A Pragmatic Real-world Multicentre Observational Research Study to Explore the Clinical and Health Economic Impact of myCOPD
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Qualitative Interviews
研究概览
简要总结
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.
详细描述
It is estimated that COPD will become the 3rd leading cause of death worldwide by 2030. 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 (AECOPD). 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 in the UK.
Hospital admissions for COPD exacerbations have declined recently from 246.7 per 100,000 population in the financial year ending 2020 to 133.5 per 100,000 population in the financial year ending 2021. Although, rates remain high in the North of England and Midlands. The reason for this decline in admissions is complex and is likely to include displacement of primary admission diagnosis due to COVID-19, less exposure to infection risk due to lockdowns, mask wearing and an increased management of care in the community instead of hospital. Nonetheless, reported estimates calculate that COPD costs the NHS £1.9 billion each year. In the UK over 130,000 people with COPD are admitted to hospital annually due to AECOPD. Admissions cluster in Winter, driving bed-pressures, impacting on the delivery of care. Once admitted, COPD patients are particularly vulnerable to further exacerbations and readmission. Over 43% are readmitted within 3 months.
COPD cannot be cured and drives excess morbidity. Current treatment for COPD includes inhaled medication and exercise programmes known as PR to improve exercise tolerance and resilience to AECOPD. Patients should be educated on the importance of taking their medication as prescribed, and attending PR to avoid AECOPD events to prevent lung function decline. The benefits of PR are widely evidenced with confirmed improvements in dyspnoea, fatigue, quality of life and exercise capacity. Despite this, the proportion of patients being referred to and completing PR remains low in the UK. Early PR after hospital discharge following AECOPD has been found to reduce the risk of hospital readmission and improve quality of life. Access to PR, an essential aspect of care, is poor in the UK and in rural areas there is little or no provision. Poor provision of PR and wide geographical variation in delivery has been highlighted. Consequently, there is a significant need to explore additional strategies to support patients and healthcare professionals (HCP) in preventing or highlighting the risk of an exacerbation event.
The reasons for PR non-attendance are multifactorial and include barriers such as work or caring commitments, lack of motivation, hospitalisation or feeling unwell, transportation, or forgetting the appointment. Since COVID-19, many healthcare services turned to digital health to support remote PR delivery in the UK. This has enabled inclusion of those who would not necessarily have attended in-person PR. Patient education is key to preventing worsening of lung function. Facilitating better access to PR and smoking services will improve quality of life and relieve the growing burden on healthcare services in the UK.
myCOPD, a digital health self-management app for patients with COPD, has been in use within the NHS since 2016. It was designed by MMH, a UK based company founded by NHS respiratory consultants and is one of four long term condition self-management apps developed by the company. All MMH apps, including myCOPD, are cloud-based, meaning data is stored, managed, and processed on a network of remote servers hosted on the internet, rather than on local servers or personal computers. The apps can be accessed using any internet connected device and by download from the Apple or Google play app store. Furthermore, myCOPD provides digital disease specific support to thousands of users through self-management plans, comprehensive education on lifestyle, device instruction (inhalers), PR, symptom, COPD Assessment Test (CAT) score and exacerbation recording, and the ability to map health trends so the user and HCPs can view health deterioration or improvement over time. Recent research studies have shown the app has many benefits for both patients and healthcare service providers including a reduction in CAT score, hospital admissions and readmissions, less frequent exacerbations and improvements in inhaler technique.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •Under 18 years of age
- •No clinical diagnosis of COPD
- •End of life care/palliative care
- •Unable to give informed consent
- •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
结局指标
主要结局
Qualitative Interviews
时间窗: 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.
Setting 1 - Hospital Readmission Reduction
时间窗: 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
时间窗: 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.
次要结局
- Mean change in Modified Medical Research Council Dyspnoea Scale(At Baseline, Months 2, 3, 6, 9, 12)
- Health Economic Analysis(12 months)
- Digital Accessibility and Support(At Baseline, Months 2, 3, 6, 9, 12)
- 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)
- Incremental Shuttle Walk Test(Baseline, month 2)
- Unscheduled Healthcare Use(At Baseline, Months 2, 3, 6, 9, 12)
- myCOPD App Use(Months 6, 12)
- myCOPD App Feedback(End of Study (12 months))
