TD‐P‐017: High‐Frequency Monitoring of Cognition, Mood and Behaviour Using Commercially Available Wearable Devices

Abstract

Background: Current cognitive and functional assessments of patients with cognitive impairment and dementia have well understood limitations including high test:re-test variability, sparse data collection in clinic environments that may not reflect 'real life' performance, and assessment tools being language, education and culture sensitive. Continuous patient data collection using wearable devices (e.g. wristbands/wristwatches) measuring factors such as activity and sleep, may provide future digital biomarkers that are more sensitive than current approaches especially for assessing function in clinical trials. It is therefore important to evaluate acceptance and tolerability of such devices for patients and caregivers, determine how such continuous data collection may fit with conventional clinical measures, and establish the technical and regulatory requirements for GCP compliance. Methods: We undertook SWOT analyses on: (1)study designs most suited to evaluate the use of wearables for clinical data collection; (2) acceptability and tolerability of a commercially available wearable device [1]; and (3)technical and regulatory challenges in in recording the study data. Using qualitative methods including semi-structured and free discussions, we held focus groups with stakeholder representatives (people with dementia and caregivers; n¼12) to explore these issues. Results: Strengths: prospect of participating in such studies; transfer and storage of data from wearables via mobile devices; and tolerability of such devices for either clinical care or research purposes. Weaknesses: potential for non-adherence with the device, particularly at night; difficulty in putting devices on without help; and loss of connectivity for data collection. The Cygnus project [2] will soon start, and deploy these technologies in a symptomatic, community population with cognitive impairment and their care-givers. Conclusions: The use of wearables for continuous clinical data collection is feasible and potentially tolerated by patients with cognitive impairment and dementia. Data security, authentication and validation challenges remain for GCP compliance but patients did not raise concerns about impact on their privacy. Studies like Cygnus are now needed to evaluate prospectively the tolerability of wearable devices and whether meaningful digital functional biomarkers can be generated from the data; further work is required to establish the regulatory path for such devices providing functional endpoints in clinical trials.[1] Withings Activity Pop [2] Cygnus, Innovate UK Grant no.102159.Background: Clinical and research assessments of cognition, mood and behaviour provide validated snapshots of functioning at specific time points. However, depression and mild cognitive impairment exhibit fluctuations which are challenging to quantify, but impact on quality of life and ability to perform daily tasks. The identification of these fluctuations has the potential to provide ecologically relevant outcomes for clinical research, complementing i...

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