Chronic Obstructive Pulmonary DiseaseMe&MyCOPDNCT02300090
A Real-World Assessment of a COPD Disease Management Support Service (Me & My COPD)
An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 23 sites in United Kingdom.
Trial summary
A real world study to determine the effectiveness of a patient support service to aid COPD patients in their self management. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Test Group
- Type of treatment
- Medical device
- How many people
- 161 participants
- Where
- 23 sitesUnited Kingdom
- Study dates
- 26 Oct 2016to 23 Aug 2018
- How long will I take part?
- 12 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Males and females, of any age with a clinical diagnosis of COPD
Who may be able to join
- Clinical diagnosis of COPD
- FEV1/FVC ratio >0.3-<0.7 and FEV1 > 30% post-bronchodilator
- Prescribed either ICS, LABA and or LAMA at dose for COPD
- Exacerbations reported within the last 12 months requiring treatment with >1 systemic steroid and/or antibiotics, OR hospitalisation within last 12 months due to exacerbation, OR have received >12 SABA prescriptions in previous 12 months
- Patient has a self management plan which includes use of an oral steroid at a dose within NICE guidelines, and additionally antibiotics as appropriate.
Who cannot join
- Symptomatic asthma or seasonal allergic rhinitis leading to hospitalisation in previous 12 months
- Patients unable to use a mobile phone
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United Kingdom23 sites
Research Site
East Cheshire, UK, CW12 1JN
Research Site
East Cheshire, UK, SK10 5JH
Research Site
East Cheshire, UK, SK11 6JL
Research Site
East Cheshire, UK, SK12 1EU
Research Site
East Cheshire, UK, SK12 1GP
Research Site
East Cheshire, UK, SK12 2BB
Research Site
Liverpool, UK, CH42 0LQ
Research Site
Liverpool, UK, CH45 3HE
Research Site
Liverpool, UK, CH45 3HF
Research Site
Liverpool, UK, CH45 4JG
Research Site
Liverpool, UK, CH45 5LN
Research Site
Liverpool, UK, CH48 4HZ
Research Site
Liverpool, UK, CH49 5PL
Research Site
Liverpool, UK, CH63 2LR
Research Site
Liverpool, UK, CH63 9JP
Research Site
Manchester, UK, BL9 0NJ
Research Site
Manchester, UK, M33 4BR
Research Site
Newcastle, UK, NE15 6TQ
Research Site
Newcastle, UK, NE15 8LX
Research Site
Oldham, UK, OL8 3HH
Research Site
Oldham, UK, OL9 0LH
Research Site
Oldham, UK, OL9 7SG
Research Site
Oldham, UK, OL9 8NH
About this study
Official title: A Real-World Assessment of a COPD Disease Management Support Service (Me & My COPD).
A real world study to determine the effectiveness of a patient support service to aid COPD patients in their self management.
Read the detailed description
The purpose of the study is to evaluate a digital health wellness support tool for patients in primary care with COPD using a smart mobile app, patient web portal and technology attached to the patients SABA reliever inhaler. Using the patients pre-defined COPD self management plan, the active arm of the study complete a daily diary (EXACT PRO) and record their daily SABA inhaler usage. After defining a health and symptom score baseline over a two week period, any significant deviations in SABA reliever use or daily diary scoring will alert patients that they may be having a change in their symptoms and advise them to refer to their self management plan and if they need to start their rescue medication. The primary outcome measure for the study is a 25% reduction in unplanned COPD hospital admissions (n=250 completing the study in each arm).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Test Group, Control Group
- Keywords
- COPD, Exacerbation, respiratory disease, lung disease, breathlessness, dyspnoea, sputum, wheezing, cough
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiration Disorders, Lung Diseases, Dyspnea, Respiratory Sounds, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test GroupDevice
Patients receive a mobile phone with the Me \& My COPD app installed. Patients also receive a bluetooth inhaler device that is fitted to their usual reliever inhaler.
Control GroupOther
Patients in the control group receive only standard care; there are no interventions within this group of patients
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | This group of patients (n=250) will receive the digital service (smart phone application and bluetooth inhaler device) in addition to current best care from their healthcare professional. Receives: Device: Test Group | |
| Control group | This group of patients (n=250) will receive current best care alone. Control patients will not have access to the digital service. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
To detect a reduction in the rate of hospitalisations due to COPD exacerbations
The mean number of COPD related hospitalisations per patient per year for patients who are receiving the digital service in the study will be compared to the rate of COPD related hospitalisations in patients receiving current best care alone over a twelve period.
Measured: Analysed over a twelve month timeframe
Secondary outcomes (3)
To detect a reduction in the duration of hospitalisations due to COPD exacerbations.
