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

NCT05835492 | Active Not Recruiting

• 1 other identifier: MMH-R05
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 3

Brief 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

Chronic Obstructive Pulmonary Disease

Keywords

Digital Health; Pulmonary Rehabilitation; Acute COPD Exacerbation; Hospital Readmission Reduction

Outcome Measures

Primary Outcomes (3)

• Setting 1 - Hospital Readmission Reduction

  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.

  At Baseline, Months 2, 3, 6, 9, 12

• Setting 2 -Pulmonary Rehabilitation Uptake, Delivery and Completion

  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.

  12 months

• Qualitative Interviews

  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.

  12 months

Secondary Outcomes (9)

• Mean change in COPD Assessment Test

  At Baseline, Months 2, 3, 6, 9, 12

• Mean change in Quality of Life Ratings measured using EuroQol 5D-5L

  At Baseline, Months 2, 3, 6, 9, 12

• Mean change in Modified Medical Research Council Dyspnoea Scale

  At Baseline, Months 2, 3, 6, 9, 12

• Health Economic Analysis

  12 months

• Incremental Shuttle Walk Test

  Baseline, month 2

Study Arms (2)

Setting 1 - Hospital Readmission Reduction

North Bristol NHS Trust and University Hospitals Bristol and Weston NHS Foundation Trust (hospital readmissions reduction): Using myCOPD to support high risk patients with a primary focus on acute hospital admission discharge bundle following AECOPD. Patients who have been discharged from hospital following an AECOPD diagnosis and assessed in a follow-up clinic, including virtual wards, within 6 weeks can be included.

Device: myCOPD

Setting 2 - Pulmonary Rehabilitation

Cornwall Partnership NHS Foundation Trust (increasing community care provision of PR): Using myCOPD to support delivery of PR and self-management in the community.

Device: myCOPD

Interventions

myCOPD DEVICE

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.

Setting 1 - Hospital Readmission Reduction; Setting 2 - Pulmonary Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Setting 1: Participants with a COPD diagnosis who have been admitted to hospital following an acute exacerbation of COPD Setting 2: Participants with a COPD diagnosis who have been referred for pulmonary rehabilitation

You may qualify if:

• 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

You may not qualify if:

• Setting 1:
• Under 18 years of age
• No clinical diagnosis of COPD
• End of life care/palliative care
• Unable to give informed consent
• Setting 2:
• Unstable angina
• MI within 6 weeks
• Uncontrolled cardiac arrhythmias
• Unstable hypertension
• Severe cognitive impairment
• Locomotor or other severe medical conditions
• Unable to give informed consent
• Any condition deemed by the PI to make the participant unsuitable for the study

Sponsors & Collaborators

• my mhealth Ltd: lead
• North Bristol NHS Trust: collaborator
• University Hospitals Bristol and Weston NHS Foundation Trust: collaborator
• Cornwall Partnership NHS Foundation Trust: collaborator
• University of Southampton: collaborator
• West of England Academic Health Science Network: collaborator
• Unity Insights Limited: collaborator

Study Sites (3)

Cornwall Partnership NHS Foundation Trust - Liskeard Community Hospital

Liskeard, Cornwall, PL14 3XD, United Kingdom

Location

North Bristol NHS Trust - Southmead Hospital

Bristol, BS10 5NB, United Kingdom

Location

University Hospital Bristol & Weston NHS Foundation Trust - Bristol Royal Infirmary

Bristol, BS2 8HW, United Kingdom

Location

Related Publications (20)

• National Institute for Health and Care Excellence (NICE). Chronic obstructive pulmonary disease in adults: Quality standard. NICE Guidel [Internet]. 2016;(July 2011):1-46. Available from: www.nice.org.uk/guidance/qs10/resources/chronic-obstructive-pulmonary-disease-in-adults-pdf-2098478592709

  BACKGROUND

• Bollmeier SG, Hartmann AP. Management of chronic obstructive pulmonary disease: A review focusing on exacerbations. Am J Health Syst Pharm. 2020 Feb 7;77(4):259-268. doi: 10.1093/ajhp/zxz306.

  PMID: 31930287 BACKGROUND

• Global Initiative for Chronic Obstructive Lung Disease. GOLD Report 2020. Glob Initiat Chronic Obstr Lung Dis [Internet]. 2020;141. Available from: https://goldcopd.org/wp-content/uploads/2019/12/GOLD-2020-FINAL-ver1.2-03Dec19_WMV.pdf

  BACKGROUND

• Gottlieb V, Lyngso AM, Nybo B, Frolich A, Backer V. Pulmonary rehabilitation for moderate COPD (GOLD 2)--does it have an effect? COPD. 2011 Oct;8(5):380-6. doi: 10.3109/15412555.2011.610393.

  PMID: 21936683 BACKGROUND

• Bourne S, DeVos R, North M, Chauhan A, Green B, Brown T, Cornelius V, Wilkinson T. Online versus face-to-face pulmonary rehabilitation for patients with chronic obstructive pulmonary disease: randomised controlled trial. BMJ Open. 2017 Jul 17;7(7):e014580. doi: 10.1136/bmjopen-2016-014580.

