A Study of Inhaler Use in the Community

Study Overview
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Brief Summary
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This is a prospective cohort observational study of inhaler adherence in a community care setting (ie. general practice clinics and pharmacies in the community).

Detailed Description
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Over a 2-4 week period, consecutive patients with a history of respiratory illness already prescribed a salmeterol/fluticasone Diskus inhaler will be asked to participate in this study. Patients will give informed consent to participate in this study of adherence, which will be assessed with the INCA device. Both clinicians and patients will be fully aware that the device is an acoustic recording device and that both time and technique of inhaler use will be assessed. Once consented, patients will be given an INCA enabled inhaler for 1 month and asked to use it as they normally would and then to return it at the end of one month. The days used and the number of doses used in the study period, as per the dose counter, will also be recorded.

Official Title
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Haphazard and Careless Use of Inhalers, an Observational Study

Conditions
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Asthma, Chronic Obstructive Pulmonary Disease, Airways Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Known history of Respiratory Illness Prescribed salmeterol/fluticasone Diskus Inhaler Exclusion Criteria: Unable to understand study protocol Refusal to sign consent form

Ages Eligible for Study
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Minimum Age: 18 Years

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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inhaler Adherence in Time | This is adherence as measured by the INCA device in regards to time of use. This is measured as a rate of use. | One month | 
| Inhaler Technique Adherence | This is adherence measured by the INCA device in regards to technique of use. This is measured as a rate. | One Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age Measured in Years at time of recruitment | Relationship of Age to Adherence | one month | 
| Gender Measured as Male or Female | Relationship of Gender to Adherence | One Month | 
| Education Level Measured as either primary, secondary or tertiary school at recruitment. | Relationship of Education Level (Primary/Secondary/Tertiary) to Adherence | One Month | 
| Socio-economic Class Measured as the patient having either Private or Public Health Insurance | Relationship of Socio-economic class (Private or Public Health Insurance) to Adherence | One Month | 
| Health Care Use Measured as the number of visits to a General Practitioner in the previous Year | Relationship of Health Care Use (Frequency of visit to General Practitioner) to Adherence | Previous Year | 
| Hospitalisation Measured as the number of hospital admissions in the previous year | Relationship of Hospitalisation in the prevoius year to Adherence | Previous Year | 
| Exacerbation Measured as the number of Respiratory Related Exacerbations in the previous year | Relationship of Exacerbation (Respiratory related in the prevoius year) to Adherence | Previous Year | 
| Background Respiratory Diagnosis, divided into Asthma, COPD and other. | Relationship of Respiratory Diagnosis (Asthma, COPD, other) to Adherence | Previous History | 
| Smoking History measured by three categories: 1. Current Smoker, 2. Ex-Smoker and 3. Never Smoker | Relationship of Smoking History (Current, Ex-smoker, never smoker) to Adherence | Previous History | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inhaler Use, Adherence, Chronic Obstructive Pulmonary Disease, Asthma