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Randomised controlled trial of a multi-component mobile-health based intervention compared with usual care to improve outcomes in COPD

 

The EDGE trial is a collaboration among The Institute of Biomedical Engineering (IBME), Oxford University Hospitals NHS Trust and Oxford Health NHS Foundation Trust to develop and test a telehealth  system for COPD.

status

In follow up phase. The pilot phase of this study, with 23 participants, was completed in July 2013. The trial (June 2013- July 2015) recruited 166 participants from Oxfordshire and Berkshire.

Background

Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory condition that affects 210 million people globally and an estimated 3 million people in the UK alone. COPD is a progressive disease without cure and it is estimated that COPD will become the third leading cause of death worldwide by 2020. The aim of current treatment is focused on avoiding deterioration, minimising risk factors and reducing symptoms.

In the UK, one in three patients with chronic obstructive pulmonary disease (COPD) are readmitted within 28 days of a hospital admission for an exacerbation (National Institute for Excellence. Chronic Obstructive Pulmonary Disease. Costing Report. London: NICE, 2011), with 50% of costs (unplanned hospital admissions) potentially avoidable with the development of more responsive models of care. (Polisena J, et al. J.Telemed.Telecare. 2010;16(3):120–7.). NICE guidelines (2010) define an exacerbation as “a defined worsening of the patients’ symptoms from their usual stable state which is beyond normal day-to-day variations”. 

Effective self-management of COPD, including the early recognition and treatment of exacerbations, has the potential to improve outcomes such as patient quality of life and reduce hospital admissions. Tele-health is increasingly seen as a way to bridge the gap between professional care and patient self-management.

Current community care for COPD draws on the strong evidence base for effective treatment. Treatment pathways include: a coordinated plan for care (disease management package), an emphasis on education about COPD, support for self-management, smoking cessation advice, medicines management, including support for better use of medications and adherence, and screening for depression and anxiety to allow more effective management. These are achieved through regular contact with community nursing staff and a well-developed pulmonary rehabilitation programme. 

The mHealth system incorporates support for all these aspects of care through personalised treatment plans, supplementing written and verbally presented material with videos and access to medical records, including medication records, to increase the impact of the measures to improve care already in place. In addition, the system includes a monitoring module which incorporates oxygen saturation measurement and a symptom diary with trend analysis to allow both patients and clinicians to identify deterioration.

Our aim is to build a generic telehealth solution for the management of chronic illness, based on mobile technologies and capable of large-scale deployment. Work on the pilot and trial has shown that a well-designed self-management application on an Android tablet computer can be made intuitive and easy to use for people with a wide range of prior computing experience. The design utilises large icons with bright colours for selecting menu options or answering diary questions. The data and diaries completed by the patients are transmits in real time to a remote server.

Study Design

EDGE COPD is an open randomised parallel group trial. Following a pilot phase, participants with moderate to severe COPD were randomised 2:1 into two groups: (i) mHealth intervention and (ii) standardised usual care. All participants will be followed up for a period of 52 weeks. We recruited participants with moderate to very severe COPD, with a history of smoking and an exacerbation within the previous year.

A sub-group of patients and their family carers (25) were included in an interview based qualitative embedded study.

Sponsor

University of Oxford

Ethical Approval

REC number: 12/SC/0437 NRES South Central Berkshire
Approval received: 26th September 2012

investigators

Professor Andrew Farmer (Department of Primary Care Health Sciences, University of Oxford), Dr Maxine Hardinge (Oxford University Hospitals NHS Trust), Professor Lionel Tarassenko (Institute of Biomedical Engineering, University of Oxford), Dr Carl Heneghan (Department of Primary Care Health Sciences, University of Oxford), Dr Johnathan Price (Department of Psychiatry, University of Oxford), Dr Grace Robinson (Royal Berkshire NHS Foundation Trust)

collaborations

The Institute of Biomedical Engineering (IBME)

Oxford Health NHS Foundation Trust

Oxford University Hospitals NHS Trust

Royal Berkshire NHS Foundation Trust

Funding

This study was part of a project funded by the Wellcome Trust and Department of Health, under the Health Innovation Challenge Fund award (HICF-1010-032).

 Contact Details

Programme Director: Professor Lionel Tarassenko
Chief Clinical Investigator: Professor Andrew Farmer
Trial Manager: Dr Louise Jones
Email:  copd.edge@phc.ox.ac.uk

see also telehealth research

 Telehealth Research Group

 

 

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