Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000862145
Ethics application status
Approved
Date submitted
11/03/2019
Date registered
18/06/2019
Date last updated
28/06/2021
Date data sharing statement initially provided
18/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
CogSCAN: Evaluation of computerised cognitive tests in healthy older adults, mild cognitive impairment and mild dementia
Scientific title
CogSCAN: Evaluation of computerised cognitive tests in healthy older adults, mild cognitive impairment and mild dementia
Secondary ID [1] 297696 0
None
Universal Trial Number (UTN)
U1111-1229-8850
Trial acronym
CogSCAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mild dementia 311986 0
mild cognitive impairment 311987 0
Condition category
Condition code
Neurological 310554 310554 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be assigned to either a reliability arm or a construct validity arm of the study.

Reliability arm:
Participants will attend 2 in-person sessions:
1. The first session (3 hours) includes an interview to collect demographic and health information, administration of 2 computerised neuropsychological assessment (CNA) batteries and an evaluation questionnaire that assesses perceived user-friendliness of the CNAs.
2. The second session (2 hours) will occur 1-month later (2-4 weeks) and includes administration of the same 2 CNA batteries and an evaluation questionnaire that assesses perceived user-friendliness of the CNAs.

Construct validity arm:
Participants will attend 4 in-person sessions:
1. The first session (3 hours) includes an interview to collect demographic and health information, either (i) administration of 2 CNA batteries and an evaluation questionnaire that assesses perceived user-friendliness of the CNAs or (ii) a Pencil-and-Paper (PnP) neuropsychological assessment and an evaluation questionnaire that assesses perceived user-friendliness of the PnP tests. The Study's schedule has equal number of CNA and PnP assessments each week. Participants will be allocated to CNA or PnP at visit 1 depending on their preference for date/time within the Study's schedule.
2. The second session (2 hours) will occur 1-week later and includes either (i) administration of 2 CNA batteries and an evaluation questionnaire that assesses perceived user-friendliness of the CNAs or (ii) a PnP assessment (whichever was not completed at the first session).
3. The third session (3 hours) will occur 1-year later and includes a brief interview to collect updated demographic and health information, and either (i) administration of the same 2 CNA batteries administered 1 year prior and an evaluation questionnaire that assesses perceived user-friendliness of the CNAs or (ii) a PnP assessment and an evaluation questionnaire that assesses perceived user-friendliness of the PnP tests (whichever was completed in the first session).
4. The fourth session (2 hours) will occur 1-week later and includes either (i) administration of the same 2 CNA batteries administered 1 year prior and an evaluation questionnaire that assesses perceived user-friendliness of the CNAs or (ii) a PnP assessment and an evaluation questionnaire that assesses perceived user-friendliness of the PnP tests (whichever was completed in the second session).

Two groups of participants will be recruited into the Study - community and patient. Community participants will be recruited from local community events and advertisements, or Medicare mail-out. An arm will be assigned to each community event or advertisement e.g. all participants recruited at a particular event will be allocated to the same arm of the study. Participants invited via Medicare mail-out will be randomly assigned to either arm by Medicare prior to mail out. Allocation to arm will occur prior to eligibility interview.
Patient participants will be randomly assigned to an arm of the Study after eligibility interview.

Four CNAs will be administered in this Study:
(1) The Cambridge Neuropsychological Test Automated Battery (Cantab);
(2) Cogstate;
(3) Cognition Battery from the NIH Toolbox for Assessment of Neurological and Behavioral Function (NIH Toolbox); and
(4) Cambridge Brain Sciences Trials (CBS).
Each participant will be randomised to undertake two of the four CNAs. There are 6 combinations of two CNAs (“pairs”). Test order will be counter-balanced to minimise fatigue or practice effects.
Participants order of PnP and CNA in the construct validity arm will be determined by the Study's schedule and available assessments. The schedule will be created so that half the participants in the construct validity arm will receive a PnP assessment first and the other half will receive a CNA assessment first.

Administration of the CNAs will be conducted in a dedicated Computerised Cognitive Testing Laboratory, in small groups of 3-4 and under the supervision of a trained research psychologist.
Neuropsychological testing will be conducted on a one-to-one basis by a research psychologist under supervision of a registered Clinical Neuropsychologist or Registered Psychologist with neuropsychological assessment experience.
Intervention code [1] 313925 0
Diagnosis / Prognosis
Intervention code [2] 313926 0
Early detection / Screening
Comparator / control treatment
The CNAs will be compared against each other, and against the PnP assessment.
Control group
Active

Outcomes
Primary outcome [1] 319415 0
Acceptability of CNAs in cognitively normal older adults assessed by CNA results and study specific questionnaire about user experience of the CNAs.
Timepoint [1] 319415 0
Participants will complete the CNAs and a questionnaire about user experience of the CNAs twice over a one month period (reliability arm) or a one year period (validity arm).
Primary outcome [2] 319761 0
Participant characteristics that influence acceptability, test completion, and test performance of the CNAs, assessed by CNA results, study specific questionnaires about user experience of the CNAs and demographics collected via interviews with participants.
Timepoint [2] 319761 0
Participants will answer questions about demographics and their medical history at their first Study visit.
Participants will complete the CNAs and a questionnaire about user experience of the CNAs twice over a one month period (reliability arm) or a one year period (validity arm).
Primary outcome [3] 320090 0
Acceptability of CNAs in MCI and dementia patients assessed by CNA results and study specific questionnaire about user experience of the CNAs.
Timepoint [3] 320090 0
Participants will complete the CNAs and a questionnaire about user experience of the CNAs twice over a one month period (reliability arm) or a one year period (validity arm).
Secondary outcome [1] 368072 0
Test-retest reliability of the four selected CNAs, assessed by CNA results at two time points in the reliability arm.
Timepoint [1] 368072 0
Participants will complete the CNAs twice over a one month period (reliability arm) or a one year period (validity arm).
Secondary outcome [2] 368073 0
Baseline categorisation of normal or cognitively impaired for global test score and each cognitive domain score, assessed by comparison of normative data provided by the 4 CNAs.
Timepoint [2] 368073 0
Participants will complete the CNAs twice over a one month period (reliability arm) or a one year period (validity arm). Normative data is provided by each CNA in the data outputs available immediately after administration.
Secondary outcome [3] 369440 0
Concurrent validity of the four selected CNAs compared to PnP testing, assessed by CNA and PnP results.
Timepoint [3] 369440 0
Post completion of the Study for participants in validity arm (54 weeks post enrollment).

