capabilities e.g. some participants may be able to navigate the system/program independently, others may need prompts to carry out the training and some may need supervision/assistance during each session. The amount of carer involvement will be decided in consultation with the participant and carer during the installation/training visit and follow-up home visit..

One follow-up visit is scheduled at two weeks after the initial training/installation visit to provide further training, support and troubleshooting (approximately 30 - 60 minutes) and will be conducted by a trained research assistant. Depending on the participants’ need, one further home visit will be performed by a trained research assistant (as required; approximately 30 - 60 minutes), approximately four weeks after the initial training/installation visit.

The cognitive training system will automatically record adherence, this will include the number of sessions and time of each session. Telephone calls to encourage adherence will be provided monthly.
Intervention code [1] 297253 0
Rehabilitation
Intervention code [2] 297398 0
Treatment: Other
Comparator / control treatment
The control group will receive usual care provided by their health service providers and a readily available booklet (Staying active and on your feet; Source: http://www.activeandhealthy.nsw.gov.au/your-active-and-healthy-guide/) which includes general information on falls prevention and healthy ageing. The control group will fill out monthly questionnaires about health service use and falls.
Control group
Active

Outcomes
Primary outcome [1] 301187 0
Change in Trail Making Test B time
Timepoint [1] 301187 0
6-months after randomisation
Primary outcome [2] 301314 0
Change in Trail Making Test A time
Timepoint [2] 301314 0
6-months after randomisation
Primary outcome [3] 301315 0
Change in Digit span score
Timepoint [3] 301315 0
6-months after randomisation
Secondary outcome [1] 332134 0
Change in Trail Making Test B time
Timepoint [1] 332134 0
12-months after randomisation
Secondary outcome [2] 332135 0
Change in Trail Making Test A time
Timepoint [2] 332135 0
12-months after randomisation
Secondary outcome [3] 332136 0
Change in Digit Span test score
Timepoint [3] 332136 0
12-months after randomisation
Secondary outcome [4] 332137 0
Change in Addenbrooke's Cognitive Examination III score
Timepoint [4] 332137 0
6-months and 12-months after randomisation
Secondary outcome [5] 332138 0
Change in Frontal Assessment Battery score
Timepoint [5] 332138 0
6-months and 12-months after randomisation
Secondary outcome [6] 332139 0
Change in the Stroop test score
Timepoint [6] 332139 0
6-months and 12-months after randomisation
Secondary outcome [7] 332140 0
Change in the Geriatric Depression Scale (short form) score
Timepoint [7] 332140 0
6-months and 12-months after randomisation
Secondary outcome [8] 332141 0
Change in gait velocity (single task) measured with a timed walking task at usual pace.

Timepoint [8] 332141 0
6-months and 12-months after randomisation
Secondary outcome [9] 332142 0
Change in gait velocity (dual task) measured with a timed walking task while counting backwards from 30.

Timepoint [9] 332142 0
6-months and 12-months after randomisation
Secondary outcome [10] 332143 0
Change in Short Physical Performance Battery score
Timepoint [10] 332143 0
6-months and 12-months after randomisation
Secondary outcome [11] 332144 0
Change in Choice Stepping Reaction Time - M time
Timepoint [11] 332144 0
6-months and 12-months after randomisation
Secondary outcome [12] 332145 0
Change in Co-ordinated Stability score
Timepoint [12] 332145 0
6-months and 12-months after randomisation
Secondary outcome [13] 332146 0
Change in Timed-up-and-go time (single task)
Timepoint [13] 332146 0
6-months and 12-months after randomisation
Secondary outcome [14] 332147 0
Change in Timed-up-and-go time (dual task)
Timepoint [14] 332147 0
6-months and 12-months after randomisation
Secondary outcome [15] 332148 0
Change in Disability Assessment for Dementia score
Timepoint [15] 332148 0
6-months and 12-months after randomisation
Secondary outcome [16] 332149 0
Change in Zarit Burden Interview score (completed by carer)
Timepoint [16] 332149 0
6-months and 12-months after randomisation
Secondary outcome [17] 332150 0
Change in Quality of Life (EuroQol 5D) (participant and carer)
Timepoint [17] 332150 0
6-months and 12-months after randomisation
Secondary outcome [18] 332151 0
System Usability Scale score (participant and carer)
Timepoint [18] 332151 0
6-months after randomisation
Secondary outcome [19] 332152 0
Adherence to the cognitive training program (measured in minutes and number of sessions by the cognitive training system/computer) in the intervention group
Timepoint [19] 332152 0
6-months after randomisation
Secondary outcome [20] 332153 0
Proportion of fallers in the control and intervention group.
Data obtained through monthly falls calendars with reply paid envelopes and telephone calls.
Timepoint [20] 332153 0
6-months and 12-months after randomisation
Secondary outcome [21] 332259 0
Change in Quality of Life (QoL-AD) (participant and carer)
Timepoint [21] 332259 0
6-months and 12-months after intervention
Secondary outcome [22] 332411 0
Change in balance score measured by Short Physical Performance Battery
Timepoint [22] 332411 0
6-months and 12-months after randomisation
Secondary outcome [23] 332412 0
Change in sit to stand ability (five times sit-to-stand test)
Timepoint [23] 332412 0
6-months and 12-months after randomisation
Secondary outcome [24] 332413 0
Change in physical activity measured using McRoberts Activity Monitors
Timepoint [24] 332413 0
6-months and 12-months after randomisation
Secondary outcome [25] 332451 0
Rate of falls in the control and intervention group.
Data obtained through monthly falls calendars with reply paid envelopes and telephone calls.
Timepoint [25] 332451 0
6-months and 12-months after randomisation

