A Pragmatic Real-world Multicentre Observational Research Study to Explore the Clinical and Health Economic Impact of myCOPD
NCT05835492 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200
Last updated 2024-11-20
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.
Conditions
Interventions
- DEVICE
-
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.
Sponsors & Collaborators
-
North Bristol NHS Trust
collaborator OTHER -
University Hospitals Bristol and Weston NHS Foundation Trust
collaborator OTHER -
Cornwall Partnership NHS Foundation Trust
collaborator NETWORK -
University of Southampton
collaborator OTHER -
West of England Academic Health Science Network
collaborator UNKNOWN -
Unity Insights Limited
collaborator UNKNOWN -
my mhealth Ltd
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-04
- Primary Completion
- 2025-06-01
- Completion
- 2025-10-01
Countries
- United Kingdom
Study Locations
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