Chronic Obstructive Pulmonary DiseaseNCT04240353
RECEIVER: Digital Service Model for Chronic Obstructive Pulmonary Disease (COPD)
An observational study of Chronic Obstructive Pulmonary Disease, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a serious but treatable chronic health condition. Optimised management improves symptoms, complications, quality of life and survival. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- COPD digital support service
- How many people
- 400 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2018to 31 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with high risk COPD presenting to secondary care with COPD exacerbation or persisting hypercapnic respiratory failure (requiring home NIV)
Who may be able to join
- 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
Who cannot join
- inability to comprehend informed consent
- communication barrier precluding use of COPD digital service
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Elizabeth University Hospital
Glasgow, Scotland, G51 4TF
About this study
Official title: Remote-management of COPD: Evaluating Implementation of Digital Innovations to Enable Routine Care
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: -
Read more
- 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.
Read the 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.
Selected patients, who are recruited during hospital admission or attendance and will be attending outpatient clinic follow up, will undergo exploratory physiology measurements - parasternal electromyography (EMG) (similar to electrocardiography (ECG) recording, takes ~20 minutes with breathing manoeuvres), oscillometry (a breathing test involving 10 resting non-effortful breaths blown into the medical device), home pollution monitoring (a pack which rests in patients bedroom +/- tube placed outside house) for 7 days - alongside routine clinical care at baseline and 3 monthly intervals.
Patients will have linked access from the patient resource to curated information about COPD diagnosis, and all aspects of management. Specific prompts about management - e.g. timing to make appointment for annual flu vaccination - will be provided through platform-text notifications. Self-management content of the resource will potentially be further developed over iterations within the study; any change in content of patient materials would be advised as a protocol amendment.
Patients will be able to message the clinical team using the patient portal. This supplements existing availability of answer phone contact details provided as part of routine clinical care. Automatic messages will notify patients that this is not for emergency contact, and that replies should be expected within Mon-Fri working hours, by next working day. This messaging system will be used to support self management, home oxygen and home NIV treatment initiation and monitoring, and practical aspects such as appointment scheduling and equipment consumable replenishment.
The clinical team will be able to access the data from the patients symptom diaries, wearable and NIV physiology directly - asynchronously, rather than delayed acquisition of this data at a clinical contact. This data visualisation will support routine clinical care, and better inform unscheduled advice contacts from patients (e.g. help determine significance of apparent worsening symptoms).
This data will be subject to machine-learning analysis, which will evaluate secondary endpoints, as per protocol.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- COPD digital support service
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COPD digital support serviceOther
Also called Lenus Health COPD
Use of COPD digital services to record patient symptoms, integrate physiology monitoring, communicate with the clinical team and track interaction
| Study group | Role | What they receive |
|---|---|---|
| COPD group | Patients with high-risk COPD with recent exacerbation requiring hospitalisation (within last 12 months) or hypercapnia respiratory failure and/or sleep disordered breathing meeting criteria for provision of home NIV. Receives: Other: COPD digital support service |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient utilisation of digital service
Proportion of enrolled high-risk COPD patients successfully utilising remote-management in a digital service model
Measured: 24 months (12 months recruiting)
Secondary outcomes (5)
Clinical outcomes
Impact of digitally-enabled remote management on clinical outcomes including COPD exacerbations, unscheduled care contact, hospitalisation and occupied bed days, compared to historical and contemporary SafeHaven cohort (electronic health care record dataset) cohorts
Measured: 24 months (12 months recruiting)
Clinical service outcomes
Impact of digital service model on clinical service outcomes including number, nature and complexity of reviews for remotely managed NIV and supported self management.
Measured: 24 months (12 months recruiting)
Machine-learning analyses
Machine-learning supported exploratory analyses of associations and relative predictive importance of electronic health record, patient-reported outcomes, wearables physiology and NIV parameters
Measured: 24 months (12 months recruiting)
Patient-centred outcomes
Impact of digital service on patient-centred outcomes including health related quality of life (EQ5-D) at baseline and monthly during study and qualitative user research with semi-structured user experience interviews.
