Capture of cognitive status and follow-up on hand-held devices in large scale clinical trials
The rising burden of dementia is a major social and healthcare issue. There is increasing need to assess any changes in participant cognitive function and mood that may occur in response to therapies during clinical trials in tens of thousands of patients followed for many years. Widespread availability of hand-held devices (such as phones and tablets) and easy access to the internet allows for the deployment of a wide range of relevant cognitive and other tests, including the ability to measure metrics such as reaction times and processing speed. Such devices can also provide opportunities to leverage a variety of clinical data that can be prompted for and captured on them.
The project will build on and extend the team’s work of enhancing cognitive testing in large-scale trials, which has included recent implementation of online cognitive testing among several thousand participants in two cardiovascular trials, and of interviewer-based cognitive testing using tablets. Challenges include developing the necessary infrastructure to deploy such tests in a reliable and homogenous fashion on several occasions across a variety of devices and browsers; developing and benchmarking the new systems; and integrating the systems into randomised clinical trials.
The project will begin with a review of the literature on self-administered computerised cognitive testing available as an online test or on hand-held devices, to evaluate the scope of tests, types of devices, technologies, software and licensing costs involved. The pros and cons of using: online, users’ own or supplied hand-held devices will be assessed.
Following this, the most suitable tests (which may include the UK Biobank online battery1, classic tests such as the Montreal Cognitive Assessment, the COGNITO system2 and potentially other tests) would be implemented on a hand-held tablet. (The tests will typically be available in some electronic format but likely to require development work to implement for our requirements.) The next stage would be to consider and check robustness on a range of devices/platforms (using emulators) and the ease of user installation of the application (where applicable).
Extension to capture new cognitive tests or other clinical data and preparation for piloting in one of our ongoing studies (eg in long-term follow-up of participants who have completed online tests in our recent trials or in UK Biobank) are further potential directions for later stages of the project.
1. UK Biobank online cognitive testing http://biobank.ctsu.ox.ac.uk/crystal/label.cgi?id=116
2. Ritchie K, et al. COGNITO: Computerized Assessment of Information Processing. J Psychol Psychother 2014; 4:136. doi:10.4172/2161-0487.1000136
RESEARCH EXPERIENCE, RESEARCH METHODS AND TRAINING
Learning from working within a multi-disciplinary team including experienced IT developers, statisticians, academic and clinical researchers across the Clinical Trial Service Unit (CTSU) and the Big Data Institute (BDI). The BDI is a dedicated interdisciplinary research centre housing ~30 research groups focusing on the analysis of large, complex, heterogeneous data sets for disease-related research.
Developing IT skills across a wide variety of platforms (particularly IOS and Android) and technologies (e.g. CORDOVA mobile application development framework) and understanding how these can link to clinical trial data planning and design skills for future research.
A BSc, or ideally MSc, in a discipline with a substantive computational component. Some basic experience with IT development is essential, and any experience with programming languages such as JAVA, or mobile devices will be particularly advantageous.