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Trial registered on ANZCTR


Registration number
ACTRN12614000335695
Ethics application status
Approved
Date submitted
20/11/2013
Date registered
27/03/2014
Date last updated
14/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Computerised cognitive training for older persons with mild cognitive impairment
Scientific title
Computerised cognitive training for older persons with mild cognitive impairment with and without mood-related symptoms: Relationship with cognitive and non-cognitive outcomes
Secondary ID [1] 283479 0
NIL
Universal Trial Number (UTN)
U1111-1149-6385
Trial acronym
CCT for MCI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild cognitive impairment 290397 0
Condition category
Condition code
Neurological 290788 290788 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants undertake 8-12 weeks of computerised cognitive training (CCT) using a commercially available program (Cognifit).

The Cognifit CCT platform will be used by participants in the experimental treatment condition and includes 33 computer tasks designed to train specific cognitive domains. The training protocol is individualised using an automated algorithm that allocates tasks to each individual, and task difficulty levels are adaptive such that they are determined based on the participant’s actual performance.

Participants will be instructed to complete training on three separate days each week. Each session will involve the completion of 9 computer tasks and will last approximately 30 minutes. The intervention period lasts a minimum of 8 weeks and a maximum of 12 weeks based on participant preference.

Adherence to the intervention is monitored via a combination of detailed automatic login and performance records provided by CogniFit, as well as by participants recording each training session in a persona diary provided to them at the start of the intervention period. A dedicated research staff follows up all participants with fortnightly phone calls to provide further support and encouragement, as appropriate.
Intervention code [1] 288272 0
Rehabilitation
Comparator / control treatment
Participants in the active control condition will play the same games as participants in the experimental condition. However, these games (presented on an identical-looking platform) will not have two key features of the games in the experimental condition - namely, adaptive difficulty levels accross sessions, and individual tailoring of task selection based on one's cognitive profile.

The training dose will be identical to that in the experimental condition. Participants will be instructed to complete training on three separate days each week, with each session lasting approximately 30 minutes. The intervention period lasts a minimum of 8 weeks and a maximum of 12 weeks based on participant preference. Adherence in this condition is monitored using a combination of personal diary entries, and fortnightly phone calls, as in the experimental condition. No automatic login and performance records are available on this participants in this condition.
Control group
Active

Outcomes
Primary outcome [1] 290876 0
Composite global cognitive score on a neuropsychological assessment. The score will be the mean of Z scores of several recognised measures of memory, attention, language and executive function. The cognitive performance measures include the Rey Auditory Verbal Learning Test (RAVLT), Logical Memory (LM, Story A only), The Rey Complex Figure Test (RCFT), the L'hermitte Board, The SydBatt, Verbal Fluency (letter and category), Trail Making Test, Digit-Symbol Coding, and Sniffin Sticks (olfactory identification)
Timepoint [1] 290876 0
The primary outcome will be assessed at all three timepoints (baseline, post-intervention, and 12 weeks post-intervention)
Secondary outcome [1] 305522 0
Domain specific cognitive performance. Composite scores in the domains of episodic memory, executive functions/working memory, and language will be calculated on the basis of performance on untrained measures listed above (e.g., the mean of the standardised delayed recall measure on the RAVLT, RCFT, LM, and L'hermitte Board for the composite memory score).
Timepoint [1] 305522 0
This secondary outcome will be assessed at all 3 time points (baseline, post-intervention, and 12 weeks post-intervention).
Secondary outcome [2] 305523 0
Subjective day-to-day memory capacity. This outcome will examine participants self-rating of the frequency of memory mistakes in day-to-day life (using the MMQ)
Timepoint [2] 305523 0
This secondary outcome will be assessed at all 3 time points (baseline, post-intervention, and 12 weeks post-intervention).
Secondary outcome [3] 307377 0
Caregiver burden and wellbeing. This will be assessed using the Zarit Caregiver Burden questionnaire and the Caregiver Distress scale in the Neuropsychiatric Inventory (NPI).
Timepoint [3] 307377 0
This secondary measure will be assessed at all 3 time points (baseline, post-intervention, and 12 weeks post-intervention).

