Title: CognoSpeak: a Cognitive Health Assessment Tool (CcHAT)
Funder: Department of Health and Social Care

Abstract: Research Question: How to develop a quicker and more accurate way to assess people with memory concerns? Background: Early diagnosis of dementia and consistent monitoring of people with mild cognitive impairment (MCI) can improve treatment and reduce anxiety for patients and families. However, the current NHS memory assessment pathway (MAP) is expensive, slow and hugely variable. This project will deliver a low-cost, accessible and repeatable tool that will provide early and accurate detection and sensitive monitoring of cognitive impairment (CI). The potential to deliver assessments remotely (e.g. in patients homes) is attractive and could make MAP more accessible to underrepresented groups (e.g., ethnic minorities). CognoSpeakTM is an online tool for assessing cognition using automated speech analytics. It engages the user in a conversation, placing a high demand on multiple cognitive domains. Extensive PPIE work has guided the development throughout. Users find the tool trustworthy and easy to use. Clinicians value the projected improvements to MAP. Accuracy exceeds that of current pen-and-paper tests. Aims & Objectives: This research aims to advance the integration of CognoSpeakTM into MAP in order to improve detection and monitoring of cognitive impairment (CI) for all. The project will deliver a market-ready CognoSpeakTM tool with UKCA Class I approval that has been co-designed with MAP-clinicians and a range of end-user groups. The main objectives are: Demonstration of feasibility of stratification in primary care using CognoSpeakTM. Co-design of CognoSpeakTM with end-users to ensure no cultural or language barriers. Demonstration of feasibility of using CognoSpeakTM with underrepresented groups. Development of AI-algorithms agnostic to language background. Tripling of data resource to allow validation in people with memory problems (primary care), ethnic minority, and in PwMCI (secondary care). Production of a health economic (HE) model to aid commercialisation and NHS implementation pathways. Delivery of a trial platform to demonstrate HE effectiveness of CognoSpeakTM. Methods Phased research plan with two cycles of software development, AI refinement and PPIE feedback. Determination of tool accuracy with sensitivity and specificity using detailed neuropsychology, structural brain imaging and clinical assessment. Regular co-production workshops with patients and families, ethnic minority groups and clinicians will improve the tool ensuring usability for all and an accessible and acceptable reporting system. Deliverable timeline 36 months project: M0-M6: Initial PPIE and CognoSpeakTM co-design. M6-M18: Phase-I data collection and evaluation; AI development; PPIE co-design of next CognoSpeakTM version. M18-M30: Phase-II using refined CognoSpeakTM. M30-M36: Final dissemination (mixed-media co-production; academic papers; end-of-project showcase); regulatory approval; AI finalising. Post-project: M36: Market-ready CognoSpeakTM. Follow-on study to demonstrate HE-benefit of CognoSpeakTM at beacon sites. Impact and Dissemination Key measures of success: Completion of evaluation to time and target. CognoSpeakTM roll-out in three beacon sites. Refined commercialisation plan informed by PPIE, HE and AI. Improved understanding of use of CognoSpeakTM in primary care. Better understanding of under-provision of diagnostic healthcare to ethnic minority groups. Future impact: Reformed, easier-to-access and faster assessment yielding benefits for patients and carers More efficient MAP (improved waiting times, accuracy and PwMCI follow-up). NHS cost savings (projected at &pound;86.3million over 5 years).

Lay abstract: 1. Aim: We will develop a quicker and more efficient way to assess people with memory concerns. Our solution is a conversational tool (CognoSpeakTM) that asks questions using a talking head on a laptop, tablet or smartphone and carefully analyses the spoken answers to detect early signs of dementia. 2. Background: Every 3 minutes, someone in the UK develops dementia; it is the leading cause of death, and care costs around &pound;26.3 billion a year. Referrals for assessment have increased six-fold leading to long, frustrating and anxious waiting times for families, delaying access to treatment and support. This is important because lifestyle changes and treatment can delay progression if a diagnosis is made early, reducing health and social care costs. Over-stretched clinics are unable to monitor people with mild cognitive impairment, despite their 50% risk of developing dementia and some ethnic groups are not accessing diagnosis services. The CognoSpeakTM system has been tested on over 220 people and shown to be reliable and more accurate than pen-and paper tests used currently. It can also detect signs of depression and anxiety. 3. Design We will undertake testing in GP clinics and peoples own homes to further develop CognoSpeakTM to make it accessible and accurate for everyone including people from ethnic minorities. Objectives: The project will Work with ethnic minority groups to understand how CognoSpeakTM can be developed to make it easier for them to access memory assessment locally and acceptably. Evaluate ease-of-use (by patients in their homes and in GP clinics) to see how it compares to current services. Collect a large amount of data from patients and healthy controls to develop a new version and further improve the accuracy. Provide cost and benefit evidence, so care commissioners can decide whether CognoSpeakTM is sufficiently helpful to justify provision via the NHS. Prepare CognoSpeakTM for NHS use with necessary regulatory approvals (at project end). Methods Regular co-production workshops with patients and families, ethnic groups and clinicians will improve CognoSpeakTM so it works for all We will test the new version with 50 people from GP referrals awaiting assessment, 50 people from local ethnic groups, 120 people with memory problems and 120 healthy controls. 4. Patient/Public involvement (PPIE): To ensure fitness for purpose, CognospeakTM will be improved via regular co-production workshops with clinicians, patients and family participants and local ethnic minority groups. We have people with lived experience on our steering group and an advisor on inclusion and diversity. 5-Dissemination : End-of-project showcase events will involve commissioners, charities, and all project participants, to share learning and prepare for large-scale testing within the NHS. We will publish results widely, via traditional academic papers, co-produced media and marketing as the product develops.

Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES;7.3 MANAGEMENT AND DECISION MAKING;4.1 DISCOVERY AND PRECLINICAL TESTING OF MARKERS AND TECHNOLOGIES
Health categories: NEUROLOGICAL