NCT05835492Active, not recruiting
A Pragmatic Real-world Multicentre Observational Research Study to Explore the Clinical and Health Economic Impact of myCOPD
Source: ClinicalTrials.gov · Last updated 20 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 200 (actual)
- First submitted
- 27 Mar 2023
- Start date
- 4 Sept 2023
- Primary completion date
- 1 Jun 2025
- Lead sponsor
- my mhealth Ltd
- Diseases
- COPD
- NCT number
- NCT05835492
What you commit to
- Study type: Observational
- Participants enrolled: 200
- From 4 Sept 2023 to the primary completion date, 1 Jun 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Unstable angina
- Uncontrolled cardiac arrhythmias
- Unstable hypertension
- Severe cognitive impairment
- Locomotor or other severe medical conditions
- Any condition deemed by the PI to make the participant unsuitable for the study
Age
- Under 18 years of age
Other
- Setting 1:
- No clinical diagnosis of COPD
- End of life care/palliative care
- Unable to give informed consent
- Setting 2:
- MI within 6 weeks
- Unable to give informed consent
Who the study is looking for
- Setting 1:
- Adult patients over 18 years of age and able to give informed consent
- A clinical diagnosis of COPD
- Admitted to hospital with a primary diagnosis of AECOPD
- Assessed in a follow-up clinic and/or virtual ward within 6 weeks of an AECOPD
- Setting 2:
- Adult patients over 18 years of age and able to give informed consent
- A clinical diagnosis of COPD, deemed suitable by the local clinical team as suitable for referral for PR
- Motivated/willing to take part
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| North Bristol NHS Trust - Southmead Hospital Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| University Hospital Bristol & Weston NHS Foundation Trust - Bristol Royal Infirmary Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| Cornwall Partnership NHS Foundation Trust - Liskeard Community Hospital Coordinator of this site? Confirm its status | Liskeard | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.