Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2016-12-31
2018-04-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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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.
Inhaler casing
Monitors inhaler use
Active
Inhaler use monitored with feedback to participants (active); participants randomized to this group sign an additional consent to receive feedback on inhaler use
Active feedback on monitored inhaler use
Feedback given on inhaler use by research nurse/ doctor based on mobile application feedback
Inhaler casing
Monitors inhaler use
Mobile application
Mobile application software linked to inhaler casing
Interventions
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Active feedback on monitored inhaler use
Feedback given on inhaler use by research nurse/ doctor based on mobile application feedback
Inhaler casing
Monitors inhaler use
Mobile application
Mobile application software linked to inhaler casing
Eligibility Criteria
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Inclusion Criteria
* Doctor's diagnosis of asthma for at least 12 months
* On BTS step 2-5 treatment via MDI \[monitoring devices to be utilised in the study are compatible with MDI inhalers\]
* Use of own internet-enabled and compatible mobile phone
Exclusion Criteria
* Other clinically significant coexisting respiratory disease e.g. fibrosis, bronchiectasis
* Patients on maintenance and reliever therapy ('SMART' or 'Fostair® MART')
18 Years
65 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Nottingham University Hospitals NHS Trust
OTHER
Responsible Party
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Principal Investigators
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Dominick Shaw
Role: PRINCIPAL_INVESTIGATOR
University of Nottingham
Locations
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Nottingham University Hospitals NHS Trust, Queens Medical Centre Campus
Nottingham, Nottinghamshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Ireti Adejumo
Role: primary
References
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Adejumo I, Patel M, McKeever TM, Shaw DE. Does inhaler technology improve adherence and asthma control? A pilot randomized controlled trial. Ann Allergy Asthma Immunol. 2022 Jun;128(6):727-729. doi: 10.1016/j.anai.2022.02.023. Epub 2022 Mar 4. No abstract available.
Other Identifiers
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193750
Identifier Type: OTHER
Identifier Source: secondary_id
14RM008
Identifier Type: -
Identifier Source: org_study_id