Improving Asthma Treatment Using Inhaler Technology
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|ClinicalTrials.gov Identifier: NCT02977078|
Recruitment Status : Recruiting
First Posted : November 30, 2016
Last Update Posted : December 7, 2016
This study will use inhaler technology to observe and feedback overall patterns of medication use. We will look at whether this improves preventer inhaler use and reduces reliever inhaler overuse.
We will also assess whether inhaler technology is patient-friendly and cost effective, whether it helps with treatment decisions in asthma and whether it can help us to predict and prevent asthma attacks.
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Behavioral: Active feedback on monitored inhaler use Device: Inhaler casing Device: Mobile application||Not Applicable|
The SmartTouch™ range of electronic casings will record the use of metered dose inhalers (MDI) by participants in the study. The actuation data can be remotely viewed and analyzed by the investigators.
The hypothesis is that employing such technology to measure medication patterns and to help provide patient feedback improves inhaler adherence and potentially clinical outcomes (asthma control and exacerbations) in asthma patients with recent asthma attacks in a practical, real-world setting.
We will assess whether electronic inhaler data capture can identify patients requiring more frequent reviews or treatment change and enable proactive self- management.
Using qualitative methods, we will explore participants' attitudes to their asthma management, whether the use of inhaler technology has had an impact on this and whether they found its use acceptable.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||Improving Asthma Treatment Using Inhaler Technology|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||April 2018|
Sham Comparator: Control
Inhaler use monitored by device but no feedback to participants (control); this group is unaware of the second arm receiving feedback on inhaler use.
Device: Inhaler casing
Monitors inhaler use
Inhaler use monitored with feedback to participants (active); participants randomized to this group sign an additional consent to receive feedback on inhaler use
Behavioral: Active feedback on monitored inhaler use
Feedback given on inhaler use by research nurse/ doctor based on mobile application feedbackDevice: Inhaler casing
Monitors inhaler useDevice: Mobile application
Mobile application software linked to inhaler casing
- Impact on adherence to preventative medication use based on the mean percentage of prescribed doses taken daily over the study period [ Time Frame: Upto 24 weeks (study duration) ]Co-primary endpoint
- Impact on adherence to reliever medication use based on the number of days with >16 actuations/day of Salbutamol taken in a 24-hour period [ Time Frame: Upto 24 weeks (study duration) ]Co-primary endpoint
- Patient acceptability via qualitative feedback with questionnaires [ Time Frame: Upto 24 weeks (study duration) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02977078
|Contact: Dominick Shaw||Dominic.Shaw@nottingham.ac.uk|
|Contact: Maria Koufaliemail@example.com|
|Nottingham University Hospitals NHS Trust, Queens Medical Centre Campus||Recruiting|
|Nottingham, Nottinghamshire, United Kingdom, NG7 2UH|
|Contact: Ireti Adejumo|
|Principal Investigator:||Dominick Shaw||University of Nottingham|