Clinical Efficacy and Cost Effectiveness of MYCOPD in Patients With Mild and Moderate Newly Diagnosed COPD

COPD is a disabling, smoking related lung disease that is associated with symptoms of shortness of breath, cough and wheeze. The natural history is one of progressive decline, frequently punctuated by periods of rapid worsening termed acute exacerbations. The functional limitation experienced by individuals with COPD, their propensity to exacerbations and the high levels of psychological and physical co-morbidities place a significant burden on health and social care systems. It is estimated that COPD will become the 4th leading cause of death worldwide by 2030. A typical UK city has over 7,500 patients with COPD on primary care registries and it is estimated that there are an additional 6,500 individuals living with the disease that have not yet been diagnosed. The NHS in England encourages opportunistic and systematic case finding to achieve early disease recognition. However, the merits of this approach are unclear due to a lack of evidence that early disease identification alters outcomes. A recent randomised controlled trial undertaken in China has suggested that initiation of Tiotropium in patients with early disease may reduce the rate of lung function decline compared to placebo. This phenomenon was also observed in a subgroup analysis of young and milder COPD patients in the UPLIFT trial. Prior to these observations, smoking cessation was the only means of altering disease course in patients with early disease and there is conflicting evidence as to whether identifying COPD in smokers helps to achieve this or not. The possibility that early drug initiation may alter disease trajectory and improve long term health outcomes, makes early diagnosis appealing. It is recognised that at the time of COPD diagnosis, patients are already less physically active than their peers that do not have airflow obstruction. This suggests that patients alter their behaviour to avoid symptoms before they perceive a problem significant enough to warrant medical attention. Physical inactivity is common in COPD patients and breathlessness is cited as the most common cause. Physical inactivity is one of the strongest predictors of death in COPD patients.To date, interventions that aim to increase physical activity have had limited success. This may be because interventions are targeted at patients with established disease when behaviour change is already established. We hypothesise that a better approach would be to prevent behaviour change in the first place rather than try to reverse it after it has occurred. Given the major barrier to physical activity is breathlessness and that this appears to impact individuals early in the disease, often before presentation, we propose that early intervention with therapies proven to reduce breathlessness will offer the greatest benefit. Recent years have seen the development of new therapeutic strategies in COPD. A new class of inhaled therapy has emerged in the form of combined long acting beta-2 agonists (LABA) and long acting muscarinic receptor antagonists (LAMA). This dual bronchodilator approach achieves greater improvements in lung function, symptoms, quality of life and exacerbation frequency compared to the individual components alone. Early initiation of therapy with dual bronchodilation has the potential to prevent the reduction in physical activity that occurs due to exertional breathlessness and is now advocated as the first line treatment for COPD. Therefore there is an increased need to explore strategies to support patients with mild, moderate and early COPD as the rationale for treatment develops. Here the evidence that self-management can play an important contribution to improving clinical outcomes whilst reducing health care resource use and associated costs is great. In order to effectively self-manage, patients require the knowledge, skills and confidence to make appropriate decisions about their care. When newly diagnosed, there are very few opportunities for patients to learn about their condition and develop the skills to case manage effectively. Consequently patients with LTC's often rely on health care professional to guide them and are unaware of appropriator measures they can take themselves to improve their own health. The use of digital technologies, particularly apps has been suggested as a way of empowering patients to self-manage effectively. The provision of high quality information and advice on medication, health promoting activities and improvements in adherence via apps can help patient gain the skills and confidence they need to effectively manage their conditions. MyMHealth is a leading digital health provider that is one of the very few MHRA approved app developers and the only provider to be funded by NHS England through the National Innovation and Technology Tariff to provide patients with high quality apps to help them manage their health. MyCOPD is such a patient platform and the NHS and NICE approvals have led to the distribution of access licenses to over 50 000 patients with COPD in England. This product is therefore at the vanguard of the digital health revolution in the UK based on a strong evidence base of benefit in patient with established and more severe disease. However the majority of patients with COPD have milder disease and currently patients with mild to moderate or newly diagnosed COPD are not funded to receive the app as part of their routine care as the evidence base for its use is not mature. This study seeks to explore the potential for the use of MyCOPD to improve COPD patients' activation, disease knowledge and self-efficacy following diagnosis and in the context of mild and moderate disease.