Study identifier:149902
ClinicalTrials.gov identifier:NCT02300090
EudraCT identifier:N/A
CTIS identifier:N/A
A Real-World Assessment of a COPD Disease Management Support Service (Me & My COPD).
Chronic Obstructive Pulmonary Disease
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No
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All
161
Observational
N/A
Allocation: -
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Aug 2018 by AstraZeneca
AstraZeneca
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A real world study to determine the effectiveness of a patient support service to aid COPD patients in their self management.
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).
Location
Location
Liverpool, UK, United Kingdom, CH48 4HZ
Location
Liverpool, UK, United Kingdom, CH45 5LN
Location
Liverpool, UK, United Kingdom, CH45 3HE
Location
Liverpool, UK, United Kingdom, CH63 2LR
Location
Liverpool, UK, United Kingdom, CH42 0LQ
Location
Liverpool, UK, United Kingdom, CH45 4JG
Location
Liverpool, UK, United Kingdom, CH45 3HF
Location
Liverpool, UK, United Kingdom, CH63 9JP
Arms | Assigned Interventions |
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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. | Device: Test Group 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 group This group of patients (n=250) will receive current best care alone. Control patients will not have access to the digital service. | Other: Control Group Patients in the control group receive only standard care; there are no interventions within this group of patients |
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