Prospective Study of the Feedback From an Adherence Monitor on Asthma Control

Study Overview
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Brief Summary
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Inhaled medications are the mainstay of the therapeutic management of respiratory disorders. Considered by many to be 'simple' and 'easy' to use, clinicians are aware that inhalers are often improperly used. However, there is no tool that can detect and record errors in either the timing or the method dose administration The investigators designed a device that makes an acoustic record each time an inhaler is used. Opening the device makes an acoustic file which is recorded, this file is time-stamped which means that the timing of drug administration is recorded. When the device is retrieved and acoustic analysis performed, the steps involved in using the inhaler can be determined. Hence, the subjects inhaler technique is assessed and errors in the inhaler use identified. Together this means that errors in inhaler technique and timing of use can be quantified. In this study the investigators attached the device to a discus dry powder inhaler. In order to eliminate the behavioral component of adherence and identify the mechanical issues associated with effective inhaler use the investigators studied subjects who were already in Hospital and already prescribed a discus inhaler. The investigators hypothesized that the device would identify which errors in technique were the most common and that this would provide insight into how these errors might be eliminated.

Official Title
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Prospective Study of the Feedback From an Adherence Monitor on Asthma Control

Conditions
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Asthma

Intervention / Treatment
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* Behavioral: Active Feedback


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients prescribed therapy equivalent to step 3 or higher on the Asthma Management Guidelines for at least 3 months At least one exacerbation in the previous year with systemic glucocorticoids Uncontrolled/Partially Controlled Asthma by GINA guidelines Exclusion Criteria: Allergy to salmeterol/fluticasone Patients Controlled by GINA guidelines

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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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Feedback<br>In this arm patients will receive monthly review and education on inhaler technique and use based on a computer download of their last month of inhaler use | Behavioral: Active Feedback<br>* The inhaler will be fitted with a device that makes an audio recording of the inhaler use. This audio data will be downloaded to a computer program, analyzed for assessment of whether the steps involved in using the inhaler have been performed correctly. This information will be discussed with the patient.<br>* Other names: Feedback from a computer log of inhaler use;|
| Placebo Comparator: Control<br>In this arm patients will be reviewed monthly, however will not have information from INCA device to tailor inhaler education. | Behavioral: Active Feedback<br>* The inhaler will be fitted with a device that makes an audio recording of the inhaler use. This audio data will be downloaded to a computer program, analyzed for assessment of whether the steps involved in using the inhaler have been performed correctly. This information will be discussed with the patient.<br>* Other names: Feedback from a computer log of inhaler use;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence rate | The rate of actual adherence at baseline and at the end of the study, which at the end of the 3 month of study will be assessed. The actual inhaler adherence, expressed as cumulative drug exposure, is calculated by combining the time of use along with the interval between doses (correct time is twice a day, in a period not less than 6 hours between the last dose and the subsequent dose or at a time greater than 18 hours apart from the previous dose.) and incorporating, by audio analysis, if the inhaler was used correctly. | at three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma quality of life score | The asthma quality of life score will be related to adherence, The baseline asthma quality of life score and the quality of life score at the end of three months will be subtracted and these will be correlated with the average rate of adherence over the three months. | at 3 months | 
| Peak Expiratory Flow Rate | The peak expiratory flow rate will be related to adherence, The baseline peak expiratory flow rate and the peak expiratory flow rate at the end of three months will be subtracted and these will be correlated with the average rate of adherence over the three months. | at 3 months | 
| Asthma Control Test | The asthma control test score will be related to adherence, The baseline asthma control test score and the score at the end of three months will be subtracted and these will be correlated with the average rate of adherence over the three months. | at 3 months | 
| Asthma Exacerbations | The frequency in exacerbations over the three months will be compared between the active and control arms. | over 3 months | 
| Asthma Reliever Medication Use | The change in frequency of reliever use per month from baseline to the end of the study will be compared between active and control patients. | over 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Inhaler use