Measured: 24 months (12 months recruiting)
Healthcare cost analyses of digital service model
Assessment of healthcare costs associated with the digital service model including development and installation costs, recurring costs, and projected direct/indirect costs savings compared to previous service model
Measured: 24 months (12 months recruiting)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Aug 2018
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Chris Carlin, Principal investigator, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240353
- Sponsor's protocol ID
- INGN18RM173
- Status last verified
- Feb 2021
- First submitted
- 21 Jan 2020
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Taylor A, Lowe DJ, McDowell G, Lua S, Burns S, McGinness P, Carlin CM. Remote-Management of COPD: Evaluating the Implementation of Digital Innovation to Enable Routine Care (RECEIVER): the protocol for a feasibility and service adoption observational cohort study. BMJ Open Respir Res. 2021 Aug;8(1):e000905. doi: 10.1136/bmjresp-2021-000905.
PubMed 34462271
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote-management of COPD: Evaluating Implementation of Digital Innovations to Enable Routine Care
- ClinicalTrials.gov ID
- NCT04240353
- Acronym / sponsor ID
- INGN18RM173
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Selected patients, who are recruited during hospital admission or attendance and will be attending outpatient clinic follow up, will undergo exploratory physiology measurements - parasternal electromyography (EMG) (similar to electrocardiography (ECG) recording, takes ~20 minutes with breathing manoeuvres), oscillometry (a breathing test involving 10 resting non-effortful breaths blown into the medical device), home pollution monitoring (a pack which rests in patients bedroom +/- tube placed outside house) for 7 days - alongside routine clinical care at baseline and 3 monthly intervals.
Patients will have linked access from the patient resource to curated information about COPD diagnosis, and all aspects of management. Specific prompts about management - e.g. timing to make appointment for annual flu vaccination - will be provided through platform-text notifications. Self-management content of the resource will potentially be further developed over iterations within the study; any change in content of patient materials would be advised as a protocol amendment.
Patients will be able to message the clinical team using the patient portal. This supplements existing availability of answer phone contact details provided as part of routine clinical care. Automatic messages will notify patients that this is not for emergency contact, and that replies should be expected within Mon-Fri working hours, by next working day. This messaging system will be used to support self management, home oxygen and home NIV treatment initiation and monitoring, and practical aspects such as appointment scheduling and equipment consumable replenishment.
The clinical team will be able to access the data from the patients symptom diaries, wearable and NIV physiology directly - asynchronously, rather than delayed acquisition of this data at a clinical contact. This data visualisation will support routine clinical care, and better inform unscheduled advice contacts from patients (e.g. help determine significance of apparent worsening symptoms).
This data will be subject to machine-learning analysis, which will evaluate secondary endpoints, as per protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD group | – | Other: COPD digital support servicePatients with high-risk COPD with recent exacerbation requiring hospitalisation (within last 12 months) or hypercapnia respiratory failure and/or sleep disordered breathing meeting criteria for provision of home NIV. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with high risk COPD presenting to secondary care with COPD exacerbation or persisting hypercapnic respiratory failure (requiring home NIV)
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- inability to comprehend informed consent
- communication barrier precluding use of COPD digital service
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COPD digital support serviceAlso: Lenus Health COPDUse of COPD digital services to record patient symptoms, integrate physiology monitoring, communicate with the clinical team and track interaction | Other | COPD group |
Primary outcome
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
5 secondary outcomes
Clinical outcomes
Time frame: 24 months (12 months recruiting)
Clinical service outcomes
Time frame: 24 months (12 months recruiting)
Machine-learning analyses
Time frame: 24 months (12 months recruiting)
Patient-centred outcomes
Time frame: 24 months (12 months recruiting)
Healthcare cost analyses of digital service model
Time frame: 24 months (12 months recruiting)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Derived from this study: PubMed 34462271Taylor A, Lowe DJ, McDowell G, Lua S, Burns S, McGinness P, Carlin CM. Remote-Management of COPD: Evaluating the Implementation of Digital Innovation to Enable Routine Care (RECEIVER): the protocol for a feasibility and service adoption observational cohort study. BMJ Open Respir Res. 2021 Aug;8(1):e000905. doi: 10.1136/bmjresp-2021-000905.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Carlin principal investigator
NHS Greater Glasgow and Clyde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient utilisation of digital service (time frame: 24 months (12 months recruiting)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04240353, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021; AzTrials last refreshed its copy on 3 Nov 2026.