Condition category
Respiratory
Date applied
05/06/2019
Date assigned
05/07/2019
Last edited
05/07/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Digital healthcare can address a number of health care needs arising from long-term conditions, including the requirement to support people in their own homes and to provide a greater focus on self-management. Substantial amounts of data are routinely captured during NHS usual care, including vital sign data (such as blood pressure and pulse rate) whilst patients are in hospital. Linking data routinely collected in hospital with data collected by monitoring devices at home has the potential to provide a better overview of health status, but the feasibility of doing this is currently unknown. Large numbers of admissions associated with an exacerbation of chronic obstructive pulmonary disease (COPD) are recorded each year with 1 in 4 patients re-admitted within 3 months of discharge. Linking data from these sources may help inform subsequent studies in developing more accurate predictive algorithms to identify deterioration and prevent readmission.

Who can participate?
Patients aged 40 years or older diagnosed with COPD who are a current or ex-smoker.

What does the study involve?
EDGE2 will recruit 200 patients diagnosed with chronic obstructive pulmonary disease (COPD). Patients will be approached if they visit hospital because of their COPD. A COPD exacerbation is a severe worsening of symptoms beyond usual day-to-day variation and can be a frightening experience. Participants will be given a tablet computer and two monitors to track oxygen saturation levels, heart rate and step count. Patients will access these devices whilst in hospital and for 6 months after discharge. EDGE2 will investigate the feasibility of accessing hospital data and see if it can be linked to self-monitored data. Linking this data together is important to develop predictive algorithms to identify and support responses to early changes in their health. EDGE2 will also monitor patients for 5 years after hospital discharge to identify hospital visits and deaths using data from NHS Digital.

What are the possible benefits and risks of participating?
Participants will be able to self-monitor their vital signs (including oxygen saturation), COPD symptoms, mood and physical activity on a regular basis over several months. They will also be able to access educational resources to support their COPD self-management, such as videos to demonstrate correct inhaler technique. In doing so participants may feel more anxious about their COPD by monitoring their condition more closely or may consider this a replacement to usual care. Incoming data will, however, be monitored by a member of the clinical research team twice-weekly and participants will also be able to contact the team themselves.

Where is the study run from?
Oxford University Hospitals NHS Foundation Trust, UK.

When is the study starting and how long is it expected to run for?
May 2019 to January 2021

Who is funding the study?
1. National Institute for Health Research Oxford Biomedical Research Centre
2. Engineering and Physical Sciences Research Council

Who is the main contact?
1. Prof. Andrew Farmer,
andrew.farmer@phc.ox.ac.uk
2. Miss Bethany Lawson,
bethany.lawson@phc.ox.ac.uk

Trial website

https://www.phc.ox.ac.uk/research/diabetes/studies/EDGE2

Contact information

Type

Scientific

Primary contact

Prof Andrew Farmer

ORCID ID

http://orcid.org/0000-0002-6170-4402

Contact details

Department of Primary Care Health Sciences
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
01865 617942
andrew.farmer@phc.ox.ac.uk

Type

Public

Additional contact

Miss Bethany Lawson

ORCID ID

Contact details

Department of Primary Care Health Sciences
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
01865 289259
bethany.lawson@phc.ox.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

PID:13866 (internal sponsor reference)

Study information

Scientific title

sElf-management anD support proGrammE (EDGE2) for COPD

Acronym

EDGE2

Study hypothesis

The aim of EDGE2 is to assess the feasibility of extracting and linking hospital data with self-monitoring data collected in a community setting by a digital health system.

Ethics approval

Approved 18/12/2018, London Surrey Research Ethics Committee (Surrey University, GU2 7XH or Royal Surrey County Hospital, GU2 7XX; 02071048238; NRESCommittee.SECoast-Surrey@nhs.net), ref 18/LO/1939.

Study design

Prospective cohort study

Primary study design

Interventional

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Chronic Obstructive Pulmonary Disease (COPD)

Intervention

EDGE2 is a cohort study and all participants will access the intervention. The intervention will comprise an internet-linked tablet computer and two monitoring devices to support their self-management of their condition. The monitoring devices will capture oxygen saturation levels, pulse rate and step count. Patients will be encouraged to wear the physical activity monitor and to use the pulse oximeter daily for 6 months after discharge. Using the tablet computer, participants will be able to answer questions about their COPD symptoms (daily) and mood (monthly) and will be able to access educational videos about COPD.

Intervention type

Device

Phase

Not Applicable

Drug names

Primary outcome measure

1. Proportion of participants in whom data can be obtained and matched from the in-hospital system and the EDGE2 platform – extract and link in-hospital data with other study data for each patient, success pre-defined as 80-90% – initiation of linkage will take place upon provision of consent with in-hospital data retrieved from point of index attendance/admission to discharge.
2. Proportion where there is sufficient data to provide clinically relevant data for use across the care pathway – obtain and link in-hospital data with other study data for each patient, success pre-defined as 80-90% – initiation of linkage will take place upon provision of consent with in-hospital data retrieved from point of index attendance/admission to discharge.

Secondary outcome measures

1. Quality of life - using St George’s Respiratory Questionnaire for COPD (SGRQ-C) - at baseline and 6 months after hospital discharge
2. Generic health status - using the EuroQol-5 Dimension (EQ-5D-5L) scale - at baseline and 6 months after hospital discharge
3. Number of hospital admissions - at baseline and 6 months after hospital discharge
4. Number of ICU admissions - at baseline and 6 months after hospital discharge
5. Number of contacts with health professionals - at baseline and 6 months after hospital discharge
6. Use of medications - at baseline and 6 months after hospital discharge
7. Physical function – using the sit-to-stand test - at baseline, 4 weeks, 12 weeks and 24 weeks after hospital discharge
8. Death - using NHS Digital’s Data Access Request Service
9. Attendance and admissions to hospital – using NHS Digital’s Data Access Request Service

Overall trial start date

01/04/2019

Overall trial end date

31/01/2027

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Be willing and able to give informed consent
2. Be aged 40 years or older
3. Have a clinical diagnosis of chronic obstructive pulmonary disease recorded in their medical history
4. Be a current or ex-smoker
5. Be an acute hospital attendance/admission for an exacerbation of chronic obstructive pulmonary disease or pulmonary infection
6. Be able to complete questionnaires (electronic or paper) and use the tablet computer
7. Confirm their post-discharge destination is not a medical facility or prison
8. Lives in Oxfordshire or surrounding counties
9. Be able to adequately understand verbal and written English

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200 (minimum of 100)

Participant exclusion criteria

1. Another significant lung disease e.g. lung cancer
2. Chronic heart failure defined by the New York Heart Association classification system as severe (Grade IV)
3. Have a life expectancy of less than six months or be on a palliative pathway

Recruitment start date

13/05/2019

Recruitment end date

01/01/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Oxford University Hospitals NHS Foundation Trust
John Radcliffe Hospital Headley Way Headington
Oxford
OX3 9DU
United Kingdom

Sponsor information

Organisation

Clinical Trials and Research Governance – University of Oxford

Sponsor details

Joint Research Office
1st Floor
Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7GB
United Kingdom
01865 289885
ctrg@admin.ox.ac.uk

Sponsor type

University/education

Website

http://www.admin.ox.ac.uk/researchsupport

Funders

Funder type

Government

Funder name

National Institute for Health Research Oxford Biomedical Research Centre

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Engineering and Physical Sciences Research Council

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The findings of this study will be disseminated through publication in a peer-reviewed journal. Findings may also be presented at international and national conferences. Participants will be informed of the trial results through an information sheet prepared for a lay audience made available on the department’s website.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.

Intention to publish date

01/01/2028

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

07/06/2019: Trial’s existence confirmed by NHS HRA London Surrey Research Ethics Committee.