Childhood Asthma
Conditions
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.
Interventions
DEVICEActivated Smartinhaler or Smartturbo
Medication reminder alarms
OTHERFeedback of adherence data
Review of adherence data with action planning
DEVICEDeactivated Smartinhaler or Smartturbo
Alarms deactivated and no feedback
Sponsors
Sheffield Children's NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 16 Years
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 1.5. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in asthma control from baseline at 3 months | 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 | 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 9 months | 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 12 months | 12 months | Recorded as an Asthma Control Questionnaire (ACQ) score.Mean score of 0 -7, lower score indicating better asthma control. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to ICS treatment | Recorded at baseline, 3, 6, 9 and 12 months. | 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. |
| 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. | Dose of ICS |
| 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. | Mean score of 0-7, lower score indicating poorer asthma - related quality of life. |
| Medication beliefs | Recorded at baseline | As measured by the beliefs about medicines questionnaire. A higher score indicates multiple concerns and doubts about inhaled steroids. |
| Rescue doses of oral steroids | Recorded at baseline, 3, 6, 9 and 12 months. | Number of rescue doses of oral steroids required in the previous 3 months. |
| Forced Expiratory Volume in 1 second (FEV1) - % predicted | Recorded at baseline, 3, 6, 9 and 12 months. | % predicted value compared with Global Lung Initiative 2012 reference values. |
| Parents' illness perceptions as measured by the brief illness perception questionnaire. | Recorded at baseline | As measured by the brief illness perception questionnaire. A higher score indicates a more threatening view of the illness. |
| Unplanned GP/ ED attendances for asthma | Recorded at baseline, 3, 6, 9 and 12 months. | Number of unplanned visits to GP or A&E for asthma in the previous 3 months. |
| Rescue beta-agonist use | Recorded at baseline, 3, 6, 9 and 12 months. | Question score on the ACQ regarding recent beta agonist use. |
Countries
United Kingdom
Outcome results
None listed