  PMID: 28716786 BACKGROUND

• North M, Bourne S, Green B, Chauhan AJ, Brown T, Winter J, Jones T, Neville D, Blythin A, Watson A, Johnson M, Culliford D, Elkes J, Cornelius V, Wilkinson TMA. A randomised controlled feasibility trial of E-health application supported care vs usual care after exacerbation of COPD: the RESCUE trial. NPJ Digit Med. 2020 Oct 30;3:145. doi: 10.1038/s41746-020-00347-7. eCollection 2020.

  PMID: 33145441 BACKGROUND

• World Health Organisation. Chronic Obstructive Pulmonary Disease (COPD) [Internet]. World Health Organisation. 2022 [cited 2022 Jul 14]. Available from: https://www.who.int/news-room/fact-sheets/detail/chronic-obstructive-pulmonary-disease-(copd)

  BACKGROUND

• GOV.UK. Official Statistics Interactive Health Atlas of Lung conditions in England (INHALE): February 2022 update [Internet]. London; 2022. Available from: https://www.gov.uk/government/statistics/interactive-health-atlas-of-lung-conditions-in-england-inhale-2022-update/interactive-health-atlas-of-lung-conditions-in-england-inhale-february-2022-update

  BACKGROUND

• The Lancet. UK COPD treatment: failing to progress. Lancet. 2018 Apr 21;391(10130):1550. doi: 10.1016/S0140-6736(18)30904-8. No abstract available.

  PMID: 29695330 BACKGROUND

• NACAP. Drawing breath [Internet]. 2023. Available from: https://www.rcplondon.ac.uk/projects/outputs/drawing-breath-clinical-audit-report-202122

  BACKGROUND

• Stone PW, Hickman K, Steiner MC, Roberts CM, Quint JK, Singh SJ. Predictors of pulmonary rehabilitation completion in the UK. ERJ Open Res. 2021 Feb 8;7(1):00509-2020. doi: 10.1183/23120541.00509-2020. eCollection 2021 Jan.

  PMID: 33585658 BACKGROUND

• Kjaergaard J, Juhl CB, Lange P, Wilcke T. Adherence to early pulmonary rehabilitation after COPD exacerbation and risk of hospital readmission: a secondary analysis of the COPD-EXA-REHAB study. BMJ Open Respir Res. 2020 Aug;7(1):e000582. doi: 10.1136/bmjresp-2020-000582.

  PMID: 32816829 BACKGROUND

• British Lung Foundation. Failing on the Fundamentals [Internet]. 2021. Available from: https://www.blf.org.uk/copd-report

  BACKGROUND

• Sahin H, Naz I. Why are COPD patients unable to complete the outpatient pulmonary rehabilitation program? Chron Respir Dis. 2018 Nov;15(4):411-418. doi: 10.1177/1479972318767206. Epub 2018 Apr 19.

  PMID: 29673263 BACKGROUND

• Mitchell AJ, Selmes T. Why don't patients attend their appointments? Maintaining engagement with psychiatric services. Adv Psychiatr Treat. 2007;13(6):423-34.

  BACKGROUND

• Crooks MG, Elkes J, Storrar W, Roy K, North M, Blythin A, Watson A, Cornelius V, Wilkinson TMA. Evidence generation for the clinical impact of myCOPD in patients with mild, moderate and newly diagnosed COPD: a randomised controlled trial. ERJ Open Res. 2020 Oct 26;6(4):00460-2020. doi: 10.1183/23120541.00460-2020. eCollection 2020 Oct.

  PMID: 33263052 BACKGROUND

• Kong CW, Wilkinson TMA. Predicting and preventing hospital readmission for exacerbations of COPD. ERJ Open Res. 2020 May 11;6(2):00325-2019. doi: 10.1183/23120541.00325-2019. eCollection 2020 Apr.

  PMID: 32420313 BACKGROUND

• GOV.UK. Respiratory Disease: Applying All Our Health [Internet]. Public Health England. 2021. Available from: https://www.gov.uk/government/publications/respiratory-disease-applying-all-our-health/respiratory-disease-applying-all-our-health

  BACKGROUND

• British Thoracic Society. British Thoracic Society Quality Standards for Pulmonary Rehabilitation in Adults. Br Thorac Soc Reports [Internet]. 2014;6(2). Available from: https://www.brit-thoracic.org.uk/guidelines

  BACKGROUND

• Evans RA, Singh SJ. Minimum important difference of the incremental shuttle walk test distance in patients with COPD. Thorax. 2019 Oct;74(10):994-995. doi: 10.1136/thoraxjnl-2018-212725. Epub 2019 May 30.

  PMID: 31147399 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 28, 2023
• Study Start: September 4, 2023
• Primary Completion: June 1, 2025
• Study Completion: October 1, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

GB (3)