The average duration of COPD related hopspitalisations (number of bed days) per patient will be compared across patients receiving the digital service and those receiving current best care alone.
Measured: 12 months
To detect a reduction in the number of exacerbations requiring treament with antibiotics and or systemic steriods
The number of exacerbations requiring treament with antibiotics and or systemic steriods will be compared across patients receiving the digital service and those receiving current best care alone.
Measured: 12 months
To detect an improvement in patients own perceived health status, as assessed by St Georges Respiratory Questionnaire-C
The patients assessment of their own health status will be assessed over time using the St Georges Respiratory Questionnaire-C, and will be compared across patients receiving the digital service and those receiving current best care alone.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study start26 Oct 2016
- Primary completion23 Aug 2018
- Study completion23 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 161 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David MG Halpin, MBBS, MRCP, FRCP, Principal investigator, Royal Devon and Exeter Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300090
- Sponsor's protocol ID
- 149902
- Acronym
- Me&MyCOPD
- Status last verified
- Aug 2018
- First submitted
- 21 Nov 2014
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Assessment of a COPD Disease Management Support Service (Me & My COPD).
- ClinicalTrials.gov ID
- NCT02300090
- Acronym / sponsor ID
- Me&MyCOPD / 149902
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Exacerbation, respiratory disease, lung disease, breathlessness, dyspnoea, sputum, wheezing, cough
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2016 (actual)
- Primary completion
- 23 Aug 2018 (actual)
- Study completion
- 23 Aug 2018 (actual)
- First posted
- 24 Nov 2014 (estimated)
- 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.
A real world study to determine the effectiveness of a patient support service to aid COPD patients in their self management.
Detailed description
The purpose of the study is to evaluate a digital health wellness support tool for patients in primary care with COPD using a smart mobile app, patient web portal and technology attached to the patients SABA reliever inhaler. Using the patients pre-defined COPD self management plan, the active arm of the study complete a daily diary (EXACT PRO) and record their daily SABA inhaler usage. After defining a health and symptom score baseline over a two week period, any significant deviations in SABA reliever use or daily diary scoring will alert patients that they may be having a change in their symptoms and advise them to refer to their self management plan and if they need to start their rescue medication. The primary outcome measure for the study is a 25% reduction in unplanned COPD hospital admissions (n=250 completing the study in each arm).
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | – | Device: Test GroupThis group of patients (n=250) will receive the digital service (smart phone application and bluetooth inhaler device) in addition to current best care from their healthcare professional. |
| Control group | – | Other: Control GroupThis group of patients (n=250) will receive current best care alone. Control patients will not have access to the digital service. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Males and females, of any age with a clinical diagnosis of COPD
Key inclusion criteria (5 listed)
- Clinical diagnosis of COPD
- FEV1/FVC ratio >0.3-<0.7 and FEV1 > 30% post-bronchodilator
- Prescribed either ICS, LABA and or LAMA at dose for COPD
- Exacerbations reported within the last 12 months requiring treatment with >1 systemic steroid and/or antibiotics, OR hospitalisation within last 12 months due to exacerbation, OR have received >12 SABA prescriptions in previous 12 months
- Patient has a self management plan which includes use of an oral steroid at a dose within NICE guidelines, and additionally antibiotics as appropriate.
Key exclusion criteria (2 listed)
- Symptomatic asthma or seasonal allergic rhinitis leading to hospitalisation in previous 12 months
- Patients unable to use a mobile phone
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 |
|---|---|---|
| Test GroupPatients receive a mobile phone with the Me \& My COPD app installed. Patients also receive a bluetooth inhaler device that is fitted to their usual reliever inhaler. | Device | Intervention group |
| Control GroupPatients in the control group receive only standard care; there are no interventions within this group of patients | Other | Control group |
Primary outcome
To detect a reduction in the rate of hospitalisations due to COPD exacerbations
Time frame: Analysed over a twelve month timeframe
The mean number of COPD related hospitalisations per patient per year for patients who are receiving the digital service in the study will be compared to the rate of COPD related hospitalisations in patients receiving current best care alone over a twelve period.
3 secondary outcomes
To detect a reduction in the duration of hospitalisations due to COPD exacerbations.
Time frame: 12 months
To detect a reduction in the number of exacerbations requiring treament with antibiotics and or systemic steriods
Time frame: 12 months
To detect an improvement in patients own perceived health status, as assessed by St Georges Respiratory Questionnaire-C
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
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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.
David MG Halpin, MBBS, MRCP, FRCP principal investigator
Royal Devon and Exeter Hospital
23 sites 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 AstraZeneca at 23 sites 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 5 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: finished, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To detect a reduction in the rate of hospitalisations due to COPD exacerbations (time frame: Analysed over a twelve month timeframe). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2018; AzTrials last refreshed its copy on 7 Nov 2026.