A Real-World Assessment of a COPD Disease Management Support Service (Me & My COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Device: Test GroupOther: Control Group
- Registration Number
- NCT02300090
- Lead Sponsor
- AstraZeneca
- Brief Summary
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 161
- 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.
- Symptomatic asthma or seasonal allergic rhinitis leading to hospitalisation in previous 12 months
- Patients unable to use a mobile phone
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Intervention group Test 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 Control Group This group of patients (n=250) will receive current best care alone. Control patients will not have access to the digital service.
- Primary Outcome Measures
Name Time Method To detect a reduction in the rate of hospitalisations due to COPD exacerbations 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.
- Secondary Outcome Measures
Name Time Method To detect a reduction in the number of exacerbations requiring treament with antibiotics and or systemic steriods 12 months 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.
To detect an improvement in patients own perceived health status, as assessed by St Georges Respiratory Questionnaire-C 12 months 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.
To detect a reduction in the duration of hospitalisations due to COPD exacerbations. 12 months 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.
Trial Locations
- Locations (1)
Research Site
🇬🇧Oldham, UK, United Kingdom