STudy of Asthma Adherence Reminders
STAAR
Can Electronic Adherence Monitors With Feedback and Daily Reminders Improve Adherence and Health Outcomes in Children With Asthma?
1 other identifier
interventional
90
1 country
1
Brief Summary
To determine whether electronic adherence monitoring with feedback and reminder alarms can improve adherence and health outcomes in childhood asthma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 5, 2015
CompletedFirst Posted
Study publicly available on registry
May 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedNovember 23, 2015
May 1, 2015
1.9 years
May 5, 2015
November 20, 2015
Conditions
Outcome Measures
Primary Outcomes (4)
Change in asthma control from baseline at 3 months
Recorded as an Asthma Control Questionnaire (ACQ) score.Mean score of 0 -7, lower score indicating better asthma control.
3 months
Change in asthma control from baseline at 6 months
Recorded as an Asthma Control Questionnaire (ACQ) score.Mean score of 0 -7, lower score indicating better asthma control.
6 months
Change in asthma control from baseline at 9 months
Recorded as an Asthma Control Questionnaire (ACQ) score.Mean score of 0 -7, lower score indicating better asthma control.
9 months
Change in asthma control from baseline at 12 months
Recorded as an Asthma Control Questionnaire (ACQ) score.Mean score of 0 -7, lower score indicating better asthma control.
12 months
Secondary Outcomes (9)
Asthma-related quality of life, as measured by the "Mini Paediatric Asthma Quality of Life Questionnaire" (Mini PAQLQ)
Recorded at baseline, 3, 6, 9 and 12 months.
Parents' illness perceptions as measured by the "brief illness perception questionnaire.
Recorded at baseline
Unplanned GP/ ED attendances for asthma
Recorded at baseline, 3, 6, 9 and 12 months.
Rescue beta-agonist use
Recorded at baseline, 3, 6, 9 and 12 months.
Adherence to ICS treatment
Recorded at baseline, 3, 6, 9 and 12 months.
- +4 more secondary outcomes
Study Arms (2)
Feedback and alarms
EXPERIMENTALStandard 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.
No feedback or alarms
ACTIVE COMPARATORStandard 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.
Interventions
Medication reminder alarms
Alarms deactivated and no feedback
Eligibility Criteria
You may qualify if:
- Doctor diagnosed asthma.
- 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
- 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.
You may not qualify if:
- BTS stage 5 asthma (complex issues, too unstable).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sheffield Children's NHS Foundation Trust
Sheffield, Sheffield (South Yorkshire District), S10 2TH, United Kingdom
Related Publications (1)
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.
PMID: 27815524DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Morton
Investigator
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2015
First Posted
May 22, 2015
Study Start
October 1, 2013
Primary Completion
September 1, 2015
Study Completion
November 1, 2015
Last Updated
November 23, 2015
Record last verified: 2015-05