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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COMPLETED
NA
90 participants
INTERVENTIONAL
2013-10-31
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Feedback and alarms
Standard education about importance of inhaled steroids and regular adherence to inhaled steroids after recruitment to study.
Randomized to receive an electronic adherence device ( activated smartinhaler or smartturbo - Nexus 6) with twice daily alarm reminders activated. Patient decides times, different times on weekdays and weekends if required. This device fitted to their regular preventer inhaler, patient aware of its presence and its purpose in the context of the study.
Reviewed in standard asthma clinic every 3 months for 12 months. At each clinic visit, adherence information downloaded from device and data shared with patient and family (feedback of adherence data). Discussion about adherence rates, and action planning for the next 3 months to improve adherence if necessary.
Activated Smartinhaler or Smartturbo
Medication reminder alarms
Feedback of adherence data
Review of adherence data with action planning
No feedback or alarms
Standard education about importance of inhaled steroids and regular adherence to inhaled steroids after recruitment to study.
Randomized to receive an electronic adherence device. Deactivated Smartinhaler or Smartturbo.
Device not activated to play reminder alarms. This device fitted to their regular preventer inhaler, patient aware of its presence and its purpose in the context of the study.
Reviewed in standard asthma clinic every 3 months for 12 months. At each clinic visit, adherence information downloaded from device but data not shared with patient, and no adherence discussion.
Deactivated Smartinhaler or Smartturbo
Alarms deactivated and no feedback
Interventions
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Activated Smartinhaler or Smartturbo
Medication reminder alarms
Feedback of adherence data
Review of adherence data with action planning
Deactivated Smartinhaler or Smartturbo
Alarms deactivated and no feedback
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* On at least BTS stage 2, which means they will be on regular inhaled steroids.
* No change in regular asthma treatment in the last 1 month (on regular inhaled steroids, no change in steroid dose for
1 month, no change in add on therapy in the last month).
* ACQ (Asthma Control Questionnaire) score more than or equal to 1.5.
* Can speak and understand English.
Exclusion Criteria
* Recent changes to asthma treatment within the last month. (see above)
* ACQ (Asthma Control Questionnaire) score \< 1.5.
* Another chronic health condition (eg diabetes, congenital heart disease, cystic fibrosis).
* Can't speak or understand English.
6 Years
16 Years
ALL
No
Sponsors
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Sheffield Children's NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Robert Morton
Role: PRINCIPAL_INVESTIGATOR
Investigator
Locations
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Sheffield Children's NHS Foundation Trust
Sheffield, Sheffield (South Yorkshire District), United Kingdom
Countries
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References
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Morton RW, Elphick HE, Rigby AS, Daw WJ, King DA, Smith LJ, Everard ML. STAAR: a randomised controlled trial of electronic adherence monitoring with reminder alarms and feedback to improve clinical outcomes for children with asthma. Thorax. 2017 Apr;72(4):347-354. doi: 10.1136/thoraxjnl-2015-208171. Epub 2016 Nov 4.
Other Identifiers
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SCH/13/041
Identifier Type: -
Identifier Source: org_study_id