Multicohort cross-sectional study of cognitive and behavioural digital biomarkers in neurodegeneration: the Living Lab Study protocol

INTRODUCTION AND AIMS: Digital biomarkers can provide a cost-effective, objective and robust measure for neurological disease progression, changes in care needs and the effect of interventions. Motor function, physiology and behaviour can provide informative measures of neurological conditions and neurodegenerative decline. New digital technologies present an opportunity to provide remote, high-frequency monitoring of patients from within their homes. The purpose of the living lab study is to develop novel digital biomarkers of functional impairment in those living with neurodegenerative disease (NDD) and neurological conditions. METHODS AND ANALYSIS: The Living Lab study is a cross-sectional observational study of cognition and behaviour in people living with NDDs and other, non-degenerative neurological conditions. Patients (n≥25 for each patient group) with dementia, Parkinson's disease, amyotrophic lateral sclerosis, mild cognitive impairment, traumatic brain injury and stroke along with controls (n≥60) will be pragmatically recruited. Patients will carry out activities of daily living and functional assessments within the Living Lab. The Living Lab is an apartment-laboratory containing a functional kitchen, bathroom, bed and living area to provide a controlled environment to develop novel digital biomarkers. The Living Lab provides an important intermediary stage between the conventional laboratory and the home. Multiple passive environmental sensors, internet-enabled medical devices, wearables and electroencephalography (EEG) will be used to characterise functional impairments of NDDs and non-NDD conditions. We will also relate these digital technology measures to clinical and cognitive outcomes. ETHICS AND DISSEMINATION: Ethical approvals have been granted by the Imperial College Research Ethics Committee (reference number: 21IC6992). Results from the study will be disseminated at conferences and within peer-reviewed journals

Computerised cognitive assessment in patients with traumatic brain injury: an observational study of feasibility and sensitivity relative to established clinical scales

Background: Online technology could potentially revolutionise how patients are cognitively assessed and monitored. However, it remains unclear whether assessments conducted remotely can match established pen-and-paper neuropsychological tests in terms of sensitivity and specificity. Methods: This observational study aimed to optimise an online cognitive assessment for use in traumatic brain injury (TBI) clinics. The tertiary referral clinic in which this tool has been clinically implemented typically sees patients a minimum of 6 months post-injury in the chronic phase. Between March and August 2019, we conducted a cross-group, cross-device and factor analyses at the St. Mary's Hospital TBI clinic and major trauma wards at Imperial College NHS trust and St. George's Hospital in London (UK), to identify a battery of tasks that assess aspects of cognition affected by TBI. Between September 2019 and February 2020, we evaluated the online battery against standard face-to-face neuropsychological tests at the Imperial College London research centre. Canonical Correlation Analysis (CCA) determined the shared variance between the online battery and standard neuropsychological tests. Finally, between October 2020 and December 2021, the tests were integrated into a framework that automatically generates a results report where patients’ performance is compared to a large normative dataset. We piloted this as a practical tool to be used under supervised and unsupervised conditions at the St. Mary's Hospital TBI clinic in London (UK). Findings: The online assessment discriminated processing-speed, visual-attention, working-memory, and executive-function deficits in TBI. CCA identified two significant modes indicating shared variance with standard neuropsychological tests (r = 0.86, p < 0.001 and r = 0.81, p = 0.02). Sensitivity to cognitive deficits after TBI was evident in the TBI clinic setting under supervised and unsupervised conditions (F (15,555) = 3.99; p < 0.001). Interpretation: Online cognitive assessment of TBI patients is feasible, sensitive, and efficient. When combined with normative sociodemographic models and autogenerated reports, it has the potential to transform cognitive assessment in the healthcare setting. Funding: This work was funded by a National Institute for Health Research (NIHR) Invention for Innovation (i4i) grant awarded to DJS and AH ( II-LB-0715-20006)

Smart home sensing and monitoring in households with dementia: user-centered design approach

Background: As life expectancy grows, so do the challenges of caring for an ageing population. Older adults, including people with dementia, want to live independently and feel in control of their lives for as long as possible. Assistive technologies powered by Artificial Intelligence and Internet of Things devices are being proposed to provide living environments that support the users’ safety, psychological, and medical needs through remote monitoring and interventions. Objective: This study investigates the functional, psychosocial, and environmental needs of people living with dementia, their caregivers, clinicians, and health and social care service providers towards the design and implementation of smart home systems. Methods: We used an iterative user-centered design approach comprising nine sub-studies. First, semi-structured interviews (N = 9 people with dementia, 9 caregivers, 10 academic and clinical staff), ethnographic observations in clinics (N = 10 people with dementia, 10 caregivers, 3 clinical monitoring team members), and workshops (N = 35 pairs of people with dementia and caregivers, 12 health and social care clinicians) were conducted to define the needs of people with dementia, home caregivers and professional stakeholders in both daily activities and technology-specific interactions. Then, the spectrum of needs identified was represented via patient-caregiver personas and discussed with stakeholders in a workshop (N = 14 occupational therapists, 4 National Health Service pathway directors, 6 researchers in occupational therapy, neuropsychiatry and engineering) and two focus groups with managers of healthcare services (N = 8), eliciting opportunities for innovative care technologies and public health strategies. Finally, these opportunities were discussed in semi-structured interviews with participants of a smart home trial involving environmental sensors, physiological measurement devices, smart watches, and tablet-based chatbots and cognitive assessment puzzles (N = 10 caregivers, 2 people with dementia). A thematic analysis revealed factors that motivate household members to use these technologies. Results: Outcomes of these activities include the definition of clinically relevant patient-caregiver personas, a qualitative and quantitative analysis of patient, caregiver and clinician needs, and the identification of challenges and opportunities for the design and implementation of remote monitoring systems in public health pathways. Conclusions: Participatory design methods increased the impact of public-patient-involvement by supporting the triangulation of perspectives, the development of more patient-centered interventions, and their translation to clinical practice and public health strategy. We discuss the implications and limitations of these dementia-specific findings, the value and the applicability of our methodology, and directions for future research