Eligibility
Key inclusion criteria
Referred by specialist, GP, or self-referred
Community-dwelling
Computer and internet access at home
Spouse/family member/informant available
Concern regarding changes in cognition
ACE-III total score> 60
Preservation of functional independence
A score of greater than or equal to 1 on the NPI (only including the depression, anxiety, and apathy items)
Minimum age
65 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis of dementia
ACE-III Total score <60 or >95
CDR score greater than or equal to 1
Education<6
Other neurological/psychiatric conditions better accounting for clinical presentation
Significant sensory/perceptual impairments
Insufficient English
Previously enrolled in a CT study
AChI<3 months
Psychotic/bi-polar symptoms
Anti-depressants <3 months

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)
Participants who meet all inclusion and no exclusion criteria and who provide consent will be invited for the baseline evaluation at the Centre for Research on Ageing, Health, and Wellbeing. Following the baseline assessment, participants will be randomised to one of two treatment conditions using a computer program. Randomisation will be conducted by a researcher who is not involved in any aspects of study recruitment, participant assessment, or intervention delivery. This same person will keep the allocation sequence concealed and will only provide the group membership to the person delivering the intervention upon commencement of the intervention phase.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be done separately to participants with and with without MCI. Within the MCI group, cluster randomization will be performed stratified by whether the person belongs to the group with or without mood-related symptoms. A randomization table created by computer software (computer sequence generation) will be used .
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

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
GPower software was used to make sample size calculations. To detect a moderate effect (0.5 SD difference between participants in the experimental and in the control group post intervention) on the primary outcome (global cognitive composite), 33 participants per intervention group are required (66 total). To account for an estimated 20% attrition rate, a total of 78 participants will be recruited. Mixed linear models will be used to assess each of the outcomes of interest with intervention group and time as the fixed factors, participants as the random factor, and group by time as the main interaction of interest. Planned comparisons will be performed between assessment outcomes immediately following the intervention completion (T1) and at baseline (T0), and between assessment outcomes at the follow-up assessment (T2) and those from immediately post-intervention (T1). All analyses will be conducted using an Intention to Treat (ITT) approach. In the event that randomisation results in unmatched groups with respect to demographic variables that may influence outcomes such as age, gender and years of education, these will be added as covariates to the analyses. In the event that other person characteristics (e.g., computer experience) are found to correlate significantly with an outcome, they will be added as additional covariates to the analyses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2014
Actual
3/02/2014
Date of last participant enrolment
Anticipated
28/11/2014
Actual
21/11/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
78
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)
ACT,NSW
Recruitment postcode(s) [1] 7570 0
2580
Recruitment postcode(s) [2] 7571 0
2600 - Barton
Recruitment postcode(s) [3] 7572 0
2620 - Yarrow
Recruitment postcode(s) [4] 7573 0
2900 - Greenway
Recruitment postcode(s) [5] 7574 0
2914 - Moncrieff

