A Pragmatic Real-world Multicentre Observational Research Study to Explore the Clinical and Health Economic Impact of myCOPD

Condition(s) studied

Investigational drug(s) / intervention(s)

myCOPD: myCOPD is a digital self-management application (app), that supports all elements of managing COPD by creating a supported self-help environment, and in turn reduce medical visits, and hospital admissions and re-admissions. myCOPD allows for key aspects of disease management, such as PR, to be provided remotely, based on a person's self-assessment. Furthermore, it can help people with COPD manage their condition at home, or anywhere away from a clinical setting. Successful implementation of myCOPD provides an opportunity to build capacity in primary and secondary care, and community teams where a blended approach with traditional PR and myCOPD is used. Studies have shown myCOPD is able to deliver similar improvements in symptoms and exercise tolerance compared to PR exercise-classes and helps patients admitted to hospital recover more quickly at home(5)(6). myCOPD is widely deployed across the NHS and is being used by patients in different areas of the UK.

Study summary

COPD is a condition which affects over 3 million people in the UK. It causes chronic symptoms including breathlessness and cough, limitations in exercise tolerance and acute exacerbations of COPD (AECOPD) which often lead to hospital admission. Current treatment for COPD includes inhaled medication and exercise programmes called Pulmonary Rehabilitation(PR) to improve exercise tolerance and resilience to AECOPD. Currently NHS respiratory services are struggling to provide support to patients with COPD, a recent-report highlighted that 75% of people with COPD are not receiving basic care. There is an increasing need therefore to improve the provision of PR and to support patients to self-manage their condition effectively, this requires new approaches and pathways of care. My mhealth Limited MMH is a UK based digital healthcare company established in 2011, specialising in the development of digital solutions for the management of long-term conditions. Evidence based, UKCA classified, and highly secure the company has developed a suite of solutions NHS approved and widely used, MHRA registered and is working towards NICE accreditation to manage patients with asthma, COPD, diabetes, and heart disease. myCOPD is a digital self-management application (app)therapeutic, developed by MMH, that supports all elements of managing COPD by creating a supported self-help environment, and in turn reduce medical visits, and hospital admissions and re-admissions. myCOPD allows for key aspects of disease management, such as PR, to be provided remotely, based on a person's self-assessment. Furthermore, it can help people with COPD manage their condition at home, or anywhere away from a clinical setting. Successful implementation of myCOPD provides an opportunity to build capacity in primary and secondary care, and community teams where a blended approach with traditional PR and myCOPD is used. Studies have shown myCOPD is able to deliver similar improvements in symptoms and exercise tolerance compared to PR exercise-classes and helps patients admitted to hospital recover more quickly at home. myCOPD is widely deployed across the NHS and is being used by patients in different areas of the UK- but to enable NICE approval and re-imbursement across all the NHS, evidence for the health-economic benefits of its use is required.

With funding from SBRI Phase 3 grant, this project will explore the implementation of myCOPD by NHS respiratory services in two regions with diverse populations and challenges. In Bristol (Setting 1) the investigators will assess the value of using myCOPD in the COPD discharge care bundle for patients admitted to hospital with AECOPD, and its ability to help accelerate recovery, and prevent unscheduled care visits and re-admissions. Data collected from a pilot will be used to support the analysis. Whilst in Cornwall (Setting 2) the investigators will work with local services to provide 'digitally-supported PR' to isolated communities and increase the service capacity, completion rates and access to specialist support for self-management.

A formal assessment will provide vital evidence for the value of myCOPD in the NHS and enable us to develop a business case for its national adoption and use, which will ultimately transform outcomes for people with this common and complex condition.

Eligibility

Primary outcome measure(s)

• Setting 1 - Hospital Readmission Reduction — At Baseline, Months 2, 3, 6, 9, 12
  myCOPD could support patients to self-manage at home with clinical oversight by reducing the risk of hospital readmission as part of the respiratory discharge bundle. Outcome will be measured by mean change in the number of reported COPD exacerbations over 12 months. Healthcare resource utilisation over 12 months including primary care using Electronic Health Record data where possible. Data relating to each patient's admissions during the 12 months prior to enrolment will also be collected. Improved patient welfare and quality of life. Mean change in results at the end of the data collection window, compared to baseline, will be aggregated and measured against the counterfactual.
• Setting 2 -Pulmonary Rehabilitation Uptake, Delivery and Completion — 12 months
  Using a digital blended approach could improve PR delivery. This outcome will be measured using the percentage of PR course completion i.e., how many sessions were attended during the 6 weeks of PR including (6 F2F sessions, 6 telephone sessions) and % of attendance. App PR course access will also be included.
• Qualitative Interviews — 12 months
  Addressing potential impacts of digital-exclusion and inequality-of-access. Semi-structured interviews with targeted patients, healthcare professionals and key stakeholders (e.g. policymakers, commissioners, technology experts, commercial partners), focusing on likely barriers e.g. time pressures, perceptions of usefulness, perceived digital literacy will be conducted.

Trial sites (3)

Other trials for the same condition