Measuring the effectiveness of a patient led, digital concussion management app with the ‘watch and wait’ approach currently employed within the NHS for the management of mTBI patients.

1.4 million people attend A&E with a head injury(1) with 47% of sufferers still living with symptoms after 6 months(2). Current 'best practice' includes providing concussed individuals with an A4 head injury advice sheet with no onward plan. The sequalae of symptoms that follows in a large percentage of patients leads to emotional, physical, and perceptual changes that severely limit lifestyle, productivity and the social impact. The sensation of helplessness felt by many concussion sufferers is testimony to the absence of a treatment pathway. Furthermore, 1.3m people in the UK now live with the consequences of traumatic brain injury, at a cost to the economy of £15bn annually(3). A 2023 government white paper(4) identified two clinics in the UK offering gold standard concussion care and highlighted the lack of expertise within public health(ref). These clinics provide evidence based and effective treatment but have limited capacity, serving less than 1% of patients and operate only within private or research capacites. We have developed a digital clinical technology for the management of and recovery from acquired brain injury. Heady® is a concussion management platform that is provided to patients through their medical provider. Heady® establishes the source of symptoms through evidence-based and patient led assessment and provides management and support through rehabilitation programming including exercise, education, cognitive and physical pacing and mental health tracking. Heady® will harness the use of machine learning to enhance treatment pathways, helping to make it more effective, scalable and accessible than any other concussion treatment currently available. Heady® is at Technology Readiness Level (TRL) 3, having progressed from TRL 1-2 through co-development with patients and clinicians with support from Imperial Enterprise Lab. We have packaged the evidence-based concussion management approach of our co-founder, Dr Theo Farley who specialises in concussed and treats at one of the two specialist concussion clinics highlighted within the government white paper, helping to improve the outcomes of concussion sufferers through exercise, advice and activity tracking. This includes the four major functional groups affected in concussion; the autonomic nervous system(5), vestibular(6), ocular-motor system(6) and cervical regions(7). Heady started as a chance encounter between a struggling concussion patient (Aaron), and Theo. After Theo treated Aaron and his symptoms resolved, the patient-clinician pair decided that Theo's expertise must be digitised and shared. Together, we have continued PPIE through hours of stakeholder interviews during Q2 2022 to Q3- 2024, including ABI patients, clinicians, NHS A&E and neurology hospitals, and national sporting governing bodies. Through using "Mom Tests", designed to gain unbiased and valuable insights in to the important features and capabilities of a concussion management app and have continued this engagement by co-designing with the same stakeholder groups. This led to the development of wireframes for modules within Heady, demonstrating market and technical feasibility. Additional volunteers have been recruited through online ABI forums to participate in for co-development and iteration. Letters of intent have been received from hospitals, practitioners, sporting bodies, and healthcare organisations, indicating market acceptance.