None listed
Conditions
Brief summary
Dementia is a major health problem with 200 Australians diagnosed every day and at least as many having mild cognitive impairment which often precedes dementia. Early diagnosis is seen as critical for interventions yet many older adults at risk do not receive a timely diagnosis. Objective assessment of cognitive abilities is essential for accurate diagnosis at mild or early stages. Traditionally, this is performed by specialist neuropsychologists using lengthy pen and paper neuropsychological test batteries, but these services are limited and associated with high healthcare costs. Computerised neuropsychological assessments (CNAs) have received considerable attention in recent years. Potentially CNAs are more time- and cost-effective, scalable, accessible, precise and can be administered by people with less expertise. But can CNAs improve timely diagnosis of dementia over pen and paper tests? There is limited information about the usability of these tests, and their validity and reliability in the older population. This type of information is critical before we can use these tests in the clinic. CogSCAN will be the first study to systematically evaluate and compare several of the most prominent and widely used CNA batteries in healthy older adults. CogSCAN will evaluate suitability and user-experience in older adults and examine relationships between test performance and the individual’s level of computer familiarity and attitude towards computers. CogSCAN will investigate how CNA test results compare to traditional pen and paper neuropsychological assessment results as well as how CNA results compare when retested at different time points. CogSCAN will assess the validity of the CNAs in people with different cognitive classifications (cognitively normal, mild cognitive impairment and dementia). It will also examine the relationship between demographic and clinical variables (e.g. age, years of education, occupation, premorbid IQ, anxiety and depression symptoms) and CNA test performance. CogSCAN will measure agreement amongst CNAs for categorisation of normal or cognitively impaired as determined by internal norms provided by the CNA developers. We anticipate this study will move the field forward and have a major impact on the practice of cognitive testing in older adults.
Interventions
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
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.
Sponsors
Centre for Healthy Brain Ageing at the University of New South Wales
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
Yes
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.
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.
Outcome results
None listed