Can Electronic Adherence Monitors With Feedback and Daily Reminders Improve Adherence and Health Outcomes in Children With Asthma?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Change in asthma control from baseline at 9 months
Study Overview
Brief Summary
To determine whether electronic adherence monitoring with feedback and reminder alarms can improve adherence and health outcomes in childhood asthma.
Detailed Description
This study will investigate whether adding an electronic adherence monitor to inhaled steroids, and feeding this information back to patients and families can improve adherence and outcomes in childhood asthma. The devices will also sound twice daily reminder alarms to act as direct medication prompts. This intervention will be compared to a control group in which adherence is monitored, but with no feedback or alarms.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •1 month, no change in add on therapy in the last month).
- •ACQ (Asthma Control Questionnaire) score more than or equal to 1.
- •Can speak and understand English.
Exclusion Criteria
- •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.
- •Another chronic health condition (eg diabetes, congenital heart disease, cystic fibrosis).
- •Can't speak or understand English.
Arms & Interventions
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.
Intervention: Activated Smartinhaler or Smartturbo (Device)
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.
Intervention: Feedback of adherence data (Other)
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.
Intervention: Deactivated Smartinhaler or Smartturbo (Device)
Outcomes
Primary Outcomes
Change in asthma control from baseline at 9 months
Time Frame: 9 months
Recorded as an Asthma Control Questionnaire (ACQ) score.Mean score of 0 -7, lower score indicating better asthma control.
Change in asthma control from baseline at 3 months
Time Frame: 3 months
Recorded as an Asthma Control Questionnaire (ACQ) score.Mean score of 0 -7, lower score indicating better asthma control.
Change in asthma control from baseline at 6 months
Time Frame: 6 months
Recorded as an Asthma Control Questionnaire (ACQ) score.Mean score of 0 -7, lower score indicating better asthma control.
Change in asthma control from baseline at 12 months
Time Frame: 12 months
Recorded as an Asthma Control Questionnaire (ACQ) score.Mean score of 0 -7, lower score indicating better asthma control.
Secondary Outcomes
- Medication beliefs(Recorded at baseline)
- Rescue beta-agonist use(Recorded at baseline, 3, 6, 9 and 12 months.)
- Forced Expiratory Volume in 1 second (FEV1) - % predicted(Recorded at baseline, 3, 6, 9 and 12 months.)
- Unplanned GP/ ED attendances for asthma(Recorded at baseline, 3, 6, 9 and 12 months.)
- Adherence to ICS treatment(Recorded at baseline, 3, 6, 9 and 12 months.)
- Level of maintenance asthma therapy. Treatment level (modified BTS step) at 12 months and individual change in modified BTS step between baseline and 12 months(Recorded at baseline, 3, 6, 9 and 12 months.)
- Rescue doses of oral steroids(Recorded at baseline, 3, 6, 9 and 12 months.)
- 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)