STudy of Asthma Adherence Reminders

Sheffield Children's NHS Foundation Trust90 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Childhood Asthma

Interventions

Activated Smartinhaler or SmartturboDEVICE

Medication reminder alarms

Feedback of adherence dataOTHER

Review of adherence data with action planning

Deactivated Smartinhaler or SmartturboDEVICE

Alarms deactivated and no feedback

Eligibility

Sex: ALLMin age: 6 YearsMax age: 16 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sheffield Children's NHS Foundation Trust

Sheffield, Sheffield (South Yorkshire District), United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 12 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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