STudy of Asthma Adherence Reminders

Study Overview
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Brief Summary
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To determine whether electronic adherence monitoring with feedback and reminder alarms can improve adherence and health outcomes in childhood asthma.

Detailed Description
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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.

Official Title
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Can Electronic Adherence Monitors With Feedback and Daily Reminders Improve Adherence and Health Outcomes in Children With Asthma?

Conditions
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Childhood Asthma

Intervention / Treatment
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* Device: Activated Smartinhaler or Smartturbo
* Other: Feedback of adherence data
* Device: Deactivated Smartinhaler or Smartturbo


Participation Criteria
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Eligibility Criteria
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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 1.5. 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 < 1.5. Another chronic health condition (eg diabetes, congenital heart disease, cystic fibrosis). Can't speak or understand English.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Feedback and alarms<br>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. | Device: Activated Smartinhaler or Smartturbo<br>* Medication reminder alarms<br>* Other names: Electronic adherence monitor;Other: Feedback of adherence data<br>* Review of adherence data with action planning<br>|
| Active Comparator: No feedback or alarms<br>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. | Device: Deactivated Smartinhaler or Smartturbo<br>* Alarms deactivated and no feedback<br>* Other names: Electronic adherence monitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma-related quality of life, as measured by the Mini Paediatric Asthma Quality of Life Questionnaire (Mini PAQLQ) | Mean score of 0-7, lower score indicating poorer asthma - related quality of life. | Recorded at baseline, 3, 6, 9 and 12 months. | 
| Parents' illness perceptions as measured by the brief illness perception questionnaire. | As measured by the brief illness perception questionnaire. A higher score indicates a more threatening view of the illness. | Recorded at baseline | 
| Unplanned GP/ ED attendances for asthma | Number of unplanned visits to GP or A&E for asthma in the previous 3 months. | Recorded at baseline, 3, 6, 9 and 12 months. | 
| Rescue beta-agonist use | Question score on the ACQ regarding recent beta agonist use. | Recorded at baseline, 3, 6, 9 and 12 months. | 
| Adherence to ICS treatment | Electronic adherence rate as measured by the smartinhaler or smartturbo. Adherence rate calculated as percentage of prescribed doses actually taken. Adherence rate capped at 100% for any single day. | 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 | Dose of ICS | Recorded at baseline, 3, 6, 9 and 12 months. | 
| Forced Expiratory Volume in 1 second (FEV1) - % predicted | % predicted value compared with Global Lung Initiative 2012 reference values. | Recorded at baseline, 3, 6, 9 and 12 months. | 
| Medication beliefs | As measured by the beliefs about medicines questionnaire. A higher score indicates multiple concerns and doubts about inhaled steroids. | Recorded at baseline | 
| Rescue doses of oral steroids | Number of rescue doses of oral steroids required in the previous 3 months. | Recorded at baseline, 3, 6, 9 and 12 months. |