Eligibility
Key inclusion criteria
Two groups of participants will be recruited into this study:
Community participants - Aged 60 and older, fluent English, living in the community and cognitive capacity to consent
Patients - Aged 60 and older, fluent English, living in the community, cognitive capacity to consent and a recent diagnosis of MCI or mild dementia.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Community participants - Dementia or ever prescribed medication for Alzheimer’s disease or substantial functional decline (requiring assistance with instrumental activities of daily living, e.g. medications); developmental disability; neurological disorder such as Parkinson’s disease; recent stroke, traumatic brain injury (TBI), myocardial infarction or general anaesthesia; life-threatening illness, psychiatric disorder such as psychosis or current major depression; visual impairment preventing visualisation of material; profound deafness, or physical handicap preventing use of a tablet computer.
Patients - Pre-existing diagnosis of moderate or severe dementia; developmental disability; neurological disorder such as Parkinson’s disease; recent traumatic brain injury (TBI), myocardial infarction or general anaesthesia; life-threatening illness; psychiatric disorder such as psychosis or current major depression; pencil-and-paper (PnP) neuropsychological assessment in the last 6 months (construct validity arm only); visual impairment preventing visualisation of material; profound deafness, or physical handicap preventing use of a tablet computer.

Study design
Purpose of the study
Diagnosis
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Regression analyses will be used to determine test performance and experience. Pearson or Spearman correlations will be used to investigate the cross-sectional relationship between 2 tests. Linear Mixed Models (LMMs) will be used to determine the significance of test-retest reliability and change in test scores from baseline to follow up.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
6/07/2018
Date of last participant enrolment
Anticipated
30/09/2021
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
570
Accrual to date
282
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13363 0
Prince of Wales Private Hospital - Randwick
Recruitment hospital [2] 13364 0
The Sutherland Hospital - Caringbah
Recruitment hospital [3] 13365 0
War Memorial Hospital - Waverley
Recruitment postcode(s) [1] 25962 0
2031 - Randwick
Recruitment postcode(s) [2] 25963 0
2229 - Caringbah
Recruitment postcode(s) [3] 25964 0
2024 - Waverley

Funding & Sponsors
Funding source category [1] 302220 0
Government body
Name [1] 302220 0
The National Health and Medical Research Council (NHMRC)
Country [1] 302220 0
Australia
Primary sponsor type
University
Name
Centre for Healthy Brain Ageing at the University of New South Wales
Address
Centre for Healthy Brain Ageing (CHeBA)
School of Psychiatry
Level 1, AGSM (G27)
Gate 11, Botany Street
UNSW SYDNEY NSW 2052 AUSTRALIA
Country
Australia
Secondary sponsor category [1] 302073 0
None
Name [1] 302073 0
Address [1] 302073 0
Country [1] 302073 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302899 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 302899 0
Ethics committee country [1] 302899 0
Australia
Date submitted for ethics approval [1] 302899 0
29/04/2018
Approval date [1] 302899 0
08/06/2018
Ethics approval number [1] 302899 0
HC180294
Ethics committee name [2] 302901 0
South Eastern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [2] 302901 0
Ethics committee country [2] 302901 0
Australia
Date submitted for ethics approval [2] 302901 0
19/07/2018
Approval date [2] 302901 0
19/12/2018
Ethics approval number [2] 302901 0
18/073

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91778 0
Dr Nicole Kochan
Address 91778 0
Centre for Healthy Brain Ageing (CHeBA)
School of Psychiatry
Level 1, AGSM (G27)
Gate 11, Botany Street
UNSW SYDNEY NSW 2052 AUSTRALIA
Country 91778 0
Australia
Phone 91778 0
+61 2 9385 0442
Fax 91778 0
Email 91778 0
[email protected]
Contact person for public queries
Name 91779 0
Karen Allison
Address 91779 0
Centre for Healthy Brain Ageing (CHeBA)
School of Psychiatry
Level 1, AGSM (G27)
Gate 11, Botany Street
UNSW SYDNEY NSW 2052 AUSTRALIA
Country 91779 0
Australia
Phone 91779 0
+61 2 9385 8327
Fax 91779 0
Email 91779 0
[email protected]
Contact person for scientific queries
Name 91780 0
Karen Croot
Address 91780 0
Centre for Healthy Brain Ageing (CHeBA)
School of Psychiatry
Level 1, AGSM (G27)
Gate 11, Botany Street
UNSW SYDNEY NSW 2052 AUSTRALIA
Country 91780 0
Australia
Phone 91780 0
+61 2 9385 0184
Fax 91780 0
Email 91780 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To be discussed with the CogSCAN Investigator group.


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.