Eligibility
Key inclusion criteria
Community-dwelling participants with mild-moderate dementia aged 60+ years, with a willing carer/person responsible who has a minimum of 3.5h face-to-face contact each week. Mild to moderate dementia will be determined by specialist diagnosis or/and Mini-Mental State Examination (MMSE) <24 and/or Addenbrooke’s Cognitive Examination III score of <83.
Minimum age
60 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe dementia (MMSE<11), progressive neurological conditions other than dementia, acute/severe psychiatric conditions, unable to speak English, blindness, delirium, current participation in another research trial and living in a residential aged care facility.

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)
Concealed randomisation will be performed by a person independent of the study using established randomisation software at Neuroscience Research Australia.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Stratified by site.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Statistical analysis:
An intention-to-treat analysis will be used for all analyses. General linear models will be used to assess the effect of group allocation on the continuously scored outcome measures. Modified Poisson regression models will be used to compare groups on dichotomous outcome measures. Predictors of adoption and adherence will be analysed using multivariate modelling techniques such as general linear models, multiple linear and logistic regression. Negative binomial regression will be used to compare the number of falls in the intervention and control group.

Recruitment
Recruitment status
Recruiting
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 in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7540 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 7541 0
Hornsby Ku-ring-gai Hospital - Hornsby
Recruitment postcode(s) [1] 15364 0
2031 - Randwick
Recruitment postcode(s) [2] 15365 0
2077 - Hornsby

Funding & Sponsors
Funding source category [1] 295701 0
Government body
Name [1] 295701 0
NHMRC
Address [1] 295701 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 295701 0
Australia
Primary sponsor type
Individual
Name
Dr Morag Taylor
Address
Neuroscience Research Australia
Falls, Balance and Injury Research Centre
PO Box 1165
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 294541 0
Individual
Name [1] 294541 0
Professor Jacqueline Close
Address [1] 294541 0
Neuroscience Research Australia
Falls, Balance and Injury Research Centre
PO Box 1165
Randwick NSW 2031
Country [1] 294541 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297007 0
South East Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 297007 0
Research Support Office
G71, East Wing
Edmund Blacket Building
Prince of Wales Hospital
Randwick NSW 2031
Ethics committee country [1] 297007 0
Australia
Date submitted for ethics approval [1] 297007 0
24/02/2016
Approval date [1] 297007 0
21/06/2016
Ethics approval number [1] 297007 0
16/040 (HREC/16/POWH/112)

Summary
Brief summary
The primary aim of this project is to evaluate the effect of cognitive training has on cognitive performance in older people with mild to moderate dementia. Additionally we will examine the effect cognitive training has on physical and functional performance and quality of life (participant and carer), as well as adherence to the intervention.

Eighty community-dwelling older people with mild to moderate dementia will be recruited from routine health services and randomised to either intervention or control. Participants will be over 60 years old and have a carer with a minimum of 3.5 hours face-to-face contact each week. Consent will be gained from both the participant and their carer/person responsible.

The intervention will consist of six months of home-based cognitive training. The cognitive training will target executive function, processing speed and attention. Both the participant and the carer/person responsible will be trained in how to use the program. Participants will be encouraged to train three times per week for 10 – 30 minutes depending on cognitive ability. The control group will receive usual care and healthy living information.

Participants will be assessed at baseline, at six months (at completion of CT for intervention group) and at 12 months (six months after completion of CT for the intervention group). Falls will be recorded prospectively for 12 months using diaries (with the assistance of carers) and telephone calls.

This study will provide valuable evidence in relation to the effect of cognitive training on cognitive, physical and functional performance measures in community-dwelling older people with dementia. Further, this study will also act as a pilot/feasibility study for a future study more suitably powered to determine whether cognitive training can reduce falls in community-dwelling older people with dementia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72698 0
Dr Morag Taylor
Address 72698 0
Neuroscience Research Australia
Falls, Balance and Injury Research Centre
PO Box 1165
Randwick NSW 2031
Country 72698 0
Australia
Phone 72698 0
+61293991852
Fax 72698 0
Email 72698 0
m.taylor@neura.edu.au
Contact person for public queries
Name 72699 0
Dr Morag Taylor
Address 72699 0
Neuroscience Research Australia
Falls, Balance and Injury Research Centre
PO Box 1165
Randwick NSW 2031
Country 72699 0
Australia
Phone 72699 0
+61293991852
Fax 72699 0
Email 72699 0
m.taylor@neura.edu.au
Contact person for scientific queries
Name 72700 0
Dr Morag Taylor
Address 72700 0
Neuroscience Research Australia
Falls, Balance and Injury Research Centre
PO Box 1165
Randwick NSW 2031
Country 72700 0
Australia
Phone 72700 0
+61293991852
Fax 72700 0
Email 72700 0
m.taylor@neura.edu.au

No data has been provided for results reporting
Summary results
Not applicable