Funding & Sponsors
Funding source category [1] 288311 0
Charities/Societies/Foundations
Name [1] 288311 0
Alzheimer's Australia Dementia Research Foundation
Country [1] 288311 0
Australia
Funding source category [2] 288312 0
Government body
Name [2] 288312 0
National Health and Medical Research Council
Country [2] 288312 0
Australia
Primary sponsor type
Individual
Name
Dr Alex Bahar-Fuchs
Address
Centre for Research on Aging, Health, and Wellbeing
62 Eggleston Rd. Acton
The Australian National University
Canberra 0200
ACT
Country
Australia
Secondary sponsor category [1] 287029 0
None
Name [1] 287029 0
Address [1] 287029 0
Country [1] 287029 0
Other collaborator category [1] 277703 0
Individual
Name [1] 277703 0
Prof Linda Clare
Address [1] 277703 0
School of Psychology, Bangor University
Adeilad Brigantia,
Penrallt Road,
Gwynedd LL57 2AS
United Kingdom
Country [1] 277703 0
United Kingdom
Other collaborator category [2] 277704 0
Individual
Name [2] 277704 0
George Rebok
Address [2] 277704 0
John Hopkins School of Public Health, 624 N. Broadway, 8th Fl, Baltimore, MD 21205
Country [2] 277704 0
United States of America
Other collaborator category [3] 277705 0
Individual
Name [3] 277705 0
Professor Kaarin Anstey
Address [3] 277705 0
Centre for Research on Ageing, Health, and Wellbeing
62 Eggleston Rd. Acton
The Australian National University
Canberra 0200
ACT
Country [3] 277705 0
Australia
Other collaborator category [4] 277706 0
Individual
Name [4] 277706 0
Dr Nicolas Cherbuin
Address [4] 277706 0
Centre for Research on Aging, Health, and Wellbeing
62 Eggleston Rd. Acton
The Australian National University
Canberra 0200
ACT
Country [4] 277706 0
Australia
Other collaborator category [5] 277707 0
Individual
Name [5] 277707 0
Dr Mary-Ann Kulh
Address [5] 277707 0
ACT Health,
Geriatric Medicine, Canberra Hospital,
Yamba Drive, Garran, ACT, 2605
Country [5] 277707 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290205 0
The Australian National University Human Research Ethics Committee
Ethics committee address [1] 290205 0
The Australian National University,
Acton
ACT 0200
Ethics committee country [1] 290205 0
Australia
Date submitted for ethics approval [1] 290205 0
20/11/2013
Approval date [1] 290205 0
13/12/2013
Ethics approval number [1] 290205 0
2013/589

Summary
Brief summary
Mounting evidence indicates that cognition-based interventions for people with mild cognitive impairment (MCI) are effective in maintaining independence and increase patient satisfaction. Studies to date have primarily focused on clarifying intervention parameters associated with greater efficacy, such as duration and frequency. Less is known, however, about the contribution of health related variables to the outcome of cognition-based treatments. Neuropsychiatric symptoms (NPS) are highly prevalent in people with MCI and are associated with greater impairment, excess disability, and worse outcomes.
Despite this, studies evaluating the efficacy of cognition-based interventions in persons with MCI tend to exclude patients with NPS. Understanding the contribution of NPS to the outcome of such interventions is important in terms of their application in clinical settings. A double-blind randomised controlled trial design is proposed to compare the efficacy of a cognitive training intervention between individuals with MCI, individuals with MCI and NPS, and individuals with NPS and no MCI. The outcomes of the study will inform the selection of candidates that have the greatest potential to benefit from cognition-based interventions, with implications for clinical practice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43946 0
Dr Alex Bahar-Fuchs
Address 43946 0
Centre for Research on Aging, Health, and Wellbeing. Building 62A, Eggleston Rd., Australian National University, Acton, ACT 0200
Country 43946 0
Australia
Phone 43946 0
+61261259705
Fax 43946 0
Email 43946 0
[email protected]
Contact person for public queries
Name 43947 0
Holly Blunden
Address 43947 0
Centre for Research on Aging, Health, and Wellbeing. Building 62A, Eggleston Rd., Australian National University, Acton, ACT 0200
Country 43947 0
Australia
Phone 43947 0
+61261258288
Fax 43947 0
Email 43947 0
[email protected]
Contact person for scientific queries
Name 43948 0
Alex Bahar-Fuchs
Address 43948 0
Centre for Research on Aging, Health, and Wellbeing. Building 62A, Eggleston Rd., Australian National University, Acton, ACT 0200
Country 43948 0
Australia
Phone 43948 0
+61261259705
Fax 43948 0
Email 43948 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
SourceTitleYear of PublicationDOI
EmbaseTailored and Adaptive Computerized Cognitive Training in Older Adults at Risk for Dementia: A Randomized Controlled Trial.2017https://dx.doi.org/10.3233/JAD-170404
N.B. These documents automatically identified may not have been verified by the study sponsor.