A Real-World Assessment of a COPD Disease Management Support Service (Me & My COPD)

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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A Real-World Assessment of a COPD Disease Management Support Service (Me & My COPD).

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: Test Group
* Other: Control Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Symptomatic asthma or seasonal allergic rhinitis leading to hospitalisation in previous 12 months Patients unable to use a mobile phone
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention group<br>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<br>* 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.<br>|
| Control group<br>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<br>* Patients in the control group receive only standard care; there are no interventions within this group of patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Exacerbation, respiratory disease, lung disease, breathlessness, dyspnoea, sputum, wheezing, cough