Clinical Efficacy and Cost Effectiveness of MYCOPD in Patients With Mild and Moderate Newly Diagnosed COPD
Condition: COPD
Study type: Interventional

Summary: 
      Millions of patients in the UK live with long term medical conditions such as diabetes, heart
      disease and lung diseases. These conditions are the major cause of ill health in the UK and
      cost the NHS billions of pounds each year. One long term condition that carries an enormous
      impact for patients and the NHS is COPD (Chronic Obstructive Pulmonary Disease). This lung
      condition affects over one million patients in the UK and is one of the major causes of
      admission to hospital.

      Involvement of patients in the management of their own medical conditions (self-care) has
      been shown to improve how individuals feel, reduce the frequency of medical emergencies and
      reduce the costs of health care. In order to self-care successfully patients require the
      correct knowledge, skills and the confidence to make the right decisions; about their
      treatments, use of healthcare services and lifestyle choices. Recently the use of digital
      tools such as apps and websites has been shown to help patients with self-care and thus to
      improve their health. However in the UK there are very few providers of apps that are fully
      accredited by the NHS and only one that has been fully funded to provide apps nationally.

      My mhealth (short for my mobile health) is a UK company founded by NHS doctors which provides
      high quality digital tools (apps) to enable patients to access information about their
      condition and treatments and to record symptoms on their phones, tablets, computers or even
      smart TVs. MyMHealth has produced an app called MyCOPD which has been issued by the NHS to
      many thousands of patients in the UK. This was because it has been shown to improve the way
      patients with more severe COPD use their treatment and improved their day to day function
      through use of an online exercise programme.

      In this proposed study the MyMHealth team will work with NHS professionals to explore how an
      app called MyCOPD could help patients with mild disease and particularly those newly
      diagnosed with the condition. Investigators will explore how these patients can use the app
      and whether it's use can improve the ability to self-manage their condition. Investigators
      will study the potential for the app to establish appropriate and active decision making by
      patients and the impact of this on the use of NHS resources and the costs of day to day care.
    

Detailed description: 
      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.
    

Intervention name(s): myCOPD
Intervention type(s): Device
Intervention description(s): myCOPD is a multi faceted web based application designed to support people with COPD in the Long term management of their COPD.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised controlled Feasibility study
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research