ANZCTR - Registration

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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

2/02/2022

Date data sharing statement initially provided

11/06/2019

Date results information initially provided

2/02/2022

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]

None

Universal Trial Number (UTN)

Trial acronym

DiCE

Linked study record

Health condition

Health condition(s) or problem(s) studied:

dementia

Condition category

Condition code

Neurological

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]

Rehabilitation

Intervention code [2]

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]

Change in Trail Making Test B time

Timepoint [1]

6-months after randomisation

Primary outcome [2]

Change in Trail Making Test A time

Timepoint [2]

6-months after randomisation

Primary outcome [3]

Change in Digit span score

Timepoint [3]

6-months after randomisation

Secondary outcome [1]

Change in Trail Making Test B time

Timepoint [1]

12-months after randomisation

Secondary outcome [2]

Change in Trail Making Test A time

Timepoint [2]

12-months after randomisation

Secondary outcome [3]

Change in Digit Span test score

Timepoint [3]

12-months after randomisation

Secondary outcome [4]

Change in Addenbrooke's Cognitive Examination III score

Timepoint [4]

6-months and 12-months after randomisation

Secondary outcome [5]

Change in Frontal Assessment Battery score

Timepoint [5]

6-months and 12-months after randomisation

Secondary outcome [6]

Change in the Stroop test score

Timepoint [6]

6-months and 12-months after randomisation

Secondary outcome [7]

Change in the Geriatric Depression Scale (short form) score

Timepoint [7]

6-months and 12-months after randomisation

Secondary outcome [8]

Change in gait velocity (single task) measured with a timed walking task at usual pace.

Timepoint [8]

6-months and 12-months after randomisation

Secondary outcome [9]

Change in gait velocity (dual task) measured with a timed walking task while counting backwards from 30.

Timepoint [9]

6-months and 12-months after randomisation

Secondary outcome [10]

Change in Short Physical Performance Battery score

Timepoint [10]

6-months and 12-months after randomisation

Secondary outcome [11]

Change in Choice Stepping Reaction Time - M time

Timepoint [11]

6-months and 12-months after randomisation

Secondary outcome [12]

Change in Co-ordinated Stability score

Timepoint [12]

6-months and 12-months after randomisation

Secondary outcome [13]

Change in Timed-up-and-go time (single task)

Timepoint [13]

6-months and 12-months after randomisation

Secondary outcome [14]

Change in Timed-up-and-go time (dual task)

Timepoint [14]

6-months and 12-months after randomisation

Secondary outcome [15]

Change in Disability Assessment for Dementia score

Timepoint [15]

6-months and 12-months after randomisation

Secondary outcome [16]

Change in Zarit Burden Interview score (completed by carer)

Timepoint [16]

6-months and 12-months after randomisation

Secondary outcome [17]

Change in Quality of Life (EuroQol 5D) (participant and carer)

Timepoint [17]

6-months and 12-months after randomisation

Secondary outcome [18]

System Usability Scale score (participant and carer)

Timepoint [18]

6-months after randomisation

Secondary outcome [19]

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]

6-months after randomisation

Secondary outcome [20]

Proportion of fallers in the control and intervention group.
Data obtained through monthly falls calendars with reply paid envelopes and telephone calls.

Timepoint [20]

6-months and 12-months after randomisation

Secondary outcome [21]

Change in Quality of Life (QoL-AD) (participant and carer)

Timepoint [21]

6-months and 12-months after intervention

Secondary outcome [22]

Change in balance score measured by Short Physical Performance Battery

Timepoint [22]

6-months and 12-months after randomisation

Secondary outcome [23]

Change in sit to stand ability (five times sit-to-stand test)

Timepoint [23]

6-months and 12-months after randomisation

Secondary outcome [24]

Change in physical activity measured using McRoberts Activity Monitors

Timepoint [24]

6-months and 12-months after randomisation

Secondary outcome [25]

Rate of falls in the control and intervention group.
Data obtained through monthly falls calendars with reply paid envelopes and telephone calls.

Timepoint [25]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

27/03/2017

Actual

12/04/2017

Date of last participant enrolment

Anticipated

Actual

18/02/2020

Date of last data collection

Anticipated

Actual

2/03/2021

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Prince of Wales Hospital - Randwick

Recruitment hospital [2]

Hornsby Ku-ring-gai Hospital - Hornsby

Recruitment postcode(s) [1]

2031 - Randwick

Recruitment postcode(s) [2]

2077 - Hornsby

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

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]

Individual

Name [1]

Professor Jacqueline Close

Address [1]

Neuroscience Research Australia
Falls, Balance and Injury Research Centre
PO Box 1165
Randwick NSW 2031

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South East Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

Research Support Office
G71, East Wing
Edmund Blacket Building
Prince of Wales Hospital
Randwick NSW 2031

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/02/2016

Approval date [1]

21/06/2016

Ethics approval number [1]

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

Recruitment for this trial was suspended March 2020 - Jan 2021 secondary to COVID-19. Face-to-face visits were not permitted during this time. Reassessments were conducted by telephone for participants areadly recruited to the study. This considerably limited the participant assessments, including two of the primary outcomes (Trail Making Test A and B). The third primary outcome (digit span) was completed over the telephone. We completed any assessment that was possible to undertake over the phone. None of the physical assessments or activity monitor assessments were completed during this time.

Caregiver assessments remained unchanged, but they were completed via telephone interview.

Contacts

Principal investigator

Name

Dr Morag Taylor

Address

Neuroscience Research Australia
Falls, Balance and Injury Research Centre
PO Box 1165
Randwick NSW 2031

Country

Australia

Phone

+61 293991885

Fax

[email protected]

Contact person for public queries

Name

Dr Morag Taylor

Address

Neuroscience Research Australia
Falls, Balance and Injury Research Centre
PO Box 1165
Randwick NSW 2031

Country

Australia

Phone

+61 293991885

Fax

[email protected]

Contact person for scientific queries

Name

Dr Morag Taylor

Address

Neuroscience Research Australia
Falls, Balance and Injury Research Centre
PO Box 1165
Randwick NSW 2031

Country

Australia

Phone

+61 293991885

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Participants have not consented to data sharing

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

Source	Title	Year of Publication	DOI
Embase	Older People with Dementia Have Reduced Daily-Life Activity and Impaired Daily-Life Gait When Compared to Age-Sex Matched Controls.	2019	https://dx.doi.org/10.3233/JAD-181174

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically