Optimising the feasibility and acceptability of a multi-component, digital health intervention to improve outcomes for people with chronic obstructive pulmonary disease
| ISRCTN | ISRCTN82570166 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82570166 |
| IRAS number | 249148 |
| Secondary identifying numbers | PID:13866 (internal sponsor reference) |
- Submission date
- 05/06/2019
- Registration date
- 05/07/2019
- Last edited
- 28/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
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
Contact information
Scientific
Department of Primary Care Health Sciences
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
 ORCID ID |
0000-0002-6170-4402 |
|---|---|
| Phone | 01865 617942 |
| andrew.farmer@phc.ox.ac.uk |
Public
Department of Primary Care Health Sciences
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
| Phone | 01865 289259 |
|---|---|
| bethany.lawson@phc.ox.ac.uk |
Study information
| Study design | Prospective cohort study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | sElf-management anD support proGrammE (EDGE2) for COPD |
| Study 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(s) | Approved 18/12/2018, London - Surrey Research Ethics Committee (Surrey University, London, GU2 7XH, United Kingdom; +44 (0)207 104 8088; surrey.rec@hra.nhs.uk), ref: 18/LO/1939 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | EDGE2 Home Monitoring System |
| 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 study start date | 01/04/2019 |
| Overall study end date | 27/01/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Sex | Both |
| Target number of participants | 200 (minimum of 100) |
| Total final enrolment | 41 |
| 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 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 | 31/03/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Sponsor information
University/education
Joint Research Office
1st Floor
Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7GB
England
United Kingdom
| Phone | +44 (0)1865 289885 |
|---|---|
| ctrg@admin.ox.ac.uk | |
| Website | http://www.admin.ox.ac.uk/researchsupport |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
No information available
Government organisation / National government
- Alternative name(s)
- UKRI Engineering and Physical Sciences Research Council, Engineering and Physical Sciences Research Council - UKRI, Engineering & Physical Sciences Research Council, EPSRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/01/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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 plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol file | version 3 | 06/10/2021 | 16/11/2023 | No | No |
Additional files
Editorial Notes
28/01/2025: The following changes were made to the study record:
1. IRAS number added.
2. Ethics approval details updated.
3. The overall study end date was changed from 31/01/2027 to 27/01/2025.
4. The intention to publish date was changed from 01/01/2028 to 01/01/2026.
16/11/2023: Total final enrolment and protocol file added.
21/09/2022: The recruitment end date was changed from 01/11/2022 to 31/03/2022.
15/01/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/01/2021 to 01/11/2022.
2. The recruitment resumed.
20/04/2020: Due to current public health guidance, recruitment for this study has been paused.
07/06/2019: Trial’s existence confirmed by NHS HRA London Surrey Research Ethics Committee.
