Teaching Inhaler Use With the INCA Device in a Community Pharmacy Setting

Study Overview
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Brief Summary
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The purpose of this trial is to discover whether providing feedback to patients from a device that records when and how well a patient uses a Seretide Diskus inhaler will lead to: Improved compliance with prescribed inhaler use Improved technique of inhaler use A reduction in respiratory health related outcomes caused by poor inhaler compliance and usage. An improvement in patient quality of life scores

Official Title
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A Randomised, Parallel-group, Multi-centre Trial Using a Novel INCA Tracker Device to Measure and Monitor Compliance and Technique of Seretide Diskus Inhaler in a Community Pharmacy Setting

Conditions
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Asthma, Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Device: Feedback
* Behavioral: Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be 18 years old or above Capable of understanding and willing to provide voluntary informed consent before any protocol specific procedures are performed Capable of understanding and complying with the requirements of the protocol, and demonstrating a willingness to attend for all required visits. Able and willing to take inhaled medication. Have a valid prescription for use of a Seretide diskus inhaler or already using a Seretide diskus inhaler. Have a history of regular attendance in the pharmacy in which they are recruited which will be demonstrated by the subject having collected three prescriptions for any medication in that pharmacy in the six months preceeding their recruitment to the study. Exclusion Criteria: Patient expressly reports that their physician has indicated that they will not be continuing to receive Seretide over the next 6 months

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Feedback<br>Feedback on the patient's own inhaler use, with personalized information on the patients technique and timing of use of the diskus inhaler as recorded on the INCA device will be provided to patients in the feedback group after 1,2 and 6 months. | Device: Feedback<br>* Feedback on the patient's own inhaler use, with personalized information on the patients technique and timing of use of the diskus inhaler as recorded on the INCA device will be provided to patients in the feedback group after 1,2 and 6 months.<br>* Other names: INCA Device;|
| Active Comparator: Demonstration<br>Current best practice - inhaler technique education | Behavioral: Education<br>* Feedback on the patient's own inhaler technique as observed by pharmacist and education to support best use will be provided to patients in the demonstration group after 1,2 and 6 months.<br>|
| No Intervention: Control<br>Usual care in the community pharmacy setting | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adherence | The rate of adherence is the proportion of correctly taken drugs at the correct time relative to the prescribed interval. | 2 months and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rescue inhaled medication use |  | Six months | 
| Rescue antibiotic and/or steroid medication use |  | 6 months | 
| Quality of life |  | 2 months and 6 months | 
| Adherence in the time domain |  | Two months and six months | 
| Technique adherence |  | Two months and six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medication Adherence, Patient Compliance