Title: In-home Tracking of glaucoma: Reliability, Acceptability, and Cost: the I-TRAC Study
Funder: Chief Scientist Office, Scotland

Abstract: Glaucoma is a common chronic eye condition and the second commonest cause of blindness in the UK. It is typically caused by the pressure in the eye (intraocular pressure) being too high, Glaucoma impairs mainly the peripheral vision (visual field). Treatments reduce eye pressure to delay or stop glaucoma getting worse. However, in some glaucoma may still progress, so patients need regular monitoring at hospital eye services where they have their eye pressure and the visual field measured. This allows doctors to assess effectiveness of current treatment and detect glaucoma progression. Patients need these check-ups for the rest of their lives. _x000D_ Hospital eye services are very busy, accounting for 10% of all NHS outpatient visits. Glaucoma patients represent a significant part of this workload, England alone over 1 million visits per year are for glaucoma patients. Providing regular surveillance and treatment is already a major challenge for the NHS. The chance of getting glaucoma increases with age. Demand for glaucoma care is increasing (and will continue to do so) due to our aging population. _x000D_ Recent advances in technology mean it is now possible for glaucoma patients to monitor eye pressure and visual fields in their own home. Their information could be transferred to the hospital, or they could request hospital appointment if the home tests show their glaucoma has worsened or eye pressure has increased. Home monitoring could mean patients requiring fewer hospital check-ups, whilst increasing convenience and potentially reducing costs and increase capacity for the NHS. _x000D_ Currently though, we do not know if home monitoring is acceptable to people with glaucoma, or if home monitoring in the general glaucoma population is feasible. The main aim of our study is assess acceptability and feasibility of home monitoring, and to make recommendations about future research to test how the NHS could use home monitoring. _x000D_ In our project, 45 patients with glaucoma from (15 each from Northern Ireland, Scotland and England) will get home monitoring equipment and an iPad tablet and a home tonometer to do home monitoring tests weekly for 4 months. We’ll train patients to perform the tests and offer refresher training throughout the study. We’ll also interview patients and their carers about their experiences of performing the tests, focusing on the difficulties experienced and what could be done to make the home tests more acceptable. _x000D_ We have chosen a visual field test and eye pressure test that previous research has shown is suitable for home monitoring use. The visual field tests display lights or patterns on an iPad tablet and patients indicate by entering information on the touch screen whenever they see the light. The iCare HOME tonometer is a device designed to check the eye pressure at home. The information from both of these tests will automatically be transferred to our research team for analysis. _x000D_ This research fits one of the top 5 research recommendations by the James Lind Alliance, i.e., “What can be done to improve early diagnosis of sight-threatening glaucoma”? We have included two patients as independent members of the Study Steering Committee who will be actively involved in the conduct and governance of the research. We will also involve the International Glaucoma Society in an advisory role. Results of the study will be shared with those who participated and with relevant stakeholders in Hospital Eye Services.

Lay abstract: The research outlined in our proposal will determine the feasibility and acceptability of digital technologies to monitor glaucoma at home and inform the possible need and design of a definitive evaluative study._x000D_ Resource constraints resulting in delays in patients’ access to glaucoma services have resulted in vision loss due to glaucoma [1]. Glaucoma services are overwhelmed and struggling to accommodate current demands [2]. Reducing the need for hospital based services will improve the ability to see those most at risk of vision loss, which could alleviate both demand on the service and improve patient outcomes. Digital technologies that provide opportunities for home monitoring of glaucoma progression have potential to contribute to solve these challenges and, potentially, improve outcomes. However, understanding which patients could benefit most, the acceptability of the technologies, and the implications for the service need to be resolved before a definitive evaluative study can be conducted. The feasibility study outlined in this application will address these uncertainties. _x000D_ Specifically, we will:_x000D_ 1. Identify which glaucoma patients are most appropriate for home monitoring (e.g. all patients, or those with stable disease, or those with severe glaucoma?);_x000D_ 2. Understand the views of key stakeholders (patients, clinicians, IT personnel, researchers) on whether home monitoring is feasible and acceptable; _x000D_ 3. Identification of key elements for an economic evaluation for home monitoring for glaucoma;_x000D_ 4. Explore the need for and provide evidence on the optimal design of a future study to evaluate the use of digital technologies for home monitoring of glaucoma. _x000D_ We will utilise a mixed-methods sequential explanatory design feasibility study with key components informed by theoretical (i.e. the Consolidated Framework for Implementation Research and Theoretical Framework of Acceptability) and conceptual (ADePT) frameworks. In brief the interlinked phases of work will survey Ophthalmologists to determine which patients would be appropriate for home monitoring of glaucoma; interview key stakeholders to determine acceptability of the technology and explore key features and feasibility of a future definitive study; and identify the key cost drivers from a range of stakeholders involved in service provision to inform development of an economic model for future evaluation. The findings from all phases will provide evidence to support a statement on feasibility and acceptability of an evaluative study (e.g. trial, longitudinal study, economic modelling) comparing current standard NHS glaucoma care with home monitoring._x000D_ The projected timetable start date for the study is 1st June 2020: the study duration will be 20 months _x000D_ All study participants will have the opportunity to receive feedback on the overall results of the study in the form of a newsletter. We will work with the PPI partners during the study to explore options for broader patient feedback. Publication of a methods paper is anticipated to raise awareness of the feasibility study. Presentation at the largest UK ophthalmic congress is planned, along with an international congress to reach an international audience. In terms of direct impact from this study, we will provide evidence to support a statement on feasibility and acceptability of an evaluative study comparing current standard NHS glaucoma care with home monitoring.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;7.3 MANAGEMENT AND DECISION MAKING
Health categories: EYE