A Real-World Assessment of a COPD Disease Management Support Service (Me & My COPD)
Me&MyCOPD
1 other identifier
observational
161
1 country
23
Brief Summary
A real world study to determine the effectiveness of a patient support service to aid COPD patients in their self management.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2016
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2014
CompletedFirst Posted
Study publicly available on registry
November 24, 2014
CompletedStudy Start
First participant enrolled
October 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 23, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 23, 2018
CompletedSeptember 11, 2018
August 1, 2018
1.8 years
November 21, 2014
September 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Analysed over a twelve month timeframe
Secondary Outcomes (3)
To detect a reduction in the duration of hospitalisations due to COPD exacerbations.
12 months
To detect a reduction in the number of exacerbations requiring treament with antibiotics and or systemic steriods
12 months
To detect an improvement in patients own perceived health status, as assessed by St Georges Respiratory Questionnaire-C
12 months
Other Outcomes (3)
To detect a difference in the use/prescribing of maintenance therapy
12 months
To detect a difference in the use/prescribing of reliever therapy
12 months
To assess patinet engagement in the use of the digital service
12 months
Study Arms (2)
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.
Control group
This group of patients (n=250) will receive current best care alone. Control patients will not have access to the digital service.
Interventions
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.
Patients in the control group receive only standard care; there are no interventions within this group of patients
Eligibility Criteria
Males and females, of any age with a clinical diagnosis of COPD
You may qualify if:
- 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.
You may not qualify if:
- Symptomatic asthma or seasonal allergic rhinitis leading to hospitalisation in previous 12 months
- Patients unable to use a mobile phone
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (23)
Research Site
East Cheshire, UK, CW12 1JN, United Kingdom
Research Site
East Cheshire, UK, SK10 5JH, United Kingdom
Research Site
East Cheshire, UK, SK11 6JL, United Kingdom
Research Site
East Cheshire, UK, SK12 1EU, United Kingdom
Research Site
East Cheshire, UK, SK12 1GP, United Kingdom
Research Site
East Cheshire, UK, SK12 2BB, United Kingdom
Research Site
Liverpool, UK, CH42 0LQ, United Kingdom
Research Site
Liverpool, UK, CH45 3HE, United Kingdom
Research Site
Liverpool, UK, CH45 3HF, United Kingdom
Research Site
Liverpool, UK, CH45 4JG, United Kingdom
Research Site
Liverpool, UK, CH45 5LN, United Kingdom
Research Site
Liverpool, UK, CH48 4HZ, United Kingdom
Research Site
Liverpool, UK, CH49 5PL, United Kingdom
Research Site
Liverpool, UK, CH63 2LR, United Kingdom
Research Site
Liverpool, UK, CH63 9JP, United Kingdom
Research Site
Manchester, UK, BL9 0NJ, United Kingdom
Research Site
Manchester, UK, M33 4BR, United Kingdom
Research Site
Newcastle, UK, NE15 6TQ, United Kingdom
Research Site
Newcastle, UK, NE15 8LX, United Kingdom
Research Site
Oldham, UK, OL8 3HH, United Kingdom
Research Site
Oldham, UK, OL9 0LH, United Kingdom
Research Site
Oldham, UK, OL9 7SG, United Kingdom
Research Site
Oldham, UK, OL9 8NH, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David MG Halpin, MBBS, MRCP, FRCP
Royal Devon and Exeter Hospital
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Target Duration
- 12 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2014
First Posted
November 24, 2014
Study Start
October 26, 2016
Primary Completion
August 23, 2018
Study Completion
August 23, 2018
Last Updated
September 11, 2018
Record last verified: 2018-08