Remote-management of COPD: Evaluating Implementation of Digital Innovations to Enable Routine Care
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Patient utilisation of digital service
Study Overview
Brief Summary
Chronic obstructive pulmonary disease (COPD) is a serious but treatable chronic health condition. Optimised management improves symptoms, complications, quality of life and survival. Disease exacerbations, which have adverse outcomes and often trigger hospital admissions, underpin the rising costs of managing COPD (projected increase in the United Kingdom (UK) to £2.3bn by 2030). The costs and care-quality gap of COPD exacerbations, coupled with the global rising prevalence present a major healthcare challenge. This study proposal, which has been developed in partnership with patients, clinicians, enterprise and government representation is to conduct an implementation and effectiveness observational cohort study to establish a continuous and preventative digital health service model for COPD.
The implementation proposals comprise: -
- Establishing a digital resource for high-risk COPD patients which contains symptom diaries (structured patient reported outcome questionnaires), integrates physiology monitoring (FitBit and home NIV therapy data), enables asynchronous communication with clinical team, supports COPD self-management and tracks interaction with the service (for endpoint analyses).
- Establishing a cloud-based clinical COPD dashboard which will integrate background electronic health record data, core COPD clinical dataset, patient-reported outcomes, physiology and therapy data and patient messaging to provide clinical decision support and practice-efficiencies, enhancing delivery of guideline-based COPD care.
- Use the acquired dataset to explore feasibility and accuracy of machine-learned predictive modelling risk scores, via cloud-based infrastructure, which will be for future prospective clinical trial.
Our primary endpoint for the effectiveness evaluation is number of patients screened and recruited who successfully utilise and engage with this RECEIVER clinical service. The implementation components of the project will be iterated during the study, based on patient and clinical user experience and engagement. Secondary endpoints include a number of specified clinical outcomes, clinical service outcomes, machine-learning supported exploratory analyses, patient-centred outcomes and healthcare cost analyses.
Detailed Description
Patients will be screened from emergency attendance or admission at South and North Sector (Queen Elizabeth University Hospital, and Glasgow Royal Infirmary) and from referrals to the COPD clinical team at these sites.
Patients meeting inclusion criteria will be approached and offered enrolment to the study. Recruitment and consent timings will be individualised to be most efficient and least burdensome for patients. For some patients it will be appropriate to do this immediately to avoid burden of repeated attendances; for some patients, delay and consideration may be appropriate; for some patients the enrolment and engagement may be a staged process (consent at time of hospital attendance, study commence at follow up home or clinic visit etc).
Patients recruited will receive support information and assistance with login setups for the digital service components. Literature with frequently asked questions (FAQs), and team contacts for service support are available for throughout the study.
Patients enrolled will be asked, and prompted with text notifications, to complete daily short structured COPD symptom questionnaire. There are a small number of additional questions on a weekly basis, with quality of life questions completed once every 28 days. Patients recruited will have a "Fitbit" wristband wearable to monitor physiology.
Patients with hypercapnic respiratory failure will additionally be on home non-invasive ventilation (NIV) treatment - this is part of their routine clinical care rather than a study intervention. However, the study patient resource and messaging system will be used to gather information and support this treatment.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •confirmed diagnosis of chronic obstructive pulmonary disease, established pre-screening or at screening, defined as per Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 guidelines
- •home non-invasive ventilation cohort: hypercapnic respiratory failure and/or sleep-disordered breathing meeting established criteria for provision of home NIV
- •exacerbation cohort: recent presentation to secondary care with exacerbation of COPD, defined as per GOLD 2019 guidelines
- •patient or close-contact has access to smartphone, tablet or daily home computer web-browser
- •informed consent
- •≥18 years of age
Exclusion Criteria
- •inability to comprehend informed consent
- •communication barrier precluding use of COPD digital service
Outcomes
Primary Outcomes
Patient utilisation of digital service
Time Frame: 24 months (12 months recruiting)
Proportion of enrolled high-risk COPD patients successfully utilising remote-management in a digital service model
Secondary Outcomes
- Machine-learning analyses(24 months (12 months recruiting))
- Clinical outcomes(24 months (12 months recruiting))
- Clinical service outcomes(24 months (12 months recruiting))
- Patient-centred outcomes(24 months (12 months recruiting))
- Healthcare cost analyses of digital service model(24 months (12 months recruiting))